Trial Outcomes & Findings for A Trial to Evaluate the Safety and Systems Biology Response of Ebolavirus Zaire Vaccine (ChAd3-EBO-Z) (NCT NCT03583606)
NCT ID: NCT03583606
Last Updated: 2025-07-29
Results Overview
Laboratory parameters include white blood cells (WBC), hemoglobin, platelet count, absolute neutrophil count, alanine aminotransferase (ALT), creatinine, sodium, potassium and blood urea nitrogen (BUN). Thresholds for adverse events were considered as WBC \<= 4.4 K/mcL or \>=13.1 K/mcL (18 to \<21 years) or \<= 4.4 K/mcL or \>= 11.1 K/mcL (\>=21 years), hemoglobin \<= 11.6 g/dL (female) or \<= 13.2 g/dL (male), platelet count \<= 134 K/mcL or \>= 467 K/mcL, absolute neutrophil count \<1.8 K/mcL or \<=0.7 K/mcL (benign ethnic neutropenia), ALT \>= 50 unit/L, creatinine \>= 0.81 mg/dL (female) or \>= 1.11 mg/dL (male), sodium \<= 135 mmol/L or \>= 146 mmol/L, potassium \<= 3.4 mmol/L or \>= 5.2 mmol/L and BUN \>= 24 mg/dL. If baseline clinical labs fell within Mild range, then a laboratory AE was reported only if the value changed such that it fell into Moderate range or higher when subsequent safety laboratory testing was done.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
61 participants
Primary outcome timeframe
Day 1 to approximately 28 Days Post Second Vaccination
Results posted on
2025-07-29
Participant Flow
Participants were males and non-pregnant females in good health, aged 19 to 45, and recruited from the community at large at the participating site. Participants were enrolled between 12NOV2018 to 10JUL2019.
Participant milestones
| Measure |
ChAd3-EBO-Z + Placebo
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8 (+2). All participants in all Study Arms received the same product (ChAd3-EBO-Z) at Day 1.
ChAd3-EBO-Z: Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10\^11 virus particles (vp)).
Placebo: 0.5 mL normal saline administered via IM injection into the deltoid.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8 (+2). All participants in all Study Arms received the same product (ChAd3-EBO-Z) at Day 1.
ChAd3-EBO-Z: Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10\^11 virus particles (vp)).
|
ChAd3-EBO-Z + MVA- BN-Filo
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8 (+2). All participants in all Study Arms received the same product (ChAd3-EBO-Z) at Day 1.
ChAd3-EBO-Z: Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10\^11 virus particles (vp)).
MVA Multi-Filo Ebola Vaccine: A booster vaccination of replication defective MVA-BN-Filo administered by an IM injection into the deltoid as a single dose of 1 x 10\^8 Infectious Units (IU).
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
20
|
19
|
|
Overall Study
COMPLETED
|
21
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
ChAd3-EBO-Z + Placebo
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8 (+2). All participants in all Study Arms received the same product (ChAd3-EBO-Z) at Day 1.
ChAd3-EBO-Z: Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10\^11 virus particles (vp)).
Placebo: 0.5 mL normal saline administered via IM injection into the deltoid.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8 (+2). All participants in all Study Arms received the same product (ChAd3-EBO-Z) at Day 1.
ChAd3-EBO-Z: Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10\^11 virus particles (vp)).
|
ChAd3-EBO-Z + MVA- BN-Filo
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8 (+2). All participants in all Study Arms received the same product (ChAd3-EBO-Z) at Day 1.
ChAd3-EBO-Z: Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10\^11 virus particles (vp)).
MVA Multi-Filo Ebola Vaccine: A booster vaccination of replication defective MVA-BN-Filo administered by an IM injection into the deltoid as a single dose of 1 x 10\^8 Infectious Units (IU).
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Ineligible at baseline
|
1
|
0
|
0
|
Baseline Characteristics
A Trial to Evaluate the Safety and Systems Biology Response of Ebolavirus Zaire Vaccine (ChAd3-EBO-Z)
Baseline characteristics by cohort
| Measure |
ChAd3-EBO-Z + Placebo
n=22 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
ChAd3-EBO-Z: Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10\^11 virus particles (vp)).
Placebo: 0.5 mL normal saline administered via IM injection into the deltoid.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
ChAd3-EBO-Z: Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10\^11 virus particles (vp)).
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
ChAd3-EBO-Z: Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10\^11 virus particles (vp)).
MVA Multi-Filo Ebola Vaccine: A booster vaccination of replication defective MVA-BN-Filo administered by an IM injection into the deltoid as a single dose of 1 x 10\^8 Infectious Units (IU).
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
33.8 Years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
26.8 Years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
31.4 Years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
30.8 Years
STANDARD_DEVIATION 7.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
20 participants
n=7 Participants
|
19 participants
n=5 Participants
|
61 participants
n=4 Participants
|
|
BMI
|
26.35 kg/m^2
STANDARD_DEVIATION 3.96 • n=5 Participants
|
25.19 kg/m^2
STANDARD_DEVIATION 3.77 • n=7 Participants
|
25.49 kg/m^2
STANDARD_DEVIATION 4.06 • n=5 Participants
|
25.70 kg/m^2
STANDARD_DEVIATION 3.90 • n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 to approximately 28 Days Post Second VaccinationPopulation: Safety Population: includes all participants who received at least one study vaccination.
Laboratory parameters include white blood cells (WBC), hemoglobin, platelet count, absolute neutrophil count, alanine aminotransferase (ALT), creatinine, sodium, potassium and blood urea nitrogen (BUN). Thresholds for adverse events were considered as WBC \<= 4.4 K/mcL or \>=13.1 K/mcL (18 to \<21 years) or \<= 4.4 K/mcL or \>= 11.1 K/mcL (\>=21 years), hemoglobin \<= 11.6 g/dL (female) or \<= 13.2 g/dL (male), platelet count \<= 134 K/mcL or \>= 467 K/mcL, absolute neutrophil count \<1.8 K/mcL or \<=0.7 K/mcL (benign ethnic neutropenia), ALT \>= 50 unit/L, creatinine \>= 0.81 mg/dL (female) or \>= 1.11 mg/dL (male), sodium \<= 135 mmol/L or \>= 146 mmol/L, potassium \<= 3.4 mmol/L or \>= 5.2 mmol/L and BUN \>= 24 mg/dL. If baseline clinical labs fell within Mild range, then a laboratory AE was reported only if the value changed such that it fell into Moderate range or higher when subsequent safety laboratory testing was done.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants With Clinical Safety Laboratory Adverse Events
WBC
|
2 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Clinical Safety Laboratory Adverse Events
Hemoglobin
|
2 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With Clinical Safety Laboratory Adverse Events
Platelet count
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinical Safety Laboratory Adverse Events
Absolute neutrophil count
|
1 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Clinical Safety Laboratory Adverse Events
ALT
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Clinical Safety Laboratory Adverse Events
Creatinine
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Clinical Safety Laboratory Adverse Events
Sodium
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Safety Laboratory Adverse Events
Potassium
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Safety Laboratory Adverse Events
BUN
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 182Population: Safety Population: includes all participants who received at least one study vaccination
SAEs included any AE that resulted in death, a life-threatening event, an inpatient hospitalization or prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 8 Post First VaccinationPopulation: Safety Population: includes all participants who received at least one study vaccination. All participants in all Study Arms received the same product (ChAd3-EBO-Z) at Day 1.
Local reactogenicity solicited on a memory aid provided to participants included pain, tenderness, erythema (redness) (functional grade based on interference with daily activities), induration (hardness/swelling) (functional grade), ecchymosis (bruising) (functional grade), pruritus (itching), erythema (redness) (any measured value), induration (hardness/swelling) (any measured value), ecchymosis (bruising) (any measured value). Participants are considered reporting the local reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants Reporting Solicited Local Reactogenicity
Any Local Symptom
|
20 Participants
|
20 Participants
|
18 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Pain
|
13 Participants
|
17 Participants
|
14 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Tenderness
|
17 Participants
|
19 Participants
|
15 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Pruritus
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Ecchymosis (Functional Grade)
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Ecchymosis (Measurement Grade)
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Erythema (Functional Grade)
|
7 Participants
|
11 Participants
|
11 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Erythema (Measurement Grade)
|
7 Participants
|
11 Participants
|
11 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Induration (Functional Grade)
|
6 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Induration (Measurement Grade)
|
6 Participants
|
7 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 8 Post Second VaccinationPopulation: Safety Population Subset: includes all participants who received the first and second study vaccination
Local reactogenicity solicited on a memory aid provided to participants included pain, tenderness, erythema (redness) (functional grade based on interference with daily activities), induration (hardness/swelling) (functional grade), ecchymosis (bruising) (functional grade), pruritus (itching), erythema (redness) (any measured value), induration (hardness/swelling) (any measured value), ecchymosis (bruising) (any measured value). Participants are considered reporting the local reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=17 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=17 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=18 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants Reporting Solicited Local Reactogenicity
Any Local Symptom
|
6 Participants
|
17 Participants
|
13 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Pain
|
1 Participants
|
13 Participants
|
5 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Tenderness
|
3 Participants
|
15 Participants
|
12 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Pruritus
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Ecchymosis (Functional Grade)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Ecchymosis (Measurement Grade)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Erythema (Functional Grade)
|
5 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Erythema (Measurement Grade)
|
5 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Induration (Functional Grade)
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Induration (Measurement Grade)
|
0 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 15Population: Safety Population: includes all participants who received at least one study vaccination.
Local reactogenicity solicited on a memory aid provided to participants included pain, tenderness, erythema (redness) (functional grade based on interference with daily activities), induration (hardness/swelling) (functional grade), ecchymosis (bruising) (functional grade), pruritus (itching), erythema (redness) (any measured value), induration (hardness/swelling) (any measured value), ecchymosis (bruising) (any measured value). Subjects are considered reporting the local reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants Reporting Solicited Local Reactogenicity
Any Local Symptom
|
20 Participants
|
20 Participants
|
18 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Pain
|
13 Participants
|
18 Participants
|
14 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Tenderness
|
17 Participants
|
19 Participants
|
15 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Pruritus
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Ecchymosis (functional grade)
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Ecchymosis (measurement grade)
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Erythema (functional grade)
|
10 Participants
|
11 Participants
|
12 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Erythema (measurement grade)
|
10 Participants
|
11 Participants
|
12 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Induration (functional grade)
|
6 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants Reporting Solicited Local Reactogenicity
Induration (measurement grade)
|
6 Participants
|
8 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 8 Post First VaccinationPopulation: Safety Population: includes all participants who received at least one study vaccination. All participants in all Study Arms received the same product (ChAd3-EBO-Z) at Day 1.
Systemic reactogenicity solicited on a memory aid provided to participants included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Participants are considered reporting the systemic reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Any Systemic Symptom
|
20 Participants
|
20 Participants
|
15 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Elevated Oral Temperature
|
11 Participants
|
9 Participants
|
9 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Feverishness
|
15 Participants
|
14 Participants
|
13 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Malaise
|
13 Participants
|
17 Participants
|
13 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Fatigue
|
17 Participants
|
15 Participants
|
13 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Myalgia
|
17 Participants
|
17 Participants
|
12 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Headache
|
10 Participants
|
10 Participants
|
12 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Nausea
|
6 Participants
|
9 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Loss of Appetite
|
4 Participants
|
9 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 8 Post Second VaccinationPopulation: Safety Population Subset: includes all participants who received the first and second study vaccination
Systemic reactogenicity solicited on a memory aid provided to participants included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Participants are considered reporting the systemic reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=17 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=17 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=18 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Myalgia
|
3 Participants
|
11 Participants
|
4 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Headache
|
7 Participants
|
9 Participants
|
4 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Nausea
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Loss of Appetite
|
3 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Any Systemic Symptom
|
8 Participants
|
14 Participants
|
6 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Elevated Oral Temperature
|
0 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Feverishness
|
3 Participants
|
11 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Malaise
|
3 Participants
|
14 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Fatigue
|
7 Participants
|
14 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 15Population: Safety Population: includes all participants who received at least one study vaccination.
Systemic reactogenicity solicited on a memory aid provided to participants included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Participants are considered reporting the systemic reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Any Systemic Symptom
|
20 Participants
|
20 Participants
|
15 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Elevated Oral Temperature
|
11 Participants
|
12 Participants
|
9 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Feverishness
|
18 Participants
|
16 Participants
|
13 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Malaise
|
14 Participants
|
19 Participants
|
13 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Fatigue
|
18 Participants
|
19 Participants
|
13 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Myalgia
|
17 Participants
|
20 Participants
|
12 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Headache
|
13 Participants
|
13 Participants
|
12 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Nausea
|
7 Participants
|
10 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactogenicity
Loss of Appetite
|
6 Participants
|
12 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 182Population: Safety Population: includes all participants who received at least one study vaccination.
Vaccine-related MAAEs include any AEs for which the participant received medical attention, defined as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason for which there is evidence to suggest a causal relationship between the study product and the adverse event.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants Reporting Vaccine-related Medically Attended Adverse Events (MAAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to approximately 28 Days Post Second VaccinationPopulation: Safety Population: includes all participants who received at least one study vaccination
Vaccine-related unsolicited AEs include any untoward medical occurrence in a participant for which there is evidence to suggest a causal relationship between the study product and the adverse event.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs)
Blood pressure diastolic decreased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs)
Transaminases increased
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs)
Dehydration
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs)
Back pain
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs)
Muscle spasms
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs)
Dizziness
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs)
Sinus headache
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs)
Taste disorder
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs)
Cough
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs)
Oropharyngeal pain
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs)
Sinus congestion
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs)
Acne
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs)
Ecchymosis
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs)
Rash
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs)
Any SOC
|
4 Participants
|
10 Participants
|
4 Participants
|
|
Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs)
Lymphadenopathy
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs)
Tachycardia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs)
Diarrhea
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs)
Vomiting
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs)
Chest discomfort
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to approximately 28 Days Post Second VaccinationPopulation: Safety Population: includes all Participants who received at least one study vaccination
Thresholds for adverse events were considered as WBC 2.5 - 4.4 K/mcL or 13.1 - 15.0 K/mcL (18 to \<21 years) or 2.5 - 4.4 K/mcL or 11.1 - 15.0 (\>=21 years) (mild), 1.5 - 2.4 K/mcL or 15.1 - 20.0 K/mcL (moderate), \<1.5 K/mcL or \>20.0 K/mcL (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 8 (Second Vaccination) · None
|
19 Participants
|
18 Participants
|
17 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 8 (Second Vaccination) · Mild (low)
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 8 (Second Vaccination) · Mild (high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 8 (Second Vaccination) · Moderate (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 8 (Second Vaccination) · Moderate (high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 8 (Second Vaccination) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 8 (Second Vaccination) · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 8 Post-Second Vaccination · None
|
20 Participants
|
17 Participants
|
18 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 8 Post-Second Vaccination · Mild (low)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 8 Post-Second Vaccination · Mild (high)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 8 Post-Second Vaccination · Moderate (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 8 Post-Second Vaccination · Moderate (high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 8 Post-Second Vaccination · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 8 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 22 Post-Second Vaccination · None
|
20 Participants
|
16 Participants
|
17 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 22 Post-Second Vaccination · Mild (low)
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 22 Post-Second Vaccination · Mild (high)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 22 Post-Second Vaccination · Moderate (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 22 Post-Second Vaccination · Moderate (high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 22 Post-Second Vaccination · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 22 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 29 Post-Second Vaccination · None
|
19 Participants
|
17 Participants
|
19 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 29 Post-Second Vaccination · Mild (low)
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 29 Post-Second Vaccination · Mild (high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 29 Post-Second Vaccination · Moderate (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 29 Post-Second Vaccination · Moderate (high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 29 Post-Second Vaccination · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Day 29 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Max Severity Post Baseline · None
|
19 Participants
|
15 Participants
|
15 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Max Severity Post Baseline · Mild (low)
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Max Severity Post Baseline · Mild (high)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Max Severity Post Baseline · Moderate (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Max Severity Post Baseline · Moderate (high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Max Severity Post Baseline · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells
Max Severity Post Baseline · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to approximately 28 Days Post Second VaccinationPopulation: Safety Population: includes all participants who received at least one study vaccination
Thresholds for adverse events were considered as hemoglobin 10.1 - 11.6 g/dL (female) or 11.0 - 13.2 (male) (mild), 8.5 - 10 g/dL (female) or 9.5 - 10.9 g/dL (male) (moderate), \<8.5 g/dL (female) or \<9.5 g/dL (male) (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Day 8 (Second Vaccination) · None
|
19 Participants
|
20 Participants
|
18 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Day 8 (Second Vaccination) · Mild
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Day 8 (Second Vaccination) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Day 8 (Second Vaccination) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Day 8 (Second Vaccination) · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Day 8 Post-Second Vaccination · None
|
19 Participants
|
14 Participants
|
17 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Day 8 Post-Second Vaccination · Mild
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Day 8 Post-Second Vaccination · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Day 8 Post-Second Vaccination · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Day 8 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Day 22 Post-Second Vaccination · None
|
19 Participants
|
15 Participants
|
17 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Day 22 Post-Second Vaccination · Mild
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Day 22 Post-Second Vaccination · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Day 22 Post-Second Vaccination · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Day 22 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Day 29 Post-Second Vaccination · None
|
19 Participants
|
16 Participants
|
18 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Day 29 Post-Second Vaccination · Mild
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Day 29 Post-Second Vaccination · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Day 29 Post-Second Vaccination · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Day 29 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Max Severity Post Baseline · None
|
19 Participants
|
14 Participants
|
17 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Max Severity Post Baseline · Mild
|
1 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Max Severity Post Baseline · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Max Severity Post Baseline · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin
Max Severity Post Baseline · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to approximately 28 Days Post Second VaccinationPopulation: Safety Population: includes all participants who received at least one study vaccination
Thresholds for adverse events were considered as platelet count 125 - 134 K/mcL or 467 - 517 K/mcL (mild), 100 - 124 K/mcL or 518 - 750 K/mcL (moderate), \<100 K/mcL or \>750 K/mcL (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 8 (Second Vaccination) · None
|
21 Participants
|
20 Participants
|
19 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 8 (Second Vaccination) · Mild (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 8 (Second Vaccination) · Mild (high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 8 (Second Vaccination) · Moderate (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 8 (Second Vaccination) · Severe (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 8 (Second Vaccination) · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 8 Post-Second Vaccination · None
|
21 Participants
|
19 Participants
|
18 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 8 Post-Second Vaccination · Mild (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 8 Post-Second Vaccination · Mild (high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 8 Post-Second Vaccination · Moderate (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 8 Post-Second Vaccination · Severe (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 8 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 22 Post-Second Vaccination · None
|
21 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 22 Post-Second Vaccination · Mild (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 22 Post-Second Vaccination · Mild (high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 22 Post-Second Vaccination · Moderate (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 22 Post-Second Vaccination · Severe (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 22 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 29 Post-Second Vaccination · None
|
21 Participants
|
18 Participants
|
19 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 29 Post-Second Vaccination · Mild (low)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 29 Post-Second Vaccination · Mild (high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 29 Post-Second Vaccination · Moderate (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 29 Post-Second Vaccination · Severe (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Day 29 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Max Severity Post Baseline · None
|
20 Participants
|
19 Participants
|
18 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Max Severity Post Baseline · Mild (low)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Max Severity Post Baseline · Mild (high)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Max Severity Post Baseline · Moderate (low)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Max Severity Post Baseline · Severe (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count
Max Severity Post Baseline · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to approximately 28 Days Post Second VaccinationPopulation: Safety Population: includes all participants who received at least one study vaccination
Thresholds for adverse events were considered as absolute neutrophil count 1.5 - \<1.8 K/mcL or 0.6 - 0.7 K/mcL (benign ethnic neutropenia) (mild), 1.0 - \<1.5 K/mcL or 0.4 - 0.5 K/mcL (benign ethnic neutropenia) (moderate), \<1.0 K/mcL or \<0.4 K/mcL (benign ethnic neutropenia) (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Day 8 (Second Vaccination) · None
|
19 Participants
|
17 Participants
|
17 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Day 8 (Second Vaccination) · Mild
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Day 8 (Second Vaccination) · Moderate
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Day 8 (Second Vaccination) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Day 8 (Second Vaccination) · Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Day 8 Post-Second Vaccination · None
|
21 Participants
|
19 Participants
|
17 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Day 8 Post-Second Vaccination · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Day 8 Post-Second Vaccination · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Day 8 Post-Second Vaccination · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Day 8 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Day 22 Post-Second Vaccination · None
|
21 Participants
|
17 Participants
|
18 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Day 22 Post-Second Vaccination · Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Day 22 Post-Second Vaccination · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Day 22 Post-Second Vaccination · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Day 22 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Day 29 Post-Second Vaccination · None
|
21 Participants
|
17 Participants
|
18 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Day 29 Post-Second Vaccination · Mild
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Day 29 Post-Second Vaccination · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Day 29 Post-Second Vaccination · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Day 29 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Max Severity Post Baseline · None
|
20 Participants
|
15 Participants
|
16 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Max Severity Post Baseline · Mild
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Max Severity Post Baseline · Moderate
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Max Severity Post Baseline · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count
Max Severity Post Baseline · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to approximately 28 Days Post Second VaccinationPopulation: Safety Population: includes all participants who received at least one study vaccination
Thresholds for adverse events were considered as 50 - 123 unit/L (mild), 124 - 245 unit/L (moderate), \>245 unit/L (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Day 8 (Second Vaccination) · None
|
20 Participants
|
20 Participants
|
19 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Day 8 (Second Vaccination) · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Day 8 (Second Vaccination) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Day 8 (Second Vaccination) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Day 8 (Second Vaccination) · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Day 8 Post-Second Vaccination · None
|
20 Participants
|
19 Participants
|
17 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Day 8 Post-Second Vaccination · Mild
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Day 8 Post-Second Vaccination · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Day 8 Post-Second Vaccination · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Day 8 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Day 22 Post-Second Vaccination · None
|
21 Participants
|
17 Participants
|
19 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Day 22 Post-Second Vaccination · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Day 22 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Day 29 Post-Second Vaccination · None
|
21 Participants
|
18 Participants
|
18 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Day 29 Post-Second Vaccination · Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Day 29 Post-Second Vaccination · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Day 29 Post-Second Vaccination · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Day 29 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Max Severity Post Baseline · None
|
20 Participants
|
18 Participants
|
18 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Max Severity Post Baseline · Mild
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Max Severity Post Baseline · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Max Severity Post Baseline · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Max Severity Post Baseline · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Day 22 Post-Second Vaccination · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT
Day 22 Post-Second Vaccination · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to approximately 28 Days Post Second VaccinationPopulation: Safety Population: includes all participants who received at least one study vaccination
Thresholds for adverse events were considered as creatinine 0.81 - 1.70 mg/dL (female) or 1.11 - 1.70 mg/dL (male) (mild), 1.71 - 2.00 mg/dL (moderate), \>2.00 mg/dL (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Day 8 (Second Vaccination) · None
|
21 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Day 8 (Second Vaccination) · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Day 8 (Second Vaccination) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Day 8 (Second Vaccination) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Day 8 (Second Vaccination) · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Day 8 Post-Second Vaccination · None
|
20 Participants
|
19 Participants
|
16 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Day 8 Post-Second Vaccination · Mild
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Day 8 Post-Second Vaccination · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Day 8 Post-Second Vaccination · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Day 8 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Day 22 Post-Second Vaccination · None
|
20 Participants
|
18 Participants
|
19 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Day 22 Post-Second Vaccination · Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Day 22 Post-Second Vaccination · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Day 22 Post-Second Vaccination · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Day 22 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Day 29 Post-Second Vaccination · None
|
19 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Day 29 Post-Second Vaccination · Mild
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Day 29 Post-Second Vaccination · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Day 29 Post-Second Vaccination · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Day 29 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Max Severity Post Baseline · None
|
19 Participants
|
19 Participants
|
17 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Max Severity Post Baseline · Mild
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Max Severity Post Baseline · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Max Severity Post Baseline · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)
Max Severity Post Baseline · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to approximately 28 Days Post Second VaccinationPopulation: Safety Population: includes all participants who received at least one study vaccination
Thresholds for adverse events were considered as sodium 130 - 135 mmol/L or 146 - 150 mmol/L (mild), 123 - 129 mmol/L or 151 - 157 mmol/L (moderate), \<123 mmol/L or \>157 mmol/L (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 8 Post-Second Vaccination · Mild (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 8 Post-Second Vaccination · Mild (high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 8 Post-Second Vaccination · Moderate (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 8 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 22 Post-Second Vaccination · None
|
20 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 22 Post-Second Vaccination · Mild (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 8 Post-Second Vaccination · Severe (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 22 Post-Second Vaccination · Mild (high)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 22 Post-Second Vaccination · Severe (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 22 Post-Second Vaccination · Moderate (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 8 (Second Vaccination) · None
|
21 Participants
|
20 Participants
|
19 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 8 (Second Vaccination) · Mild (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 8 (Second Vaccination) · Mild (high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 8 (Second Vaccination) · Moderate (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 8 (Second Vaccination) · Severe (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 8 (Second Vaccination) · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 8 Post-Second Vaccination · None
|
21 Participants
|
19 Participants
|
18 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 22 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 29 Post-Second Vaccination · None
|
21 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 29 Post-Second Vaccination · Mild (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 29 Post-Second Vaccination · Mild (high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 29 Post-Second Vaccination · Moderate (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 29 Post-Second Vaccination · Severe (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Day 29 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Max Severity Post Baseline · None
|
20 Participants
|
20 Participants
|
19 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Max Severity Post Baseline · Mild (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Max Severity Post Baseline · Mild (high)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Max Severity Post Baseline · Moderate (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Max Severity Post Baseline · Severe (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium
Max Severity Post Baseline · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to approximately 28 Days Post Second VaccinationPopulation: Safety Population: includes all participants who received at least one study vaccination
Thresholds for adverse events were considered as potassium 3.0 - 3.4 mmol/L or 5.2 - 6.0 mmol/L (mild), 2.5 - 2.9 mmol/L or 6.1 - 6.5 mmol/L (moderate), \<2.5 mmol/L or \>6.5 mmol/L (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 8 (Second Vaccination) · None
|
20 Participants
|
20 Participants
|
19 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 8 (Second Vaccination) · Mild (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 8 (Second Vaccination) · Mild (high)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 8 (Second Vaccination) · Moderate (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 8 (Second Vaccination) · Severe (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 8 (Second Vaccination) · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 8 Post-Second Vaccination · None
|
20 Participants
|
19 Participants
|
18 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 8 Post-Second Vaccination · Mild (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 8 Post-Second Vaccination · Mild (high)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 8 Post-Second Vaccination · Moderate (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 8 Post-Second Vaccination · Severe (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 8 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 22 Post-Second Vaccination · None
|
21 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 22 Post-Second Vaccination · Mild (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 22 Post-Second Vaccination · Mild (high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 22 Post-Second Vaccination · Moderate (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 22 Post-Second Vaccination · Severe (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 22 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 29 Post-Second Vaccination · None
|
20 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 29 Post-Second Vaccination · Mild (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 29 Post-Second Vaccination · Mild (high)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 29 Post-Second Vaccination · Moderate (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 29 Post-Second Vaccination · Severe (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Day 29 Post-Second Vaccination · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Max Severity Post Baseline · None
|
20 Participants
|
20 Participants
|
19 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Max Severity Post Baseline · Mild (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Max Severity Post Baseline · Mild (high)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Max Severity Post Baseline · Moderate (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Max Severity Post Baseline · Severe (low or high)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium
Max Severity Post Baseline · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to approximately 28 Days Post Second VaccinationPopulation: Safety Population: includes all participants who received at least one study vaccination
Thresholds for adverse events were considered as BUN 24 - 26 mg/dL (mild), 27 - 31 mg/dL (moderate), \>31 mg/dL (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Day 8 (Second Vaccination) · None
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Day 8 (Second Vaccination) · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Day 8 (Second Vaccination) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Day 8 (Second Vaccination) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Day 8 (Second Vaccination) · Missing
|
20 Participants
|
17 Participants
|
18 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Day 8 Post-Second Vaccination · None
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Day 8 Post-Second Vaccination · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Day 8 Post-Second Vaccination · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Day 8 Post-Second Vaccination · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Day 8 Post-Second Vaccination · Missing
|
18 Participants
|
18 Participants
|
15 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Day 22 Post-Second Vaccination · None
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Day 22 Post-Second Vaccination · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Day 22 Post-Second Vaccination · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Day 22 Post-Second Vaccination · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Day 22 Post-Second Vaccination · Missing
|
19 Participants
|
18 Participants
|
19 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Day 29 Post-Second Vaccination · None
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Day 29 Post-Second Vaccination · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Day 29 Post-Second Vaccination · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Day 29 Post-Second Vaccination · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Day 29 Post-Second Vaccination · Missing
|
18 Participants
|
19 Participants
|
17 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Max Severity Post Baseline · None
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Max Severity Post Baseline · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Max Severity Post Baseline · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Max Severity Post Baseline · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN
Max Severity Post Baseline · Missing
|
17 Participants
|
17 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 8 Post First VaccinationPopulation: Safety Population: includes all participants who received at least one study vaccination. All participants in all Study Arms received the same product (ChAd3-EBO-Z) at Day 1.
Local reactogenicity solicited on memory aid include pain; tenderness; pruritus (itch); erythema (redness), induration (hardness/swelling), and ecchymosis (bruising) (functional and measurement). Thresholds for severity were pain: aware, no interference with activity, no pain med (mild), aware, interferes with activity or requires repeated use of a non-narcotic pain reliever for \>24 hr (moderate), aware, prevents activity or requires prescription med use (severe); tenderness: area surrounding injection hurts when touched or with arm motion, no interference with daily activity (mild), hurts when touched or with arm motion, interferes with activity (moderate), hurts when touched or with arm motion and prevents activity (severe); functional erythema, induration, ecchymosis, and pruritus: no activity interference (mild), interferes with activity (moderate), prevents activity (severe); erythema, induration, and ecchymosis (measurement): \<20mm (mild), 20 - 50mm (moderate), \>50mm (severe).
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Any Local Symptom · None
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Any Local Symptom · Mild
|
17 Participants
|
17 Participants
|
11 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Any Local Symptom · Moderate
|
3 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Any Local Symptom · Severe
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pain · None
|
8 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pain · Mild
|
11 Participants
|
15 Participants
|
10 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pain · Moderate
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pain · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Tenderness · None
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Tenderness · Mild
|
16 Participants
|
18 Participants
|
12 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Tenderness · Moderate
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Tenderness · Severe
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pruritus · None
|
20 Participants
|
20 Participants
|
19 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pruritus · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pruritus · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pruritus · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (Functional grade) · None
|
21 Participants
|
18 Participants
|
17 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (Functional grade) · Mild
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (Functional grade) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (Functional grade) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (Measurement grade) · None
|
21 Participants
|
18 Participants
|
17 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (Measurement grade) · Mild
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (Measurement grade) · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (Measurement grade) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (Functional grade) · None
|
14 Participants
|
9 Participants
|
8 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (Functional grade) · Mild
|
7 Participants
|
10 Participants
|
11 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (Functional grade) · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (Functional grade) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (Measurement grade) · None
|
14 Participants
|
9 Participants
|
8 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (Measurement grade) · Mild
|
7 Participants
|
10 Participants
|
10 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (Measurement grade) · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (Measurement grade) · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (Functional grade) · None
|
15 Participants
|
13 Participants
|
14 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (Functional grade) · Mild
|
6 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (Functional grade) · Moderate
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (Functional grade) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (Measurement grade) · None
|
15 Participants
|
13 Participants
|
14 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (Measurement grade) · Mild
|
5 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (Measurement grade) · Moderate
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (Measurement grade) · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 8 Post Second VaccinationPopulation: Safety Population Subset: includes all participants who received the first and second study vaccination
Local reactogenicity solicited on memory aid include pain; tenderness; pruritus (itch); erythema (redness), induration (hardness/swelling), and ecchymosis (bruising) (functional and measurement). Thresholds for severity grading were pain: aware, no interference with activity, no pain med (mild), aware, interferes with activity or requires repeated use of a non-narcotic pain reliever for \>24hr (moderate), aware, prevents activity or requires prescription med use (severe); tenderness: area surrounding injection hurts when touched or with arm motion, no interference with daily activity (mild), hurts when touched or with arm motion, interferes with activity (moderate), hurts when touched or with arm motion, prevents activity (severe); functional erythema, induration, ecchymosis, and pruritus: no activity interference (mild), interferes with activity (moderate), prevents activity (severe); erythema, induration, and ecchymosis (measurement): \<20mm (mild), 20-50mm (moderate), \>50mm (severe).
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=17 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=17 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=18 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Any Local Symptom · None
|
11 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Any Local Symptom · Mild
|
6 Participants
|
10 Participants
|
13 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Any Local Symptom · Moderate
|
0 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Any Local Symptom · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pain · None
|
16 Participants
|
4 Participants
|
13 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pain · Mild
|
1 Participants
|
11 Participants
|
5 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pain · Moderate
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Tenderness · None
|
14 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Tenderness · Mild
|
3 Participants
|
9 Participants
|
12 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Tenderness · Moderate
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Tenderness · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pruritus · None
|
17 Participants
|
16 Participants
|
17 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pruritus · Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pruritus · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pruritus · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (Functional grade) · None
|
17 Participants
|
17 Participants
|
18 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (Functional grade) · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (Functional grade) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (Functional grade) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (Measurement grade) · None
|
17 Participants
|
17 Participants
|
18 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (Measurement grade) · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (Measurement grade) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (Measurement grade) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (Functional grade) · None
|
12 Participants
|
10 Participants
|
12 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (Functional grade) · Mild
|
5 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (Functional grade) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (Functional grade) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (Measurement grade) · None
|
12 Participants
|
10 Participants
|
12 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (Measurement grade) · Mild
|
5 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (Measurement grade) · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (Measurement grade) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (Functional grade) · None
|
17 Participants
|
14 Participants
|
17 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (Functional grade) · Mild
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (Functional grade) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (Functional grade) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (Measurement grade) · None
|
17 Participants
|
14 Participants
|
17 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (Measurement grade) · Mild
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (Measurement grade) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (Measurement grade) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 15Population: Safety Population: includes all participants who received at least one study vaccination.
Local reactogenicity solicited on memory aid include pain; tenderness; pruritus (itch); erythema (redness), induration (hardness/swelling), and ecchymosis (bruising) (functional and measurement). Thresholds for severity grading were pain: aware, no interference with activity, no pain med (mild), aware, interferes with activity or requires repeated use of a non-narcotic pain reliever for \>24hr (moderate), aware, prevents activity or requires prescription med use (severe); tenderness: area surrounding injection hurts when touched or with arm motion, no interference with daily activity (mild), hurts when touched or with arm motion, interferes with activity (moderate), hurts when touched or with arm motion, prevents activity (severe); functional erythema, induration, ecchymosis, and pruritus: no activity interference (mild), interferes with activity (moderate), prevents activity (severe); erythema, induration, and ecchymosis (measurement): \<20mm (mild), 20-50mm (moderate), \>50mm (severe).
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Any local symptom · Mild
|
17 Participants
|
11 Participants
|
11 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Any local symptom · Moderate
|
3 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Any local symptom · Severe
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Any local symptom · None
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pain · Mild
|
11 Participants
|
15 Participants
|
10 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pain · Moderate
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pain · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pain · None
|
8 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Tenderness · Mild
|
16 Participants
|
12 Participants
|
12 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Tenderness · Moderate
|
1 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Tenderness · Severe
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Tenderness · None
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (functional) · Mild
|
10 Participants
|
10 Participants
|
12 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (functional) · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (functional) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (functional) · None
|
11 Participants
|
9 Participants
|
7 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (measured) · Mild
|
10 Participants
|
9 Participants
|
11 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (measured) · Moderate
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (measured) · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Erythema (measured) · None
|
11 Participants
|
9 Participants
|
7 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (functional) · Mild
|
6 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (functional) · Moderate
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (functional) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (functional) · None
|
15 Participants
|
12 Participants
|
14 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (measured) · Mild
|
5 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (measured) · Moderate
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (measured) · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Induration (measured) · None
|
15 Participants
|
12 Participants
|
14 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (functional) · Mild
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (functional) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (functional) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (functional) · None
|
21 Participants
|
18 Participants
|
17 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (measured) · Mild
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (measured) · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (measured) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Ecchymosis (measured) · None
|
21 Participants
|
18 Participants
|
17 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pruritus · Mild
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pruritus · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pruritus · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Local Reactogenicity
Pruritus · None
|
20 Participants
|
19 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 8 Post First VaccinationPopulation: Safety Population: includes all participants who received at least one study vaccination. All participants in all Study Arms received the same product (ChAd3-EBO-Z) at Day 1.
Systemic reactogenicity solicited on memory aid included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Thresholds for severity include feverishness, malaise, fatigue, myalgia, nausea, and loss of appetite: Noticeable but does not interfere with daily activity (Mild), Interferes with daily activity (Moderate), Significant interference, prevents daily activity (Severe); headache: Noticeable but does not interfere with daily activity (Mild), Any use of pain reliever or interferes with daily activity (Moderate), Significant interference, prevents daily activity, or requires any use of a prescription medication (Severe); elevated oral temperature: 37.8°C - 38.4°C or 100.00°F - 101.1°F (Mild), 38.5°C - 38.9°C or 101.2°F - 102.0°F (Moderate), \>38.9°C or \>102.0°F (Severe).
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Any Systemic Symptom · None
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Any Systemic Symptom · Mild
|
7 Participants
|
8 Participants
|
3 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Any Systemic Symptom · Moderate
|
7 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Malaise · None
|
8 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Any Systemic Symptom · Severe
|
6 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Elevated Oral Temperature · None
|
10 Participants
|
11 Participants
|
10 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Elevated Oral Temperature · Mild
|
7 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Elevated Oral Temperature · Moderate
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Malaise · Mild
|
7 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Malaise · Moderate
|
6 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Elevated Oral Temperature · Severe
|
2 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Malaise · Severe
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Fatigue · None
|
4 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Feverishness · None
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Fatigue · Mild
|
13 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Feverishness · Mild
|
5 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Feverishness · Moderate
|
7 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Feverishness · Severe
|
3 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Fatigue · Moderate
|
4 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Fatigue · Severe
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Myalgia · None
|
4 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Myalgia · Mild
|
11 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Myalgia · Moderate
|
6 Participants
|
7 Participants
|
4 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Myalgia · Severe
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Headache · None
|
11 Participants
|
10 Participants
|
7 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Headache · Mild
|
9 Participants
|
3 Participants
|
8 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Headache · Moderate
|
1 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Headache · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Nausea · None
|
15 Participants
|
11 Participants
|
16 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Nausea · Mild
|
5 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Nausea · Moderate
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Nausea · Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Loss of Appetite · None
|
17 Participants
|
11 Participants
|
11 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Loss of Appetite · Mild
|
2 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Loss of Appetite · Moderate
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Loss of Appetite · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 8 Post Second VaccinationPopulation: Safety Population Subset: includes all participants who received the first and second study vaccination
Systemic reactogenicity solicited on memory aid included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Thresholds for severity include feverishness, malaise, fatigue, myalgia, nausea, and loss of appetite: Noticeable but does not interfere with daily activity (Mild), Interferes with daily activity (Moderate), Significant interference, prevents daily activity (Severe); headache: Noticeable but does not interfere with daily activity (Mild), Any use of pain reliever or interferes with daily activity (Moderate), Significant interference, prevents daily activity, or requires any use of a prescription medication (Severe); elevated oral temperature: 37.8°C - 38.4°C or 100.00°F - 101.1°F (Mild), 38.5°C - 38.9°C or 101.2°F - 102.0°F (Moderate), \>38.9°C or \>102.0°F (Severe).
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=17 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=17 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=18 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Headache · Mild
|
6 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Fatigue · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Myalgia · None
|
14 Participants
|
6 Participants
|
14 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Myalgia · Mild
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Myalgia · Moderate
|
1 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Myalgia · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Headache · None
|
10 Participants
|
8 Participants
|
14 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Headache · Moderate
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Nausea · None
|
15 Participants
|
13 Participants
|
17 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Nausea · Mild
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Nausea · Moderate
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Loss of Appetite · None
|
14 Participants
|
10 Participants
|
18 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Loss of Appetite · Mild
|
3 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Loss of Appetite · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Loss of Appetite · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Fatigue · Moderate
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Any Systemic Symptom · None
|
9 Participants
|
3 Participants
|
12 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Any Systemic Symptom · Mild
|
6 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Any Systemic Symptom · Moderate
|
2 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Any Systemic Symptom · Severe
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Elevated Oral Temperature · None
|
17 Participants
|
9 Participants
|
18 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Elevated Oral Temperature · Mild
|
0 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Elevated Oral Temperature · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Elevated Oral Temperature · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Feverishness · None
|
14 Participants
|
6 Participants
|
17 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Feverishness · Mild
|
2 Participants
|
7 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Feverishness · Moderate
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Feverishness · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Malaise · None
|
14 Participants
|
3 Participants
|
17 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Malaise · Mild
|
2 Participants
|
9 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Malaise · Moderate
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Malaise · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Fatigue · None
|
10 Participants
|
3 Participants
|
15 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Fatigue · Mild
|
6 Participants
|
9 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 15Population: Safety Population: includes all participants who received at least one study vaccination.
Systemic reactogenicity solicited on memory aid included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Thresholds for severity include feverishness, malaise, fatigue, myalgia, nausea, and loss of appetite: Noticeable but does not interfere with daily activity (Mild), Interferes with daily activity (Moderate), Significant interference, prevents daily activity (Severe); headache: Noticeable but does not interfere with daily activity (Mild), Any use of pain reliever or interferes with daily activity (Moderate), Significant interference, prevents daily activity, or requires any use of a prescription medication (Severe); elevated oral temperature: 37.8°C - 38.4°C or 100.00°F - 101.1°F (Mild), 38.5°C - 38.9°C or 101.2°F - 102.0°F (Moderate), \>38.9°C or \>102.0°F (Severe).
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Any Systemic Symptom · Mild
|
6 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Any Systemic Symptom · Moderate
|
8 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Any Systemic Symptom · Severe
|
6 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Any Systemic Symptom · None
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Elevated Oral Temperature · Mild
|
7 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Elevated Oral Temperature · Moderate
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Elevated Oral Temperature · Severe
|
2 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Elevated Oral Temperature · None
|
10 Participants
|
8 Participants
|
10 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Feverishness · Mild
|
7 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Feverishness · Moderate
|
8 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Feverishness · Severe
|
3 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Feverishness · None
|
3 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Malaise · Mild
|
7 Participants
|
10 Participants
|
7 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Malaise · Moderate
|
7 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Malaise · Severe
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Malaise · None
|
7 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Fatigue · Mild
|
13 Participants
|
9 Participants
|
7 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Fatigue · Moderate
|
5 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Fatigue · Severe
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Fatigue · None
|
3 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Myalgia · Mild
|
10 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Myalgia · Moderate
|
7 Participants
|
9 Participants
|
4 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Myalgia · Severe
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Myalgia · None
|
4 Participants
|
0 Participants
|
7 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Headache · Mild
|
11 Participants
|
5 Participants
|
8 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Headache · Moderate
|
2 Participants
|
7 Participants
|
4 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Headache · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Headache · None
|
8 Participants
|
7 Participants
|
7 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Nausea · Mild
|
6 Participants
|
7 Participants
|
1 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Nausea · Moderate
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Nausea · Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Nausea · None
|
14 Participants
|
10 Participants
|
16 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Loss of Appetite · Mild
|
4 Participants
|
11 Participants
|
5 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Loss of Appetite · Moderate
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Loss of Appetite · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Solicited Systemic Reactogenicity
Loss of Appetite · None
|
15 Participants
|
8 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Day 1 to approximately 28 Days Post Second VaccinationPopulation: Safety Population: includes all participants who received at least one study vaccination
Vaccine-related unsolicited AEs include any untoward medical occurrence in a participant for which there is evidence to suggest a causal relationship between the study product and the adverse event. Thresholds for severity include events require minimal or no treatment and do not interfere with the subject's daily activities (mild), events result in a low level of inconvenience or concern with therapeutic measures and may cause some interference with functioning and daily activities (moderate), and events interrupt the subject's daily activities and may require systemic drug therapy or other treatment and are usually incapacitating (severe). Participants are counted once per preferred term and are summarized according to their highest severity. No severe events were reported.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Vomiting · Mild
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Any Event · Mild
|
3 Participants
|
7 Participants
|
4 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Any Event · Moderate
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Any Event · None
|
17 Participants
|
10 Participants
|
15 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Lymphadenopathy · Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Lymphadenopathy · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Lymphadenopathy · None
|
20 Participants
|
19 Participants
|
18 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Tachycardia · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Tachycardia · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Tachycardia · None
|
21 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Diarrhea · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Diarrhea · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Diarrhea · None
|
21 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Vomiting · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Vomiting · None
|
20 Participants
|
18 Participants
|
18 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Chest discomfort · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Chest discomfort · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Chest discomfort · None
|
21 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Blood pressure diastolic decreased · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Blood pressure diastolic decreased · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Blood pressure diastolic decreased · None
|
21 Participants
|
20 Participants
|
18 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Transaminases increased · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Transaminases increased · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Transaminases increased · None
|
21 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Dehydration · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Dehydration · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Dehydration · None
|
21 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Back pain · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Back pain · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Back pain · None
|
21 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Muscle Spasms · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Muscle Spasms · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Muscle Spasms · None
|
21 Participants
|
20 Participants
|
18 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Dizziness · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Dizziness · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Dizziness · None
|
21 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Sinus headache · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Sinus headache · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Sinus headache · None
|
20 Participants
|
20 Participants
|
19 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Taste Disorder · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Taste Disorder · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Taste Disorder · None
|
21 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Cough · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Cough · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Cough · None
|
20 Participants
|
20 Participants
|
19 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Oropharyngeal pain · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Oropharyngeal pain · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Oropharyngeal pain · None
|
20 Participants
|
20 Participants
|
19 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Sinus Congestion · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Sinus Congestion · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Sinus Congestion · None
|
21 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Acne · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Acne · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Acne · None
|
21 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Ecchymosis · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Ecchymosis · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Ecchymosis · None
|
21 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Rash · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Rash · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)
Rash · None
|
21 Participants
|
19 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 29 and 36 compared to baseline (Day 1) reported as Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively.Population: ITT Population: includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination blood samples for immunogenicity testing for which valid results were reported
The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Geometric mean fold rise (GMFR) compared to baseline (Day 1) was calculated for each study arm.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population
Day 8 Post-First Vaccination (Second Vaccination)
|
1.1 titer
Interval 0.9 to 1.3
|
1.2 titer
Interval 0.8 to 1.7
|
1.3 titer
Interval 0.8 to 1.9
|
|
Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population
Day 8 Post-Second Vaccination
|
21.5 titer
Interval 13.3 to 35.0
|
21.0 titer
Interval 11.9 to 37.0
|
25.4 titer
Interval 11.3 to 57.1
|
|
Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population
Day 15 Post-Second Vaccination
|
54.3 titer
Interval 32.3 to 91.0
|
54.9 titer
Interval 28.2 to 106.6
|
49.6 titer
Interval 25.6 to 96.0
|
|
Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population
Day 22 Post-Second Vaccination
|
70.7 titer
Interval 41.2 to 121.2
|
77.6 titer
Interval 40.3 to 149.5
|
74.1 titer
Interval 37.4 to 146.6
|
|
Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population
Day 29 Post-Second Vaccination
|
83.3 titer
Interval 44.9 to 154.8
|
97.8 titer
Interval 52.2 to 183.0
|
82.6 titer
Interval 38.8 to 176.1
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 29 and 36 compared to baseline (Day 1) reported as Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively.Population: Per Protocol population includes all participants who received at least one study vaccination, contributed both pre- and at least one post-study vaccination blood samples for immunogenicity testing for which valid results were reported, were eligible at baseline and have no major protocol deviations.
The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Geometric mean fold rise (GMFR) compared to baseline (Day 1) was calculated for each study arm.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population
Day 8 Post-First Vaccination (Second Vaccination)
|
1.1 titer
Interval 0.9 to 1.3
|
1.2 titer
Interval 0.8 to 1.7
|
1.3 titer
Interval 0.8 to 1.9
|
|
Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population
Day 8 Post-Second Vaccination
|
25.1 titer
Interval 15.2 to 41.4
|
17.4 titer
Interval 9.9 to 30.9
|
23.1 titer
Interval 10.0 to 53.3
|
|
Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population
Day 15 Post-Second Vaccination
|
61.3 titer
Interval 33.3 to 112.8
|
45.3 titer
Interval 24.0 to 85.2
|
43.5 titer
Interval 23.0 to 82.5
|
|
Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population
Day 22 Post-Second Vaccination
|
75.3 titer
Interval 42.0 to 135.2
|
66.8 titer
Interval 33.4 to 133.8
|
64.0 titer
Interval 32.1 to 127.6
|
|
Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population
Day 29 Post-Second Vaccination
|
92.4 titer
Interval 46.3 to 184.4
|
83.0 titer
Interval 44.2 to 156.0
|
66.7 titer
Interval 30.8 to 144.2
|
SECONDARY outcome
Timeframe: Day 1, 8, 15, 22, 29 and 36 reported as Day 1 first vaccination, Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively.Population: ITT Population: includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination blood samples for immunogenicity testing for which valid results were reported
The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Geometric Mean Titer (GMT) was calculated for each study arm.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population
Day 1 First Vaccination
|
29.5 titer
Interval 23.1 to 37.6
|
33.5 titer
Interval 23.0 to 48.7
|
32.3 titer
Interval 23.0 to 45.3
|
|
Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population
Day 8 Post-First Vaccination (Second Vaccination)
|
32.6 titer
Interval 23.9 to 44.3
|
40.2 titer
Interval 26.9 to 60.1
|
35.4 titer
Interval 23.0 to 54.4
|
|
Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population
Day 8 Post-Second Vaccination
|
635.0 titer
Interval 424.3 to 950.3
|
712.7 titer
Interval 413.3 to 1229.2
|
831.4 titer
Interval 411.2 to 1681.2
|
|
Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population
Day 15 Post-Second Vaccination
|
1600.0 titer
Interval 1012.9 to 2527.5
|
1866.4 titer
Interval 1003.4 to 3471.8
|
1600.0 titer
Interval 937.9 to 2729.4
|
|
Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population
Day 22 Post-Second Vaccination
|
2083.5 titer
Interval 1312.2 to 3308.3
|
2639.6 titer
Interval 1539.3 to 4526.2
|
2390.0 titer
Interval 1483.9 to 3849.3
|
|
Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population
Day 29 Post-Second Vaccination
|
2457.4 titer
Interval 1456.6 to 4145.8
|
3325.6 titer
Interval 1898.7 to 5824.8
|
2666.4 titer
Interval 1497.5 to 4747.9
|
SECONDARY outcome
Timeframe: Day 1, 8, 15, 22, 29 and 36 reported as Day 1 first vaccination, Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively.Population: Per Protocol population includes all participants who received at least one study vaccination, contributed both pre- and at least one post-study vaccination blood samples for immunogenicity testing for which valid results were reported, were eligible at baseline and have no major protocol deviations.
The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Geometric Mean Titer (GMT) was calculated for each study arm.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population
Day 1 First Vaccination
|
29.5 titer
Interval 23.1 to 37.6
|
33.5 titer
Interval 23.0 to 48.7
|
32.3 titer
Interval 23.0 to 45.3
|
|
Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population
Day 8 Post-First Vaccination (Second Vaccination)
|
32.6 titer
Interval 23.9 to 44.3
|
40.2 titer
Interval 26.9 to 60.1
|
35.4 titer
Interval 23.0 to 54.4
|
|
Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population
Day 8 Post-Second Vaccination
|
679.6 titer
Interval 420.4 to 1098.6
|
590.7 titer
Interval 344.6 to 1012.6
|
768.0 titer
Interval 370.5 to 1592.1
|
|
Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population
Day 15 Post-Second Vaccination
|
1670.8 titer
Interval 935.9 to 2983.0
|
1532.2 titer
Interval 845.0 to 2778.1
|
1425.4 titer
Interval 860.2 to 2362.1
|
|
Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population
Day 22 Post-Second Vaccination
|
2043.5 titer
Interval 1180.9 to 3536.1
|
2262.7 titer
Interval 1297.6 to 3945.8
|
2128.5 titer
Interval 1374.2 to 3296.8
|
|
Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population
Day 29 Post-Second Vaccination
|
2505.6 titer
Interval 1335.4 to 4701.0
|
2810.0 titer
Interval 1605.7 to 4917.6
|
2217.1 titer
Interval 1259.9 to 3901.4
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 29 and 36 reported as Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively.Population: ITT Population: includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination blood samples for immunogenicity testing for which valid results were reported
The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Seroconversion was calculated for each study arm and was defined as anti-EBOV GP ELISA titer \> 50 if baseline (Day 1) titer = 50 or fold rise \> 4 as compared to baseline if baseline titer \> 50.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population
Day 8 Post-First Vaccination (Second Vaccination)
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population
Day 8 Post-Second Vaccination
|
20 Participants
|
17 Participants
|
17 Participants
|
|
Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population
Day 15 Post-Second Vaccination
|
21 Participants
|
17 Participants
|
19 Participants
|
|
Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population
Day 22 Post-Second Vaccination
|
21 Participants
|
17 Participants
|
18 Participants
|
|
Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population
Day 29 Post-Second Vaccination
|
21 Participants
|
18 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 29 and 36 reported as Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively.Population: Per Protocol population includes all participants who received at least one study vaccination, contributed both pre- and at least one post-study vaccination blood samples for immunogenicity testing for which valid results were reported, were eligible at baseline and have no major protocol deviations.
The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Seroconversion was calculated for each study arm and was defined as anti-EBOV GP ELISA titer \> 50 if baseline (Day 1) titer = 50 or fold rise \> 4 as compared to baseline if baseline titer \> 50.
Outcome measures
| Measure |
ChAd3-EBO-Z + Placebo
n=21 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 Participants
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population
Day 8 Post-First Vaccination (Second Vaccination)
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population
Day 8 Post-Second Vaccination
|
17 Participants
|
15 Participants
|
16 Participants
|
|
Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population
Day 15 Post-Second Vaccination
|
16 Participants
|
15 Participants
|
18 Participants
|
|
Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population
Day 22 Post-Second Vaccination
|
17 Participants
|
15 Participants
|
16 Participants
|
|
Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population
Day 29 Post-Second Vaccination
|
17 Participants
|
16 Participants
|
16 Participants
|
Adverse Events
ChAd3-EBO-Z + Placebo
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
ChAd3-EBO-Z + ChAd3-EBO-Z
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
ChAd3-EBO-Z + MVA- BN-Filo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ChAd3-EBO-Z + Placebo
n=21 participants at risk
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + ChAd3-EBO-Z
n=20 participants at risk
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
|
ChAd3-EBO-Z + MVA- BN-Filo
n=19 participants at risk
ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
|
|---|---|---|---|
|
General disorders
Pyrexia
|
52.4%
11/21 • Number of events 11 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
60.0%
12/20 • Number of events 17 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
47.4%
9/19 • Number of events 9 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
General disorders
Malaise
|
66.7%
14/21 • Number of events 16 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
95.0%
19/20 • Number of events 31 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
68.4%
13/19 • Number of events 14 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
General disorders
Fatigue
|
85.7%
18/21 • Number of events 24 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
95.0%
19/20 • Number of events 29 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
68.4%
13/19 • Number of events 16 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
81.0%
17/21 • Number of events 20 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
100.0%
20/20 • Number of events 28 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
63.2%
12/19 • Number of events 16 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
General disorders
Headache
|
61.9%
13/21 • Number of events 17 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
65.0%
13/20 • Number of events 19 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
63.2%
12/19 • Number of events 16 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
General disorders
Nausea
|
33.3%
7/21 • Number of events 8 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
50.0%
10/20 • Number of events 13 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
15.8%
3/19 • Number of events 4 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
28.6%
6/21 • Number of events 7 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
60.0%
12/20 • Number of events 16 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
42.1%
8/19 • Number of events 8 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Reproductive system and breast disorders
Vulvovaginal Pruritus
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/19 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/19 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/19 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/20 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/19 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Investigations
Blood Pressure Diastolic Decreased
|
4.8%
1/21 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/20 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
General disorders
Chest Discomfort
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/19 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/19 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/19 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/19 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
General disorders
Feeling Of Body Temperature Change
|
85.7%
18/21 • Number of events 18 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
80.0%
16/20 • Number of events 25 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
68.4%
13/19 • Number of events 14 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
General disorders
Injection Site Haemorrhage
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
10.0%
2/20 • Number of events 2 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
10.5%
2/19 • Number of events 2 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/19 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/20 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
9.5%
2/21 • Number of events 3 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Injury, poisoning and procedural complications
Muscle Injury
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/19 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/20 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
4.8%
1/21 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/20 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/20 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Nervous system disorders
Presyncope
|
4.8%
1/21 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/19 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.8%
1/21 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/19 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Infections and infestations
Sinusitis
|
4.8%
1/21 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/19 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/19 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Nervous system disorders
Taste Disorder
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/19 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/19 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/19 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Investigations
Transaminases Increased
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/19 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.8%
1/21 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
15.8%
3/19 • Number of events 3 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
10.0%
2/20 • Number of events 2 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
General disorders
Vaccination Site Erythema
|
47.6%
10/21 • Number of events 12 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
55.0%
11/20 • Number of events 18 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
63.2%
12/19 • Number of events 17 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
General disorders
Vaccination Site Induration
|
28.6%
6/21 • Number of events 6 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
40.0%
8/20 • Number of events 10 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
26.3%
5/19 • Number of events 6 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
General disorders
Vaccination Site Pain
|
85.7%
18/21 • Number of events 21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
100.0%
20/20 • Number of events 37 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
94.7%
18/19 • Number of events 31 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
General disorders
Vaccination Site Pruritus
|
4.8%
1/21 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Investigations
Alanine Aminotransferase Increased
|
4.8%
1/21 • Number of events 2 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
10.0%
2/20 • Number of events 2 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Investigations
Blood Creatinine Increased
|
9.5%
2/21 • Number of events 2 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
10.5%
2/19 • Number of events 2 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Investigations
Haemoglobin Decreased
|
9.5%
2/21 • Number of events 4 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
30.0%
6/20 • Number of events 6 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
10.5%
2/19 • Number of events 3 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Investigations
Neutrophil Count Decreased
|
4.8%
1/21 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
25.0%
5/20 • Number of events 6 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
15.8%
3/19 • Number of events 4 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Investigations
White Blood Cell Count Decreased
|
9.5%
2/21 • Number of events 4 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
20.0%
4/20 • Number of events 5 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
21.1%
4/19 • Number of events 5 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
|
Investigations
White Blood Cell Count Increased
|
0.00%
0/21 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
5.0%
1/20 • Number of events 1 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
0.00%
0/19 • Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60