Trial Outcomes & Findings for Dosage-Escalation Study of the Safety and Immunogenicity of a Novel Rabies Vaccine ChAd155-RG vs. the Comparator RABAVERT Vaccine in Healthy Adult Subjects (NCT NCT04019444)
NCT ID: NCT04019444
Last Updated: 2024-06-03
Results Overview
Injection site reactogenicity events were solicited on a memory aid completed by participants from the time of each vaccination through Day 7 following each vaccination. Injection site reactogenicity events included pruritus, erythema, ecchymosis, induration/swelling, pain, and tenderness. Each event was graded as mild, moderate, or severe. Participants are counted according to their maximum severity of injection site event reported. Participants reporting no injection site events are counted under "None".
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
50 participants
Primary outcome timeframe
Day 1 through Day 29
Results posted on
2024-06-03
Participant Flow
Participants were healthy adult volunteers meeting all protocol-defined eligibility criteria. Participants were recruited through IRB-approved flyers on the Emory University campus, social media, list serves, clinical trial recruitment websites, a HIPAA-compliant clinical trials database to identify participants of previous trials at the Hope Clinic who had agreed to future contact, presentations by Hope Clinic faculty, and word-of-mouth. Enrollment occurred between 19SEP2019 and 07MAR2022.
Participant milestones
| Measure |
Low Dose ChAd155-RG
One dose (1 ml (5x10\^10 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x1)
One dose (1 ml (1x10\^11 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x2)
Two doses (1 ml (1x10\^11 vp) each) of ChAd155-RG vaccine administered intramuscularly on Day 1 (first dose) and Day 15 (second dose), and 1 ml of matching placebo administered intramuscularly on Days 8 and 22.
|
RABAVERT
Three doses (1 ml each) of RABAVERT vaccine administered intramuscularly on Day 1 (first dose), Day 8 (second dose), and Day 22 (third dose), and 1 ml of matching placebo administered intramuscularly on Day 15.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
10
|
12
|
|
Overall Study
COMPLETED
|
14
|
13
|
8
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
Low Dose ChAd155-RG
One dose (1 ml (5x10\^10 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x1)
One dose (1 ml (1x10\^11 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x2)
Two doses (1 ml (1x10\^11 vp) each) of ChAd155-RG vaccine administered intramuscularly on Day 1 (first dose) and Day 15 (second dose), and 1 ml of matching placebo administered intramuscularly on Days 8 and 22.
|
RABAVERT
Three doses (1 ml each) of RABAVERT vaccine administered intramuscularly on Day 1 (first dose), Day 8 (second dose), and Day 22 (third dose), and 1 ml of matching placebo administered intramuscularly on Day 15.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
|
Overall Study
Solicited Event
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Dosage-Escalation Study of the Safety and Immunogenicity of a Novel Rabies Vaccine ChAd155-RG vs. the Comparator RABAVERT Vaccine in Healthy Adult Subjects
Baseline characteristics by cohort
| Measure |
Low Dose ChAd155-RG
n=14 Participants
One dose (1 ml (5x10\^10 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x1)
n=14 Participants
One dose (1 ml (1x10\^11 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x2)
n=10 Participants
Two doses (1 ml (1x10\^11 vp) each) of ChAd155-RG vaccine administered intramuscularly on Day 1 (first dose) and Day 15 (second dose), and 1 ml of matching placebo administered intramuscularly on Days 8 and 22.
|
RABAVERT
n=12 Participants
Three doses (1 ml each) of RABAVERT vaccine administered intramuscularly on Day 1 (first dose), Day 8 (second dose), and Day 22 (third dose), and 1 ml of matching placebo administered intramuscularly on Day 15.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30.7 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
30.4 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
28.6 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
26.8 years
STANDARD_DEVIATION 4.4 • n=4 Participants
|
29.2 years
STANDARD_DEVIATION 7.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
47 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
10 participants
n=5 Participants
|
12 participants
n=4 Participants
|
50 participants
n=21 Participants
|
|
BMI
|
27.7 kg/m^2
STANDARD_DEVIATION 4.3 • n=5 Participants
|
27.5 kg/m^2
STANDARD_DEVIATION 3.5 • n=7 Participants
|
25.2 kg/m^2
STANDARD_DEVIATION 3.6 • n=5 Participants
|
26.5 kg/m^2
STANDARD_DEVIATION 3.1 • n=4 Participants
|
26.9 kg/m^2
STANDARD_DEVIATION 3.7 • n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 29Population: The Safety Population consists of all participants who received at least one dose of vaccine and for whom any data on safety are available.
Injection site reactogenicity events were solicited on a memory aid completed by participants from the time of each vaccination through Day 7 following each vaccination. Injection site reactogenicity events included pruritus, erythema, ecchymosis, induration/swelling, pain, and tenderness. Each event was graded as mild, moderate, or severe. Participants are counted according to their maximum severity of injection site event reported. Participants reporting no injection site events are counted under "None".
Outcome measures
| Measure |
Low Dose ChAd155-RG
n=14 Participants
One dose (1 ml (5x10\^10 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x1)
n=14 Participants
One dose (1 ml (1x10\^11 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x2)
n=10 Participants
Two doses (1 ml (1x10\^11 vp) each) of ChAd155-RG vaccine administered intramuscularly on Day 1 (first dose) and Day 15 (second dose), and 1 ml of matching placebo administered intramuscularly on Days 8 and 22.
|
RABAVERT
n=12 Participants
Three doses (1 ml each) of RABAVERT vaccine administered intramuscularly on Day 1 (first dose), Day 8 (second dose), and Day 22 (third dose), and 1 ml of matching placebo administered intramuscularly on Day 15.
|
All Participants
n=50 Participants
All participants include every participant in the Low Dose ChAd155-RG arm, High Dose ChAd155-RG (x1) arm, High Dose ChAd155-RG (x2) arm, and RABAVERT arm.
|
|---|---|---|---|---|---|
|
Number and Percentage of Participants With Solicited Injection Site Reactogenicity Events in Each Treatment Arm and Overall
None
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
|
Number and Percentage of Participants With Solicited Injection Site Reactogenicity Events in Each Treatment Arm and Overall
Mild
|
10 Participants
|
11 Participants
|
8 Participants
|
9 Participants
|
38 Participants
|
|
Number and Percentage of Participants With Solicited Injection Site Reactogenicity Events in Each Treatment Arm and Overall
Moderate
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
|
Number and Percentage of Participants With Solicited Injection Site Reactogenicity Events in Each Treatment Arm and Overall
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 29Population: The Safety Population consists of all participants who received at least one dose of vaccine and for whom any data on safety are available.
Systemic reactogenicity events were solicited on a memory aid completed by participants from the time of each vaccination through Day 7 following each vaccination. Systemic reactogenicity events included fever, chills/shivering/sweating, fatigue, malaise, myalgia and arthralgia (exclusive of the injection site), headache, and nausea. Each event was graded as mild, moderate, or severe. Participants are counted according to their maximum severity of systemic event reported. Participants reporting no systemic events are counted under "None".
Outcome measures
| Measure |
Low Dose ChAd155-RG
n=14 Participants
One dose (1 ml (5x10\^10 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x1)
n=14 Participants
One dose (1 ml (1x10\^11 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x2)
n=10 Participants
Two doses (1 ml (1x10\^11 vp) each) of ChAd155-RG vaccine administered intramuscularly on Day 1 (first dose) and Day 15 (second dose), and 1 ml of matching placebo administered intramuscularly on Days 8 and 22.
|
RABAVERT
n=12 Participants
Three doses (1 ml each) of RABAVERT vaccine administered intramuscularly on Day 1 (first dose), Day 8 (second dose), and Day 22 (third dose), and 1 ml of matching placebo administered intramuscularly on Day 15.
|
All Participants
n=50 Participants
All participants include every participant in the Low Dose ChAd155-RG arm, High Dose ChAd155-RG (x1) arm, High Dose ChAd155-RG (x2) arm, and RABAVERT arm.
|
|---|---|---|---|---|---|
|
Number and Percentage of Participants With Solicited Systemic Reactogenicity Events in Each Treatment Arm and Overall
None
|
3 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
9 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactogenicity Events in Each Treatment Arm and Overall
Mild
|
5 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
15 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactogenicity Events in Each Treatment Arm and Overall
Moderate
|
5 Participants
|
8 Participants
|
5 Participants
|
5 Participants
|
23 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Reactogenicity Events in Each Treatment Arm and Overall
Severe
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 381Population: The Safety Population consists of all participants who received at least one dose of vaccine and for whom any data on safety are available.
An AE or suspected AE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Events were determined to be related if there was a reasonable possibility that the study product caused the AE; that is, there was evidence to suggest a causal relationship between the study product and the AE. Each event was graded as mild, moderate, or severe. Participants are counted according to their maximum severity of event reported. Participants reporting no vaccine-related SAEs are counted under "None".
Outcome measures
| Measure |
Low Dose ChAd155-RG
n=14 Participants
One dose (1 ml (5x10\^10 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x1)
n=14 Participants
One dose (1 ml (1x10\^11 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x2)
n=10 Participants
Two doses (1 ml (1x10\^11 vp) each) of ChAd155-RG vaccine administered intramuscularly on Day 1 (first dose) and Day 15 (second dose), and 1 ml of matching placebo administered intramuscularly on Days 8 and 22.
|
RABAVERT
n=12 Participants
Three doses (1 ml each) of RABAVERT vaccine administered intramuscularly on Day 1 (first dose), Day 8 (second dose), and Day 22 (third dose), and 1 ml of matching placebo administered intramuscularly on Day 15.
|
All Participants
n=50 Participants
All participants include every participant in the Low Dose ChAd155-RG arm, High Dose ChAd155-RG (x1) arm, High Dose ChAd155-RG (x2) arm, and RABAVERT arm.
|
|---|---|---|---|---|---|
|
Number and Percentage of Participants With Serious Adverse Events (SAEs) Considered Study Vaccine-Related in Each Treatment Arm and Overall
None
|
14 Participants
|
14 Participants
|
10 Participants
|
12 Participants
|
50 Participants
|
|
Number and Percentage of Participants With Serious Adverse Events (SAEs) Considered Study Vaccine-Related in Each Treatment Arm and Overall
Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Serious Adverse Events (SAEs) Considered Study Vaccine-Related in Each Treatment Arm and Overall
Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Serious Adverse Events (SAEs) Considered Study Vaccine-Related in Each Treatment Arm and Overall
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 22Population: The Safety Population consists of all participants who received at least one dose of vaccine and for whom any data on safety are available.
Clinical safety lab parameters evaluated after receipt of vaccine (on Days 2, 8, 16, and Day 22) included WBCs, hemoglobin, platelets, absolute neutrophil count, absolute lymphocyte count, ALT, AST, total bilirubin, BUN, and creatinine. Lab events were assessed for relatedness and were determined to be related if there was a reasonable possibility that the study product caused the AE; that is, there was evidence to suggest a causal relationship between the study product and the AE. Each lab event was graded as mild, moderate, or severe. Participants are counted according to their maximum severity of event reported. Participants reporting no lab events are counted under "None".
Outcome measures
| Measure |
Low Dose ChAd155-RG
n=14 Participants
One dose (1 ml (5x10\^10 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x1)
n=14 Participants
One dose (1 ml (1x10\^11 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x2)
n=10 Participants
Two doses (1 ml (1x10\^11 vp) each) of ChAd155-RG vaccine administered intramuscularly on Day 1 (first dose) and Day 15 (second dose), and 1 ml of matching placebo administered intramuscularly on Days 8 and 22.
|
RABAVERT
n=12 Participants
Three doses (1 ml each) of RABAVERT vaccine administered intramuscularly on Day 1 (first dose), Day 8 (second dose), and Day 22 (third dose), and 1 ml of matching placebo administered intramuscularly on Day 15.
|
All Participants
n=50 Participants
All participants include every participant in the Low Dose ChAd155-RG arm, High Dose ChAd155-RG (x1) arm, High Dose ChAd155-RG (x2) arm, and RABAVERT arm.
|
|---|---|---|---|---|---|
|
Number and Percentage of Participants With Study Vaccine-related Lab Adverse Events (AEs) in Each Treatment Arm and Overall
None
|
8 Participants
|
6 Participants
|
3 Participants
|
8 Participants
|
25 Participants
|
|
Number and Percentage of Participants With Study Vaccine-related Lab Adverse Events (AEs) in Each Treatment Arm and Overall
Mild
|
5 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
17 Participants
|
|
Number and Percentage of Participants With Study Vaccine-related Lab Adverse Events (AEs) in Each Treatment Arm and Overall
Moderate
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
7 Participants
|
|
Number and Percentage of Participants With Study Vaccine-related Lab Adverse Events (AEs) in Each Treatment Arm and Overall
Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 50Population: The Safety Population consists of all participants who received at least one dose of vaccine and for whom any data on safety are available.
Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation participant administered a study product regardless of its causal relationship to the study product administration. Unsolicited, non-serious AEs were collected from participants from Day 1 through Day 28 after the last vaccination (Day 50). Events were determined to be related if there was a reasonable possibility that the study product caused the AE; that is, there was evidence to suggest a causal relationship between the study product and the AE. Each event was graded as mild, moderate, or severe. Participants are counted according to their maximum severity of event reported. Participants reporting no vaccine-related AEs are counted under "None".
Outcome measures
| Measure |
Low Dose ChAd155-RG
n=14 Participants
One dose (1 ml (5x10\^10 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x1)
n=14 Participants
One dose (1 ml (1x10\^11 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x2)
n=10 Participants
Two doses (1 ml (1x10\^11 vp) each) of ChAd155-RG vaccine administered intramuscularly on Day 1 (first dose) and Day 15 (second dose), and 1 ml of matching placebo administered intramuscularly on Days 8 and 22.
|
RABAVERT
n=12 Participants
Three doses (1 ml each) of RABAVERT vaccine administered intramuscularly on Day 1 (first dose), Day 8 (second dose), and Day 22 (third dose), and 1 ml of matching placebo administered intramuscularly on Day 15.
|
All Participants
n=50 Participants
All participants include every participant in the Low Dose ChAd155-RG arm, High Dose ChAd155-RG (x1) arm, High Dose ChAd155-RG (x2) arm, and RABAVERT arm.
|
|---|---|---|---|---|---|
|
Number and Percentage of Participants With Unsolicited Study Vaccine-related Adverse Events (AEs) in Each Treatment Arm and Overall
None
|
14 Participants
|
13 Participants
|
10 Participants
|
11 Participants
|
48 Participants
|
|
Number and Percentage of Participants With Unsolicited Study Vaccine-related Adverse Events (AEs) in Each Treatment Arm and Overall
Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number and Percentage of Participants With Unsolicited Study Vaccine-related Adverse Events (AEs) in Each Treatment Arm and Overall
Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Unsolicited Study Vaccine-related Adverse Events (AEs) in Each Treatment Arm and Overall
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 381Population: The Safety Population consists of all participants who received at least one dose of vaccine and for whom any data on safety are available
Participants were queried at each visit for the occurrence of new onset chronic medical conditions throughout the duration of the study.
Outcome measures
| Measure |
Low Dose ChAd155-RG
n=14 Participants
One dose (1 ml (5x10\^10 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x1)
n=14 Participants
One dose (1 ml (1x10\^11 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x2)
n=10 Participants
Two doses (1 ml (1x10\^11 vp) each) of ChAd155-RG vaccine administered intramuscularly on Day 1 (first dose) and Day 15 (second dose), and 1 ml of matching placebo administered intramuscularly on Days 8 and 22.
|
RABAVERT
n=12 Participants
Three doses (1 ml each) of RABAVERT vaccine administered intramuscularly on Day 1 (first dose), Day 8 (second dose), and Day 22 (third dose), and 1 ml of matching placebo administered intramuscularly on Day 15.
|
All Participants
n=50 Participants
All participants include every participant in the Low Dose ChAd155-RG arm, High Dose ChAd155-RG (x1) arm, High Dose ChAd155-RG (x2) arm, and RABAVERT arm.
|
|---|---|---|---|---|---|
|
Number and Percentage of Participants With New Onset of a Chronic Medical Condition in Each Treatment Arm and Overall
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 381Population: The Safety Population consists of all participants who received at least one dose of vaccine and for whom any data on safety are available.
An AE or suspected AE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Each event was graded as mild, moderate, or severe. Participants are counted according to their maximum severity of event reported. Participants reporting no SAEs are counted under "None".
Outcome measures
| Measure |
Low Dose ChAd155-RG
n=14 Participants
One dose (1 ml (5x10\^10 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x1)
n=14 Participants
One dose (1 ml (1x10\^11 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x2)
n=10 Participants
Two doses (1 ml (1x10\^11 vp) each) of ChAd155-RG vaccine administered intramuscularly on Day 1 (first dose) and Day 15 (second dose), and 1 ml of matching placebo administered intramuscularly on Days 8 and 22.
|
RABAVERT
n=12 Participants
Three doses (1 ml each) of RABAVERT vaccine administered intramuscularly on Day 1 (first dose), Day 8 (second dose), and Day 22 (third dose), and 1 ml of matching placebo administered intramuscularly on Day 15.
|
All Participants
n=50 Participants
All participants include every participant in the Low Dose ChAd155-RG arm, High Dose ChAd155-RG (x1) arm, High Dose ChAd155-RG (x2) arm, and RABAVERT arm.
|
|---|---|---|---|---|---|
|
Number and Percentage of Participants With Serious Adverse Events (SAEs) in Each Treatment Arm and Overall
None
|
14 Participants
|
14 Participants
|
10 Participants
|
12 Participants
|
50 Participants
|
|
Number and Percentage of Participants With Serious Adverse Events (SAEs) in Each Treatment Arm and Overall
Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Serious Adverse Events (SAEs) in Each Treatment Arm and Overall
Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Serious Adverse Events (SAEs) in Each Treatment Arm and Overall
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 8, Day 15, Day 22, Day 29, Day 91, Day 181, and Day 381Population: The Modified Intent-to-Treat population consists of all subjects who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Serum samples for rabies VNA were collected prior to vaccination (Day 1) and on Day 8, Day 15, Day 22, Day 29, Day 91, Day 181, and Day 381. Results from the rabies VNA RFFIT assay were reported in IU/mL, with a typical range of 1-15 IU/mL. Results beyond 15 IU/mL required dilution and retesting per the lab's standard operating procedures. The lower limit of quantification for the RFFIT assay is 0.1 IU/mL; values below the LLOQ were imputed as 1/2 the LLOQ, or 0.05 IU/mL. Seroconverting to rabies virus is defined as VNA concentration =0.5 IU/mL post-vaccination.
Outcome measures
| Measure |
Low Dose ChAd155-RG
n=14 Participants
One dose (1 ml (5x10\^10 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x1)
n=14 Participants
One dose (1 ml (1x10\^11 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x2)
n=10 Participants
Two doses (1 ml (1x10\^11 vp) each) of ChAd155-RG vaccine administered intramuscularly on Day 1 (first dose) and Day 15 (second dose), and 1 ml of matching placebo administered intramuscularly on Days 8 and 22.
|
RABAVERT
n=11 Participants
Three doses (1 ml each) of RABAVERT vaccine administered intramuscularly on Day 1 (first dose), Day 8 (second dose), and Day 22 (third dose), and 1 ml of matching placebo administered intramuscularly on Day 15.
|
All Participants
n=49 Participants
All participants include every participant in the Low Dose ChAd155-RG arm, High Dose ChAd155-RG (x1) arm, High Dose ChAd155-RG (x2) arm, and RABAVERT arm.
|
|---|---|---|---|---|---|
|
Percentage of Participants Seroconverting to Rabies Virus in Each Treatment Arm and Overall
Day 8
|
0 percentage of participants
Interval 0.0 to 24.7
|
0 percentage of participants
Interval 0.0 to 23.2
|
0 percentage of participants
Interval 0.0 to 30.8
|
0 percentage of participants
Interval 0.0 to 28.5
|
0 percentage of participants
Interval 0.0 to 7.4
|
|
Percentage of Participants Seroconverting to Rabies Virus in Each Treatment Arm and Overall
Day 15
|
43 percentage of participants
Interval 17.7 to 71.1
|
57 percentage of participants
Interval 28.9 to 82.3
|
89 percentage of participants
Interval 51.8 to 99.7
|
82 percentage of participants
Interval 48.2 to 97.7
|
65 percentage of participants
Interval 49.5 to 77.8
|
|
Percentage of Participants Seroconverting to Rabies Virus in Each Treatment Arm and Overall
Day 22
|
50 percentage of participants
Interval 23.0 to 77.0
|
64 percentage of participants
Interval 35.1 to 87.2
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 71.5 to 100.0
|
76 percentage of participants
Interval 61.1 to 86.7
|
|
Percentage of Participants Seroconverting to Rabies Virus in Each Treatment Arm and Overall
Day 29
|
64 percentage of participants
Interval 35.1 to 87.2
|
62 percentage of participants
Interval 31.6 to 86.1
|
100 percentage of participants
Interval 66.4 to 100.0
|
100 percentage of participants
Interval 71.5 to 100.0
|
79 percentage of participants
Interval 64.3 to 89.3
|
|
Percentage of Participants Seroconverting to Rabies Virus in Each Treatment Arm and Overall
Day 91
|
40 percentage of participants
Interval 12.2 to 73.8
|
70 percentage of participants
Interval 34.8 to 93.3
|
67 percentage of participants
Interval 22.3 to 95.7
|
100 percentage of participants
Interval 63.1 to 100.0
|
68 percentage of participants
Interval 49.5 to 82.6
|
|
Percentage of Participants Seroconverting to Rabies Virus in Each Treatment Arm and Overall
Day 181
|
29 percentage of participants
Interval 8.4 to 58.1
|
40 percentage of participants
Interval 12.2 to 73.8
|
33 percentage of participants
Interval 7.5 to 70.1
|
91 percentage of participants
Interval 58.7 to 99.8
|
48 percentage of participants
Interval 32.5 to 63.3
|
|
Percentage of Participants Seroconverting to Rabies Virus in Each Treatment Arm and Overall
Day 381
|
29 percentage of participants
Interval 8.4 to 58.1
|
22 percentage of participants
Interval 2.8 to 60.0
|
13 percentage of participants
Interval 0.3 to 52.7
|
63 percentage of participants
Interval 24.5 to 91.5
|
31 percentage of participants
Interval 17.0 to 47.6
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 15, Day 22, Day 29, Day 91, Day 181, and Day 381Population: The Modified Intent-to-Treat population consists of all subjects who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Serum samples for rabies VNA were collected prior to vaccination (Day 1) and on Day 8, Day 15, Day 22, Day 29, Day 91, Day 181, and Day 381. Results from the rabies VNA RFFIT assay were reported in IU/mL, with a typical range of 1-15 IU/mL. Results beyond 15 IU/mL required dilution and retesting per the lab's standard operating procedures. The lower limit of quantification for the RFFIT assay is 0.1 IU/mL; values below the LLOQ were imputed as 1/2 the LLOQ, or 0.05 IU/mL. The geometric mean titer was calculated for each study arm at each immunogenicity time point.
Outcome measures
| Measure |
Low Dose ChAd155-RG
n=14 Participants
One dose (1 ml (5x10\^10 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x1)
n=14 Participants
One dose (1 ml (1x10\^11 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x2)
n=10 Participants
Two doses (1 ml (1x10\^11 vp) each) of ChAd155-RG vaccine administered intramuscularly on Day 1 (first dose) and Day 15 (second dose), and 1 ml of matching placebo administered intramuscularly on Days 8 and 22.
|
RABAVERT
n=11 Participants
Three doses (1 ml each) of RABAVERT vaccine administered intramuscularly on Day 1 (first dose), Day 8 (second dose), and Day 22 (third dose), and 1 ml of matching placebo administered intramuscularly on Day 15.
|
All Participants
n=49 Participants
All participants include every participant in the Low Dose ChAd155-RG arm, High Dose ChAd155-RG (x1) arm, High Dose ChAd155-RG (x2) arm, and RABAVERT arm.
|
|---|---|---|---|---|---|
|
Rabies VNA Geometric Mean Titer
Day 1
|
0.05 titer
Interval 0.05 to 0.06
|
0.05 titer
Not calculable due to insufficient variability.
|
0.05 titer
Not calculable due to insufficient variability.
|
0.05 titer
Not calculable due to insufficient variability.
|
0.05 titer
Interval 0.05 to 0.05
|
|
Rabies VNA Geometric Mean Titer
Day 8
|
0.05 titer
Interval 0.05 to 0.06
|
0.05 titer
Not calculable due to insufficient variability.
|
0.05 titer
Not calculable due to insufficient variability.
|
0.06 titer
Interval 0.05 to 0.09
|
0.05 titer
Interval 0.05 to 0.06
|
|
Rabies VNA Geometric Mean Titer
Day 15
|
0.41 titer
Interval 0.15 to 1.16
|
0.54 titer
Interval 0.25 to 1.16
|
0.78 titer
Interval 0.44 to 1.38
|
0.89 titer
Interval 0.39 to 2.03
|
0.60 titer
Interval 0.4 to 0.89
|
|
Rabies VNA Geometric Mean Titer
Day 22
|
0.7 titer
Interval 0.28 to 1.76
|
0.79 titer
Interval 0.39 to 1.6
|
1.65 titer
Interval 0.86 to 3.17
|
2.35 titer
Interval 1.13 to 4.88
|
1.13 titer
Interval 0.78 to 1.66
|
|
Rabies VNA Geometric Mean Titer
Day 29
|
0.67 titer
Interval 0.27 to 1.65
|
0.68 titer
Interval 0.33 to 1.4
|
1.30 titer
Interval 0.73 to 2.31
|
10.58 titer
Interval 6.48 to 17.3
|
1.45 titer
Interval 0.91 to 2.33
|
|
Rabies VNA Geometric Mean Titer
Day 91
|
0.28 titer
Interval 0.1 to 0.8
|
0.49 titer
Interval 0.24 to 0.98
|
0.44 titer
Interval 0.2 to 0.96
|
2.49 titer
Interval 1.28 to 4.88
|
0.60 titer
Interval 0.38 to 0.95
|
|
Rabies VNA Geometric Mean Titer
Day 181
|
0.20 titer
Interval 0.08 to 0.5
|
0.37 titer
Interval 0.16 to 0.86
|
0.19 titer
Interval 0.1 to 0.37
|
0.92 titer
Interval 0.43 to 1.97
|
0.33 titer
Interval 0.22 to 0.51
|
|
Rabies VNA Geometric Mean Titer
Day 381
|
0.14 titer
Interval 0.06 to 0.31
|
0.16 titer
Interval 0.07 to 0.34
|
0.16 titer
Interval 0.07 to 0.34
|
0.84 titer
Interval 0.36 to 1.99
|
0.21 titer
Interval 0.14 to 0.33
|
SECONDARY outcome
Timeframe: Day 8 through Day 381Population: The Modified Intent-to-Treat population consists of all subjects who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Serum samples for rabies VNA were collected prior to vaccination (Day 1) and on Day 8, Day 15, Day 22, Day 29, Day 91, Day 181, and Day 381. Results from the rabies VNA RFFIT assay were reported in IU/mL, with a typical range of 1-15 IU/mL. Results beyond 15 IU/mL required dilution and retesting per the lab's standard operating procedures. The lower limit of quantification for the RFFIT assay is 0.1 IU/mL; values below the LLOQ were imputed as 1/2 the LLOQ, or 0.05 IU/mL. Peak geometric mean titer was defined for each study arm as the geometric mean of the highest titer per participant across all post-vaccination antibody timepoints.
Outcome measures
| Measure |
Low Dose ChAd155-RG
n=14 Participants
One dose (1 ml (5x10\^10 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x1)
n=14 Participants
One dose (1 ml (1x10\^11 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x2)
n=10 Participants
Two doses (1 ml (1x10\^11 vp) each) of ChAd155-RG vaccine administered intramuscularly on Day 1 (first dose) and Day 15 (second dose), and 1 ml of matching placebo administered intramuscularly on Days 8 and 22.
|
RABAVERT
n=11 Participants
Three doses (1 ml each) of RABAVERT vaccine administered intramuscularly on Day 1 (first dose), Day 8 (second dose), and Day 22 (third dose), and 1 ml of matching placebo administered intramuscularly on Day 15.
|
All Participants
n=49 Participants
All participants include every participant in the Low Dose ChAd155-RG arm, High Dose ChAd155-RG (x1) arm, High Dose ChAd155-RG (x2) arm, and RABAVERT arm.
|
|---|---|---|---|---|---|
|
Peak Rabies VNA Geometric Mean Titer
|
0.94 titer
Interval 0.37 to 2.36
|
0.90 titer
Interval 0.44 to 1.84
|
1.65 titer
Interval 0.86 to 3.17
|
10.63 titer
Interval 6.5 to 17.38
|
1.79 titer
Interval 1.15 to 2.79
|
Adverse Events
Low Dose ChAd155-RG
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
High Dose ChAd155-RG (x1)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
High Dose ChAd155-RG (x2)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
RABAVERT
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose ChAd155-RG
n=14 participants at risk
One dose (1 ml (5x10\^10 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x1)
n=14 participants at risk
One dose (1 ml (1x10\^11 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, and 22.
|
High Dose ChAd155-RG (x2)
n=10 participants at risk
Two doses (1 ml (1x10\^11 vp) each) of ChAd155-RG vaccine administered intramuscularly on Day 1 (first dose) and Day 15 (second dose), and 1 ml of matching placebo administered intramuscularly on Days 8 and 22.
|
RABAVERT
n=12 participants at risk
Three doses (1 ml each) of RABAVERT vaccine administered intramuscularly on Day 1 (first dose), Day 8 (second dose), and Day 22 (third dose), and 1 ml of matching placebo administered intramuscularly on Day 15.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
7.1%
1/14 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/10 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/12 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Gastrointestinal disorders
Nausea
|
21.4%
3/14 • Number of events 5 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
7.1%
1/14 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
30.0%
3/10 • Number of events 5 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
8.3%
1/12 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
General disorders
Fatigue
|
57.1%
8/14 • Number of events 16 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
78.6%
11/14 • Number of events 16 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
90.0%
9/10 • Number of events 13 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
50.0%
6/12 • Number of events 8 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
General disorders
Feeling of body temperature change
|
35.7%
5/14 • Number of events 6 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
42.9%
6/14 • Number of events 8 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
70.0%
7/10 • Number of events 8 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
25.0%
3/12 • Number of events 7 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
7.1%
1/14 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/10 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
8.3%
1/12 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
General disorders
Malaise
|
42.9%
6/14 • Number of events 7 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
71.4%
10/14 • Number of events 12 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
60.0%
6/10 • Number of events 8 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
33.3%
4/12 • Number of events 7 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
General disorders
Pyrexia
|
7.1%
1/14 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
40.0%
4/10 • Number of events 4 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
25.0%
3/12 • Number of events 3 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
General disorders
Vaccination site erythema
|
14.3%
2/14 • Number of events 3 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
14.3%
2/14 • Number of events 2 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
30.0%
3/10 • Number of events 5 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
25.0%
3/12 • Number of events 3 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
General disorders
Vaccination site induration
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
10.0%
1/10 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
8.3%
1/12 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
General disorders
Vaccination site pain
|
64.3%
9/14 • Number of events 19 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
78.6%
11/14 • Number of events 22 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
100.0%
10/10 • Number of events 29 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
91.7%
11/12 • Number of events 44 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
General disorders
Vaccination site pruritus
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/10 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
8.3%
1/12 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Infections and infestations
Gastroenteritis
|
7.1%
1/14 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/10 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/12 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
7.1%
1/14 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/10 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/12 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
1/14 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
7.1%
1/14 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/10 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/12 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/10 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
8.3%
1/12 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
7.1%
1/14 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/10 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/12 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
7.1%
1/14 • Number of events 2 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/10 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/12 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
1/14 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
7.1%
1/14 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
10.0%
1/10 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/12 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
7.1%
1/14 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
10.0%
1/10 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/12 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
21.4%
3/14 • Number of events 6 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/10 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/12 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Investigations
Blood pressure diastolic increased
|
7.1%
1/14 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/10 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/12 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Investigations
Blood pressure systolic increased
|
7.1%
1/14 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/10 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
8.3%
1/12 • Number of events 2 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Investigations
Blood urea increased
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
14.3%
2/14 • Number of events 6 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
10.0%
1/10 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/12 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Investigations
Haemoglobin decreased
|
7.1%
1/14 • Number of events 4 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
7.1%
1/14 • Number of events 4 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
20.0%
2/10 • Number of events 6 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
25.0%
3/12 • Number of events 8 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Investigations
Lymphocyte count decreased
|
7.1%
1/14 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
21.4%
3/14 • Number of events 3 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
30.0%
3/10 • Number of events 3 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
8.3%
1/12 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Investigations
Neutrophil count decreased
|
14.3%
2/14 • Number of events 2 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
14.3%
2/14 • Number of events 2 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
10.0%
1/10 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
8.3%
1/12 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Investigations
Platelet count decreased
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
7.1%
1/14 • Number of events 3 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/10 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/12 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Investigations
Platelet count increased
|
7.1%
1/14 • Number of events 8 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
7.1%
1/14 • Number of events 2 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
10.0%
1/10 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
16.7%
2/12 • Number of events 3 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Investigations
White blood cell count decreased
|
28.6%
4/14 • Number of events 6 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
28.6%
4/14 • Number of events 7 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
20.0%
2/10 • Number of events 2 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
8.3%
1/12 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Investigations
White blood cell count increased
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
7.1%
1/14 • Number of events 2 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
10.0%
1/10 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
8.3%
1/12 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
7.1%
1/14 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/10 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/12 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.4%
3/14 • Number of events 6 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
7.1%
1/14 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
30.0%
3/10 • Number of events 5 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
16.7%
2/12 • Number of events 2 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/10 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
8.3%
1/12 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.6%
4/14 • Number of events 5 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
64.3%
9/14 • Number of events 10 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
50.0%
5/10 • Number of events 10 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
33.3%
4/12 • Number of events 7 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Nervous system disorders
Headache
|
64.3%
9/14 • Number of events 17 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
92.9%
13/14 • Number of events 20 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
70.0%
7/10 • Number of events 13 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
41.7%
5/12 • Number of events 8 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Reproductive system and breast disorders
Vulval disorder
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
10.0%
1/10 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/12 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
7.1%
1/14 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/10 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/12 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
|
Vascular disorders
Hypotension
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/14 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
0.00%
0/10 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
8.3%
1/12 • Number of events 1 • Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.
|
Additional Information
Varun K. Phadke, MD
The Hope Clinic of the Emory Vaccine Center
Phone: 404-712-9046
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60