Trial Outcomes & Findings for Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-naïve Adults (NCT NCT03611946)
NCT ID: NCT03611946
Last Updated: 2025-08-05
Results Overview
Evaluated using the Adverse Event Grading Table in the study protocol.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
Solicited AE's assessed every visit through Day 28
Results posted on
2025-08-05
Participant Flow
Participant milestones
| Measure |
Cohort 1 - Vaccine
Single dose of rZIKV/D4Δ30-713 (10\^3 PFU) administered via subcutaneous injection (0.5ml).
|
Cohort 1 - Placebo
Single dose of placebo administered via subcutaneous injection (0.5ml).
|
Cohort 2 - Vaccine
Single dose of rZIKV/D4Δ30-713 (10\^4 PFU) administered via subcutaneous injection (0.5ml)
|
Cohort 2 - Placebo
Single dose of placebo administered via subcutaneous injection (0.5ml)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
8
|
20
|
8
|
|
Overall Study
COMPLETED
|
20
|
8
|
19
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 - Vaccine
Single dose of rZIKV/D4Δ30-713 (10\^3 PFU) administered via subcutaneous injection (0.5ml).
|
Cohort 1 - Placebo
Single dose of placebo administered via subcutaneous injection (0.5ml).
|
Cohort 2 - Vaccine
Single dose of rZIKV/D4Δ30-713 (10\^4 PFU) administered via subcutaneous injection (0.5ml)
|
Cohort 2 - Placebo
Single dose of placebo administered via subcutaneous injection (0.5ml)
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-naïve Adults
Baseline characteristics by cohort
| Measure |
Cohort 1 - Vaccine
n=20 Participants
rZIKV/D4Δ30-713 (10\^3 PFU) via subcutaneous injection (0.5ml).
|
Cohort 1 - Placebo
n=8 Participants
Administered via subcutaneous injection (0.5ml).
|
Cohort 2 - Vaccine
n=20 Participants
rZIKV/D4Δ30-713 (10\^4 PFU) via subcutaneous injection (0.5ml)
|
Cohort 2 - Placebo
n=8 Participants
Administered via subcutaneous injection (0.5ml).
|
Total
n=56 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
56 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
19 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
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 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
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
PRNT (50) ZIKV <= 10
|
20 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Solicited AE's assessed every visit through Day 28Evaluated using the Adverse Event Grading Table in the study protocol.
Outcome measures
| Measure |
Cohort 1 - Vaccine
n=20 Participants
rZIKV/D4Δ30-713 (10\^3 PFU) administered via subcutaneous injection (0.5ml)
|
Cohort 1 Placebo
n=8 Participants
Placebo administered via subcutaneous injection (0.5ml)
|
Cohort 2 - Vaccine
n=20 Participants
rZIKV/D4Δ30-713 (10\^4 PFU) administered via subcutaneous injection (0.5ml)
|
Cohort 2 Placebo
n=8 Participants
Placebo administered via subcutaneous injection (0.5ml)
|
|---|---|---|---|---|
|
Number of Participants With Solicited Local and General Adverse Events (AEs)
headache
|
10 Participants
|
5 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants With Solicited Local and General Adverse Events (AEs)
fatigue
|
5 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Solicited Local and General Adverse Events (AEs)
nausea
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Solicited Local and General Adverse Events (AEs)
myalgia
|
4 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Solicited Local and General Adverse Events (AEs)
arthralgia
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and General Adverse Events (AEs)
retro-orbital pain (ROP)
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Solicited Local and General Adverse Events (AEs)
photophobia
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and General Adverse Events (AEs)
injection site erythema
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and General Adverse Events (AEs)
muscle weakness
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and General Adverse Events (AEs)
fever
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and General Adverse Events (AEs)
Zika-like rash
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and General Adverse Events (AEs)
elevated ALT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and General Adverse Events (AEs)
Neutropenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and General Adverse Events (AEs)
Thrombocytopenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and General Adverse Events (AEs)
Injection Site Pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and General Adverse Events (AEs)
Injection Site Tenderness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and General Adverse Events (AEs)
Injection Site Induration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and General Adverse Events (AEs)
Injection Site Pruritus
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and General Adverse Events (AEs)
prolonged PT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and General Adverse Events (AEs)
prolonged PTT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Day 28Population: Note "titer" is not available under "measure type" option. Therefore we went with the best-fitting answer of "number".
Determination of the serum plaque reduction neutralization titer 50% (PRNT50) to ZIKV for each subject at Study Day 28 post-inoculation. Seroconversion will be defined as achieving a PRNT50 ≥ 1:10 at any time-point through Study Day 28. The peak PRNT50 to ZIKV through Study Day 28 will be calculated for each subject included in the per-protocol an intent-to-treat analysis and the geometric mean peak titer for vaccinated subjects will be calculated.
Outcome measures
| Measure |
Cohort 1 - Vaccine
n=20 Participants
rZIKV/D4Δ30-713 (10\^3 PFU) administered via subcutaneous injection (0.5ml)
|
Cohort 1 Placebo
n=19 Participants
Placebo administered via subcutaneous injection (0.5ml)
|
Cohort 2 - Vaccine
rZIKV/D4Δ30-713 (10\^4 PFU) administered via subcutaneous injection (0.5ml)
|
Cohort 2 Placebo
Placebo administered via subcutaneous injection (0.5ml)
|
|---|---|---|---|---|
|
To Determine the Immunogenicity of a Single Dose of rZIKV/D4Δ30-713
|
56.1 PRNT(50) Titer
Interval 12.3 to 59.2
|
126.1 PRNT(50) Titer
Interval 49.8 to 320.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Day 90Population: Analysis that is applicable only to post-vaccine (not placebo) subjects.
Assess the frequency, quantity, and duration of viremia (virus in the blood) induced by a single dose of the rZIKV/D4Δ30-713 vaccine. The mean peak viremia, mean day of onset of viremia, and mean duration of viremia will be calculated. Viremia will be detected by culture (infectious virus) and by RT-PCR.
Outcome measures
| Measure |
Cohort 1 - Vaccine
n=20 Participants
rZIKV/D4Δ30-713 (10\^3 PFU) administered via subcutaneous injection (0.5ml)
|
Cohort 1 Placebo
Placebo administered via subcutaneous injection (0.5ml)
|
Cohort 2 - Vaccine
n=19 Participants
rZIKV/D4Δ30-713 (10\^4 PFU) administered via subcutaneous injection (0.5ml)
|
Cohort 2 Placebo
Placebo administered via subcutaneous injection (0.5ml)
|
|---|---|---|---|---|
|
Viremia Induced by Vaccine (Number of Participants With Detectable Virus at Any Time Point)
|
0 #participants w/ vaccine-induced viremia
|
—
|
0 #participants w/ vaccine-induced viremia
|
—
|
SECONDARY outcome
Timeframe: Measured through Day 180Population: Analysis that is applicable only to post-vaccine (not placebo) subjects.
Determine the number of vaccinees infected with rZIKV/D4Δ30-713. Infection is defined as recovery of infectious vaccine virus from the blood, serum or urine of a subject and/or by seroconversion to ZIKV. Seroconversion will be defined as achieving a PRNT50 ≥ 1:10 by Study Day 90 post-vaccination.
Outcome measures
| Measure |
Cohort 1 - Vaccine
n=20 Participants
rZIKV/D4Δ30-713 (10\^3 PFU) administered via subcutaneous injection (0.5ml)
|
Cohort 1 Placebo
Placebo administered via subcutaneous injection (0.5ml)
|
Cohort 2 - Vaccine
n=19 Participants
rZIKV/D4Δ30-713 (10\^4 PFU) administered via subcutaneous injection (0.5ml)
|
Cohort 2 Placebo
Placebo administered via subcutaneous injection (0.5ml)
|
|---|---|---|---|---|
|
Number of Vaccinees Infected With rZIKV/D4Δ30-713
|
9 #participants who seroconverted
|
—
|
7 #participants who seroconverted
|
—
|
SECONDARY outcome
Timeframe: Measured through Day 180Population: Analysis that is applicable only to post-vaccine (not placebo) subjects.
Evaluate the immunogenicity of rZIKV/D4Δ30-713 in flavivirus-naïve subjects as assessed by the PRNT50 to ZIKV, for each subject at Study Day 28, 56, and 90 post-administration of LA Zika vaccine. Expressed as geometric mean peak titer, reciprocal (median). Geometric mean titer was calculated at each time point for only those subjects with a titer of \>= 10, reciprocal. Seroconversion was defined as a PRNT(50) of \>= 10, reciprocal.
Outcome measures
| Measure |
Cohort 1 - Vaccine
n=20 Participants
rZIKV/D4Δ30-713 (10\^3 PFU) administered via subcutaneous injection (0.5ml)
|
Cohort 1 Placebo
Placebo administered via subcutaneous injection (0.5ml)
|
Cohort 2 - Vaccine
n=19 Participants
rZIKV/D4Δ30-713 (10\^4 PFU) administered via subcutaneous injection (0.5ml)
|
Cohort 2 Placebo
Placebo administered via subcutaneous injection (0.5ml)
|
|---|---|---|---|---|
|
Immunogenicity of rZIKV/D4Δ30-713 in Flavivirus-naïve Subjects
|
56.1 titer
Interval 12.3 to 59.2
|
—
|
126.1 titer
Interval 15.2 to 320.0
|
—
|
SECONDARY outcome
Timeframe: 26 Weeks post vaccinationPopulation: Analysis that is applicable only to post-vaccine (not placebo) subjects.
Determine the durability of antibody response 26 weeks after vaccination. Neutralizing antibody titers to ZIKV were measured at 0, 28, 56, 90, 150, and 180 days following vaccination, with the peak neutralizing antibody titer determined as the peak titer in the 90 days following vaccination for either dose cohort.
Outcome measures
| Measure |
Cohort 1 - Vaccine
n=20 Participants
rZIKV/D4Δ30-713 (10\^3 PFU) administered via subcutaneous injection (0.5ml)
|
Cohort 1 Placebo
Placebo administered via subcutaneous injection (0.5ml)
|
Cohort 2 - Vaccine
n=19 Participants
rZIKV/D4Δ30-713 (10\^4 PFU) administered via subcutaneous injection (0.5ml)
|
Cohort 2 Placebo
Placebo administered via subcutaneous injection (0.5ml)
|
|---|---|---|---|---|
|
Durability of Antibody Response
|
56.1 titer
Interval 12.3 to 59.2
|
—
|
126.1 titer
Interval 15.2 to 320.0
|
—
|
SECONDARY outcome
Timeframe: 90 days post vaccinationPopulation: Number of participants with recovered ZIKV from any bodily fluid (serum, urine, semen, and cervico-vaginal secretions) at any time point post-vaccination, as assessed by PCR and culture.
Determine the quantity and duration of ZIKV presence as determined by: * The peak virus titer in the blood and the duration of viremia induced by the LA Zika vaccine as determined by RT-PCR and virus culture * The quantity and duration of possible Zika vaccine shedding in urine determined by RT-PCR and virus culture * The quantity and duration of possible Zika vaccine shedding in vaginal secretions determined by RT-PCR and virus culture * The quantity and duration of possible Zika vaccine shedding in semen determined by RT-PCR and virus culture
Outcome measures
| Measure |
Cohort 1 - Vaccine
n=20 Participants
rZIKV/D4Δ30-713 (10\^3 PFU) administered via subcutaneous injection (0.5ml)
|
Cohort 1 Placebo
n=8 Participants
Placebo administered via subcutaneous injection (0.5ml)
|
Cohort 2 - Vaccine
n=19 Participants
rZIKV/D4Δ30-713 (10\^4 PFU) administered via subcutaneous injection (0.5ml)
|
Cohort 2 Placebo
n=8 Participants
Placebo administered via subcutaneous injection (0.5ml)
|
|---|---|---|---|---|
|
Quantity and Duration of ZIKV Presence
Recovered vaccine virus from serum at any time point post-vaccination as assessed by PCR and culture
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Quantity and Duration of ZIKV Presence
Recovered vaccine virus from urine at any time point post-vaccination as assessed by PCR and culture
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Quantity and Duration of ZIKV Presence
Recovered vaccine virus from semen at any time point post-vaccination as assessed by PCR and culture
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Quantity and Duration of ZIKV Presence
Recovered vaccine virus from CVS at any time point post-vaccination as assessed by PCR and culture
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
Adverse Events
Cohort 1 - Vaccine
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Cohort 1 - Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2 - Vaccine
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort 2 - Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 - Vaccine
n=20 participants at risk
rZIKV/D4Δ30-713 (10\^3 PFU) administered via subcutaneous injection (0.5ml)
|
Cohort 1 - Placebo
n=8 participants at risk
Placebo administered via subcutaneous injection (0.5ml)
|
Cohort 2 - Vaccine
n=20 participants at risk
rZIKV/D4Δ30-713 (10\^4 PFU) administered via subcutaneous injection (0.5ml)
|
Cohort 2 - Placebo
n=8 participants at risk
Placebo administered via subcutaneous injection (0.5ml)
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/20 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
0.00%
0/8 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
5.0%
1/20 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
0.00%
0/8 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
Other adverse events
| Measure |
Cohort 1 - Vaccine
n=20 participants at risk
rZIKV/D4Δ30-713 (10\^3 PFU) administered via subcutaneous injection (0.5ml)
|
Cohort 1 - Placebo
n=8 participants at risk
Placebo administered via subcutaneous injection (0.5ml)
|
Cohort 2 - Vaccine
n=20 participants at risk
rZIKV/D4Δ30-713 (10\^4 PFU) administered via subcutaneous injection (0.5ml)
|
Cohort 2 - Placebo
n=8 participants at risk
Placebo administered via subcutaneous injection (0.5ml)
|
|---|---|---|---|---|
|
General disorders
Headache
|
50.0%
10/20 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
62.5%
5/8 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
40.0%
8/20 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
62.5%
5/8 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
4/20 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
25.0%
2/8 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
15.0%
3/20 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
25.0%
2/8 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
2/20 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
12.5%
1/8 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
10.0%
2/20 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
0.00%
0/8 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
|
Eye disorders
Retroorbital pain
|
5.0%
1/20 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
12.5%
1/8 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
0.00%
0/20 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
25.0%
2/8 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
|
General disorders
Fatigue
|
25.0%
5/20 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
25.0%
2/8 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
20.0%
4/20 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
25.0%
2/8 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
4/20 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
25.0%
2/8 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
10.0%
2/20 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
25.0%
2/8 • All AEs will be evaluated for severity, action taken, seriousness, outcome, and relationship to the investigational vaccine as described in Section 8.2 in this protocol. AEs will be collected through the 28- day period following inoculation, and any test agent-related AEs (adverse reactions) identified in the 28-day post-inoculation period will be followed until resolution.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place