Trial Outcomes & Findings for Safety/Immunogenicity/Genetic Drift of MP-12 Rift Valley Fever Vaccine (NCT NCT00415051)
NCT ID: NCT00415051
Last Updated: 2020-01-03
Results Overview
AE's will be assessed through study completion. Safety will be evaluated by recording the frequency of clinical reactions to the vaccine and by measuring complete blood counts and selected serum biochemistry (enzyme) values, rates of hospitalizations, and rates of lost duty/work time overall and by gender.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
up to 1 year
Results posted on
2020-01-03
Participant Flow
Twenty subjects were planned; 31 were screened, 11 did not meet the inclusion/exclusion criteria, 20 satisfied inclusion/exclusion criteria, 20 were enrolled, 1 was excluded (received another vaccine within 30 days of intended MP-12 vaccination), and 19 received vaccine and completed the study.
Participant milestones
| Measure |
Single Group Assignment
RVF MP-12
RVF MP-12: Administer 1 ml SQ
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Single Group Assignment
RVF MP-12
RVF MP-12: Administer 1 ml SQ
|
|---|---|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Safety/Immunogenicity/Genetic Drift of MP-12 Rift Valley Fever Vaccine
Baseline characteristics by cohort
| Measure |
Single Group Assignment
n=19 Participants
RVF MP-12
RVF MP-12: Administer 1 ml SQ
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
33 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 1 yearAE's will be assessed through study completion. Safety will be evaluated by recording the frequency of clinical reactions to the vaccine and by measuring complete blood counts and selected serum biochemistry (enzyme) values, rates of hospitalizations, and rates of lost duty/work time overall and by gender.
Outcome measures
| Measure |
Single Group Assignment
n=19 Participants
RVF MP-12
RVF MP-12: Administer 1 ml SQ
|
|---|---|
|
Safety as Measured by the Number of Adverse Events
Local AEs Related and Not Related to Study Drug
|
22 AEs
|
|
Safety as Measured by the Number of Adverse Events
Systemic AEs Related and Not Related to Study Drug
|
130 AEs
|
SECONDARY outcome
Timeframe: Days 0, 1, 2, 3, 7, 10, 14 and 28, Months 3, 6 and 12Immune response will be assessed by measuring days to peak response for PRNT80 antibodies to RVF virus
Outcome measures
| Measure |
Single Group Assignment
n=19 Participants
RVF MP-12
RVF MP-12: Administer 1 ml SQ
|
|---|---|
|
Immune Response Assessed by Measuring Days to Peak Response for PRNT80 Antibodies to RVF Virus
Days to peak PRNT80
|
71.1 Days
Standard Deviation 74.4
|
|
Immune Response Assessed by Measuring Days to Peak Response for PRNT80 Antibodies to RVF Virus
Days to peak PRNT80 response
|
16.6 Days
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Days 0, 1, 2, 3, 7, 10, 14 and 28, Months 3, 6 and 12Immune response will be assessed by measuring days to peak response for PRNT50 antibodies to RVF virus
Outcome measures
| Measure |
Single Group Assignment
n=19 Participants
RVF MP-12
RVF MP-12: Administer 1 ml SQ
|
|---|---|
|
Immune Response Assessed by Measuring Days to Peak Response for (PRNT50) RVP MP-12 Vaccine
Days to peak PRNT50
|
82.2 Days
Standard Deviation 101.1
|
|
Immune Response Assessed by Measuring Days to Peak Response for (PRNT50) RVP MP-12 Vaccine
Days to peak PRNT50 response
|
15.0 Days
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Days 0-14Population: 1 subject was excluded for receiving another vaccination within 30 days of intended MP-12 vaccination.
In vitro systems will be used to evaluate genetic stability (examining viremia levels in plasma by direct plaque assay techniques or by blind passage of plasma on Vero cells and sequencing the ribonucleic acid (RNA) and comparing these findings with those from the vaccine virus inoculum).
Outcome measures
| Measure |
Single Group Assignment
n=19 Participants
RVF MP-12
RVF MP-12: Administer 1 ml SQ
|
|---|---|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 13 after vaccination - Negative
|
19 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 13 after vaccination - Positive
|
0 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 14 after vaccination - Negative
|
19 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 14 after vaccination - Positive
|
0 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 0 after vaccination - Negative
|
18 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 0 after vaccination - Positive
|
0 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 1 after vaccination - Negative
|
19 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 1 after vaccination - Positive
|
0 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 2 after vaccination - Negative
|
19 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 2 after vaccination - Positive
|
0 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 3 after vaccination - Negative
|
19 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 3 after vaccination - Positive
|
0 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 4 after vaccination - Negative
|
18 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 4 after vaccination - Positive
|
1 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 5 after vaccination - Negative
|
17 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 5 after vaccination - Positive
|
2 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 6 after vaccination - Negative
|
17 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 6 after vaccination - Positive
|
2 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 7 after vaccination - Negative
|
18 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 7 after vaccination - Positive
|
1 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 8 after vaccination - Negative
|
18 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 8 after vaccination - Positive
|
1 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 9 after vaccination - Negative
|
17 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 9 afterr vaccination - Positive
|
2 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 10 after vaccination - Negative
|
19 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 10 after vaccination - Positive
|
0 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 11 after vaccination - Negative
|
19 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 11 after vaccination - Positive
|
0 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 12 afterr vaccination - Negative
|
19 Participants
|
|
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Day 12 after vaccination - Positive
|
0 Participants
|
Adverse Events
Single Group Assignment
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Group Assignment
n=19 participants at risk
RVF MP-12
RVF MP-12: Administer 1 ml SQ
|
|---|---|
|
Nervous system disorders
Headache
|
84.2%
16/19 • Number of events 16 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
General disorders
Fatigue
|
52.6%
10/19 • Number of events 10 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Flu-like symptoms
|
31.6%
6/19 • Number of events 6 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
General disorders
Fever
|
21.1%
4/19 • Number of events 4 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Musculoskeletal and connective tissue disorders
Chills
|
10.5%
2/19 • Number of events 2 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Reproductive system and breast disorders
Menstrual cramps
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
26.3%
5/19 • Number of events 5 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Gastrointestinal disorders
Sore throat
|
10.5%
2/19 • Number of events 2 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Nervous system disorders
Blurred vision
|
10.5%
2/19 • Number of events 2 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Infections and infestations
Conjunctivitis (OS)
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Ear and labyrinth disorders
Ear discomfort
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Gastrointestinal disorders
Throat scratchy and sore
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Eye disorders
Left eye itching
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Nervous system disorders
Eyelid twitching
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Gastrointestinal disorders
Diarrhea
|
21.1%
4/19 • Number of events 4 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
2/19 • Number of events 2 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Gastrointestinal disorders
Abdominal cramping
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Gastrointestinal disorders
Dehydration
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Blood and lymphatic system disorders
Cervial nodes slightly tender
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Blood and lymphatic system disorders
Increase in bleeding post venipuncture
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
31.6%
6/19 • Number of events 6 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Musculoskeletal and connective tissue disorders
Lower back discomfort
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Musculoskeletal and connective tissue disorders
Knee joint pain
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Musculoskeletal and connective tissue disorders
Dental pain
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Musculoskeletal and connective tissue disorders
Ankel pain
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Musculoskeletal and connective tissue disorders
Stiff neck
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Nervous system disorders
Dizziness
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Nervous system disorders
Lightheaded
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Nervous system disorders
Spacey
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.8%
3/19 • Number of events 3 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chest congestion
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Skin and subcutaneous tissue disorders
Tenderness (vaccine site)
|
47.4%
9/19 • Number of events 9 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Skin and subcutaneous tissue disorders
Induration
|
15.8%
3/19 • Number of events 3 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Skin and subcutaneous tissue disorders
Redness (vaccine site)
|
15.8%
3/19 • Number of events 3 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Skin and subcutaneous tissue disorders
Clammy skin (hands)
|
10.5%
2/19 • Number of events 2 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Skin and subcutaneous tissue disorders
Bruise
|
10.5%
2/19 • Number of events 2 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Skin and subcutaneous tissue disorders
Itching
|
10.5%
2/19 • Number of events 2 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Skin and subcutaneous tissue disorders
Injection site warm
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Skin and subcutaneous tissue disorders
Redness (phlebotomy site)
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Skin and subcutaneous tissue disorders
Cold sore
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Immune system disorders
Allergic reaction
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Psychiatric disorders
Insomnia
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Reproductive system and breast disorders
Pain (testicle)
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Cardiac disorders
Heart palpitations
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
10.5%
2/19 • Number of events 2 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Nervous system disorders
Eye twitching
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Gastrointestinal disorders
Emesis
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Gastrointestinal disorders
Indigestion
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle ache
|
15.8%
3/19 • Number of events 3 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain (chest and back)
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain (lower back)
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain (shoulder)
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Surgical and medical procedures
Scar reconstruction ABD wall liposuction
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Musculoskeletal and connective tissue disorders
Shin splints
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Injury, poisoning and procedural complications
Shoulder injury
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Injury, poisoning and procedural complications
Traumatic injury to L middle finger
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Nervous system disorders
Migrane
|
10.5%
2/19 • Number of events 2 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.3%
1/19 • Number of events 1 • 1 year
Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
|
Additional Information
COL Phillip R. Pittman, MD, MPH
US Army Medical Research Institute of infectious Diseases (USAMRIID)
Phone: 301-619-4994
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place