Trial Outcomes & Findings for A Phase I Study of Safety & Immunogenicity of AERAS-456 in HIV-Neg. Adults Treated for Drug-susceptible Pulmonary TB (NCT NCT02375698)
NCT ID: NCT02375698
Last Updated: 2024-07-30
Results Overview
Unsolicited AEs: 28 days after each vaccination Solicited AEs: 7 days after each vaccination SAEs: through Day 420 Adverse events of special interest: through Day 420
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
Day 0 to Day 420
Results posted on
2024-07-30
Participant Flow
Participant milestones
| Measure |
H56:IC31 5/500
5ug H56 + 500 ug IC31
H56:IC31: H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c).
|
Placebo
The placebo consists of 10mM Tris and 169 mM NaCl pH 7.4.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
6
|
|
Overall Study
COMPLETED
|
14
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
H56:IC31 5/500
5ug H56 + 500 ug IC31
H56:IC31: H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c).
|
Placebo
The placebo consists of 10mM Tris and 169 mM NaCl pH 7.4.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Physician Decision
|
2
|
0
|
Baseline Characteristics
A Phase I Study of Safety & Immunogenicity of AERAS-456 in HIV-Neg. Adults Treated for Drug-susceptible Pulmonary TB
Baseline characteristics by cohort
| Measure |
H56:IC31 5/500
n=16 Participants
5ug H56 + 500 ug IC31
H56:IC31: H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c).
|
Placebo
n=6 Participants
The placebo consists of 10mM Tris and 169 mM NaCl pH 7.4.
|
Total
n=22 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
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
16 participants
n=5 Participants
|
6 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 420Population: Safety analysis set
Unsolicited AEs: 28 days after each vaccination Solicited AEs: 7 days after each vaccination SAEs: through Day 420 Adverse events of special interest: through Day 420
Outcome measures
| Measure |
H56:IC31 5/500
n=16 Participants
5ug H56 + 500 ug IC31
H56:IC31: H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c).
|
Placebo
n=6 Participants
The placebo consists of 10mM Tris and 169 mM NaCl pH 7.4.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with any AE
|
14 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with SAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 224Population: Immunogenicity analysis set
13-Color PBMC Intracellular Cytokine Staining (ICS) Assay using PBMCs Percent Antigen-specific T Cell DMSO-subtracted, ANY Cytokine Response - Change from Baseline T Cell: CD4
Outcome measures
| Measure |
H56:IC31 5/500
n=14 Participants
5ug H56 + 500 ug IC31
H56:IC31: H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c).
|
Placebo
n=4 Participants
The placebo consists of 10mM Tris and 169 mM NaCl pH 7.4.
|
|---|---|---|
|
Mean Percent Change From Baseline of Participants' Responses to TB Antigens Ag85A and ESAT-6
Stimulation Ag: ESAT-6
|
0.026 Percent change from baseline
Standard Deviation 0.0384
|
-0.018 Percent change from baseline
Standard Deviation 0.0037
|
|
Mean Percent Change From Baseline of Participants' Responses to TB Antigens Ag85A and ESAT-6
Stimulation Ag: Ag85B
|
0.014 Percent change from baseline
Standard Deviation 0.0375
|
-0.029 Percent change from baseline
Standard Deviation 0.0405
|
Adverse Events
Gr 1 H56:IC31 5/500
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gr 1 H56:IC31 5/500
n=16 participants at risk
5ug H56 + 500 ug IC31
H56:IC31: H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c).
|
Placebo
n=6 participants at risk
The placebo consists of 10mM Tris and 169 mM NaCl pH 7.4.
Placebo: The placebo consists of 10mM Tris and 169 mM NaCl pH 7.4.
|
|---|---|---|
|
Blood and lymphatic system disorders
EOSINOPHILIA
|
6.2%
1/16 • Number of events 1 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
0.00%
0/6 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/16 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
16.7%
1/6 • Number of events 1 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Cardiac disorders
BRADYCARDIA
|
25.0%
4/16 • Number of events 4 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
50.0%
3/6 • Number of events 3 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Cardiac disorders
TACHYCARDIA
|
12.5%
2/16 • Number of events 3 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
16.7%
1/6 • Number of events 1 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Gastrointestinal disorders
NAUSEA
|
12.5%
2/16 • Number of events 2 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
0.00%
0/6 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
General disorders
FATIGUE
|
25.0%
4/16 • Number of events 5 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
50.0%
3/6 • Number of events 4 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
General disorders
INJECTION SITE ERYTHEMA
|
18.8%
3/16 • Number of events 3 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
0.00%
0/6 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
General disorders
INJECTION SITE PAIN
|
37.5%
6/16 • Number of events 8 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
0.00%
0/6 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
General disorders
INJECTION SITE SWELLING
|
25.0%
4/16 • Number of events 4 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
0.00%
0/6 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
General disorders
PYREXIA
|
12.5%
2/16 • Number of events 2 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
0.00%
0/6 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Infections and infestations
BRONCHITIS
|
6.2%
1/16 • Number of events 1 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
0.00%
0/6 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Infections and infestations
CONJUNCTIVITIS VIRAL
|
0.00%
0/16 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
16.7%
1/6 • Number of events 1 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Infections and infestations
INFLUENZA
|
6.2%
1/16 • Number of events 1 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
0.00%
0/6 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Infections and infestations
TONSILLITIS
|
6.2%
1/16 • Number of events 1 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
0.00%
0/6 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.2%
1/16 • Number of events 1 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
0.00%
0/6 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Injury, poisoning and procedural complications
CONTUSION
|
6.2%
1/16 • Number of events 1 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
0.00%
0/6 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
25.0%
4/16 • Number of events 4 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
16.7%
1/6 • Number of events 1 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
31.2%
5/16 • Number of events 5 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
0.00%
0/6 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
6.2%
1/16 • Number of events 1 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
0.00%
0/6 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Investigations
BLOOD PRESSURE DIASTOLIC INCREASED
|
31.2%
5/16 • Number of events 7 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
0.00%
0/6 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Investigations
BLOOD PRESSURE SYSTOLIC INCREASED
|
6.2%
1/16 • Number of events 1 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
0.00%
0/6 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
25.0%
4/16 • Number of events 4 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
33.3%
2/6 • Number of events 2 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Investigations
HAEMOGLOBIN DECREASED
|
18.8%
3/16 • Number of events 4 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
0.00%
0/6 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
12.5%
2/16 • Number of events 2 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
16.7%
1/6 • Number of events 1 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.00%
0/16 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
16.7%
1/6 • Number of events 1 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
18.8%
3/16 • Number of events 3 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
0.00%
0/6 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/16 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
16.7%
1/6 • Number of events 1 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
6.2%
1/16 • Number of events 1 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
0.00%
0/6 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/16 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
16.7%
1/6 • Number of events 2 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
12.5%
2/16 • Number of events 2 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
0.00%
0/6 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Renal and urinary disorders
HAEMATURIA
|
6.2%
1/16 • Number of events 1 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
16.7%
1/6 • Number of events 1 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Renal and urinary disorders
PROTEINURIA
|
18.8%
3/16 • Number of events 4 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
16.7%
1/6 • Number of events 1 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
|
Skin and subcutaneous tissue disorders
HIDRADENITIS
|
6.2%
1/16 • Number of events 1 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
0.00%
0/6 • Unsolicited AEs: for 28 days after each vaccination. Solicited AEs: for 7 days after each vaccination (with diary cards). SAEs: for entire study period (i.e., Study Days 0 to 420). Adverse events of special interest: for entire study period (i.e., Study Days 0 to 420).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place