Trial Outcomes & Findings for The Safety and Immunogenicity of a Potential HIV Vaccine (NCT NCT01966900)
NCT ID: NCT01966900
Last Updated: 2019-11-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
7 days
Results posted on
2019-11-07
Participant Flow
Participant milestones
| Measure |
Group A
Biological/Vaccine: CN54gp140 mixed with GLA-AF
Vaccination at Months 0, 1, 2 and 6; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
CN54gp140 mixed with GLA-AF: Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
|
Group B
Biological/Vaccine: CN54gp140 mixed with GLA-AF
Vaccination at Months 0, 1, 2 and 12; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
CN54gp140 mixed with GLA-AF: Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group A
n=8 Participants
Biological/Vaccine: CN54gp140 mixed with GLA-AF
Vaccination at Months 0, 1, 2 and 6; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
CN54gp140 mixed with GLA-AF: Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
|
Group B
n=6 Participants
Biological/Vaccine: CN54gp140 mixed with GLA-AF
Vaccination at Months 0, 1, 2 and 12; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
CN54gp140 mixed with GLA-AF: Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=8 Participants
|
6 Participants
n=6 Participants
|
14 Participants
n=14 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=8 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=8 Participants
|
4 Participants
n=6 Participants
|
9 Participants
n=14 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=8 Participants
|
6 participants
n=6 Participants
|
14 participants
n=14 Participants
|
PRIMARY outcome
Timeframe: 7 daysOutcome measures
| Measure |
Group A
n=8 Participants
Biological/Vaccine: CN54gp140 mixed with GLA-AF
Vaccination at Months 0, 1, 2 and 6; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
CN54gp140 mixed with GLA-AF: Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
|
Group B
n=6 Participants
Biological/Vaccine: CN54gp140 mixed with GLA-AF
Vaccination at Months 0, 1, 2 and 12; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
CN54gp140 mixed with GLA-AF: Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
|
|---|---|---|
|
Number of Participants With Moderate or Greater Reactogenicity (i.e., Solicited Adverse Events)
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 28 daysIncluding safety laboratory (biochemical, haematological) parameters, from the day of each vaccination up to 28 days post each vaccination.
Outcome measures
| Measure |
Group A
n=8 Participants
Biological/Vaccine: CN54gp140 mixed with GLA-AF
Vaccination at Months 0, 1, 2 and 6; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
CN54gp140 mixed with GLA-AF: Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
|
Group B
n=6 Participants
Biological/Vaccine: CN54gp140 mixed with GLA-AF
Vaccination at Months 0, 1, 2 and 12; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
CN54gp140 mixed with GLA-AF: Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
|
|---|---|---|
|
Number of Participants With Moderate or Greater and/or Vaccine-related Unsolicited Adverse Events (AEs)
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 13 monthsOutcome measures
| Measure |
Group A
n=8 Participants
Biological/Vaccine: CN54gp140 mixed with GLA-AF
Vaccination at Months 0, 1, 2 and 6; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
CN54gp140 mixed with GLA-AF: Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
|
Group B
n=6 Participants
Biological/Vaccine: CN54gp140 mixed with GLA-AF
Vaccination at Months 0, 1, 2 and 12; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
CN54gp140 mixed with GLA-AF: Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
|
|---|---|---|
|
Number of Participants With Vaccine Related Serious Adverse Events (SAEs) Collected Throughout the Study Period
|
0 Participants
|
0 Participants
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group B
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 |
Group A
n=8 participants at risk
Biological/Vaccine: CN54gp140 mixed with GLA-AF
Vaccination at Months 0, 1, 2 and 6; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
CN54gp140 mixed with GLA-AF: Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
|
Group B
n=6 participants at risk
Biological/Vaccine: CN54gp140 mixed with GLA-AF
Vaccination at Months 0, 1, 2 and 12; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
CN54gp140 mixed with GLA-AF: Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/8 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
16.7%
1/6 • Number of events 1 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
|
Investigations
Blood creatine phosphokinase increased
|
12.5%
1/8 • Number of events 1 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
0.00%
0/6 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • Number of events 1 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
0.00%
0/6 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
|
Cardiac disorders
Palpitations
|
12.5%
1/8 • Number of events 1 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
0.00%
0/6 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/8 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
16.7%
1/6 • Number of events 1 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
33.3%
2/6 • Number of events 2 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
16.7%
1/6 • Number of events 1 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
|
General disorders
Myalgia
|
25.0%
2/8 • Number of events 2 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
0.00%
0/6 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
|
General disorders
Malaise
|
12.5%
1/8 • Number of events 1 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
50.0%
3/6 • Number of events 3 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
16.7%
1/6 • Number of events 1 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
16.7%
1/6 • Number of events 1 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/8 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
16.7%
1/6 • Number of events 1 • 13 months
Data on local and systemic reactogenicity (i.e., solicited adverse events) was collected by structured interview and medical examination at clinic visits. Data on other adverse events was collected with open-ended questions. Volunteers were given diary cards as a memory aid for collecting adverse events during the 7 days after each vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place