Trial Outcomes & Findings for Safety and Immunogenicity of HIV DNA-C CN54ENV and Recombinant HIV CN54gp140 Vaccines in Healthy Volunteers (NCT NCT02589795)
NCT ID: NCT02589795
Last Updated: 2025-01-31
Results Overview
Number of participants experiencing a Grade 3 or above solicited local, systemic or laboratory adverse event, or any grade of adverse event leading to a clinical decision to discontinue immunizations, or any grade of unsolicited adverse event with onset within 7 days of immunization
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
From first dose until up to Week 22
Results posted on
2025-01-31
Participant Flow
Healthy volunteers were recruited
All enrolled participants received at least one vaccination.
Participant milestones
| Measure |
Group 1: ID/EP + IM
0.6 mg DNA-C CN54ENV, intradermally with electroporation, at Weeks 0, 4 and 8. 2 mg DNA-C CN54ENV, intramuscularly without electroporation, at Weeks 0, 4 and 8.
50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
Group 2: ID + IM/EP
0.6 mg DNA-C CN54ENV, intradermally without electroporation, at Weeks 0, 4 and 8.
2 mg DNA-C CN54ENV, intramuscularly with electroporation, at Weeks 0, 4 and 8. 50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
Group 3: ID/EP + IM/EP
0.6 mg DNA-C CN54ENV, intradermally with electroporation, at Weeks 0, 4 and 8. 2 mg DNA-C CN54ENV, intramuscularly with electroporation, at Weeks 0, 4 and 8. 50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
11
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
Reasons for withdrawal
| Measure |
Group 1: ID/EP + IM
0.6 mg DNA-C CN54ENV, intradermally with electroporation, at Weeks 0, 4 and 8. 2 mg DNA-C CN54ENV, intramuscularly without electroporation, at Weeks 0, 4 and 8.
50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
Group 2: ID + IM/EP
0.6 mg DNA-C CN54ENV, intradermally without electroporation, at Weeks 0, 4 and 8.
2 mg DNA-C CN54ENV, intramuscularly with electroporation, at Weeks 0, 4 and 8. 50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
Group 3: ID/EP + IM/EP
0.6 mg DNA-C CN54ENV, intradermally with electroporation, at Weeks 0, 4 and 8. 2 mg DNA-C CN54ENV, intramuscularly with electroporation, at Weeks 0, 4 and 8. 50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Immunogenicity of HIV DNA-C CN54ENV and Recombinant HIV CN54gp140 Vaccines in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Group 1: ID/EP + IM
n=8 Participants
0.6 mg DNA-C CN54ENV, intradermally with electroporation, at Weeks 0, 4 and 8. 2 mg DNA-C CN54ENV, intramuscularly without electroporation, at Weeks 0, 4 and 8.
50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
Group 2: ID + IM/EP
n=8 Participants
0.6 mg DNA-C CN54ENV, intradermally without electroporation, at Weeks 0, 4 and 8.
2 mg DNA-C CN54ENV, intramuscularly with electroporation, at Weeks 0, 4 and 8. 50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
Group 3: ID/EP + IM/EP
n=8 Participants
0.6 mg DNA-C CN54ENV, intradermally with electroporation, at Weeks 0, 4 and 8. 2 mg DNA-C CN54ENV, intramuscularly with electroporation, at Weeks 0, 4 and 8. 50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31 years
n=5 Participants
|
27 years
n=7 Participants
|
22 years
n=5 Participants
|
27 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White British
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Body weight
|
82 kilograms
n=5 Participants
|
62 kilograms
n=7 Participants
|
73 kilograms
n=5 Participants
|
75 kilograms
n=4 Participants
|
|
Body Mass Index (BMI)
|
24 kilograms per square metre
n=5 Participants
|
21 kilograms per square metre
n=7 Participants
|
25 kilograms per square metre
n=5 Participants
|
24 kilograms per square metre
n=4 Participants
|
PRIMARY outcome
Timeframe: From first dose until up to Week 22Population: All enrolled participants
Number of participants experiencing a Grade 3 or above solicited local, systemic or laboratory adverse event, or any grade of adverse event leading to a clinical decision to discontinue immunizations, or any grade of unsolicited adverse event with onset within 7 days of immunization
Outcome measures
| Measure |
Group 1: ID/EP + IM
n=9 Participants
0.6 mg DNA-C CN54ENV, intradermally with electroporation, at Weeks 0, 4 and 8. 2 mg DNA-C CN54ENV, intramuscularly without electroporation, at Weeks 0, 4 and 8.
50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
Group 2: ID + IM/EP
n=8 Participants
0.6 mg DNA-C CN54ENV, intradermally without electroporation, at Weeks 0, 4 and 8.
2 mg DNA-C CN54ENV, intramuscularly with electroporation, at Weeks 0, 4 and 8. 50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
Group 3: ID/EP + IM/EP
n=11 Participants
0.6 mg DNA-C CN54ENV, intradermally with electroporation, at Weeks 0, 4 and 8. 2 mg DNA-C CN54ENV, intramuscularly with electroporation, at Weeks 0, 4 and 8. 50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
|---|---|---|---|
|
Primary Safety Endpoint
|
7 Participants
|
8 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Week 22Population: All enrolled participants
Magnitude of antigen-specific systemic IgG antibody binding responses (ng/mL) to CN54gp140
Outcome measures
| Measure |
Group 1: ID/EP + IM
n=9 Participants
0.6 mg DNA-C CN54ENV, intradermally with electroporation, at Weeks 0, 4 and 8. 2 mg DNA-C CN54ENV, intramuscularly without electroporation, at Weeks 0, 4 and 8.
50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
Group 2: ID + IM/EP
n=8 Participants
0.6 mg DNA-C CN54ENV, intradermally without electroporation, at Weeks 0, 4 and 8.
2 mg DNA-C CN54ENV, intramuscularly with electroporation, at Weeks 0, 4 and 8. 50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
Group 3: ID/EP + IM/EP
n=11 Participants
0.6 mg DNA-C CN54ENV, intradermally with electroporation, at Weeks 0, 4 and 8. 2 mg DNA-C CN54ENV, intramuscularly with electroporation, at Weeks 0, 4 and 8. 50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
|---|---|---|---|
|
Primary Immunogenicity
|
13934 nanograms per millilitre
Interval 9884.0 to 38050.0
|
11292 nanograms per millilitre
Interval 9608.0 to 15568.0
|
31418 nanograms per millilitre
Interval 6304.0 to 128259.0
|
SECONDARY outcome
Timeframe: 7 days after injectionPopulation: Population does not include replacement participants
Number of participants experiencing an adverse event local to the injection sites, starting within 7 days of injection
Outcome measures
| Measure |
Group 1: ID/EP + IM
n=8 Participants
0.6 mg DNA-C CN54ENV, intradermally with electroporation, at Weeks 0, 4 and 8. 2 mg DNA-C CN54ENV, intramuscularly without electroporation, at Weeks 0, 4 and 8.
50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
Group 2: ID + IM/EP
n=8 Participants
0.6 mg DNA-C CN54ENV, intradermally without electroporation, at Weeks 0, 4 and 8.
2 mg DNA-C CN54ENV, intramuscularly with electroporation, at Weeks 0, 4 and 8. 50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
Group 3: ID/EP + IM/EP
n=8 Participants
0.6 mg DNA-C CN54ENV, intradermally with electroporation, at Weeks 0, 4 and 8. 2 mg DNA-C CN54ENV, intramuscularly with electroporation, at Weeks 0, 4 and 8. 50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
|---|---|---|---|
|
Adverse Event Local to the Injection Sites, Starting Within 7 Days of Injection
|
8 Participants
|
8 Participants
|
8 Participants
|
Adverse Events
Group 1: ID/EP + IM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2: ID + IM/EP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3: ID/EP + IM/EP
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: ID/EP + IM
n=9 participants at risk
0.6 mg DNA-C CN54ENV, intradermally with electroporation, at Weeks 0, 4 and 8. 2 mg DNA-C CN54ENV, intramuscularly without electroporation, at Weeks 0, 4 and 8.
50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
Group 2: ID + IM/EP
n=8 participants at risk
0.6 mg DNA-C CN54ENV, intradermally without electroporation, at Weeks 0, 4 and 8.
2 mg DNA-C CN54ENV, intramuscularly with electroporation, at Weeks 0, 4 and 8. 50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
Group 3: ID/EP + IM/EP
n=11 participants at risk
0.6 mg DNA-C CN54ENV, intradermally with electroporation, at Weeks 0, 4 and 8. 2 mg DNA-C CN54ENV, intramuscularly with electroporation, at Weeks 0, 4 and 8. 50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/9 • Week 0 to Week 22
|
0.00%
0/8 • Week 0 to Week 22
|
9.1%
1/11 • Number of events 1 • Week 0 to Week 22
|
Other adverse events
| Measure |
Group 1: ID/EP + IM
n=9 participants at risk
0.6 mg DNA-C CN54ENV, intradermally with electroporation, at Weeks 0, 4 and 8. 2 mg DNA-C CN54ENV, intramuscularly without electroporation, at Weeks 0, 4 and 8.
50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
Group 2: ID + IM/EP
n=8 participants at risk
0.6 mg DNA-C CN54ENV, intradermally without electroporation, at Weeks 0, 4 and 8.
2 mg DNA-C CN54ENV, intramuscularly with electroporation, at Weeks 0, 4 and 8. 50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
Group 3: ID/EP + IM/EP
n=11 participants at risk
0.6 mg DNA-C CN54ENV, intradermally with electroporation, at Weeks 0, 4 and 8. 2 mg DNA-C CN54ENV, intramuscularly with electroporation, at Weeks 0, 4 and 8. 50 µg CN54gp140, intradermally without electroporation, at Week 20.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/9 • Week 0 to Week 22
|
0.00%
0/8 • Week 0 to Week 22
|
9.1%
1/11 • Number of events 1 • Week 0 to Week 22
|
|
General disorders
Fatigue
|
0.00%
0/9 • Week 0 to Week 22
|
0.00%
0/8 • Week 0 to Week 22
|
9.1%
1/11 • Number of events 1 • Week 0 to Week 22
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place