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NCT02935686 · ClinicalTrials.gov registry record · Phase 1
A Safety, Tolerability and Immunogenicity Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Tetravalent Ad26.Mos4.HIV Along With Either Clade C gp140 Plus Adjuvant OR With a Combination of Mosaic and Clade C gp140 Plus Adjuvant in Healthy HIV Uninfected Adults
A Phase 1 study, sponsored by Janssen Vaccines & Prevention B.V..
- Completed
- Registry status
- Phase 1
- Development phase
- 155
- Enrollment target
NCT02935686: Completed Phase 1 study, sponsored by Janssen Vaccines & Prevention B.V..
NCT02935686 is a Phase 1 study that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 155 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (158% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02935686, a Phase 1 study, has completed, sponsored by Janssen Vaccines & Prevention B.V..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 155 participants
- Enrollment target
Study Summary
The primary purpose of this study is to assess safety/tolerability of the different vaccine regimens and of a late boost vaccination; and to assess envelope (Env)-binding antibody (Ab) responses of the 2 different vaccine regimens.
Primary Outcome
Number of participants with solicited local and systemic AEs for 7 days post-vaccination 1 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Solicited AEs were precisely local and systemic events for which the participant is specifically questioned and symptoms of which were noted by participant in their diary.
Interventions
- OTHER Placebo
- BIOLOGICAL Ad26.Mos4.HIV
- BIOLOGICAL Clade C gp140 plus adjuvant
- BIOLOGICAL Clade C gp140/Mosaic gp140 plus adjuvant
- BIOLOGICAL gp140 HIV Bivalent Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2017-03-31 |
| Est. Completion | 2023-11-22 |
| Phase | Phase 1 |
What the finished NCT02935686 record still lists
NCT02935686 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (158% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02935686 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02935686 about?
NCT02935686 is a clinical study titled "A Safety, Tolerability and Immunogenicity Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Tetravalent Ad26.Mos4.HIV Along With Either Clade C gp140 Plus Adjuvant OR With a Combination of Mosaic and Clade C gp140 Plus Adjuvant in Healthy HIV Uninfected Adults". The primary purpose of this study is to assess safety/tolerability of the different vaccine regimens and of a late boost vaccination; and to assess envelope (Env)-binding antibody (Ab) responses of the 2 different vaccine regimens.
What is the current status of trial NCT02935686?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 155 participants. The study started on 2017-03-31. Estimated completion is 2023-11-22.
What interventions are being tested in trial NCT02935686?
The interventions under investigation include: Placebo (OTHER), Ad26.Mos4.HIV (BIOLOGICAL), Clade C gp140 plus adjuvant (BIOLOGICAL), Clade C gp140/Mosaic gp140 plus adjuvant (BIOLOGICAL), gp140 HIV Bivalent Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02935686?
This trial is sponsored by Janssen Vaccines & Prevention B.V., which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02935686's enrollment target sits among peer trials
155 352nd of 2000 higher than 1,645 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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