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NCT02315703 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Immunogenicity Study of Homologous Ad26 Mosaic Vector Vaccine Regimens or Heterologous Ad26 Mosaic and MVA Mosaic Vector Vaccine Regimens With Glycoprotein 140 (gp140) for Human Immunodeficiency Virus (HIV) Prevention
A Phase 1 study, sponsored by Janssen Vaccines & Prevention B.V..
- Completed
- Registry status
- Phase 1
- Development phase
- 393
- Enrollment target
NCT02315703: Completed Phase 1 study, sponsored by Janssen Vaccines & Prevention B.V..
NCT02315703 is a Phase 1 study that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 393 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (555% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02315703, a Phase 1 study, has completed, sponsored by Janssen Vaccines & Prevention B.V..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 393 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and tolerability of various regimens containing adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV), Modified Vaccinia Ankara (MVA)-Mosaic, and/or HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) components and to compare envelope binding antibody responses between the different vaccine regimens.
Primary Outcome
Solicited local AEs (at injection site) included erythema, induration, swelling, itching and warmth were collected within 7 days after vaccination.
Interventions
- DRUG Placebo
- BIOLOGICAL Ad26.Mos.HIV
- BIOLOGICAL MVA-Mosaic
- BIOLOGICAL gp140 DP Low-dose
- BIOLOGICAL gp140 DP High-dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 393 participants |
| Start Date | 2014-12-22 |
| Est. Completion | 2022-03-28 |
| Phase | Phase 1 |
What the finished NCT02315703 record still lists
NCT02315703 is an interventional study that assigns participants to a tested intervention. The registered 393 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 (555% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02315703 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02315703 about?
NCT02315703 is a clinical study titled "Safety, Tolerability, and Immunogenicity Study of Homologous Ad26 Mosaic Vector Vaccine Regimens or Heterologous Ad26 Mosaic and MVA Mosaic Vector Vaccine Regimens With Glycoprotein 140 (gp140) for Human Immunodeficiency Virus (HIV) Prevention". The purpose of this study is to assess the safety and tolerability of various regimens containing adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV), Modified Vaccinia Ankara (MVA)-Mosaic, and/or HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) components and to co...
What is the current status of trial NCT02315703?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 393 participants. The study started on 2014-12-22. Estimated completion is 2022-03-28.
What interventions are being tested in trial NCT02315703?
The interventions under investigation include: Placebo (DRUG), Ad26.Mos.HIV (BIOLOGICAL), MVA-Mosaic (BIOLOGICAL), gp140 DP Low-dose (BIOLOGICAL), gp140 DP High-dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT02315703?
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 NCT02315703's enrollment target sits among peer trials
393 77th of 2000 higher than 1,924 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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