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NCT02915016 · ClinicalTrials.gov registry record · Phase 1
Evaluating the Safety and Immunogenicity of HIV Clade C DNA Vaccine and MF59- or AS01B-Adjuvanted Clade C Env Protein Vaccines in Various Combinations in Healthy, HIV-Uninfected Adults
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 334
- Enrollment target
NCT02915016: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02915016 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 334 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (457% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02915016, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 334 participants
- Enrollment target
Study Summary
This study will evaluate the safety and immune response to the DNA-HIV-PT123 vaccine used in combination with one of two protein vaccines (Bivalent Subtype C gp120/MF59 or Bivalent Subtype C gp120/AS01B) in healthy, HIV-uninfected adults.
Primary Outcome
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL DNA-HIV-PT123 vaccine
- BIOLOGICAL Bivalent Subtype C gp120/MF59 vaccine
- BIOLOGICAL Bivalent Subtype C gp120/AS01B vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 334 participants |
| Start Date | 2016-12-07 |
| Est. Completion | 2020-02-12 |
| Phase | Phase 1 |
What the finished NCT02915016 record still lists
NCT02915016 is an interventional study that assigns participants to a tested intervention. The registered 334 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 (457% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02915016 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02915016 about?
NCT02915016 is a clinical study titled "Evaluating the Safety and Immunogenicity of HIV Clade C DNA Vaccine and MF59- or AS01B-Adjuvanted Clade C Env Protein Vaccines in Various Combinations in Healthy, HIV-Uninfected Adults". This study will evaluate the safety and immune response to the DNA-HIV-PT123 vaccine used in combination with one of two protein vaccines (Bivalent Subtype C gp120/MF59 or Bivalent Subtype C gp120/AS01B) in healthy, HIV-uninfected adults.
What is the current status of trial NCT02915016?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 334 participants. The study started on 2016-12-07. Estimated completion is 2020-02-12.
What interventions are being tested in trial NCT02915016?
The interventions under investigation include: Placebo (BIOLOGICAL), DNA-HIV-PT123 vaccine (BIOLOGICAL), Bivalent Subtype C gp120/MF59 vaccine (BIOLOGICAL), Bivalent Subtype C gp120/AS01B vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02915016?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02915016's enrollment target sits among peer trials
334 108th of 2000 higher than 1,893 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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