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NCT03122223 · ClinicalTrials.gov registry record · Phase 1
Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59®- or AS01B-adjuvanted Bivalent Subtype C gp120 in Healthy, HIV-uninfected Adult Participants
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 160
- Enrollment target
NCT03122223: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03122223 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 160 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (167% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03122223, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 160 participants
- Enrollment target
Study Summary
A phase 1/2a clinical trial to evaluate the safety and immunogenicity of ALVAC-HIV (vCP2438) and of MF59®- or AS01B-adjuvanted clade C Env protein, in healthy, HIV-uninfected adult participants
Primary Outcome
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented;
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL ALVAC-HIV (vCP2438)
- BIOLOGICAL Bivalent subtype C gp120/MF59
- BIOLOGICAL Bivalent subtype C gp120/AS01(B)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2018-01-16 |
| Est. Completion | 2020-07-30 |
| Phase | Phase 1 |
What the finished NCT03122223 record still lists
NCT03122223 is an interventional study that assigns participants to a tested intervention. The registered 160 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 (167% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03122223 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03122223 about?
NCT03122223 is a clinical study titled "Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59®- or AS01B-adjuvanted Bivalent Subtype C gp120 in Healthy, HIV-uninfected Adult Participants". A phase 1/2a clinical trial to evaluate the safety and immunogenicity of ALVAC-HIV (vCP2438) and of MF59®- or AS01B-adjuvanted clade C Env protein, in healthy, HIV-uninfected adult participants
What is the current status of trial NCT03122223?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 160 participants. The study started on 2018-01-16. Estimated completion is 2020-07-30.
What interventions are being tested in trial NCT03122223?
The interventions under investigation include: Placebo (BIOLOGICAL), ALVAC-HIV (vCP2438) (BIOLOGICAL), Bivalent subtype C gp120/MF59 (BIOLOGICAL), Bivalent subtype C gp120/AS01(B) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03122223?
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 NCT03122223's enrollment target sits among peer trials
160 340th of 2000 higher than 1,655 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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