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NCT04177355 · ClinicalTrials.gov registry record · Phase 1
Evaluating the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Alum Adjuvants 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
- 127
- Enrollment target
NCT04177355: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04177355 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 127 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (112% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04177355, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 127 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 BG505 SOSIP.664 gp140 with TLR agonist and/or alum adjuvants 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 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL 3M-052-AF
- BIOLOGICAL BG505 SOSIP.664 gp140
- BIOLOGICAL CpG 1018
- BIOLOGICAL GLA-LSQ
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2020-01-13 |
| Est. Completion | 2024-11-04 |
| Phase | Phase 1 |
What the finished NCT04177355 record still lists
NCT04177355 is an interventional study that assigns participants to a tested intervention. The registered 127 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 (112% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04177355 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04177355 about?
NCT04177355 is a clinical study titled "Evaluating the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Alum Adjuvants in Healthy, HIV-uninfected Adults". The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 BG505 SOSIP.664 gp140 with TLR agonist and/or alum adjuvants in healthy, HIV-uninfected adults.
What is the current status of trial NCT04177355?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 127 participants. The study started on 2020-01-13. Estimated completion is 2024-11-04.
What interventions are being tested in trial NCT04177355?
The interventions under investigation include: Placebo (BIOLOGICAL), 3M-052-AF (BIOLOGICAL), BG505 SOSIP.664 gp140 (BIOLOGICAL), CpG 1018 (BIOLOGICAL), GLA-LSQ (BIOLOGICAL).
Who is sponsoring clinical trial NCT04177355?
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 NCT04177355's enrollment target sits among peer trials
127 459th of 2000 higher than 1,540 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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