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NCT03856996 · ClinicalTrials.gov registry record · Phase 1
A Clinical Trial in Healthy, HIV-1-Uninfected Adult Participants to Compare the Safety, Tolerability and Immunogenicity of CH505TF gp120 Produced From Stably Transfected Cells to CH505TF gp120 Produced From Transiently Transfected Cells
A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 3
- Study locations
NCT03856996: Completed Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03856996 is a Phase 1 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 30 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03856996, a Phase 1 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to compare the safety, tolerability, and immunogenicity of CH505TF gp120 produced from stably transfected cells to CH505TF gp120 produced from transiently transfected cells in healthy, HIV-1-uninfected adult participants.
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.
Conditions Studied
Interventions
- BIOLOGICAL Stable CH505TF gp120
- BIOLOGICAL Transient CH505TF gp120
- BIOLOGICAL Glucopyranosyl Lipid Adjuvant-Stable Emulsion (GLA-SE)
Study Locations (3)
Georgia
- The Hope Clinic of the Emory Vaccine Center CRS - Decatur
Massachusetts
- Brigham and Women's Hospital Vaccine CRS (BWH VCRS) - Boston
Tennessee
- Vanderbilt Vaccine (VV) CRS - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-05-23 |
| Est. Completion | 2021-09-07 |
| Phase | Phase 1 |
What the finished NCT03856996 record still lists
NCT03856996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which Stable CH505TF gp120 is the first listed.
NCT03856996 reports a single indexed study location in Georgia, Massachusetts, Tennessee.
Frequently Asked Questions
What is clinical trial NCT03856996 about?
NCT03856996 is a clinical study titled "A Clinical Trial in Healthy, HIV-1-Uninfected Adult Participants to Compare the Safety, Tolerability and Immunogenicity of CH505TF gp120 Produced From Stably Transfected Cells to CH505TF gp120 Produced From Transiently Transfected Cells". The purpose of this study is to compare the safety, tolerability, and immunogenicity of CH505TF gp120 produced from stably transfected cells to CH505TF gp120 produced from transiently transfected cells in healthy, HIV-1-uninfected adult participants.
What is the current status of trial NCT03856996?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2019-05-23. Estimated completion is 2021-09-07.
What conditions does trial NCT03856996 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT03856996?
The interventions under investigation include: Stable CH505TF gp120 (BIOLOGICAL), Transient CH505TF gp120 (BIOLOGICAL), Glucopyranosyl Lipid Adjuvant-Stable Emulsion (GLA-SE) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03856996?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03856996 being conducted?
This trial has 3 study locations across Georgia, Massachusetts, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03856996's enrollment target sits among peer trials
30 426th of 542 higher than 102 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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.
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