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NCT03409276 · ClinicalTrials.gov registry record · Phase 1

Evaluating the Safety and Immunogenicity of Env (A,B,C,A/E)/Gag (C) DNA and gp120 (A,B,C,A/E) Protein/GLA-SE HIV Vaccines, Given Individually or Co-administered, in Healthy, HIV-1-Uninfected Adults

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
60
Enrollment target

NCT03409276: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT03409276 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03409276, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
60 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of env (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein/GLA-SE HIV-1 vaccines (PDPHV-201401) as a prime-boost regimen or co-administered in repeated doses, in healthy, HIV-1-uninfected adults.

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 env (A,B,C,A/E)/gag (C) DNA Vaccine
  • BIOLOGICAL gp120 (A,B,C,A/E) Protein Vaccine
  • BIOLOGICAL GLA-SE adjuvant

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2018-03-16
Est. Completion 2020-10-22
Phase Phase 1

What the finished NCT03409276 record still lists

NCT03409276 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT03409276 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03409276 about?

NCT03409276 is a clinical study titled "Evaluating the Safety and Immunogenicity of Env (A,B,C,A/E)/Gag (C) DNA and gp120 (A,B,C,A/E) Protein/GLA-SE HIV Vaccines, Given Individually or Co-administered, in Healthy, HIV-1-Uninfected Adults". The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of env (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein/GLA-SE HIV-1 vaccines (PDPHV-201401) as a prime-boost regimen or co-administered in repeated doses, in healthy, HIV-1-uninfected adults.

What is the current status of trial NCT03409276?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2018-03-16. Estimated completion is 2020-10-22.

What interventions are being tested in trial NCT03409276?

The interventions under investigation include: Placebo (BIOLOGICAL), env (A,B,C,A/E)/gag (C) DNA Vaccine (BIOLOGICAL), gp120 (A,B,C,A/E) Protein Vaccine (BIOLOGICAL), GLA-SE adjuvant (BIOLOGICAL).

Who is sponsoring clinical trial NCT03409276?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03409276's enrollment target sits among peer trials

60 831st of 2000 higher than 1,106 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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Source: ClinicalTrials.gov NCT03409276, the US trial registry maintained by the National Library of Medicine. NCT03409276 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.