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NCT06919016 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate the Safety and Immunogenicity of the V3-region Directed Immunogens DV700P-RNA Followed by DV701B1.1-RNA in Adults Without HIV

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

Active
Registry status
Phase 1
Development phase
45
Enrollment target
8
Study locations

NCT06919016 is a Phase 1 study of HIV-1-infection that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 45 participants, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (87% lower). The trial reports 8 study locations across 7 states.

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The verdict

NCT06919016, a Phase 1 study of HIV-1-infection, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
45 participants
Enrollment target
8
Study locations

Study Summary

This is a phase 1, first-in-human (FIH) trial for two vaccines, DV700P-RNA and DV701B1.1-RNA. This means it is the first time these study products are being tested in people. The purpose of this study is to see if the study products are safe, if people are able to take them without becoming too uncomfortable, and how a person's immune system responds to them (a person's immune system protects them from infections and disease). Forty-five volunteers without HIV and in overall good health, aged 18 to 55 years, will be enrolled and be in this study for about 16 months (about 12 visits), Study procedures will include blood draws, injections, and the collection of white blood cells and cells from their lymph nodes.

Conditions Studied

HIV-1-infection

Interventions

  • BIOLOGICAL DV700P-RNA
  • BIOLOGICAL DV701B1.1-RNA

Study Locations (8)

New York

  • Columbia P&S CRS (Site ID: 30329) - New York
  • University of Rochester Medical Center (Site ID: 31467) - Rochester

Alabama

  • University of Alabama Medical Center (Site ID: 31788) - Birmingham

Georgia

  • The Hope Clinic of the Emory Vaccine Center CRS (Site ID: 31440) - Decatur

Massachusetts

  • Brigham and Women's Hospital (Site ID: 30007) - Boston

Pennsylvania

  • University of Pittsburgh (Site ID: 1001) - Pittsburgh

Tennessee

  • Vanderbilt University Medical Center (Site ID: 30352) - Nashville

Washington

  • Seattle Vaccine and Prevention CRS (Site ID: 30331) - Seattle

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2025-08-06
Est. Completion 2027-03-25
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06919016

The ClinicalTrials.gov registry entry for NCT06919016 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (87% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 2 interventions - of which DV700P-RNA is the first listed.

NCT06919016 reports 8 study locations spanning 7 distinct geographic areas - top geographies include New York, Alabama, Georgia.

Frequently Asked Questions

What is clinical trial NCT06919016 about?

NCT06919016 is a clinical study titled "A Study to Evaluate the Safety and Immunogenicity of the V3-region Directed Immunogens DV700P-RNA Followed by DV701B1.1-RNA in Adults Without HIV". This is a phase 1, first-in-human (FIH) trial for two vaccines, DV700P-RNA and DV701B1.1-RNA. This means it is the first time these study products are being tested in people. The purpose of this study is to see if the study products are safe, if people are able to take them without becoming too unc...

What is the current status of trial NCT06919016?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2025-08-06. Estimated completion is 2027-03-25.

What conditions does trial NCT06919016 study?

This clinical trial studies the following conditions: HIV-1-infection.

What interventions are being tested in trial NCT06919016?

The interventions under investigation include: DV700P-RNA (BIOLOGICAL), DV701B1.1-RNA (BIOLOGICAL).

Who is sponsoring clinical trial NCT06919016?

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 NCT06919016 being conducted?

This trial has 8 study locations across Alabama, Georgia, Massachusetts, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.