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ACTIVE NOT RECRUITING 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

NCT06919016 · View on ClinicalTrials.gov ↗

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

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

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06919016 reports 8 study locations spanning 7 distinct geographic areas — top geographies include New York, Alabama, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06919016?

The interventions under investigation include: DV700P-RNA (BIOLOGICAL), DV701B1.1-RNA (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06919016?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial