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NCT07569029 · ClinicalTrials.gov registry record · Phase 1

A Trial to Evaluate the Safety and Tolerability of DV700P-RNA and DV701B1.1-RNA Immunization in Combination With Antiretroviral Analytical Treatment Interruption (ATI) in People Living With HIV for Elicitation of V3-glycan Antibodies

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

Not yet
Registry status
Phase 1
Development phase
42
Enrollment target

NCT07569029: Clinical Trial Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT07569029 is a Phase 1 study that has not yet begun recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07569029, a Phase 1 study, has not yet begun recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NOT YET RECRUITING
Registry status
Phase 1
Development phase
42 participants
Enrollment target

Study Summary

This phase 1 study will evaluate the safety, tolerability, and immune responses of two experimental mRNA HIV vaccines in adults living with HIV who are in overall good health. The study will enroll about 42 participants at multiple study sites. Researchers will assess whether these vaccines can start or strengthen antibody responses against HIV. The study will also evaluate how a closely monitored planned pause in antiretroviral therapy affects these immune responses.

Primary Outcome

Incidence and severity of solicited local reactogenicity signs and symptoms (injection site pain, erythema, and swelling), graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events

Interventions

  • BIOLOGICAL DV700P-RNA 100 mcg
  • BIOLOGICAL DV701B1.1-RNA 100 mcg

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2026-06-02
Est. Completion 2027-08-31
Phase Phase 1

What is known before NCT07569029 opens enrollment

NCT07569029 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).

The record links to 0 conditions, and to 2 interventions - of which DV700P-RNA 100 mcg is the first listed.

NCT07569029 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07569029 about?

NCT07569029 is a clinical study titled "A Trial to Evaluate the Safety and Tolerability of DV700P-RNA and DV701B1.1-RNA Immunization in Combination With Antiretroviral Analytical Treatment Interruption (ATI) in People Living With HIV for Elicitation of V3-glycan Antibodies". This phase 1 study will evaluate the safety, tolerability, and immune responses of two experimental mRNA HIV vaccines in adults living with HIV who are in overall good health. The study will enroll about 42 participants at multiple study sites. Researchers will assess whether these vaccines can star...

What is the current status of trial NCT07569029?

This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2026-06-02. Estimated completion is 2027-08-31.

What interventions are being tested in trial NCT07569029?

The interventions under investigation include: DV700P-RNA 100 mcg (BIOLOGICAL), DV701B1.1-RNA 100 mcg (BIOLOGICAL).

Who is sponsoring clinical trial NCT07569029?

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 NCT07569029's enrollment target sits among peer trials

42 1105th of 2000 higher than 876 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 NCT07569029, the US trial registry maintained by the National Library of Medicine. NCT07569029 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.