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

Recruiting now · Phase 1

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT07569029

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

42

Starts

2026-09-15

Expected to finish

2027-08-31

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able and willing to provide informed consent.
• Age 18 to 60 years.
• Documented HIV infection.
• Lowest (nadir) CD4+ count between 250 and 450 cells/mm³.
• On stable combination antiretroviral therapy (ART) for at least 48 weeks prior to screening.
• Plasma HIV RNA <50 copies/mL for at least 48 weeks prior to enrollment, allowing limited transient increases.
• CD4+ count >450 cells/mm³ and CD4+ percentage ≥15%.
• Willing and able to comply with study visits and procedures.
• Agrees not to participate in another investigational study during participation unless approved.
• In general good health, with no clinically significant findings on physical exam or laboratory testing.
• Hemoglobin ≥11.0 g/dL (women) or ≥13.0 g/dL (men).
• Absolute neutrophil count ≥750/mm³.
• Platelet count ≥100,000/mm³.
• ALT <2.5 × upper limit of normal.
• Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m².
• Serum creatinine ≤1.1 × upper limit of normal.
• Serum calcium >8.5 mg/dL.
• Blood pressure within acceptable limits.
• Agrees to use condoms during the specified period when ART is interrupted until HIV RNA is undetectable.
• No evidence of active hepatitis C infection.
• No evidence of active hepatitis B infection.
• For individuals of pregnancy potential: negative pregnancy test prior to enrollment and agreement to use effective contraception during the required study period.
• Agreement not to seek pregnancy during the required study period.

You may not qualify if…

• Current use of ART that includes non-nucleoside reverse transcriptase inhibitors (NNRTIs).
• Use of long-acting ART within 3 months prior to enrollment.
• Known resistance to any component of the current ART regimen (excluding M184V/I mutation).
• Resistance to one or more drugs in two or more ART classes (excluding M184V/I mutation).
• Initiation of ART during acute HIV infection (within 1 year of HIV acquisition, if known).
• History of advanced HIV-related illness (CDC Category C), except recurrent pneumonia, within 10 years prior to screening, or history of CD4 count <200 cells/mm³ within the past 10 years.
• History of severe HIV-related conditions, including opportunistic infections, HIV-associated cancers, lymphoma, neurocognitive disease, or progressive multifocal leukoencephalopathy.
• Active or recent non-HIV-related cancer requiring systemic treatment within 36 months or expected need for treatment within 12 months (excluding minor skin cancers).
• Active hepatitis B or hepatitis C infection.
• Significant liver disease, including cirrhosis or advanced fatty liver disease.
• Untreated or incompletely treated active or latent tuberculosis.
• Pregnancy or breastfeeding.
• Body mass index (BMI) ≥40 kg/m², unless approved.
• Diabetes mellitus, except well-controlled type 2 diabetes as allowed.
• History of or current atherosclerotic cardiovascular disease, including heart attack, angina, stroke, or peripheral arterial disease.
• Previous receipt of an investigational HIV vaccine (prior placebo recipients allowed).
• Receipt of a non-HIV investigational vaccine within 1 year, unless approved or licensed.
• Conditions causing impaired immune function or use of immunosuppressive medications within the specified timeframe.
• Prior receipt of anti-HIV monoclonal antibody therapy.
• Receipt of certain vaccines within restricted timeframes prior to enrollment (including live or mRNA vaccines within 4 weeks).
• Receipt of other vaccines within 14 days prior to enrollment.
• History of myocarditis or pericarditis.
• Recent initiation of allergy immunotherapy within 1 year (unless stable or approved).
• Recent use of investigational agents within restricted timeframes prior to enrollment.
• History of severe allergic reaction to mRNA vaccines or polyethylene glycol-containing products.

Where it is running

• The Ponce de Leon Center CRS (Site ID: 5802) — Atlanta, Georgia, United States (enrolling)
• Beth Israel Deaconess Medical Center / BIDMC VCRS (Site ID: 32077) — Boston, Massachusetts, United States (enrolling)
• Seattle Vaccine and Prevention CRS (Site ID: 30331) — Seattle, Washington, United States (enrolling)
• Alabama CRS (Site ID: 31788) — Birmingham, Alabama, United States (enrolling)
• Columbia P&S CRS (Site#: 30329) — New York, New York, United States
• University of Rochester Vaccines to Prevent HIV Infection CRS (Site#: 31467) — Rochester, New York, United States
• Penn Prevention CRS (Site#: 30310) — Philadelphia, Pennsylvania, United States
• University of Pittsburgh CRS (Site#: 1001) — Pittsburgh, Pennsylvania, United States
• Vanderbilt Vaccine (VV) CRS (Site#: 30352) — Nashville, Tennessee, United States
• Fundacion Huesped CRS (Site ID: 31957) — Buenos Aires, Argentina
• Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site ID: 31970) — Bellavista, Provincia Constitucional del Callao, Peru
• Via Libre CRS (Site ID: 31909) — Lima, Peru
• Barranco CRS (Site ID: 11301) — Lima, Peru
• San Miguel CRS (Site ID: 11302) — Lima, Peru
• Seke South CRS/30294 University of Zimbabwe -Clinical Trials Research Centre (UZ-CTRC) — Harare, Zimbabwe
• Spilhaus CRS/30314 University of Zimbabwe -Clinical Trials Research Centre (UZ-CTRC) — Harare, Zimbabwe
• Bridge HIV CRS (Site#: 30305) — San Francisco, California, United States
• The Hope Clinic of the Emory Vaccine Center CRS (Site #: 31440) — Decatur, Georgia, United States
• Brigham and Women's Hospital Vaccine CRS (BWH VCRS) (Site#: 30007) — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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