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

NCT07569029 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: HVTN 80839218
• Study Type: interventional
• Target: 42
• Locations: 3 countries
• Sites: 9

Brief 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.

Conditions

HIV

Outcome Measures

Primary Outcomes (11)

• Local reactogenicity following study product administration

  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

  14 days following each vaccination

• Systemic reactogenicity following study product administration

  Incidence and severity of solicited systemic reactogenicity signs and symptoms (fever, fatigue, myalgia, arthralgia, headache, chills, nausea), graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events

  14 days following each vaccination

• Number and description of serious adverse events (SAEs)

  Through study completion, expected to be up to 88 weeks

• Number and description of medically attended adverse events (MAAEs)

  Through study completion, expected to be up to 88 weeks

• Number and description of adverse events of special interest (AESIs)

  Through study completion, expected to be up to 88 weeks

• Number and description of adverse events leading to study product discontinuation or participant withdrawal

  Through study completion, expected to be up to 88 weeks

• Number and description of adverse events (AEs) following study product administration

  30 days following each vaccination

• Response rate of differential serum neutralizing antibody responses to precursor detection viruses

  Proportion of participants with serum antibody responses demonstrating differential neutralization of precursor detection viruses and corresponding epitope knock-out mutant viruses, as measured by TZM-bl pseudovirus assay

  At Baseline (Week 0) and 2 weeks after last vaccination

• Magnitude of differential serum neutralizing antibody responses to precursor detection viruses

  Magnitude of serum antibody neutralization of precursor detection viruses and corresponding epitope knock-out mutant viruses, as measured by TZM-bl pseudovirus assay

  At Baseline (Week 0) and 2 weeks after last vaccination

• Response rate of differential serum neutralizing antibody responses to precursor detection viruses after last vaccination and after ART restart

  Proportion of participants with serum antibody responses demonstrating differential neutralization of precursor detection viruses and corresponding epitope knock-out mutant viruses, as measured by TZM-bl pseudovirus assay

  6 weeks after last vaccination and 8 weeks after ART restart

• Magnitude of differential serum neutralizing antibody responses to precursor detection viruses after last vaccination and after ART restart

  Magnitude of serum antibody neutralization of precursor detection viruses and corresponding epitope knock-out mutant viruses, as measured by TZM-bl pseudovirus assay

  6 weeks after last vaccination and 8 weeks after ART restart

Secondary Outcomes (18)

• Frequency of Env-specific and V3-glycan-specific B cells

  At Baseline (Week 0) and 2 weeks after last vaccination

• Frequency of mutation of V3-glycan-specific B-cell receptor (BCR) sequences

  At Baseline (Week 0) and 2 weeks after last vaccination

• Frequency of Env-specific and V3-glycan-specific B cells after last vaccination and after ART restart

  6 weeks after last vaccination and 8 weeks after ART restart

• Frequency of mutation of V3-glycan-specific B-cell receptor (BCR) sequences after last vaccination and after ART restart

  6 weeks after last vaccination and 8 weeks after ART restart

• Response rate of serum IgG binding antibodies to autologous HIV Env stabilized trimers

  At Baseline (Week 0) and 2 weeks after last vaccination

Study Arms (2)

Group 1

EXPERIMENTAL

Participants will receive: * Week 0: DV700P-RNA * Week 8: DV700P-RNA * Week 16: DV701B1.1-RNA

Biological: DV700P-RNA 100 mcg; Biological: DV701B1.1-RNA 100 mcg

Group 2

EXPERIMENTAL

Participants will receive: * Week 0: DV700P-RNA * Week 8: DV701B1.1-RNA

Biological: DV700P-RNA 100 mcg; Biological: DV701B1.1-RNA 100 mcg

Interventions

DV700P-RNA 100 mcg BIOLOGICAL

Intramuscular injection

Group 1; Group 2

DV701B1.1-RNA 100 mcg BIOLOGICAL

Intramuscular injection

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

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.

Sponsors & Collaborators

• Department of Health and Human Services (HHS): collaborator
• Duke University: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (9)

Alabama CRS (Site ID: 31788)

Birmingham, Alabama, 35222, United States

Location

The Ponce de Leon Center CRS (Site ID: 5802)

Atlanta, Georgia, 30308, United States

Location

Beth Israel Deaconess Medical Center / BIDMC VCRS (Site ID: 32077)

Boston, Massachusetts, 02115, United States

Location

Seattle Vaccine and Prevention CRS (Site ID: 30331)

Seattle, Washington, 98109, United States

Location

Fundacion Huesped CRS (Site ID: 31957)

Buenos Aires, C1427CEA, Argentina

Location

Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site ID: 31970)

Bellavista, Provincia Constitucional del Callao, 07006, Peru

Location

Via Libre CRS (Site ID: 31909)

Lima, 15001, Peru

Location

Barranco CRS (Site ID: 11301)

Lima, 15063, Peru

Location

San Miguel CRS (Site ID: 11302)

Lima, 15088, Peru

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): June 2, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1); US (4); PE (4)