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HIVPhase 1NCT07569029

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 testing DV700P-RNA 100 mcg and DV701B1.1-RNA 100 mcg in people with HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 16 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
HIV
What is being tested?
DV700P-RNA 100 mcg and DV701B1.1-RNA 100 mcg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
16 sitesin 4 countries
Study dates
15 Sep 2026to 31 Aug 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
Show all 23Show fewer
  • 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.

Who cannot join

  • 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.
Show all 39Show fewer
  • 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.
  • History of angioedema.
  • Idiopathic urticaria within the past year.
  • Chronic urticaria or urticaria within the past year.
  • History of urticaria associated with vaccination.
  • Bleeding disorders or use of systemic anticoagulants.
  • Conditions associated with increased risk of clotting or bleeding.
  • History of seizures within the past 3 years or use of anti-seizure medications within that period.
  • Absence of spleen or impaired splenic function.
  • Active duty or reserve military personnel (U.S.).
  • Any clinically significant medical, psychiatric, or substance use condition that may affect safety or study participation.
  • Uncontrolled or severe asthma.
  • History of immune-mediated medical conditions, except limited stable or resolved conditions as allowed.
  • Allergy to local anesthetics (e.g., lidocaine).
  • Difficulty with venous access that would interfere with study procedures.

Trial locations and contacts

16 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

16 sites in 4 countries

United States9 sites, 9 recruiting

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

    Atlanta, Georgia, 30308

    Ericka Patrick, 4046166313, erpatri@emory.edu

    Recruiting

  • Alabama CRS (Site ID: 31788)

    Birmingham, Alabama, 35222

    Heather Logan, 1-205-8738686, heatherlogan@uabmc.edu

    Recruiting

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

    Boston, Massachusetts, 02115

    Jose Licona, 1-617-5259433, jlicona@partners.org

    Recruiting

  • The Hope Clinic of the Emory Vaccine Center CRS (Site #: 31440)

    Decatur, Georgia, 30030

    Emily Osborne, 1-404-7121433, emily.claire.osborne@emory.edu

    Not yet recruiting

  • Houston Advancing Research Team CRS (Site # 31473)

    Houston, Texas, 77030-1501

    Maria Martinez, 1-713-5006718, Maria.L.Martinez@uth.tmc.edu

    Not yet recruiting

  • Columbia P&S CRS (Site#: 30329)

    New York, New York, 10032

    Anyelina Cantos, 1-212-3052201, ac4314@cumc.columbia.edu

    Not yet recruiting

  • Penn Prevention CRS (Site#: 30310)

    Philadelphia, Pennsylvania, 19104

    Debora Dunbar, 1-215-7463713, ddunbar@pennmedicine.upenn.edu

    Not yet recruiting

  • University of Rochester Vaccines to Prevent HIV Infection CRS (Site#: 31467)

    Rochester, New York, 14642

    Emily Smith, 1-585-7522768, emily_smith@urmc.rochester.edu

    Not yet recruiting

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

    Seattle, Washington, 98109

    Jennifer Han, jhan23@fredhutch.org

    Recruiting

Other trials in United States

Peru4 sites, 4 recruiting

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

    Bellavista, Provincia Constitucional del Callao, 07006

    Fanny G. Rosas Benancio, 51-1-4800401 ext. 1007, frosas@citbm.pe

    Not yet recruiting

  • Via Libre CRS (Site ID: 31909)

    Lima, Lima Province, 15001

    Judith A. Jajaycucho Palomino, 51-01-2039900 ext. 156, jjajaycucho@vialibre.org.pe

    Not yet recruiting

  • Barranco CRS (Site ID: 11301)

    Lima, Lima Province, 15063

    Consuelo T. Ramirez, 51-1-2067800 ext. 210

    Not yet recruiting

  • San Miguel CRS (Site ID: 11302)

    Lima, Lima Province, 15088

    Helen B. Chapa Garcia, 51-1-2067800 ext. 653, hchapa@impactaperu.org

    Not yet recruiting

Other trials in Peru

Zimbabwe2 sites, 2 recruiting

  • Seke South CRS/30294 University of Zimbabwe -Clinical Trials Research Centre (UZ-CTRC)

    Harare

    Thandiwe Chirenda, RGN, MPH, 263-77-2460038, tchirenda@uz-ctrc.org

    Not yet recruiting

  • Spilhaus CRS/30314 University of Zimbabwe -Clinical Trials Research Centre (UZ-CTRC)

    Harare

    Muchaneta Bhondai-Mhuri, 263-772859799, mbhondai@uz-ctrc.org

    Not yet recruiting

Other trials in Zimbabwe

Argentina1 site, 1 recruiting

  • Fundacion Huesped CRS (Site ID: 31957)

    Buenos Aires, Buenos Aires, C1427CEA

    Daniela P. Converso, 54-1121209999 ext. 2013, daniela.converso@huesped.org.ar

    Not yet recruiting

Other trials in Argentina

About this study

Official title: A Nonrandomized Phase 1 Clinical 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 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
Being tested
DV700P-RNA 100 mcg, DV701B1.1-RNA 100 mcg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DV700P-RNA 100 mcgBiological

    Intramuscular injection

  • DV701B1.1-RNA 100 mcgBiological

    Intramuscular injection

Study groups in NCT07569029
Study groupRoleWhat they receive
Group 1ExperimentalParticipants will receive: * Week 0: DV700P-RNA * Week 8: DV700P-RNA * Week 16: DV701B1.1-RNA
Receives: Biological: DV700P-RNA 100 mcg; Biological: DV701B1.1-RNA 100 mcg
Group 2ExperimentalParticipants will receive: * Week 0: DV700P-RNA * Week 8: DV701B1.1-RNA
Receives: Biological: DV700P-RNA 100 mcg; Biological: DV701B1.1-RNA 100 mcg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 14 days following each vaccination

  2. 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

    Measured: 14 days following each vaccination

  3. Number and description of serious adverse events (SAEs)

    Measured: Through study completion, expected to be up to 88 weeks

  4. Number and description of medically attended adverse events (MAAEs)

    Measured: Through study completion, expected to be up to 88 weeks

  5. Number and description of adverse events of special interest (AESIs)

    Measured: Through study completion, expected to be up to 88 weeks

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

    Measured: Through study completion, expected to be up to 88 weeks

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

    Measured: 30 days following each vaccination

  8. 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

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

  9. 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

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

  10. 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

    Measured: 6 weeks after last vaccination and 8 weeks after ART restart

  11. 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

    Measured: 6 weeks after last vaccination and 8 weeks after ART restart

Secondary outcomes (18)

  1. Frequency of Env-specific and V3-glycan-specific B cells

    Frequency of total Env-specific and V3-glycan-specific B cells, as assessed by flow cytometry

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

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

    Frequency of mutation of V3-glycan-specific B-cell receptor (BCR) sequences, as assessed by B-cell sorting and BCR sequencing

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

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

    Frequency of total Env-specific and V3-glycan-specific B cells, as assessed by flow cytometry

    Measured: 6 weeks after last vaccination and 8 weeks after ART restart

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

    Frequency of mutation of V3-glycan-specific B-cell receptor (BCR) sequences, as assessed by B-cell sorting and BCR sequencing

    Measured: 6 weeks after last vaccination and 8 weeks after ART restart

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

    Proportion of participants with serum IgG binding antibody responses to autologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA)

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

  6. Magnitude of serum IgG binding antibodies to autologous HIV Env stabilized trimers

    Magnitude of serum IgG binding antibody responses to autologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA)

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

  7. Epitope specificity of serum IgG binding antibodies to autologous HIV Env stabilized trimers

    Epitope specificity of serum IgG binding antibody responses to autologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA)

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

  8. Response rate of neutralization activity against heterologous tier 2 viruses

    Proportion of participants with neutralizing responses against heterologous tier 2 viruses, as measured by TZM-bl pseudovirus assay

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

  9. Magnitude of neutralization activity against heterologous tier 2 viruses

    Magnitude of neutralizing responses against heterologous tier 2 viruses, as measured by TZM-bl pseudovirus assay

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

  10. Breadth of neutralization activity against heterologous tier 2 viruses

    Breadth of neutralizing responses against heterologous tier 2 viruses, as measured by TZM-bl pseudovirus assay

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

  11. Response rate of serum IgG binding antibodies to autologous HIV Env stabilized trimers after last vaccination and after ART restart

    Proportion of participants with serum IgG binding antibody responses to autologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA)

    Measured: 6 weeks after last vaccination and 8 weeks after ART restart

  12. Magnitude of serum IgG binding antibodies to autologous HIV Env stabilized trimers after last vaccination and after ART restart

    Magnitude of serum IgG binding antibody responses to autologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA)

    Measured: 6 weeks after last vaccination and 8 weeks after ART restart

  13. Epitope specificity of serum IgG binding antibodies to autologous HIV Env stabilized trimers after last vaccination and after ART restart

    Epitope specificity of serum IgG binding antibody responses to autologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA)

    Measured: 6 weeks after last vaccination and 8 weeks after ART restart

  14. Response rate of neutralization activity against heterologous tier 2 viruses after last vaccination and after ART restart

    Proportion of participants with neutralizing responses against heterologous tier 2 viruses, as measured by TZM-bl pseudovirus assay

    Measured: 6 weeks after last vaccination and 8 weeks after ART restart

  15. Magnitude of neutralization activity against heterologous tier 2 viruses after last vaccination and after ART restart

    Magnitude of neutralizing responses against heterologous tier 2 viruses, as measured by TZM-bl pseudovirus assay

    Measured: 6 weeks after last vaccination and 8 weeks after ART restart

  16. Breadth of neutralization activity against heterologous tier 2 viruses after last vaccination and after ART restart

    Breadth of neutralizing responses against heterologous tier 2 viruses, as measured by TZM-bl pseudovirus assay

    Measured: 6 weeks after last vaccination and 8 weeks after ART restart

  17. Change in HIV Env sequence characteristics during ATI

    Comparison of HIV envelope (Env) sequence evolution during analytic treatment interruption (ATI) between participants who develop V3-glycan-specific antibodies and those who do not

    Measured: During ATI

  18. Change in HIV gag sequence characteristics during ATI

    Comparison of HIV gag sequence evolution during analytic treatment interruption (ATI) between participants who develop V3-glycan-specific antibodies and those who do not

    Measured: During ATI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2026
  2. Study start15 Sep 2026 (estimated)
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07569029
Sponsor's protocol ID
HVTN 808
Other IDs
39218
Status last verified
Aug 2026
First submitted
15 Apr 2026
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DV700P-RNA 100 mcg and DV701B1.1-RNA 100 mcg in people with HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 16 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Peru, Zimbabwe, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local reactogenicity following study product administration (time frame: 14 days following each vaccination). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07569029.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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