NCT07569029 · National Institute of Allergy and Infectious Diseases (NIAID)
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
What this study is about
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.
View original scientific description
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.
Interventions
BIOLOGICAL
DV700P-RNA 100 mcg
Intramuscular injection
BIOLOGICAL
DV701B1.1-RNA 100 mcg
Intramuscular injection
Primary outcome measures
Local reactogenicity following study product administration
Time frame: 14 days following each vaccination
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
Systemic reactogenicity following study product administration
Time frame: 14 days following each vaccination
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
Number and description of serious adverse events (SAEs)
Time frame: Through study completion, expected to be up to 88 weeks
Number and description of medically attended adverse events (MAAEs)
Time frame: Through study completion, expected to be up to 88 weeks
Number and description of adverse events of special interest (AESIs)
Time frame: Through study completion, expected to be up to 88 weeks
Number and description of adverse events leading to study product discontinuation or participant withdrawal
Time frame: Through study completion, expected to be up to 88 weeks
Number and description of adverse events (AEs) following study product administration
Time frame: 30 days following each vaccination
Response rate of differential serum neutralizing antibody responses to precursor detection viruses
Time frame: At Baseline (Week 0) and 2 weeks after last vaccination
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
Magnitude of differential serum neutralizing antibody responses to precursor detection viruses
Time frame: At Baseline (Week 0) and 2 weeks after last vaccination
Magnitude of serum antibody neutralization of precursor detection viruses and corresponding epitope knock-out mutant viruses, as measured by TZM-bl pseudovirus assay
Response rate of differential serum neutralizing antibody responses to precursor detection viruses after last vaccination and after ART restart
Time frame: 6 weeks after last vaccination and 8 weeks 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
Magnitude of differential serum neutralizing antibody responses to precursor detection viruses after last vaccination and after ART restart
Time frame: 6 weeks after last vaccination and 8 weeks 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- 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.
Where
- Birmingham, Alabama
- San Francisco, California
- Atlanta, Georgia
- Decatur, Georgia
- Boston, Massachusetts
- New York, New York
- Rochester, New York
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Nashville, Tennessee
- Seattle, Washington
Collaborators
Department of Health and Human Services, Duke University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 6, 2026 · Source of record for eligibility and locations