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New HIV vaccine duo enters first human safety trial

NCT ID NCT06919016

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing two experimental HIV vaccines, DV700P-RNA and DV701B1.1-RNA, for the first time in people. The study will enroll 45 healthy adults without HIV to check if the vaccines are safe and whether they trigger an immune response. Participants will receive a prime shot followed by a booster, and researchers will monitor side effects and immune system activity over about 16 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Two experimental HIV vaccines: DV700P-RNA (prime) and DV701B1.1-RNA (boost)
What this could lead to
If successful, this could point toward a safe and effective HIV vaccine strategy that trains the immune system to fight the virus.
What could go wrong
This is a very early Phase 1 trial with only 45 people, so it is too soon to know if the vaccines will work. The main goal is safety, not proof of protection against HIV.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

45 people

The number who actually took part.

Started

Aug 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Understands the study and agrees to complete the consent process. * Can attend all clinic visits until the end of the study. * Agrees to follow all study procedures. * Will not join another study with experimental treatments during this trial, unless approved by both study sponsors. * Generally healthy according to the study doctor. * Physical exam and lab results show no major issues that could affect safety or study results. * Agrees to discuss HIV risk and prevention. * Hemoglobin levels: at least 11.0 g/dL for women and 13.0 g/dL for men. * White blood cell count between 2,500 to 12,000/mm³ (higher levels okay if health is otherwise good and approved). * Platelet count between 125,000 to 550,000/mm³. * ALT enzyme level less than 2.5 times the upper limit of normal. * Serum creatinine level within 1.1 times the upper limit of normal. * Serum calcium level at least 8.5 mg/dL. * Blood pressure within acceptable range (systolic 90-140 mmHg, diastolic 50-90 mmHg), with average below 140/90 mmHg and no single reading over 160/100 mmHg. * Negative HIV test. * Negative for Hepatitis C. * Negative for Hepatitis B. * Women who can become pregnant must use effective contraception from 21 days before joining the study until 8 weeks after the last vaccination and must have a negative pregnancy test on enrollment day. * Women of pregnancy potential must agree not to seek pregnancy through methods like IVF from 21 days before joining the study until 8 weeks after the last vaccination. Exclusion Criteria: * Breastfeeding or pregnant. * Body mass index (BMI) of 40 or higher, unless in good health and approved. * Diabetes, unless it is well-controlled Type 2 diabetes or gestational diabetes. * Previous or current investigational HIV vaccine recipients (placebo recipients are allowed). * Received non-HIV investigational vaccines within the last year, unless they are now licensed or authorized. * Immunodeficiency or medications that impair immune response, such as high-dose steroids. * Received blood products or immunoglobulin within 16 weeks before enrollment. * Received certain vaccines within the last 4 weeks before enrollment. * Received other vaccines within 14 days before enrollment. * History of myocarditis or pericarditis. * Started allergy immunotherapy in the past year (unless stable and approved). * Taken investigational research agents recently. * Serious allergic reactions to any mRNA vaccine or drugs containing polyethylene glycol. * History of hereditary or acquired angioedema. * Any episode of hives (urticaria) within the past year. * Chronic hives (urticaria). * Hives previously caused by immunization. * Bleeding disorder that would make study procedures unsafe. * Seizures or use of seizure medications in the past 3 years. * Absence of spleen or non-functional spleen. * Active duty and reserve US military personnel. * Any other significant condition that could affect safety or participation, including substance use, psychiatric disorders, recent suicide attempts, or cancer with potential for recurrence. * Asthma that requires frequent or high-dose medication, recent emergency care, or multiple daily medications. * History of certain immune-mediated conditions (mild, localized conditions may be okay). * Allergy to local anesthetics like Novocaine or Lidocaine. * Difficulty with venous access, such as history of intravenous drug use or problems with blood draws.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Brigham and Women's Hospital (Site ID: 30007)

    Boston, Massachusetts, 02215, United States

  • Columbia P&S CRS (Site ID: 30329)

    New York, New York, 10032, United States

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

    Seattle, Washington, 98104, United States

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

    Decatur, Georgia, 30030, United States

  • University of Alabama Medical Center (Site ID: 31788)

    Birmingham, Alabama, 35222, United States

  • University of Pittsburgh (Site ID: 1001)

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Rochester Medical Center (Site ID: 31467)

    Rochester, New York, 14642, United States

  • Vanderbilt University Medical Center (Site ID: 30352)

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.