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HIV vaccine candidate VIR-1388 passes early safety check in 93 volunteers

NCT ID NCT05854381

Vaccine Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a new HIV vaccine called VIR-1388 in 93 healthy adults who did not have HIV. The goal was to see if the vaccine is safe and whether it triggers an immune response. Participants received either the vaccine or a placebo, and researchers monitored side effects and immune cell activity. The trial is now complete, and results will help decide if further testing is warranted.

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

93 people

The number who actually took part.

Started

Sep 2023

Finished

Nov 2025

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: * In overall good health as determined by medical history, physical exam, and laboratory values * HIV uninfected * CMV seropositive * Willing to use condoms during intercourse for the duration of the study * Assessed by clinic staff as being low risk for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last protocol visit * Childbearing status * Part A: Only participants of non-childbearing potential * Part B: Participants of childbearing potential must be on 2 forms of contraception and not planning on becoming pregnant for the duration of the study Exclusion Criteria: * Participant is immunocompromised * Participant has an autoimmune disorder * Participants having intimate contact with immunocompromised individuals * Participants having intimate contact with a pregnant partner or partner planning to become pregnant * Participants who are breastfeeding

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Conditions

The condition(s) this trial relates to.

HIV infectious disease prevention target

As listed by the trial registrant

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

HIV I infection

Contacts and locations

Locations

  • Alabama CRS

    Birmingham, Alabama, 35222, United States

  • Beth Israel Deconess Medical Center VCRS

    Boston, Massachusetts, 32077, United States

  • Chatsworth Clinical Research Site

    Overport, KwaZulu-Natal, 4092, South Africa

  • Isipingo Clinical Research Site

    Isipingo, KwaZulu-Natal, 4110, South Africa

  • Penn Prevention CRS

    Philadelphia, Pennsylvania, 19104, United States

  • Perinatal HIV Research Unit

    Soweto, Gauteng, 1862, South Africa

  • Seattle Vaccine and Prevention CRS

    Seattle, Washington, 98104, United States

  • Setshaba Research Centre CRS

    Soshanguve, Gauteng, 0152, South Africa

  • The Hope Clinic of the Emory Vaccine Center CRS

    Decatur, Georgia, 30030, United States

  • University of Pittsburgh CRS

    Pittsburgh, Pennsylvania, 15213, United States

More trials for these conditions

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