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RSV vaccine may shield babies born to mothers with HIV

NCT ID NCT07693166

Disease control Sponsor: University of British Columbia 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study looks at whether the RSV vaccine given in late pregnancy can help protect babies born to mothers with HIV. RSV is a leading cause of infant hospitalization, and babies exposed to HIV are at higher risk. Researchers will measure antibody levels in mothers and infants to see how well protection is passed across the placenta. The study involves 20 pregnant women with HIV and aims to guide future vaccination policies.

What this could mean

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

Active substance
RSVpreF vaccine (Abrysvo®)
What this could lead to
If successful, this could show that the RSV vaccine works in pregnant women with HIV, helping protect their babies from severe RSV illness.
What could go wrong
This is a small, early-phase study with only 20 participants, so results may not apply broadly. The vaccine may not transfer enough antibodies to infants in this group.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

19 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Pregnant women/people aged ≥19 years 2. Confirmed diagnosis of HIV 3. Gestational age between 28 and 34 weeks at enrollment (to allow scheduling of vaccination at 32-36 weeks) 4. Able to provide informed consent Exclusion Criteria: 1. Contraindications to RSVpreF vaccine per product monograph 2. History of severe allergic reaction to any vaccine component 3. Planned delivery outside of British Columbia 4. Received RSVpreF in current or previous pregnancy 5. Received immunoglobulins (except Rh (D) immuneglobulin) within 1 year of enrollment 6. Unable to complete in-person follow-up for infant at the Oak Tree Clinic

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Conditions

The condition(s) this trial relates to.

HIV infectious disease respiratory syncytial virus infectious disease prevention target

As listed by the trial registrant

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

HIV RSV immunization

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

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