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One shot may shield HIV-Positive women from HPV

NCT ID NCT06436274

Prevention Sponsor: Massachusetts General Hospital 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a single dose of the HPV vaccine (Gardasil 9) can prevent persistent HPV infection in women living with HIV who have already been vaccinated. About 778 women will receive either the HPV vaccine or a meningitis vaccine (placebo) and be monitored for safety and infection. The goal is to see if one dose is enough to protect this vulnerable group.

What this could mean

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

Active substance
HPV vaccine (Gardasil 9)
What this could lead to
If successful, a single HPV vaccine dose could protect women with HIV from persistent HPV infection, reducing cancer risk.
What could go wrong
This is a Phase 4 study, but results may not apply to all populations. The single-dose approach may be less effective than the standard series, and safety in this group is still being evaluated.

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

778 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Jun 2027

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

16 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. Age 16 years and above on the day of signing the ICF 2. Living with HIV with confirmed test results or clinic records 3. History of receiving HPV vaccine 4. Self-reported sexually active in the last six months 5. Lives within the study area and willing to provide updated locator information over the course of the study 6. Does not have an autoimmune, degenerative, or genetic disease 7. Does not have known advanced HIV (as per stage IV WHO clinical staging criteria for HIV) 8. No other Investigator-determined factor would limit participation in the trial 9. Has not and is not enrolled in a monoclonal, investigational vaccine, or a large quantity blood draw study 10. The participant has a cervix Exclusion Criteria: 1. Anyone with cervical abnormality on examination 2. Anyone with an allergy to vaccine components or yeast

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease human papilloma virus infection prevention target

As listed by the trial registrant

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

HIV Human papilloma virus

Contacts and locations

Locations

  • Botswana Harvard Health Partnership

    Gaborone, 0000, Botswana

  • Ministry of Health and Center for Family Health Research

    Kigali, Kigali, +250, Rwanda

  • Wits RHI, University of the Witwatersrand

    Johannesburg, Gauteng, 2001, South Africa

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