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One shot to stop HPV spread? new trial tests Vaccine's hidden power

NCT ID NCT07303751

Disease control Sponsor: Institut d'Investigació Biomèdica de Bellvitge 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether a single dose of the HPV vaccine (Gardasil-9) can reduce the infectivity of high-risk HPV in women aged 18-29 who already have the virus. Researchers will compare cervical samples from vaccinated and unvaccinated women at 6 months to see if vaccine-induced antibodies neutralize the virus. If successful, it could suggest a new way to control HPV transmission.

What this could mean

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

Active substance
Nonavalent HPV vaccine (Gardasil-9)
What this could lead to
If it works, this could show that a single HPV vaccine dose reduces how easily the virus spreads, potentially lowering infection rates in communities.
What could go wrong
This is a small, early-phase trial with only 80 participants. It measures infectivity in lab samples, not actual transmission, so real-world impact is uncertain. The vaccine may not reduce infectivity as hoped.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Feb 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

18 to 29 years

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: * Born female * Aged between 18-29 years old; * Living in Kambia district (or neighbouring district if included) without plans to move away in the next 12 months; * Willing to participate in the study and have signed the informed consent form; * In good health as determined by a medical history (a physical examination will be conducted if necessary according to the clinician's judgement); * Willing to be tested for HIV; * Are HIV negative at the screening visit; * Not pregnant; * Able to pass a Test of Understanding (TOU); * Willing to provide cervical, urine and blood samples; * Agree to be vaccinated with a single dose of Gardasil9® if randomised to the vaccine arm at Day 0; * Have no visible suspicious cervical lesions on examination. * Agree to a pregnancy test at screening and before any HPV vaccination. Exclusion Criteria: * They have been previously vaccinated against HPV; * They have a chronic condition, such as autoimmune conditions, degenerative diseases, neurologic or genetic diseases among others; * They are HIV positive or immunocompromised; * They are pregnant or planning to get pregnant in the next 12 months; * They are less than three months post-partum or currently breastfeeding; * They are allergic to one of the vaccine components or to latex; * They are sexually active and are not using, or are not willing to use, an effective birth control method from D-14 until 60 days after the last vaccine dose * The nurse or clinician determining the eligibility, in agreement with principal investigator, considers that there is a reason that precludes participation.

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Conditions

The condition(s) this trial relates to.

cervical squamous intraepithelial neoplasia human papilloma virus infection Infections Uterine Cervical Neoplasms

As listed by the trial registrant

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

High-risk HPV (any strain) HPV Human papillomavirus (HPV) infections

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Kambia Research Centre

    Freetown, Sierra Leone

More trials for these conditions

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