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Can a new vaccine shield against more HPV types?

NCT ID NCT06623409

Prevention Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This Phase 1 trial tests an experimental vaccine called V540B in healthy adults. V540B aims to protect against the same nine HPV types as the standard Gardasil 9 vaccine, plus additional types, potentially preventing more HPV-related cancers. Researchers will compare V540B to Gardasil 9 to see if it is safe, well-tolerated, and triggers a similar immune response. The study focuses on safety first, with immune response as a secondary measure.

What this could mean

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

Active substance
V540B, an experimental HPV vaccine with an adjuvant, given as an injection
What this could lead to
If V540B proves safe and triggers a strong immune response, it could lead to a vaccine that protects against more HPV types than current shots, potentially preventing more HPV-related cancers.
What could go wrong
This is an early Phase 1 trial with only 72 healthy adults, so the main focus is safety, not proof of effectiveness. The vaccine may not produce a strong enough immune response or may cause side effects, and more studies would be needed before it could reach the public.

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

About 72 people

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

Started

Nov 2024

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 45 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: The key inclusion criteria include but are not limited to the following: * Is in good health based on medical history, physical examination, vital sign (VS) measurements and electrocardiograms (ECGs) performed before randomization. Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * Has a history of abnormal Pap smears, HPV- related external genital lesions (eg,condyloma acuminate, vulval intraepithelial neoplasia (VIN), or prostatic intraepithelial neoplasia (PIN)) or external genital cancer (eg, penile cancer), HPV-related vaginal or anal lesions (eg, condyloma acuminata or vaginal intraepithelial neoplasia (VaIN)) or vaginal or anal cancer. * Has a history of cancer (malignancy). * Has received any HPV vaccine or is expected to receive any HPV vaccine during the study, outside the protocol.

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As listed by the trial registrant

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

Healthy

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Anaheim Clinical Trials ( Site 0002)

    ACTIVE_NOT_RECRUITING

    Anaheim, California, 92801, United States

  • California Clinical Trials Medical Group managed by PAREXEL ( Site 0008)

    COMPLETED

    Glendale, California, 91206, United States

  • Research Centers of America ( Hollywood ) ( Site 0001)

    RECRUITING

    Hollywood, Florida, 33024, United States

  • Velocity Clinical Research, Hallandale Beach ( Site 0003)

    ACTIVE_NOT_RECRUITING

    Hallandale, Florida, 33009, United States

  • Velocity Clinical Research, Omaha ( Site 0005)

    ACTIVE_NOT_RECRUITING

    Omaha, Nebraska, 68134, United States

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