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Could a tiny HPV shot still protect? small study tests lower dose

NCT ID NCT04235257

Knowledge-focused Sponsor: University of Washington 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a smaller, one-fifth dose of the HPV vaccine, given into the skin instead of the muscle, can still trigger a good immune response in adults aged 27 to 45. Researchers are comparing two types of HPV vaccines in 40 volunteers in Seattle. The goal is to see if a lower dose could be a practical option for expanding vaccine access.

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 or bivalent HPV VLP vaccine), given as a one-fifth dose into the skin
What this could lead to
If successful, this could show that a smaller, cheaper dose of HPV vaccine is effective, potentially making vaccination more accessible for adults.
What could go wrong
This is a very small early-phase trial with only 40 participants, so results may not apply to the general population. The fractional dose might not produce a strong enough immune response.

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 40 people

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

Started

Nov 2020

Expected to finish

Dec 2026

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

27 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: * Age 27-45 years at enrollment * Not intending to receive the HPV vaccine series for the duration of the study participation * Willing and able to provide written informed consent, undergo clinical evaluation, and adhere to follow-up schedule Exclusion Criteria: * Prior immunization with HPV-vaccine (Cervarix, Gardasil-4, Gardasil-9) * Currently pregnant or breastfeeding * Immune deficiency or other immune disorder * HIV infection or continued high risk for HIV; patients at risk for HIV who do not have a negative HIV test in the last 6 months will be excluded * Cancer or chemotherapy (current, within 6 months, or anticipated in the future) except for fully excised non-melanoma skin cancer) * Unstable medical condition (e.g., malignant hypertension, poorly controlled diabetes, * Known allergy to vaccine components * Prior history of HPV-associated cancer

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Conditions

The condition(s) this trial relates to.

human papilloma virus infection prevention target

As listed by the trial registrant

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

HPV infection HPV vaccine

Contacts and locations

Locations

  • University of Washington Virology Research Clinic

    Seattle, Washington, 98104, United States

More trials for these conditions

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