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Could a delayed booster still protect against HPV?

NCT ID NCT02568566

Vaccine Sponsor: National Cancer Institute (NCI) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study is testing whether giving the HPV vaccine (Gardasil 9) on a different schedule still works well in healthy 9-11 year olds. The standard schedule uses two or three doses, but this study gives a first dose and then a booster later. Researchers will measure antibody levels over two years to see if protection lasts. The goal is to find a simpler schedule that might be easier for families to complete.

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, this could support a simpler, delayed-booster schedule for the HPV vaccine, making it easier to complete.
What could go wrong
This is a small, early-phase study (Phase 2) with no control group. The alternative schedule may not provide the same long-term protection as the standard one.

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

201 people

The number who actually took part.

Started

May 2016

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

9 to 11 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: * Healthy, medically well girls and boys * Ability to understand and the willingness to sign a written informed consent document by the legal representative(s) of the participant * Ability to understand and the willingness to sign a written assent document by the participant Exclusion Criteria: * Previous vaccination against HPV * The use of any investigational agent within 30 days preceding the first dose of the study vaccine or subsequent participation in another clinical trial at any time during the study period, in which the subject will be exposed to an investigational product * Chronic administration of immunosuppressive agents or other immune-modifying drugs or chemotherapeutic agents within six months prior to the first vaccine dose; use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed * Receiving active treatment for cancer or an autoimmune condition * Confirmed or suspected immunosuppressive or immunodeficient condition * Known bleeding disorders that preclude intramuscular injection (e.g., on anticoagulants or thrombocytopenia) * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal dysfunction, which in the opinion of the investigator precludes administration of the study vaccine * History of allergic reactions attributed to compounds of similar chemical or biologic composition of GARDASIL 9 (recombinant human papillomavirus nonavalent vaccine), including yeast allergy * Are pregnant

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Conditions

The condition(s) this trial relates to.

human papillomavirus-related squamous cell carcinoma human papilloma virus infection prevention target

As listed by the trial registrant

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

Human papillomavirus-related carcinoma

Contacts and locations

Locations

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719, United States

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095, United States

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