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Could HPV shots start earlier? study tests vaccine in kids as young as 4

NCT ID NCT05329961

Vaccine Sponsor: Boston Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study looks at whether a 2-dose regimen of the Gardasil 9 HPV vaccine, given 12 months apart, triggers a strong immune response in children aged 4 to 8. The vaccine is currently approved for ages 9 and up, but this research explores if starting earlier could provide protection against HPV-related cancers. Researchers will measure antibody levels over four years and monitor for side effects like swelling at the injection site.

What this could mean

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

Active substance
Gardasil 9 (9-valent HPV vaccine)
What this could lead to
If successful, this could support expanding HPV vaccination to children under 9, potentially preventing more HPV-related cancers later in life.
What could go wrong
This is an early exploratory study with only 155 children, so results may not apply broadly. The vaccine is not yet licensed for this age group, and immune responses may differ from older children.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

155 people

The number who actually took part.

Started

Sep 2022

Expected to finish

Dec 2028

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

4 to 8 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: 1. Children aged 4-8 years old 2. Receives care at the Boston Medical Center or one of the affiliated Community heath centers 3. Naïve to HPV Vaccine Exclusion Criteria: 1. A history of severe allergic reaction, including known allergy to any vaccine component, specially severe allergic reaction to yeast 2. Immunocompromised/previous immunosuppressive therapy 3. Thrombocytopenia or other coagulation disorder

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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.

Human papilloma virus

Contacts and locations

Locations

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

More trials for these conditions

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