An Extended Follow-Up Study of the HPV Vaccine Delayed Booster Trial

NCT ID: NCT04688476

Last Updated: 2025-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-17

Study Completion Date

2025-12-31

Brief Summary

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This is an extended follow-up study to follow-up study participants who received 1 booster dose of Gardasil 9 in the "HPV vaccine delayed booster trial." This was a prospective, single-arm, open-label, non-randomized, phase IIa trial among 9-11 year-old girls and boys to determine the immunogenicity after a single dose of the nonavalent HPV vaccine (Gardasil 9) over 24 months, with a delayed booster dose at 24 months and an optional booster at 30 months after the first dose. Participants provided blood specimens at 6, 12, 18, 24, and 30 months after the first dose. Serologic geometric mean titers (GMT) of the nine vaccine types (HPV 16/18/ 6/11/31/33/45/52/58) were measured at each time point. One hundred and thirty-three (133) participants received one booster dose at month 24 and elected not to receive the second booster at month 30.

For this follow-up study, we anticipate that we will be able to accrue 120 participants from the original study who received just one booster dose. Participants who received one booster dose of Gardasil 9 will be contacted to return to the clinic to provide blood specimens at 48 (±3), 60 (±3), and 72 (±3) months after the priming dose. Serologic geometric mean titers (GMT) of the nine vaccine types (HPV 16/18/ 6/11/31/33/45/52/58) will be measured at each time point.

Detailed Description

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Conditions

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HPV-associated Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Study participants who received one booster dose of Gardasil 9 at month 24 and elected not to receive the second booster at month 30 in the original "HPV vaccine delayed booster trial"
* 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

\- Has received any HPV vaccine dose from an external source at any point during or after participation in the HPV vaccine delayed booster trial.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role collaborator

University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Sherry Chow

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Arizona

Tucson, Arizona, United States

Site Status

University of California, Los Angeles

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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UG1 242596

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2007882387

Identifier Type: -

Identifier Source: org_study_id

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