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

HPV-associated Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04688476
• Other study ID #: 2007882387
• Secondary ID: UG1 242596
• Status: Active, not recruiting
• Start date: November 17, 2020
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 113
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• HPV-associated Cancer

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California
United States	University of Arizona	Tucson	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
University of Arizona	National Cancer Institute (NCI), University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The differences in geometric mean titer (GMT) of HPV 16 and HPV18 between 30 vs. 48, 48 vs. 60, and 60 vs. 72 months after the priming dose of Gardasil		72 months
Secondary	The differences in geometric mean titer of other HPV types (HPV6/11/31/33/45/52/58) between 30 vs. 48, 48 vs. 60, and 60 vs. 72 months after the priming dose of Gardasil 9		72 months