Summary

Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Keywords

HPV-associated Cancer

Eligibility

You can join if…

  • 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.

You CAN'T join if...

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

Locations

  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • University of Arizona accepting new patients
    Tucson Arizona 85724 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Arizona
ID
NCT04688476
Study Type
Observational
Last Updated