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

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ClinicalTrials.gov Identifier: NCT04688476
Recruitment Status : Recruiting
First Posted : December 30, 2020
Last Update Posted : December 30, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of California, Los Angeles
Information provided by (Responsible Party):
Sherry Chow, University of Arizona

Brief 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.


Condition or disease
HPV-associated Cancer

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Extended Follow-Up Study of the HPV Vaccine Delayed Booster Trial
Actual Study Start Date : November 6, 2020
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025



Primary Outcome Measures :
  1. 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 [ Time Frame: 72 months ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 72 months ]

Biospecimen Retention:   Samples Without DNA

Blood serum will be collected at each visit for Serologic geometric mean titers (GMT) of the nine vaccine types (HPV 16/18/ 6/11/31/33/45/52/58).

Urine will be collected at each visit to explore the potential of assessing HPV DNA and antibodies in the urine.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study population is restricted to 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".
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04688476


Contacts
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Contact: Sherry Chow, PhD 520-626-3358 schow@arizona.edu

Locations
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United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Anna-Barbara Moscicki, MD    310-825-5995    AMoscicki@mednet.ucla.edu   
Sponsors and Collaborators
University of Arizona
National Cancer Institute (NCI)
University of California, Los Angeles
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Responsible Party: Sherry Chow, Principal Investigator, University of Arizona
ClinicalTrials.gov Identifier: NCT04688476    
Other Study ID Numbers: 2007882387
UG1 242596 ( Other Grant/Funding Number: DCP )
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: December 30, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No