An Extended Follow-Up Study of the HPV Vaccine Delayed Booster Trial
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|ClinicalTrials.gov Identifier: NCT04688476|
Recruitment Status : Active, not recruiting
First Posted : December 30, 2020
Last Update Posted : May 31, 2022
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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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||113 participants|
|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|
- 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 ]
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- 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.
- Has received any HPV vaccine dose from an external source at any point during or after participation in the HPV vaccine delayed booster trial.
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
|United States, Arizona|
|University of Arizona|
|Tucson, Arizona, United States, 85724|
|United States, California|
|University of California, Los Angeles|
|Los Angeles, California, United States, 90095|
|Responsible Party:||Sherry Chow, Principal Investigator, University of Arizona|
|Other Study ID Numbers:||
UG1 242596 ( Other Grant/Funding Number: DCP )
|First Posted:||December 30, 2020 Key Record Dates|
|Last Update Posted:||May 31, 2022|
|Last Verified:||May 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|