The University of Arizona Cancer Prevention Clinical Trials Network (UA CP-CTNet) has enrolled the first participant onto a CP-CTNet trial, An Extended Follow-up Study of the HPV Vaccine Delayed Booster Trial (UAZ20-01-02).
This is a follow-up study to A prospective, single-arm, open-label, non-randomized, phase IIA trial of a nonavalent prophylactic HPV vaccine (Gardasil 9) to assess immunogenicity of a prime and deferred-booster dosing schedule among 9-11 year old girls and boys (UAZ2015-05-01). The original study from the Consortia program examined the persistence and stability of serologic response after a single dose of the nonavalent HPV vaccine over 24 months. The trial also offered the unprecedented opportunity to determine whether the 24-month delayed booster of the nonavalent vaccine would generate a stable and persistent immunogenicity. The study accrued very well, had outstanding retention, and will provide important data on stability of the vaccine response up to 24 months post initial vaccination. A booster (second dose) was given to all participants at 24 months with an option for a third dose to be administered at 30 months. The majority of families in the study refused the third dose.
The CP-CTNet extension trial intends to determine the stability of the type-specific serologic response in geometric mean titer (GMT) of HPV16 and HPV18 between 30 vs. 48, 48 vs. 60, and 60 vs. 72 months after the delayed booster of Gardasil 9 (primary endpoint). 120 total participants are expected to be enrolled at UA and UCLA. Secondary endpoints are to determine the stability of type-specific serologic GMT for the other HPV types in the vaccine during the same time points.
The Study Initiation Meeting was held August 19, 2020 and included staff from the University of Arizona (LAO), University of California, Los Angeles (AO), as well as staff from the Division of Cancer Prevention (DCP) and the Data Management, Auditing, and Coordinating Center (DMACC).
The enrollment of the first participant on UAZ20-01-02 is a major milestone for the CP-CTNet project. This was a true collaborative effort involving members from DCP, the DMACC, UA CP-CTNet, and UCLA.