A Phase II Study of Gardasil in Human Papillomavirus Research The Mid-Adult Male Vaccine Study - The MAM STUDY
The MAM Study is a prospective pilot intervention trial to investigate patterns of human
papillomavirus (HPV) vaccine immunogenicity in men, aged 27-45 years, in which the men will
receive Gardasil. Gardasil will be administered at 0, 2, and 6 months. Blood will be drawn
at 0 and 7 months to provide a quadrivalent HPV antibody serologic profile. Each participant
will also complete surveys (CASI) at Day 1 and Month 7 to record sexual behavior.
Our overall goal is to test the efficacy of Gardasil to reduce HPV 6, 11, 16, 18 persistent
infection among men at the external genital epithelium, anal canal, and oral cavity, and to
reduce lesions caused by these HPV types at the external genital epithelium and anal canal.
The purpose of this Phase II trial is to establish the immunogenicity of Gardasil among
mid-adult men and to establish the infrastructure with which to build the larger Phase III
trial in the future.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Number of Participants Who Sero-convert
Assess the percent of men who sero-convert to each of the 4 vaccine components 1 month post-dose 3 of vaccine. At Day 1 and Month 7, the seroconversion percentage to HPV 6/11/16/18 will be calculated separately as 100*(m/n), where n is number of participants contributing to the analyses and m is number of participants with the indicated response. Its 95% confidence interval (CI) will be calculated based on exact method.
Anna Giuliano, Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|