Study of Gardasil in Mid-Adult Males (MAM)
The purpose of this study is to test the effectiveness of the research study vaccine, Gardasil, in men ages 27-45 who have completed 4 years of observation in The Human Papillomavirus [HPV] infection in men (HIM) Study.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Phase II Study of Gardasil in Human Papillomavirus Research The Mid-Adult Male Vaccine Study - The MAM STUDY|
- Number of Participants Who Sero-convert [ Time Frame: 7 Months ] [ Designated as safety issue: No ]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.
- Number of Participants With Rise in Antibody Titers [ Time Frame: 7 Months ] [ Designated as safety issue: No ]Determine the rise in antibody titers 1 month post-dose 3 of vaccine. For each vaccine component, the geometric mean titers (GMT) and the corresponding 95% confidence intervals (CI) will be calculated for antibody titers at each time-point (Day 1 and Month 7). For each participant, the difference in antibody titers between these 2 time-points (titers at Month 7 minus titers at Day 1) will be calculated. If the data of the antibody titer difference is not normally distributed, then appropriate transformation will be conducted. The mean of antibody titer rise and its 95% CI will be calculated.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Gardasil Vaccine
Participants will be given a total of 3 injections (shots) at 3 separate visits.
The first shot will be given on the day they join the study (Visit 1). The second shot will be given about 2 months later (Visit 2) and the third shot will be given about 6 months after the first (Visit 3).
Other Name: HPV vaccine
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.
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|National Institute of Public Health, Mexico|
|Cuernavaca, Mexico, 62209|
|Principal Investigator:||Anna Giuliano, Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|