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|
- Percentage of Participants Seropositive at Month 7 [ Time Frame: 7 Months ] [ Designated as safety issue: No ]Immune response was measured with a multiplex competitive Luminex immunoassay (anti-HPV-6, -11, -16, and -18 chemiluminescence immunoassay analyzer (cLIA); Merck) at Pharmaceutical Product Development (PPD). Briefly, this assay simultaneously quantitates neutralizing antibodies to HPV 6, 11, 16, and 18 in 50 μL of serum. The seronegative study population at Day 1 (no detectable HPV antibody titers at Day 1) were to be categorized as seroconverted due to increase in titer levels for each vaccine component at Month 7.
- Change in Antibody Titers [ Time Frame: Points: Day 1 and Month 7 ] [ Designated as safety issue: No ]Change 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) were 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) was calculated. The mean of antibody titer change and its 95% CI were calculated. Immune response was measured with a multiplex competitive Luminex immunoassay (anti-HPV-6, -11, -16, and -18 chemiluminescence immunoassay analyzer (cLIA); Merck) at Pharmaceutical Product Development (PPD). Briefly, this assay simultaneously quantitates neutralizing antibodies to HPV 6, 11, 16, and 18 in 50 μL of serum. mMU/ml is an arbitrary unit of measure derived after comparing relative inhibition of mAb-PE binding to a pooled standard reference serum using a four-parameter logistic curve fit and correcting for dilution.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: Gardasil Vaccine
Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.
The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: 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 was administered at 0, 2, and 6 months. Blood was drawn at 0 and 7 months to provide a quadrivalent HPV antibody serologic profile. Participants also completed surveys via computer-assisted interviews (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432574
|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|