This trial is active, not recruiting.

Condition human papillomavirus
Treatment gardasil
Phase phase 2
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborator Merck Sharp & Dohme Corp.
Start date December 2012
End date May 2014
Trial size 150 participants
Trial identifier NCT01432574, MCC-16593


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.
gardasil HPV vaccine
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).

Primary Outcomes

Percentage of Participants Seropositive at Month 7
time frame: 7 Months

Secondary Outcomes

Change in Antibody Titers
time frame: Points: Day 1 and Month 7

Eligibility Criteria

Male participants from 27 years up to 45 years old.

Inclusion Criteria: - Men that have completed 4 years of follow-up in the on-going international prospective natural history study of HPV in men (The HIM Study) - Willing to comply with 4 scheduled visits within a 7-month period Exclusion Criteria: - Have received an HPV vaccine - Have a prior diagnosis of penile or anal cancers - Have a prior diagnosis of high grade anal intraepithelial neoplasia - Have been diagnosed with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) - Have a history of anaphylaxis to vaccines - Have known impairment of the immune system - Have received any blood products within 6 months of enrollment

Additional Information

Official title A Phase II Study of Gardasil in Human Papillomavirus Research The Mid-Adult Male Vaccine Study - The MAM STUDY
Principal investigator Anna Giuliano, Ph.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute.