NCT01432574

Study of Gardasil in Mid-Adult Males (MAM)

A Phase II Study of Gardasil in Human Papillomavirus Research The Mid-Adult Male Vaccine Study - The MAM STUDY

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Male
• Age: 27 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Human Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	Gardasil	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).

Timeline

• Start date: 2013-02-19
• Primary completion: 2014-05-23
• Completion: 2020-11-03
• First posted: 2011-09-13
• Last updated: 2021-09-16
• Results posted: 2015-06-01

Locations

2 sites across 2 countries: United States, Mexico

Regulatory

• FDA-regulated drug study