Study of Gardasil in Mid-Adult Males (MAM)

H. Lee Moffitt Cancer Center and Research Institute

Status and phase

Completed

Phase 2

Conditions

Human Papillomavirus

Treatments

Biological: Gardasil

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01432574

MCC-16593

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

Male

Ages

27 to 45 years old

Volunteers

Accepts Healthy Volunteers

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