Study of Gardasil in Mid-Adult Males (MAM)

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.

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