Study of Gardasil in Mid-Adult Males (MAM)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-19

Study Completion Date

2020-11-03

Brief Summary

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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.

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Detailed Description

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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

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Human Papillomavirus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Gardasil Vaccine

Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.

Group Type EXPERIMENTAL

Gardasil

Intervention Type BIOLOGICAL

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).

Interventions

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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).

Intervention Type BIOLOGICAL

Other Intervention Names

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HPV vaccine

Eligibility Criteria

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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

Minimum Eligible Age

27 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes