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Completed

NCT Number: NCT01432574

Study of Gardasil in Mid-Adult Males (MAM)

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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Key information

Conditions

Human Papillomavirus

Age range

27 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

National Institute of Public Health, Mexico, Cuernavaca, Mexico

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GARDASIL

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).

Other names: HPV vaccine

Primary outcomes

  1. Percentage of Participants Seropositive at Month 7

    Time frame: 7 Months

    Immune response was measured with a multiplex competitive Luminex immunoassay (anti-HPV-6, -11, -16, and -18 chemiluminescence immunoassay analyzer (cLIA); Merck) at Pharmaceutical Product Development (PPD). Briefly, this assay simultaneously quantitates neutralizing antibodies to HPV 6, 11, 16, and 18 in 50 μL of serum. The seronegative study population at Day 1 (no detectable HPV antibody titers at Day 1) were to be categorized as seroconverted due to increase in titer levels for each vaccine component at Month 7.

Secondary outcomes

  1. Change in Antibody Titers

    Time frame: Points: Day 1 and Month 7

    Change in antibody titers 1 month post-dose 3 of vaccine. For each vaccine component, the geometric mean titers (GMT) and the corresponding 95% confidence intervals (CI) were calculated for antibody titers at each time-point (Day 1 and Month 7). For each participant, the difference in antibody titers between these 2 time-points (titers at Month 7 minus titers at Day 1) was calculated. The mean of antibody titer change and its 95% CI were calculated. Immune response was measured with a multiplex competitive Luminex immunoassay (anti-HPV-6, -11, -16, and -18 chemiluminescence immunoassay analyzer (cLIA); Merck) at Pharmaceutical Product Development (PPD). Briefly, this assay simultaneously quantitates neutralizing antibodies to HPV 6, 11, 16, and 18 in 50 μL of serum. mMU/ml is an arbitrary unit of measure derived after comparing relative inhibition of mAb-PE binding to a pooled standard reference serum using a four-parameter logistic curve fit and correcting for dilution.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2020
First posted
Sep 13, 2011
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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