Study of Gardasil in Mid-Adult Males (MAM)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01432574
First received: September 9, 2011
Last updated: May 28, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Human Papillomavirus
Biological: Gardasil
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II Study of Gardasil in Human Papillomavirus Research The Mid-Adult Male Vaccine Study - The MAM STUDY

Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Percentage of Participants Seropositive at Month 7 [ Time Frame: 7 Months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change in Antibody Titers [ Time Frame: Points: Day 1 and Month 7 ] [ Designated as safety issue: No ]
    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.


Enrollment: 150
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gardasil Vaccine
Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.
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).
Other Name: HPV vaccine

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.

  Eligibility

Ages Eligible for Study:   27 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432574

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Mexico
National Institute of Public Health, Mexico
Cuernavaca, Mexico, 62209
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Anna Giuliano, Ph.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01432574     History of Changes
Other Study ID Numbers: MCC-16593
Study First Received: September 9, 2011
Results First Received: April 23, 2015
Last Updated: May 28, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
HPV

ClinicalTrials.gov processed this record on September 03, 2015