Study of Gardasil in Mid-Adult Males (MAM)

NCT01432574 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: MCC-16593
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Human Papillomavirus

Keywords

HPV

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Seropositive at Month 7

  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.

  7 Months

Secondary Outcomes (1)

• Change in Antibody Titers

  Points: Day 1 and Month 7

Study Arms (1)

Gardasil Vaccine

EXPERIMENTAL

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

Biological: Gardasil

Interventions

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).

Also known as: HPV vaccine

Gardasil Vaccine

Eligibility Criteria

• Age: 27 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

National Institute of Public Health, Mexico

Cuernavaca, 62209, Mexico

Location

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; Papillomavirus Vaccines

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Viral Vaccines

Limitations and Caveats

Participants were followed for just 7 months post-dose one of the vaccine; therefore, investigators were unable to assess the durability of the vaccine response in men vaccinated at an older age.

Results Point of Contact

• Title: Anna Giuliano, Ph.D.
• Organization: H. Lee Moffitt Cancer Center and Research Institute

anna.giuliano@moffitt.org

813-745-6820

Study Officials

• Anna Giuliano, Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2011
• First Posted: September 13, 2011
• Study Start: February 19, 2013
• Primary Completion: May 23, 2014
• Study Completion: November 3, 2020
• Last Updated: September 16, 2021
• Results First Posted: June 1, 2015

Record last verified: 2021-09

Locations

US (1); ME (1)