A Phase II Study of Gardasil in Human Papillomavirus Research The Mid-Adult Male Vaccine Study - The MAM STUDY
27 Years
45 Years
Male
Human Papillomavirus
Trial Information
A Phase II Study of Gardasil in Human Papillomavirus Research The Mid-Adult Male Vaccine Study - The MAM 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 will be administered at 0, 2, and 6 months. Blood will be drawn
at 0 and 7 months to provide a quadrivalent HPV antibody serologic profile. Each participant
will also complete surveys (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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Number of Participants Who Sero-convert
Outcome Description:
Assess the percent of men who sero-convert to each of the 4 vaccine components 1 month post-dose 3 of vaccine. At Day 1 and Month 7, the seroconversion percentage to HPV 6/11/16/18 will be calculated separately as 100*(m/n), where n is number of participants contributing to the analyses and m is number of participants with the indicated response. Its 95% confidence interval (CI) will be calculated based on exact method.
Outcome Time Frame:
7 Months
Safety Issue:
No
Principal Investigator
Anna Giuliano, Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
H. Lee Moffitt Cancer Center and Research Institute
Authority:
United States: Food and Drug Administration
Study ID:
MCC-16593
NCT ID:
NCT01432574
Start Date:
December 2012
Completion Date:
November 2013
Related Keywords:
- Human Papillomavirus
- HPV
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
