Study of Gardasil in Mid-Adult Males (MAM)

Human Papillomavirus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01432574
• Other study ID #: MCC-16593
• Status: Completed
• Phase: Phase 2
• Start date: February 19, 2013
• Est. completion date: November 3, 2020

Study information

• Verified date: September 2021
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 3, 2020
• Est. primary completion date: May 23, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 27 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Human Papillomavirus

Intervention

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).

Locations

Country	Name	City	State
Mexico	National Institute of Public Health, Mexico	Cuernavaca
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Antibody Titers	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.	Points: Day 1 and Month 7

External Links

•   Moffitt Cancer Center Clinical Trials website