Study of Gardasil in Mid-Adult Males (MAM)

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Human Papillomavirus

Clinical Trial Details

NCT number	NCT01432574
Study type	Interventional
Source	H. Lee Moffitt Cancer Center and Research Institute
Contact
Status	Completed
Phase	Phase 2
Start date	February 19, 2013
Completion date	November 3, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02740790` - Immunogenicity and Safety of Human Papillomavirus (HPV)-16/18 Vaccine in Healthy Females	Phase 2
Completed	`NCT01845779` - Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal	N/A
Completed	`NCT01422356` - Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men	N/A
Completed	`NCT02808832` - An HPV Vaccine Provider Intervention in Safety Net Clinics	N/A
Completed	`NCT01159834` - Human Papillomavirus (HPV) Vaccination in Barretos (Pio XII Foundation - Barretos Cancer Hospital)	N/A
Completed	`NCT01456715` - Immunogenicity of Gardasil and Twinrix and the Effect of a Dose of Gardasil or Cervarix Given 42 Months Later.	Phase 3
Completed	`NCT02968420` - Long Term Immune Memory Responses to HPV Vaccination Following 2 vs 3 Doses of Quad-HPV Vaccine	Phase 4
Completed	`NCT02007421` - Study of the Prevention of Anal Cancer	N/A
Recruiting	`NCT04708470` - A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers	Phase 1/Phase 2
Completed	`NCT02267876` - Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens
Recruiting	`NCT01459289` - Psychosocial Effect of HPV Positivity	N/A
Completed	`NCT01358097` - Role of Immune Activation in Response of Head and Neck Squamous Cell Carcinoma to Therapy	N/A
Completed	`NCT01342978` - Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time	N/A
Not yet recruiting	`NCT06434337` - Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV)
Active, not recruiting	`NCT02576561` - Safety and Efficacy Study of TVGV-1 Vaccine to Treat HPV Induced Cervical HSIL	Phase 2
Terminated	`NCT02503111` - The HPV-SAVE Study Team: HPV Screening and Vaccine Evaluation in Men Who Have Sex With Men	N/A
Recruiting	`NCT02126189` - The Princess Alexandra Hospital and the QIMR Berghofer Medical Research Institute Head and Neck Cancer Study	N/A
Completed	`NCT01766284` - Study of the Diagnostic Efficacy of "Real Time" Niris 1300e Optical Coherence Tomography (OCT) Imaging System in the Management of Pre-invasive and Invasive Neoplasia of the Uterine Cervix	N/A
Completed	`NCT01524003` - Chinese Cancer Prevention Study(CHICAPS)	N/A
Recruiting	`NCT05026138` - Natural History, Epidemiology and Pathogenesis of Severe HPV-Related Diseases (Neptune)