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An Investigational Study of Gardasil™ (qHPV, V501) Vaccine in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00090285
First received: August 25, 2004
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

This study is to evaluate an investigational vaccine with the following objectives: to demonstrate that the vaccine is well tolerated in young men; to demonstrate that the vaccine reduces incidence of external genital lesions (Condylomata acuminata [anogenital warts], penile/perianal/perineal intraepithelial neoplasia [PIN], penile, perianal, perineal cancer) in young men; to demonstrate that the vaccine reduces the incidence of anal intraepithelial neoplasia (AIN) or anal cancer in men having sex with men (MSM); and to demonstrate that the vaccine reduces incidence of Human Papilloma Virus (HPV) infection in young men.


Condition Intervention Phase
Condylomata Acuminata
Biological: (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Biological: Comparator: placebo (unspecified)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: An Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Incidence of Human Papillomavirus (HPV) Related External Genital Warts, Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer [ Time Frame: Base study: through Month 36 ] [ Designated as safety issue: No ]
    Subjects with HPV 6/11/16/18-related external genital warts, PIN, penile, perianal or perineal cancer per 100 person-years of follow-up.

  • Number of Participants With Severe Injection Site Adverse Experiences (AEs) [ Time Frame: Base study: through Day 5 after any vaccination ] [ Designated as safety issue: Yes ]
  • Number of Participants With Vaccine-Related Serious Adverse Events (SAEs) [ Time Frame: Base study: through Month 36 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of HPV 6/11/16/18-related Persistent Infection [ Time Frame: Base study: through Month 36 ] [ Designated as safety issue: No ]
    Subjects with HPV 6/11/16/18-related persistent infection per 100 person-years of follow-up.

  • Incidence of HPV 6/11/16/18-related Deoxyribonucleic Acid (DNA) Detection [ Time Frame: Base study: through Month 36 ] [ Designated as safety issue: No ]
    Subjects with HPV 6/11/16/18-related DNA detection per 100 person-years of follow-up.


Other Outcome Measures:
  • Substudy to Evaluate the Incidence of HPV 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer in Men Having Sex With Men (MSM) [ Time Frame: Base study: through Month 36 ] [ Designated as safety issue: No ]
    Participants with HPV 6/11/16/18-related AIN or anal cancer per 100 person-years of follow-up


Enrollment: 4065
Study Start Date: September 2004
Estimated Study Completion Date: December 2017
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: qHPV Vaccine Biological: (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Duration of Treatment: 6 months
Other Names:
  • qHPV
  • V501
Placebo Comparator: Placebo Biological: Comparator: placebo (unspecified)
Duration of Treatment: 6 months

Detailed Description:

The base study (V501-020) encompassed Day 1 through Month 7, during which time participants received randomly assigned Gardasil™ (qHPV vaccine) or placebo at Day 1, Month 2, and Month 6. Base study follow-up continued through Month 36.

The base study was extended in protocol V501-020-10 Extension 1 (EXT1). Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the base study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants were followed to EXT1 Month 7.

A second extension study, V501-020-21 (EXT2), will estimate the long-term safety and effectiveness of qHPV vaccine during a period of 10 years following initial enrollment in the base study. Subjects who received at least one dose of qHPV vaccine in either the base study or EXT1 are eligible to enroll in EXT2.

  Eligibility

Ages Eligible for Study:   16 Years to 26 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male between the ages of 16 years and 23 years and 364 days. For the MSM substudy, between the ages of 16 years and 26 years and 364 days.
  • No clinical evidence of genital lesions suggesting sexually-transmitted disease, and no history of anogenital warts
  • Additional criteria will be discussed with you by the physician

Exclusion Criteria:

  • Concurrently enrolled in a clinical study involving collection of genital specimens
  • History of known prior vaccination with an HPV vaccine
  • Received an inactivated vaccine within 14 days or a live virus vaccine within 21 days prior to enrollment
  • History of a severe allergic reaction that required medical intervention
  • Received any immune globulin or blood-derived products within 6 months prior to the first study injection
  • History of splenectomy, immune disorders, or receiving immunosuppressives
  • Immunocompromised or diagnosed with HIV infection
  • Known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
  • History of recent or ongoing alcohol or drug abuse
  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: NCT00090285

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00090285     History of Changes
Other Study ID Numbers: V501-020, Formerly-0904HPVHMES, 2004_103
Study First Received: August 25, 2004
Results First Received: October 14, 2009
Last Updated: August 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
anogenital warts

ClinicalTrials.gov processed this record on November 20, 2014