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

• 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 ]

• 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.

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.

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.

• Biological: (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
  Duration of Treatment: 6 months
  Other Names:

  • qHPV
  • V501
• Biological: Comparator: placebo (unspecified)
  Duration of Treatment: 6 months

• Experimental: qHPV Vaccine
  Intervention: Biological: (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
• Placebo Comparator: Placebo
  Intervention: Biological: Comparator: placebo (unspecified)

• Goldstone SE, Jessen H, Palefsky JM, Giuliano AR, Moreira ED Jr, Vardas E, Aranda C, Hillman RJ, Ferris DG, Coutlee F, Marshall JB, Vuocolo S, Haupt RM, Guris D, Garner E. Quadrivalent HPV vaccine efficacy against disease related to vaccine and non-vaccine HPV types in males. Vaccine. 2013 Aug 20;31(37):3849-55. doi: 10.1016/j.vaccine.2013.06.057. Epub 2013 Jul 2.
• Palefsky JM, Giuliano AR, Goldstone S, Moreira ED Jr, Aranda C, Jessen H, Hillman R, Ferris D, Coutlee F, Stoler MH, Marshall JB, Radley D, Vuocolo S, Haupt RM, Guris D, Garner EI. HPV vaccine against anal HPV infection and anal intraepithelial neoplasia. N Engl J Med. 2011 Oct 27;365(17):1576-85. doi: 10.1056/NEJMoa1010971.
• Giuliano AR, Palefsky JM, Goldstone S, Moreira ED Jr, Penny ME, Aranda C, Vardas E, Moi H, Jessen H, Hillman R, Chang YH, Ferris D, Rouleau D, Bryan J, Marshall JB, Vuocolo S, Barr E, Radley D, Haupt RM, Guris D. Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males. N Engl J Med. 2011 Feb 3;364(5):401-11. doi: 10.1056/NEJMoa0909537. Erratum in: N Engl J Med. 2011 Apr 14;364(15):1481.

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