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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Condylomata Acuminata

Treatments: Biological: Comparator: placebo (unspecified); Biological: (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00090285

Formerly-0904HPVHMES

2004_103

V501-020 (Other Identifier)

2004-002945-10 (EudraCT Number)

Details and patient eligibility

About

This study was conducted to demonstrate that Gardasil™ (quadrivalent human papillomavirus [qHPV] vaccine) 1) is well tolerated in young men, 2) reduces incidence of external genital lesions in young men, 3) reduces the incidence of anal intraepithelial neoplasia (AIN) or anal cancer in men having sex with men (MSM), and 4) reduces incidence of Human Papillomavirus (HPV) infection in young men. In the 7-month Base Study participants received randomly assigned qHPV vaccine or placebo at Day 1, Month 2, and Month 6. Base Study follow-up continued through Month 36. In Extension 1 (EXT1), participants who received placebo or an incomplete qHPV vaccine regimen in the Base Study were offered qHPV vaccine. Participants were followed in EXT1 for 7 months. In Extension 2 [LTFU (EXT2)], long-term effectiveness, immunogenicity, and safety of qHPV vaccine were followed up to 10 years following study enrollment. Participants who received ≥1 dose of qHPV vaccine in the Base Study or EXT1 were eligible to enroll in LTFU (EXT2).

Enrollment: 4,065 patients

Sex: Male

Ages: 16 to 26 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy heterosexual males between the ages of 16 years and 23 years and 364 days. Healthy men having sex with men (MSM) 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

4,065 participants in 2 patient groups, including a placebo group

qHPV Vaccine

Experimental group

Description:

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6. Follow-up for the Base Study encompassed Month 7 through Month 36.

Treatment:

Biological: (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine

Placebo

Placebo Comparator group

Description:

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6. Follow-up for the Base Study encompassed Month 7 through Month 36.

Treatment:

Biological: Comparator: placebo (unspecified)