A Phase 3 Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy, Immunogenicity, and Safety of V503, a 9-Valent Human Papillomavirus (HPV) Vaccine, in Chinese Males 20 to 45 Years of Age
Overview
- Phase
- Phase 3
- Intervention
- 9vHPV Vaccine
- Conditions
- Papillomavirus Infections
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 8100
- Locations
- 34
- Primary Endpoint
- Stages I and II: Combined Incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related Genital Warts, PIN, or Penile/Perianal/Perineal Cancer
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
This study will evaluate the efficacy, immunogenicity, and safety of 9-valent human papillomavirus (9vHPV; V503) vaccine in Chinese men 20 to 45 years of age. It will enroll heterosexual men (HM) and men who have sex with men (MSM), will be stratified by age and sexual orientation, and will have two stages. The primary hypothesis of Stage I is: 9vHPV vaccine reduces the combined incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related external genital and intra-anal 12-month persistent infection (PI) compared with placebo in males 20 to 45 years of age who are seronegative at Day 1 and polymerase chain reaction (PCR) negative from Day 1 through one month post-Dose 3 to the relevant HPV type. The primary hypothesis of Stages I and II combined is: 9vHPV vaccine reduces the combined incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related genital warts, penile/perianal/perineal intraepithelial neoplasia (PIN), or penile/perianal/perineal cancer compared with placebo in males 20 to 45 years of age who are seronegative at Day 1 and PCR negative from Day 1 through one month post-Dose 3 to the relevant HPV type.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Is a Chinese male.
- •Has no more than 5 lifetime sexual partners.
Exclusion Criteria
- •Has a history of known prior vaccination with an HPV vaccine.
- •Has a history of HPV-related external genital lesions, HPV-related intra-anal lesions, or HPV-related head and neck cancer.
- •Has a history of severe allergic reaction that required medical intervention.
- •Has received immune globulin or blood-derived products in the past 3 months or plans to receive any before Month 7 of the study.
- •Has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
- •Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids.
- •Has a known thrombocytopenia or coagulation disorder that would contraindicate IM injections.
Arms & Interventions
V503
Participants will receive a single 0.5 mL intramuscular (IM) injection of V503 at Day 1, Month 2, and Month 6.
Intervention: 9vHPV Vaccine
Placebo
Participants will receive a single 0.5 mL IM injection of placebo at Day 1, Month 2, and Month 6.
Intervention: Placebo
Outcomes
Primary Outcomes
Stages I and II: Combined Incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related Genital Warts, PIN, or Penile/Perianal/Perineal Cancer
Time Frame: Up to approximately 78 months
This endpoint is defined as having occurred if on a single biopsy or excised tissue from a participant, there is: (a) a pathology panel consensus diagnosis of genital warts, PIN of any grade, or penile/perianal/perineal cancer; and (b) detection of at least 1 of HPV types 6, 11, 16, 18, 31, 33, 45, 52 or 58 by Thinsection PCR in an adjacent section from the same tissue block.
Stage I: Combined Incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related External Genital and Intra-anal 12-month Persistent Infection
Time Frame: Up to approximately 30 months
This endpoint is defined as having occurred if a participant is positive for the same HPV type by the HPV PCR assay in the penile, scrotum, perineal, perianal and intra-anal swabs, biopsy, or excised samples obtained in 3 or more consecutive visits over a period of at least 12 months.
Secondary Outcomes
- Stage 1: Combined Incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related External Genital and Intra-anal 6-month Persistent Infection(Up to approximately 30 months)
- Stage I: Percentage of Participants Who Report at Least 1 Solicited Systemic AE(Day 1 through Day 8 following any vaccination)
- Stage I: Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)(Up to approximately 30 months)
- Stages I and II: Percentage of Participants Who Experience at Least 1 SAE(Up to approximately 78 months)
- Stage 1: Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at One Month Post-Dose 3(Month 7)
- Stage 1: Percentage of Participants Achieving Seroconversion to HPV 6, 11, 16, 18, 31, 33, 45, 52, or 58 at One Month Post-Dose 3(Month 7)
- Stages I and II: Combined Incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related Anal Intraepithelial Neoplasia (AIN) or Anal Cancer (MSM participants only)(Up to approximately 78 months)
- Stage I: Percentage of Participants Who Report at Least 1 Solicited Injection-site Adverse Event (AE)(Day 1 through Day 8 following any vaccination)