Phase 3
N=1,059
Efficacy, Immunogenicity, and Safety Study of the 9vHPV Vaccine in Japanese Males (V503-064)
Warts, Genital · Neoplasms, Anal
Bottom Line
View on ClinicalTrials.gov: NCT04635423 ↗Enrolled (actual)
1,059
Serious AEs
1.1%
Results posted
Jan 2025
Primary outcome: Primary: Combined Incidence of Human Papillomavirus (HPV) 6/11/16/18-related Anogenital Persistent Infection — 0.2; 2.2 Cases per 100 Person-years — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- V503 (Biological); Placebo (Other)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Male
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Combined Incidence of Human Papillomavirus (HPV) 6/11/16/18-related Anogenital Persistent Infection |
0.2; 2.2 | <0.001 sig |
| PRIMARY Percentage of Participants With Solicited Injection-site Adverse Events (AEs) |
69.8; 29.6 | — |
| PRIMARY Percentage of Participants With ≥1 Systemic AE |
20.2; 19.8 | — |
| PRIMARY Percentage of Participants With ≥1 Serious Adverse Events (SAEs) |
1.3; 0.9 | — |
| PRIMARY Number of Participants With Elevated Oral Body Temperature |
502; 496; 19; 22; 1; 1 | — |
| SECONDARY Combined Incidence of HPV 31/33/45/52/58-related Anogenital Persistent Infection |
0.7; 1.9 | 0.023 sig |
| SECONDARY Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants |
927.3; 21.1; 716.5; NA; 3491.6; NA | — |
| SECONDARY Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup |
950.2; 21.0; 730.6; NA; 3608.3; NA | — |
| SECONDARY Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup |
740.2; 21.5; 598.8; NA; 2599.5; NA | — |
| SECONDARY Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants |
99.7; 3.5; 99.7; 4.1; 99.6; 4.3 | — |
| SECONDARY Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup |
99.7; 3.5; 99.7; 4.4; 99.5; 3.7 | — |
| SECONDARY Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup |
100.0; 3.6; 100.0; 0.0; 100.0; 9.5 | — |
Summary
The purposes of this phase 3, double-blind, placebo-controlled clinical study are to evaluate the efficacy of V503 (9-valent human papillomavirus [9vHPV] vaccine) in preventing human papillomavirus (HPV)-related anogenital persistent infection, and to evaluate the safety/tolerability of V503, in Japanese males who are 16 to 26 years of age. It is hypothesized that administration of a 3-dose regimen of V503 reduces the combined incidence of HPV 6/11/16/18-related anogenital persistent infection, as well as the combined incidence of HPV 31/33/45/52/58-related anogenital persistent infection, compared with placebo.
The study includes a Base Study to assess efficacy and safety of V503, and an Extension Study. Participants who received placebo in the Base Study will be eligible to receive V503 vaccine on Day 1, Month 2, and Month 6 of the Extension Study. Participants who received less than 3 doses of V503 in the Base Study will be offered the opportunity to complete the 3-dose regimen in the Extension Study.
Eligibility Criteria
Inclusion Criteria
- Is a Japanese male 16 to 26 years of age
- Has no more than 5 lifetime sexual partners
Exclusion Criteria
- Has a history of known prior vaccination with an HPV vaccine or plans to receive one outside the study
- Has a history of external genital warts
- 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 plan 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 intramuscular injections
- Has ongoing alcohol or drug abuse within the past 12 months
Data sourced from ClinicalTrials.gov (NCT04635423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.