Clinical trial NCT04635423: Efficacy, Immunogenicity, and Safety Study of the 9vHPV Vaccine in Japanese Males (V503-064)
Official title: A Phase 3, Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9vHPV Vaccine in Japanese Males, 16 to 26 Years of Age.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Warts, Genital
Neoplasms, Anal
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2020-11-19
Enrollment: 1059
Sex: MALE
Minimum age (years): 16
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Primary outcomes:
measure: Combined Incidence of Human Papillomavirus (HPV) 6/11/16/18-related Anogenital Persistent Infection
timeFrame: Up to approximately 36 Months
measure: Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
timeFrame: Up to 5 days after any vaccination
measure: Percentage of Participants With ≥1 Systemic AE
timeFrame: Up to 15 days after any vaccination
measure: Percentage of Participants With ≥1 Serious Adverse Events (SAEs)
timeFrame: Up to approximately 37 months
measure: Number of Participants With Elevated Oral Body Temperature
timeFrame: Up to 5 days after any vaccination
Secondary outcomes:
measure: Combined Incidence of HPV 31/33/45/52/58-related Anogenital Persistent Infection
timeFrame: Up to approximately 36 Months
measure: Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
timeFrame: Month 7
measure: Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
timeFrame: Month 7
measure: Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
timeFrame: Month 7
measure: Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
timeFrame: Month 7
measure: Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
timeFrame: Month 7
measure: 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
timeFrame: Month 7
Other outcomes:
Locations:
city: Takasaki
country: Japan
facility: Umeyama Clinic ( Site 6406)
state: Gunma
city: Kawasaki
country: Japan
facility: Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 6424)
state: Kanagawa
city: Yokohama
country: Japan
facility: Ocean Clinic ( Site 6407)
state: Kanagawa
city: Sakai
country: Japan
facility: Kanno Clinic ( Site 6402)
state: Osaka
city: Hachioji
country: Japan
facility: P-One Clinic, Keikokai Medical Corp. ( Site 6419)
state: Tokyo
city: Osaka
country: Japan
facility: Iwasa Clinic ( Site 6411)
city: Osaka
country: Japan
facility: Nomura Clinic Namba ( Site 6405)
city: Osaka
country: Japan
facility: Medical Corporation Seiwakai Hayakawa Clinic ( Site 6409)
city: Osaka
country: Japan
facility: Yamanaka Clinic ( Site 6410)
city: Tokyo
country: Japan
facility: Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 6404)
city: Tokyo
country: Japan
facility: Yuge Clinic ( Site 6421)
city: Tokyo
country: Japan
facility: Taisei Clinic ( Site 6403)
city: Tokyo
country: Japan
facility: Mildix Skin Clinic ( Site 6423)
city: Tokyo
country: Japan
facility: Sugisawa Dermatology Clinic ( Site 6422)
city: Tokyo
country: Japan
facility: Medical Corporation Sanshikai Toru Clinic ( Site 6401)
city: Tokyo
country: Japan
facility: Medical Corporation Mori to Umi Tokyo Tokyo Kamata Hospital ( Site 6418)
city: Tokyo
country: Japan
facility: Seiyukai Medical Corporation Itoh Skin Clinic ( Site 6416)
city: Tokyo
country: Japan
facility: Naoko Dermatology Clinic ( Site 6417)
city: Tokyo
country: Japan
facility: Medical Corporation Iseikai My City Clinic ( Site 6414)
city: Tokyo
country: Japan
facility: Shinjuku Higashiguchi Clinic ( Site 6415)
city: Tokyo
country: Japan
facility: Ogikuboekimae Clinic ( Site 6413)
city: Tokyo
country: Japan
facility: Kusunoki Clinic ( Site 6412)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: