Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052)
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
1 other identifier
interventional
8,100
1 country
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2022
Longer than P75 for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 18, 2022
CompletedFirst Submitted
Initial submission to the registry
March 8, 2022
CompletedFirst Posted
Study publicly available on registry
March 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 25, 2029
December 16, 2024
December 1, 2024
7.3 years
March 8, 2022
December 11, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
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.
Up to approximately 30 months
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
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.
Up to approximately 78 months
Secondary Outcomes (8)
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 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
Stage I: Percentage of Participants Who Report at Least 1 Solicited Injection-site Adverse Event (AE)
Day 1 through Day 8 following any vaccination
Stage I: Percentage of Participants Who Report at Least 1 Solicited Systemic AE
Day 1 through Day 8 following any vaccination
- +3 more secondary outcomes
Study Arms (2)
V503
EXPERIMENTALParticipants will receive a single 0.5 mL intramuscular (IM) injection of V503 at Day 1, Month 2, and Month 6.
Placebo
PLACEBO COMPARATORParticipants will receive a single 0.5 mL IM injection of placebo at Day 1, Month 2, and Month 6.
Interventions
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) L1 virus-like particle vaccine administered as a 0.5-mL IM injection
Eligibility Criteria
You may qualify if:
- Is a Chinese male.
- Has no more than 5 lifetime sexual partners.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Beijing Youan Hospital ( Site 0001)
Beijing, Beijing Municipality, 100069, China
The Second Affiliated Hospital Chongqing Medical University ( Site 0052)
Chongqing, Chongqing Municipality, 400010, China
Chongqing Public Health Medical Center ( Site 0003)
Chongqing, Chongqing Municipality, 400036, China
The First Hospital of Lanzhou University ( Site 0034)
Lanzhou, Gansu, 730000, China
Southern Medical University Nanfang Hospital-Center for Drug Clinical Research ( Site 0031)
Guangzhou, Guangdong, 510515, China
The University of Hong Kong - Shenzhen Hospital ( Site 0049)
Shenzhen, Guangdong, 518053, China
Center for Disease Control and Prevention of Rong An ( Site 0046)
Liuchow, Guangxi, 545400, China
Liucheng County Centers for Disease Control and Prevention ( Site 0045)
Liuchow, Guangxi, China
Wuhan Union Hospital ( Site 0032)
Wuhan, Hubei, 430022, China
Hunan Provincial Center for Disease Control and Prevention ( Site 0040)
Changsha, Hunan, 410005, China
The Third Xiangya Hospital of Central South University ( Site 0033)
Changsha, Hunan, 410013, China
Loudi Disease Prevention and Control Center Zhiyebing Prevention And Treatment Hospital ( Site 0015)
Louxing District, Hunan, 417000, China
Xiangtan Disease Prevention and Control Center ( Site 0030)
Xiangtan, Hunan, China
Xiangxiang Disease Prevention and Control Center ( Site 0016)
Xiangxiang, Hunan, China
Qiyang Center for Disease Control and Prevention ( Site 0014)
Yongzhou, Hunan, 426100, China
The Second Hospital of Nanjing (Tangshan Branch) ( Site 0028)
Nanjing, Jiangsu, 2100003, China
The first affiliated hospital of China medical university ( Site 0041)
Shenyang, Liaoning, 110001, China
Liaoning University of Traditional Chinese Medicine Affiliated Hospital ( Site 0048)
Shenyang, Liaoning, 110031, China
Yuanqu Center for Disease Control and Prevention ( Site 0019)
Yuncheng, Shanxi, 043700, China
Yanhu Center for Disease Control and Prevention of Yuncheng ( Site 0018)
Yuncheng, Shanxi, 044000, China
Yongji Center for Disease Control and Prevention ( Site 0026)
Yuncheng, Shanxi, 044599, China
Ruicheng Center for Disease Control and Prevention ( Site 0025)
Yuncheng, Shanxi, 044600, China
Dazhu Disease Prevention and Control Center ( Site 0010)
Dazhou, Sichuan, 635100, China
Yuechi Disease Prevention and Control Center ( Site 0009)
Guang’an, Sichuan, 638399, China
Mianyang Center for Disease Control and Prevention ( Site 0007)
Mianyang, Sichuan, 621000, China
Santai County Center for Disease Control and Prevention ( Site 0008)
Mianyang, Sichuan, 621100, China
Neijiang Center for Disease Control and Prevention ( Site 0011)
Neijiang, Sichuan, 641000, China
Tianjin Second People's Hospital ( Site 0004)
Tianjin, Tianjin Municipality, 300192, China
Tianjin People' s Hospital ( Site 0038)
Tianjin, Tianjin Municipality, China
Binchuan County Center for Disease Control and Prevention ( Site 0022)
Dali, Yunnan, 671600, China
Xiangyun County Center for Disease Control and Prevention ( Site 0021)
Dali, Yunnan, 672100, China
First Affiliated Hospital of Kunming Medical University ( Site 0051)
Kunming, Yunnan, 650032, China
Yunnan Provincial Infectious Disease Hospital ( Site 0042)
Kunming, Yunnan, 650111, China
Zhejiang University School of Medicine - Affiliated Wenzhou Traditional Chinese Medicine Hospital (W
Wenzhou, Zhejiang, 325000, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2022
First Posted
March 18, 2022
Study Start
February 18, 2022
Primary Completion (Estimated)
May 25, 2029
Study Completion (Estimated)
May 25, 2029
Last Updated
December 16, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf