Clinical trial NCT05285826: Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052)
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Papillomavirus Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-03-18
Enrollment: 8100
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: 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
timeFrame: Up to approximately 30 months
measure: 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
timeFrame: Up to approximately 78 months
Secondary outcomes:
measure: 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
timeFrame: Up to approximately 30 months
measure: 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
timeFrame: Month 7
measure: 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
timeFrame: Month 7
measure: Stage I: Percentage of Participants Who Report at Least 1 Solicited Injection-site Adverse Event (AE)
timeFrame: Day 1 through Day 8 following any vaccination
measure: Stage I: Percentage of Participants Who Report at Least 1 Solicited Systemic AE
timeFrame: Day 1 through Day 8 following any vaccination
measure: Stage I: Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)
timeFrame: Up to approximately 30 months
measure: 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)
timeFrame: Up to approximately 78 months
measure: Stages I and II: Percentage of Participants Who Experience at Least 1 SAE
timeFrame: Up to approximately 78 months
Other outcomes:
Locations:
city: Bejing
country: China
facility: Beijing Youan Hospital ( Site 0001)
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated Hospital Chongqing Medical University ( Site 0052)
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Public Health Medical Center ( Site 0003)
state: Chongqing
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University ( Site 0034)
state: Gansu
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital-Center for Drug Clinical Research ( Site 0031)
state: Guangdong
city: Shenzhen
country: China
facility: The University of Hong Kong - Shenzhen Hospital ( Site 0049)
state: Guangdong
city: Liuzhou
country: China
facility: Center for Disease Control and Prevention of Rong An ( Site 0046)
state: Guangxi
city: Liuzhou
country: China
facility: Liucheng County Centers for Disease Control and Prevention ( Site 0045)
state: Guangxi
city: Wuhan
country: China
facility: Wuhan Union Hospital ( Site 0032)
state: Hubei
city: Changsha
country: China
facility: Hunan Provincial Center for Disease Control and Prevention ( Site 0040)
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University ( Site 0033)
state: Hunan
city: Louxing District
country: China
facility: Loudi Disease Prevention and Control Center Zhiyebing Prevention And Treatment Hospital ( Site 0015)
state: Hunan
city: XiangTan
country: China
facility: Xiangtan Disease Prevention and Control Center ( Site 0030)
state: Hunan
city: Xiangxiang
country: China
facility: Xiangxiang Disease Prevention and Control Center ( Site 0016)
state: Hunan
city: Yongzhou
country: China
facility: Qiyang Center for Disease Control and Prevention ( Site 0014)
state: Hunan
city: Nanjing
country: China
facility: The Second Hospital of Nanjing (Tangshan Branch) ( Site 0028)
state: Jiangsu
city: Shenyang
country: China
facility: The first affiliated hospital of China medical university ( Site 0041)
state: Liaoning
city: Shenyang
country: China
facility: Liaoning University of Traditional Chinese Medicine Affiliated Hospital ( Site 0048)
state: Liaoning
city: Yuncheng
country: China
facility: Yuanqu Center for Disease Control and Prevention ( Site 0019)
state: Shanxi
city: Yuncheng
country: China
facility: Yanhu Center for Disease Control and Prevention of Yuncheng ( Site 0018)
state: Shanxi
city: Yuncheng
country: China
facility: Yongji Center for Disease Control and Prevention ( Site 0026)
state: Shanxi
city: Yuncheng
country: China
facility: Ruicheng Center for Disease Control and Prevention ( Site 0025)
state: Shanxi
city: Dazhou
country: China
facility: Dazhu Disease Prevention and Control Center ( Site 0010)
state: Sichuan
city: Guang'an
country: China
facility: Yuechi Disease Prevention and Control Center ( Site 0009)
state: Sichuan
city: Mianyang
country: China
facility: Mianyang Center for Disease Control and Prevention ( Site 0007)
state: Sichuan
city: Mianyang
country: China
facility: Santai County Center for Disease Control and Prevention ( Site 0008)
state: Sichuan
city: Neijiang
country: China
facility: Neijiang Center for Disease Control and Prevention ( Site 0011)
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Second People's Hospital ( Site 0004)
state: Tianjin
city: Tianjin
country: China
facility: Tianjin People' s Hospital ( Site 0038)
state: Tianjin
city: Dali
country: China
facility: Binchuan County Center for Disease Control and Prevention ( Site 0022)
state: Yunnan
city: Dali
country: China
facility: Xiangyun County Center for Disease Control and Prevention ( Site 0021)
state: Yunnan
city: Kunming City
country: China
facility: Yunnan Provincial Infectious Disease Hospital ( Site 0042)
state: Yunnan
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University ( Site 0051)
state: Yunnan
city: Wenzhou Shi
country: China
facility: Zhejiang University School of Medicine - Affiliated Wenzhou Traditional Chinese Medicine Hospital (W
state: Zhejiang
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: