Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052)

Papillomavirus Infections Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05285826
• Other study ID #: V503-052
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 18, 2022
• Est. completion date: May 25, 2029

Study information

• Verified date: November 2022
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8100
• Est. completion date: May 25, 2029
• Est. primary completion date: November 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Papillomavirus Infections

Intervention

Biological:
• 9vHPV Vaccine
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

Other:
• Placebo
Sterile saline solution administered as a 0.5 mL IM injection

Locations

Country	Name	City	State
China	Beijing Youan Hospital ( Site 0001)	Bejing	Beijing
China	Hunan Provincial Center for Disease Control and Prevention ( Site 0040)	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University ( Site 0033)	Changsha	Hunan
China	Chongqing Public Health Medical Center ( Site 0003)	Chongqing	Chongqing
China	The Second Affiliated Hospital Chongqing Medical University ( Site 0052)	Chongqing	Chongqing
China	Binchuan County Center for Disease Control and Prevention ( Site 0022)	Dali	Yunnan
China	Xiangyun County Center for Disease Control and Prevention ( Site 0021)	Dali	Yunnan
China	Dazhu Disease Prevention and Control Center ( Site 0010)	Dazhou	Sichuan
China	Yuechi Disease Prevention and Control Center ( Site 0009)	Guang'an	Sichuan
China	Southern Medical University Nanfang Hospital-Center for Drug Clinical Research ( Site 0031)	Guangzhou	Guangdong
China	First Affiliated Hospital of Kunming Medical University ( Site 0051)	Kunming	Yunnan
China	Yunnan Provincial Infectious Disease Hospital ( Site 0042)	Kunming City	Yunnan
China	The First Hospital of Lanzhou University ( Site 0034)	Lanzhou	Gansu
China	Center for Disease Control and Prevention of Rong An ( Site 0046)	Liuzhou	Guangxi
China	Liucheng County Centers for Disease Control and Prevention ( Site 0045)	Liuzhou	Guangxi
China	Loudi Disease Prevention and Control Center Zhiyebing Prevention And Treatment Hospital ( Site 0015)	Louxing District	Hunan
China	Mianyang Center for Disease Control and Prevention ( Site 0007)	Mianyang	Sichuan
China	Santai County Center for Disease Control and Prevention ( Site 0008)	Mianyang	Sichuan
China	The Second Hospital of Nanjing (Tangshan Branch) ( Site 0028)	Nanjing	Jiangsu
China	Neijiang Center for Disease Control and Prevention ( Site 0011)	Neijiang	Sichuan
China	Liaoning University of Traditional Chinese Medicine Affiliated Hospital ( Site 0048)	Shenyang	Liaoning
China	The first affiliated hospital of China medical university ( Site 0041)	Shenyang	Liaoning
China	The University of Hong Kong - Shenzhen Hospital ( Site 0049)	Shenzhen	Guangdong
China	Tianjin People' s Hospital ( Site 0038)	Tianjin	Tianjin
China	Tianjin Second People's Hospital ( Site 0004)	Tianjin	Tianjin
China	Zhejiang University School of Medicine - Affiliated Wenzhou Traditional Chinese Medicine Hospital (W	Wenzhou Shi	Zhejiang
China	Wuhan Union Hospital ( Site 0032)	Wuhan	Hubei
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
China	Ruicheng Center for Disease Control and Prevention ( Site 0025)	Yuncheng	Shanxi
China	Yanhu Center for Disease Control and Prevention of Yuncheng ( Site 0018)	Yuncheng	Shanxi
China	Yongji Center for Disease Control and Prevention ( Site 0026)	Yuncheng	Shanxi
China	Yuanqu Center for Disease Control and Prevention ( Site 0019)	Yuncheng	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	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 2 or more consecutive visits over a period of at least 6 months.	Up to approximately 30 months
Secondary	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	GMTs to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 will be measured with a Competitive Luminex Immunoassay (cLIA).	Month 7
Secondary	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	A participant who changes serostatus from seronegative at Day 1 to seropositive at one month post-Dose 3 for a given HPV type is considered to have achieved seroconversion for that type. A participant with a titer at or above the seropositivity cutoff for a given HPV type, as measured by cLIA, is considered seropositive for that type.	Month 7
Secondary	Stage I: Percentage of Participants Who Report at Least 1 Solicited Injection-site Adverse Event (AE)	An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Solicited injection-site AEs such as erythema, swelling, pain, and induration at the injection site will be recorded.	Day 1 through Day 8 following any vaccination
Secondary	Stage I: Percentage of Participants Who Report at Least 1 Solicited Systemic AE	An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Systemic AEs are those not categorized as injection-site AEs.	Day 1 through Day 8 following any vaccination
Secondary	Stage I: Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)	An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.	Up to approximately 30 months
Secondary	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)	This endpoint is defined to have occurred if on a single biopsy or excised tissue from a participant, there is: (a) a pathology panel consensus diagnosis of AIN of any grade or anal 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	Stages I and II: Percentage of Participants Who Experience at Least 1 SAE	An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.	Up to approximately 78 months