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

Primary Purpose

Papillomavirus Infections

Status

Active

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

9vHPV Vaccine

Placebo

About this trial

This is an interventional prevention trial for Papillomavirus Infections

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Beijing Youan Hospital ( Site 0001)
The Second Affiliated Hospital Chongqing Medical University ( Site 0052)
Chongqing Public Health Medical Center ( Site 0003)
The First Hospital of Lanzhou University ( Site 0034)
Southern Medical University Nanfang Hospital-Center for Drug Clinical Research ( Site 0031)
The University of Hong Kong - Shenzhen Hospital ( Site 0049)
Center for Disease Control and Prevention of Rong An ( Site 0046)
Liucheng County Centers for Disease Control and Prevention ( Site 0045)
Wuhan Union Hospital ( Site 0032)
Hunan Provincial Center for Disease Control and Prevention ( Site 0040)
The Third Xiangya Hospital of Central South University ( Site 0033)
Loudi Disease Prevention and Control Center Zhiyebing Prevention And Treatment Hospital ( Site 0015)
Xiangtan Disease Prevention and Control Center ( Site 0030)
Xiangxiang Disease Prevention and Control Center ( Site 0016)
Qiyang Center for Disease Control and Prevention ( Site 0014)
The Second Hospital of Nanjing (Tangshan Branch) ( Site 0028)
The first affiliated hospital of China medical university ( Site 0041)
Liaoning University of Traditional Chinese Medicine Affiliated Hospital ( Site 0048)
Yuanqu Center for Disease Control and Prevention ( Site 0019)
Yanhu Center for Disease Control and Prevention of Yuncheng ( Site 0018)
Yongji Center for Disease Control and Prevention ( Site 0026)
Ruicheng Center for Disease Control and Prevention ( Site 0025)
Dazhu Disease Prevention and Control Center ( Site 0010)
Yuechi Disease Prevention and Control Center ( Site 0009)
Mianyang Center for Disease Control and Prevention ( Site 0007)
Santai County Center for Disease Control and Prevention ( Site 0008)
Neijiang Center for Disease Control and Prevention ( Site 0011)
Tianjin Second People's Hospital ( Site 0004)
Tianjin People' s Hospital ( Site 0038)
Binchuan County Center for Disease Control and Prevention ( Site 0022)
Xiangyun County Center for Disease Control and Prevention ( Site 0021)
Yunnan Provincial Infectious Disease Hospital ( Site 0042)
First Affiliated Hospital of Kunming Medical University ( Site 0051)
Zhejiang University School of Medicine - Affiliated Wenzhou Traditional Chinese Medicine Hospital (W

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

V503

Placebo

Arm Description

Participants will receive a single 0.5 mL intramuscular (IM) injection of V503 at Day 1, Month 2, and Month 6.

Participants will receive a single 0.5 mL IM injection of placebo at Day 1, Month 2, and Month 6.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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).

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT05285826

First Posted

March 8, 2022

Last Updated

November 16, 2022

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT05285826

Brief Title

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

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 18, 2022 (Actual)

Primary Completion Date

November 25, 2024 (Anticipated)

Study Completion Date

May 25, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Papillomavirus Infections

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

8100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

V503

Arm Type

Experimental

Arm Description

Participants will receive a single 0.5 mL intramuscular (IM) injection of V503 at Day 1, Month 2, and Month 6.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants will receive a single 0.5 mL IM injection of placebo at Day 1, Month 2, and Month 6.

Intervention Type

Biological

Intervention Name(s)

9vHPV Vaccine

Other Intervention Name(s)

V503

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Sterile saline solution administered as a 0.5 mL IM injection

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Up to approximately 30 months

Title

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

Description

Time Frame

Up to approximately 78 months

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Up to approximately 30 months

Title

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

Description

GMTs to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 will be measured with a Competitive Luminex Immunoassay (cLIA).

Time Frame

Month 7

Title

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

Description

Time Frame

Month 7

Title

Stage I: Percentage of Participants Who Report at Least 1 Solicited Injection-site Adverse Event (AE)

Description

Time Frame

Day 1 through Day 8 following any vaccination

Title

Stage I: Percentage of Participants Who Report at Least 1 Solicited Systemic AE

Description

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.

Time Frame

Day 1 through Day 8 following any vaccination

Title

Stage I: Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)

Description

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.

Time Frame

Up to approximately 30 months

Title

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)

Description

Time Frame

Up to approximately 78 months

Title

Stages I and II: Percentage of Participants Who Experience at Least 1 SAE

Description

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.

Time Frame

Up to approximately 78 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

Facility Information:

Facility Name

Beijing Youan Hospital ( Site 0001)

City

Bejing

State/Province

Beijing

ZIP/Postal Code

100069

Country

China

Facility Name

The Second Affiliated Hospital Chongqing Medical University ( Site 0052)

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400010

Country

China

Facility Name

Chongqing Public Health Medical Center ( Site 0003)

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400036

Country

China

Facility Name

The First Hospital of Lanzhou University ( Site 0034)

City

Lanzhou

State/Province

Gansu

ZIP/Postal Code

730000

Country

China

Facility Name

Southern Medical University Nanfang Hospital-Center for Drug Clinical Research ( Site 0031)

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510515

Country

China

Facility Name

The University of Hong Kong - Shenzhen Hospital ( Site 0049)

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518053

Country

China

Facility Name

Center for Disease Control and Prevention of Rong An ( Site 0046)

City

Liuzhou

State/Province

Guangxi

ZIP/Postal Code

545400

Country

China

Facility Name

Liucheng County Centers for Disease Control and Prevention ( Site 0045)

City

Liuzhou

State/Province

Guangxi

Country

China

Facility Name

Wuhan Union Hospital ( Site 0032)

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430022

Country

China

Facility Name

Hunan Provincial Center for Disease Control and Prevention ( Site 0040)

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410005

Country

China

Facility Name

The Third Xiangya Hospital of Central South University ( Site 0033)

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410013

Country

China

Facility Name

Loudi Disease Prevention and Control Center Zhiyebing Prevention And Treatment Hospital ( Site 0015)

City

Louxing District

State/Province

Hunan

ZIP/Postal Code

417000

Country

China

Facility Name

Xiangtan Disease Prevention and Control Center ( Site 0030)

City

XiangTan

State/Province

Hunan

Country

China

Facility Name

Xiangxiang Disease Prevention and Control Center ( Site 0016)

City

Xiangxiang

State/Province

Hunan

Country

China

Facility Name

Qiyang Center for Disease Control and Prevention ( Site 0014)

City

Yongzhou

State/Province

Hunan

ZIP/Postal Code

426100

Country

China

Facility Name

The Second Hospital of Nanjing (Tangshan Branch) ( Site 0028)

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

2100003

Country

China

Facility Name

The first affiliated hospital of China medical university ( Site 0041)

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110001

Country

China

Facility Name

Liaoning University of Traditional Chinese Medicine Affiliated Hospital ( Site 0048)

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110031

Country

China

Facility Name

Yuanqu Center for Disease Control and Prevention ( Site 0019)

City

Yuncheng

State/Province

Shanxi

ZIP/Postal Code

043700

Country

China

Facility Name

Yanhu Center for Disease Control and Prevention of Yuncheng ( Site 0018)

City

Yuncheng

State/Province

Shanxi

ZIP/Postal Code

044000

Country

China

Facility Name

Yongji Center for Disease Control and Prevention ( Site 0026)

City

Yuncheng

State/Province

Shanxi

ZIP/Postal Code

044599

Country

China

Facility Name

Ruicheng Center for Disease Control and Prevention ( Site 0025)

City

Yuncheng

State/Province

Shanxi

ZIP/Postal Code

044600

Country

China

Facility Name

Dazhu Disease Prevention and Control Center ( Site 0010)

City

Dazhou

State/Province

Sichuan

ZIP/Postal Code

635100

Country

China

Facility Name

Yuechi Disease Prevention and Control Center ( Site 0009)

City

Guang'an

State/Province

Sichuan

ZIP/Postal Code

638399

Country

China

Facility Name

Mianyang Center for Disease Control and Prevention ( Site 0007)

City

Mianyang

State/Province

Sichuan

ZIP/Postal Code

621000

Country

China

Facility Name

Santai County Center for Disease Control and Prevention ( Site 0008)

City

Mianyang

State/Province

Sichuan

ZIP/Postal Code

621100

Country

China

Facility Name

Neijiang Center for Disease Control and Prevention ( Site 0011)

City

Neijiang

State/Province

Sichuan

ZIP/Postal Code

641000

Country

China

Facility Name

Tianjin Second People's Hospital ( Site 0004)

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300192

Country

China

Facility Name

Tianjin People' s Hospital ( Site 0038)

City

Tianjin

State/Province

Tianjin

Country

China

Facility Name

Binchuan County Center for Disease Control and Prevention ( Site 0022)

City

Dali

State/Province

Yunnan

ZIP/Postal Code

671600

Country

China

Facility Name

Xiangyun County Center for Disease Control and Prevention ( Site 0021)

City

Dali

State/Province

Yunnan

ZIP/Postal Code

672100

Country

China

Facility Name

Yunnan Provincial Infectious Disease Hospital ( Site 0042)

City

Kunming City

State/Province

Yunnan

ZIP/Postal Code

650111

Country

China

Facility Name

First Affiliated Hospital of Kunming Medical University ( Site 0051)

City

Kunming

State/Province

Yunnan

ZIP/Postal Code

650032

Country

China

Facility Name

Zhejiang University School of Medicine - Affiliated Wenzhou Traditional Chinese Medicine Hospital (W

City

Wenzhou Shi

State/Province

Zhejiang

ZIP/Postal Code

325000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Learn more about this trial

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

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