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

December 11, 2024 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Bejing, Beijing, China, 100069
        • Beijing Youan Hospital ( Site 0001)
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • The Second Affiliated Hospital Chongqing Medical University ( Site 0052)
      • Chongqing, Chongqing, China, 400036
        • Chongqing Public Health Medical Center ( Site 0003)
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • The First Hospital of Lanzhou University ( Site 0034)
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Southern Medical University Nanfang Hospital-Center for Drug Clinical Research ( Site 0031)
      • Shenzhen, Guangdong, China, 518053
        • The University of Hong Kong - Shenzhen Hospital ( Site 0049)
    • Guangxi
      • Liuzhou, Guangxi, China, 545400
        • Center for Disease Control and Prevention of Rong An ( Site 0046)
      • Liuzhou, Guangxi, China
        • Liucheng County Centers for Disease Control and Prevention ( Site 0045)
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Union Hospital ( Site 0032)
    • Hunan
      • Changsha, Hunan, China, 410005
        • Hunan Provincial Center for Disease Control and Prevention ( Site 0040)
      • Changsha, Hunan, China, 410013
        • The Third Xiangya Hospital of Central South University ( Site 0033)
      • Louxing District, Hunan, China, 417000
        • Loudi Disease Prevention and Control Center Zhiyebing Prevention And Treatment Hospital ( Site 0015)
      • XiangTan, Hunan, China
        • Xiangtan Disease Prevention and Control Center ( Site 0030)
      • Xiangxiang, Hunan, China
        • Xiangxiang Disease Prevention and Control Center ( Site 0016)
      • Yongzhou, Hunan, China, 426100
        • Qiyang Center for Disease Control and Prevention ( Site 0014)
    • Jiangsu
      • Nanjing, Jiangsu, China, 2100003
        • The Second Hospital of Nanjing (Tangshan Branch) ( Site 0028)
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • The first affiliated hospital of China medical university ( Site 0041)
      • Shenyang, Liaoning, China, 110031
        • Liaoning University of Traditional Chinese Medicine Affiliated Hospital ( Site 0048)
    • Shanxi
      • Yuncheng, Shanxi, China, 043700
        • Yuanqu Center for Disease Control and Prevention ( Site 0019)
      • Yuncheng, Shanxi, China, 044000
        • Yanhu Center for Disease Control and Prevention of Yuncheng ( Site 0018)
      • Yuncheng, Shanxi, China, 044599
        • Yongji Center for Disease Control and Prevention ( Site 0026)
      • Yuncheng, Shanxi, China, 044600
        • Ruicheng Center for Disease Control and Prevention ( Site 0025)
    • Sichuan
      • Dazhou, Sichuan, China, 635100
        • Dazhu Disease Prevention and Control Center ( Site 0010)
      • Guang'an, Sichuan, China, 638399
        • Yuechi Disease Prevention and Control Center ( Site 0009)
      • Mianyang, Sichuan, China, 621000
        • Mianyang Center for Disease Control and Prevention ( Site 0007)
      • Mianyang, Sichuan, China, 621100
        • Santai County Center for Disease Control and Prevention ( Site 0008)
      • Neijiang, Sichuan, China, 641000
        • Neijiang Center for Disease Control and Prevention ( Site 0011)
    • Tianjin
      • Tianjin, Tianjin, China, 300192
        • Tianjin Second People's Hospital ( Site 0004)
      • Tianjin, Tianjin, China
        • Tianjin People' s Hospital ( Site 0038)
    • Yunnan
      • Dali, Yunnan, China, 671600
        • Binchuan County Center for Disease Control and Prevention ( Site 0022)
      • Dali, Yunnan, China, 672100
        • Xiangyun County Center for Disease Control and Prevention ( Site 0021)
      • Kunming, Yunnan, China, 650032
        • First Affiliated Hospital of Kunming Medical University ( Site 0051)
      • Kunming City, Yunnan, China, 650111
        • Yunnan Provincial Infectious Disease Hospital ( Site 0042)
    • Zhejiang
      • Wenzhou Shi, Zhejiang, China, 325000
        • Zhejiang University School of Medicine - Affiliated Wenzhou Traditional Chinese Medicine Hospital (W

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: V503
Participants will receive a single 0.5 mL intramuscular (IM) injection of V503 at Day 1, Month 2, and Month 6.
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 Names:
  • V503
Placebo Comparator: Placebo
Participants will receive a single 0.5 mL IM injection of placebo at Day 1, Month 2, and Month 6.
Other: Placebo
Sterile saline solution administered as a 0.5 mL IM injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Up to approximately 30 months
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
Time Frame: Up to approximately 78 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Up to approximately 30 months
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
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
Time Frame: Month 7
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
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
Time Frame: Month 7
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
Stage I: Percentage of Participants Who Report at Least 1 Solicited Injection-site Adverse Event (AE)
Time Frame: Day 1 through Day 8 following any vaccination
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
Stage I: Percentage of Participants Who Report at Least 1 Solicited Systemic AE
Time Frame: Day 1 through Day 8 following any vaccination
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
Stage I: Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)
Time Frame: Up to approximately 30 months
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
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)
Time Frame: Up to approximately 78 months
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
Stages I and II: Percentage of Participants Who Experience at Least 1 SAE
Time Frame: Up to approximately 78 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 18, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 25, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • V503-052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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