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ACTIVE NOT RECRUITING

NCT04199689

PHASE3

Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of the 9vHPV vaccine in men 20 to 45 years of age. The primary hypothesis tested after the primary database lock is that administration of a 3-dose regimen of 9vHPV vaccine will reduce the incidence of human papillomavirus (HPV) 16/18/31/33/45/52/58-related oral persistent infection (6 months or longer) compared with placebo. There will also be an Extension Study to offer an opportunity to complete the 3 dose regimen of 9vHPV vaccine for participants who received placebo in the Base Study, or received less than 3 doses of 9vHPV vaccine in the Base Study.

Official title: A Phase 3, International, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy, Immunogenicity, and Safety of the 9vHPV Vaccine, a Multivalent L1 Virus-like Particle Vaccine, in the Prevention of Oral Persistent Infection With HPV Types 16, 18, 31, 33, 45, 52, or 58 in Adult Males, 20 to 45 Years of Age

Key Details

Gender

MALE

Age Range

20 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

6033

Start Date

2020-02-27

Completion Date

2028-08-31

Last Updated

2025-03-25

Healthy Volunteers

Yes

Conditions

Papillomavirus Infections

Interventions

BIOLOGICAL

9vHPV Vaccine

9vHPV is an aluminum-adjuvanted recombinant protein vaccine prepared from the highly purified virus-like particles of the recombinant major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 given as a 0.5 mL intramuscular injection.

OTHER

Placebo (Saline for Injection)

0.9% sodium chloride given as a 0.5-mL intramuscular injection

Inclusion Criteria: Base Study: * Is healthy and is judged to be in good physical health based on medical history and physical examination * Has provided written informed consent for the study. The participant may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research * Agrees to provide study personnel with a primary telephone number as well as an alternate means of contact, if available (such as an alternate telephone number or email) for follow-up purposes * Can read, understand, and complete the electronic vaccination report card (eVRC) * Has had at least 1 lifetime sexual partner Extension Study: * Participants may continue in the Extension Study if Inclusion Criteria #1 and #4 are still met, and the participants was in either the placebo group in the Base Study or the vaccine group in the Base Study but did not complete the vaccination series * Provides documented consent for the Extension Study Exclusion Criteria: Base Study: * Has a history of HPV-related anal lesion (anal intraepithelial neoplasia or anal cancer) or HPV related head and neck cancer * Has a history of or clinical evidence at the Day 1 external genital examination of HPV-related external lesion * Has clinical evidence at the Day 1 external genital examination of gross genital lesion suggesting sexually transmitted disease * Has a fever (defined as oral temperature ≥100.0°F or ≥37.8°C) within a 24-hour period prior to Day 1 visit * Has a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention * Is allergic to any vaccine component, including aluminum, yeast, or BENZONASE® * Has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections * Is currently immunocompromised or has been diagnosed as having congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition * Has a history of splenectomy * Has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate by judgment of investigator * Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence at the discretion of the investigator. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems because of alcohol use * Has received within 12 months prior to enrollment, is receiving, or plans to receive during the study, the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (ARAVA®), TNF-α antagonists, monoclonal antibody therapies (including rituximab \[RITUXAN®\]), intravenous immunoglobulin (IVIG), anti-lymphocyte sera, or other therapy known to interfere with the immune response. Regarding systemic corticosteroids, a participant will be excluded if he is currently receiving steroid therapy, has recently received such therapy, or has received 2 or more courses of high-dose corticosteroids (≥20 mg/day of prednisone \[or equivalent\] orally or parenterally) lasting at least 1 week in duration in the year prior. Participants using inhaled, nasal, or topical steroids are considered eligible for the study * Has received within the 3 months prior to vaccination, is receiving, or plans to receive during the study, any immune globulin product (including RhoGAM™) or blood-derived product other than IVIG * Has received inactivated or recombinant vaccines within 14 days prior to vaccination or receipt of live vaccines within 21 days prior to vaccination * Is concurrently enrolled in other clinical studies of investigational agents * Has previously received a marketed HPV vaccine, or has participated in a clinical trial for any HPV vaccine (receiving either active agent or placebo) * Has engaged in sexual activity 48 hours prior to vaccination. Sexual activity is defined as: penile penetrative vaginal intercourse with female partner; penile penetrative or receptive anal intercourse with male or female partner; or oral sex involving any contact between participant's mouth with a female partner's vagina, genital or anal area or male partner's penis or genital or anal area. This also includes any contact between participant's partner's mouth with participant's penis, genital or anal area * Is unlikely to adhere to the study procedures, keep appointments, or is planning to permanently relocate from the area prior to the completion of the study or to leave for an extended period when study visits would need to be scheduled * Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study Extension Study: \- Participants must be excluded from the Extension Study if Base Study Exclusion Criteria #4, 5, 6, 7, 10, 16, or 18 are met

Locations (103)

Valley Clinical Trials Inc. ( Site 0002)

Northridge, California, United States

Inland Empire Clinical Trials, LLC ( Site 0025)

Rialto, California, United States

Alta California Medical Group ( Site 0031)

Simi Valley, California, United States

Encompass Clinical Research ( Site 0028)

Spring Valley, California, United States

Diablo Clinical Research, Inc ( Site 0042)

Walnut Creek, California, United States

Clinical Research of South Florida ( Site 0036)

Coral Gables, Florida, United States

Acevedo Clinical Research Associates ( Site 0001)

Miami, Florida, United States

Moffitt Cancer Center ( Site 0017)

Tampa, Florida, United States

Augusta University ( Site 0010)

Augusta, Georgia, United States

Solaris Clinical Research, LLC ( Site 0003)

Meridian, Idaho, United States

Cotton-O'Neil Clinical Research Center ( Site 0044)

Topeka, Kansas, United States

Heartland Research Associates, LLC ( Site 0034)

Wichita, Kansas, United States

Kentucky Pediatric/Adult Research Inc ( Site 0011)

Bardstown, Kentucky, United States

Healthcare Research Network LLC ( Site 0035)

Hazelwood, Missouri, United States

Alliance for Multispecialty Reseach, LLC ( Site 0021)

Las Vegas, Nevada, United States

Certified Research Associates ( Site 0041)

Cortland, New York, United States

Laser Surgery Care ( Site 0018)

New York, New York, United States

Weill Cornell Medicine ( Site 0046)

New York, New York, United States

Rochester Clinical Research, Inc. ( Site 0008)

Rochester, New York, United States

PMG Research of Salisbury ( Site 0009)

Salisbury, North Carolina, United States

Rapid Medical Research, Inc. ( Site 0037)

Cleveland, Ohio, United States

Preferred Primary Care Physicians ( Site 0032)

Pittsburgh, Pennsylvania, United States

Coastal Carolina Research Center ( Site 0043)

North Charleston, South Carolina, United States

Holston Medical Group ( Site 0030)

Kingsport, Tennessee, United States

University of Texas Medical Branch at Galveston ( Site 0038)

Galveston, Texas, United States

Texas Center For Drug Development ( Site 0013)

Houston, Texas, United States

Crossroads Clinical Research LLC ( Site 0027)

Victoria, Texas, United States

J Lewis Research Inc/Foothill Family Clinic South ( Site 0006)

Salt Lake City, Utah, United States

J Lewis Research Inc/Jordan River Family Medicine ( Site 0023)

South Jordan, Utah, United States

Charlottesville Medical Research Center, LLC ( Site 0007)

Charlottesville, Virginia, United States

Health Research of Hampton Roads, Inc. ( Site 0015)

Newport News, Virginia, United States

Clinical Research Partners, LLC. ( Site 0004)

Richmond, Virginia, United States

University of Antwerp ( Site 0352)

Wilrijk, Antwerpen, Belgium

Universitair Ziekenhuis Gasthuisberg ( Site 0353)

Leuven, Vlaams-Brabant, Belgium

Femicare VZW ( Site 0350)

Tienen, Vlaams-Brabant, Belgium

Hospital Santo Antonio - Obras Sociais Irma Dulce ( Site 0101)

Salvador, Estado de Bahia, Brazil

CPCLIN ( Site 0100)

Natal, Rio Grande do Norte, Brazil

Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0102)

São Paulo, Brazil

Fundacion Centro de Investigacion Clinica CIC ( Site 0153)

Medellín, Antioquia, Colombia

Clinica de la Costa Ltda. ( Site 0152)

Barranquilla, Atlántico, Colombia

Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0156)

Chía, Cundinamarca, Colombia

Centrum ambulantni gynekologie a primarni pece ( Site 0401)

Brno, Brno-mesto, Czechia

G-CENTRUM Olomouc s.r.o. ( Site 0400)

Olomouc, Czechia

MediStar s.r.o. ( Site 0403)

Prague, Czechia

FN Motol ( Site 0402)

Prague, Czechia

CHU Dijon Bourgogne - Hopital F. Mitterrand ( Site 0223)

Dijon, Cote-d Or, France

Hopital Saint Eloi ( Site 0504)

Montpellier, Herault, France

C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0507)

Rennes, Ille-et-Vilaine, France

CHU Nantes - Hopital Hotel Dieu ( Site 0510)

Nantes, Loire-Atlantique, France

Hopital Cochin ( Site 0506)

Paris, Île-de-France Region, France

Infektiologikum Frankfurt-Sachsenhausen ( Site 0456)

Frankfurt am Main, Hesse, Germany

Epimed GmbH ( Site 0450)

Berlin, Germany

Klinische Forschung Berlin ( Site 0454)

Berlin, Germany

Universitatsklinikum Hamburg-Eppendorf ( Site 0451)

Hamburg, Germany

Meir Medical Center ( Site 0602)

Kfar Saba, Central District, Israel

Maccabi Health Services Medical Center ( Site 0604)

Tel Aviv, Central District, Israel

Rambam Medical Center ( Site 0601)

Haifa, Israel

Hadassah Medical Center. Ein Kerem ( Site 0600)

Jerusalem, Israel

Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 0551)

Rome, Roma, Italy

Azienda Ospedaliera - Universita di Padova ( Site 0555)

Padova, Veneto, Italy

Azienda Ospedaliera Policlinico di Bari ( Site 0550)

Bari, Italy

AOU Policlinico Vittorio Emanuele ( Site 0552)

Catania, Italy

Universita di Roma "La Sapienza" ( Site 0553)

Roma, Italy

P-One Clinic, Keikokai Medical Corp. ( Site 1101)

Hachiōji, Tokyo, Japan

Sagiyama Urology Clinic ( Site 1116)

Fukuoka, Japan

Souseikai PS Clinic ( Site 1103)

Fukuoka, Japan

Souseikai Nishikumamoto Hospital ( Site 1104)

Kumamoto, Japan

Medical Corporation Heishinkai OPHAC Hospital ( Site 1105)

Osaka, Japan

Nomura Clinic Namba ( Site 1114)

Osaka, Japan

Medical Corporation Seiwakai Hayakawa Clinic ( Site 1113)

Osaka, Japan

Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 1111)

Tokyo, Japan

Taisei Clinic ( Site 1109)

Tokyo, Japan

Medical Corporation Mori to Umi Tokyo Tokyo Kamata Hospital ( Site 1112)

Tokyo, Japan

Naoko Dermatology Clinic ( Site 1107)

Tokyo, Japan

Medical Corporation Shinanokai Shinanozaka Clinic ( Site 1106)

Tokyo, Japan

Medical Corporation Iseikai My City Clinic ( Site 1108)

Tokyo, Japan

Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 1102)

Tokyo, Japan

Kusunoki Clinic ( Site 1110)

Tokyo, Japan

Arke Estudios Clinicos S.A. de C.V. ( Site 0203)

Mexico City, Mexico City, Mexico

Instituto Nacional de Salud Publica ( Site 0202)

Cuernavaca, Morelos, Mexico

Icaro Investigaciones en Medicina S.A. de C.V. ( Site 0200)

Chihuahua City, Mexico

ARKE Estudios Clinicos S.A de C.V ( Site 0211)

Veracruz, Mexico

Asociacion Civil Selva Amazonica ( Site 0252)

Iquitos, Loreto, Peru

Policlinico Universidad Nacional Mayor de San Marcos ( Site 0257)

Lima, Peru

Investigaciones Medicas en Salud - INMENSA ( Site 0255)

Lima, Peru

Instituto de Investigacion Nutricional - Anexo Huascar ( Site 0251)

Lima, Peru

Asociacion Via Libre ( Site 0250)

Lima, Peru

Korea University Ansan Hospital ( Site 0952)

Ansan-si, Kyonggi-do, South Korea

The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 0954)

Seoul, South Korea

Severance Hospital ( Site 0953)

Seoul, South Korea

Hallym University Kangnam Sacred Heart Hospital ( Site 0951)

Seoul, South Korea

Korea University Guro Hospital ( Site 0950)

Seoul, South Korea

Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0755)

Badalona, Barcelona, Spain

CAP Centelles ( Site 0751)

Centelles, Barcelona, Spain

ICO L Hospitalet ( Site 0754)

L'Hospitalet de Llobregat, Barcelona, Spain

Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1003)

Kaohsiung City, Taiwan

National Cheng Kung University Hospital ( Site 1002)

Tainan, Taiwan

National Taiwan University Hospital ( Site 1000)

Taipei, Taiwan

Chang Gung Medical Foundation.Linkou Branch ( Site 1001)

Taoyuan District, Taiwan

Armed Forces Research Institute of Medical Sciences ( Site 1051)

Bangkok, Bangkok, Thailand

Vaccine Trial Center Faculty of Tropical Medicine ( Site 1052)

Bangkok, Bangkok, Thailand

Faculty of Medicine Siriraj Hospital ( Site 1050)

Bangkok, Bangkok, Thailand

Research Institute for Health Sciences ( Site 1053)

Chiang Mai, Thailand

Clinical Research Directory

Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (103)