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

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

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of the 9-valent human papillomavirus (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 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Papillomavirus Infections
• Intervention / Treatment: Biological: 9vHPV Vaccine; Other: Placebo (Saline for Injection)

• Study Type: Interventional
• Enrollment (Actual): 6033
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen
    • Wilrijk, Antwerpen, Belgium, 2610
      • University of Antwerp ( Site 0352)
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Universitair Ziekenhuis Gasthuisberg ( Site 0353)
    • Tienen, Vlaams-Brabant, Belgium, 3300
      • Femicare VZW ( Site 0350)
• Brazil
  • Sao Paulo, Brazil, 05402-000
    • Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0102)
  • Bahia
    • Salvador, Bahia, Brazil, 40415-006
      • Hospital Santo Antonio - Obras Sociais Irma Dulce ( Site 0101)
  • Rio Grande Do Norte
    • Natal, Rio Grande Do Norte, Brazil, 59025-050
      • CPCLIN ( Site 0100)
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, 050021
      • Fundacion Centro de Investigacion Clinica CIC ( Site 0153)
  • Atlantico
    • Barranquilla, Atlantico, Colombia, 080020
      • Clinica de la Costa Ltda. ( Site 0152)
  • Cundinamarca
    • Chia, Cundinamarca, Colombia, 250001
      • Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0156)
• Czechia
  • Olomouc, Czechia, 772 00
    • G-CENTRUM Olomouc s.r.o. ( Site 0400)
  • Praha 2, Czechia, 120 00
    • MediStar s.r.o. ( Site 0403)
  • Praha 5, Czechia, 150 06
    • FN Motol ( Site 0402)
  • Brno-mesto
    • Brno, Brno-mesto, Czechia, 602 00
      • Centrum ambulantni gynekologie a primarni pece ( Site 0401)
• France
  • Cote-d Or
    • Dijon, Cote-d Or, France, 21079
      • CHU Dijon Bourgogne - Hopital F. Mitterrand ( Site 0223)
  • Herault
    • Montpellier, Herault, France, 34295
      • Hopital Saint Eloi ( Site 0504)
  • Ile-de-France
    • Paris, Ile-de-France, France, 75014
      • Hopital Cochin ( Site 0506)
  • Ille-et-Vilaine
    • Rennes, Ille-et-Vilaine, France, 35033
      • C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0507)
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • CHU Nantes - Hopital Hotel Dieu ( Site 0510)
• Germany
  • Berlin, Germany, 10787
    • Epimed GmbH ( Site 0450)
  • Berlin, Germany, 10787
    • Klinische Forschung Berlin ( Site 0454)
  • Hamburg, Germany, 20246
    • Universitatsklinikum Hamburg-Eppendorf ( Site 0451)
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60596
      • Infektiologikum Frankfurt-Sachsenhausen ( Site 0456)
• Israel
  • Haifa, Israel, 3525408
    • Rambam Medical Center ( Site 0601)
  • Jerusalem, Israel, 9112001
    • Hadassah Medical Center. Ein Kerem ( Site 0600)
  • Central
    • Kfar Saba, Central, Israel, 4428164
      • Meir Medical Center ( Site 0602)
  • HaMerkaz
    • Tel Aviv, HaMerkaz, Israel, 6789140
      • Maccabi Health Services Medical Center ( Site 0604)
• Italy
  • Bari, Italy, 70124
    • Azienda Ospedaliera Policlinico di Bari ( Site 0550)
  • Catania, Italy, 95123
    • AOU Policlinico Vittorio Emanuele ( Site 0552)
  • Roma, Italy, 00161
    • Universita di Roma "La Sapienza" ( Site 0553)
  • Roma
    • Rome, Roma, Italy, 00144
      • Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 0551)
  • Veneto
    • Padova, Veneto, Italy, 35128
      • Azienda Ospedaliera - Universita di Padova ( Site 0555)
• Japan
  • Fukuoka, Japan, 810-0001
    • Sagiyama Urology Clinic ( Site 1116)
  • Fukuoka, Japan, 812-0025
    • Souseikai PS Clinic ( Site 1103)
  • Kumamoto, Japan, 861-4157
    • Souseikai Nishikumamoto Hospital ( Site 1104)
  • Osaka, Japan, 532-0003
    • Medical Corporation Heishinkai OPHAC Hospital ( Site 1105)
  • Osaka, Japan, 542-0076
    • Nomura Clinic Namba ( Site 1114)
  • Osaka, Japan, 542-0086
    • Medical Corporation Seiwakai Hayakawa Clinic ( Site 1113)
  • Tokyo, Japan, 101-0041
    • Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 1111)
  • Tokyo, Japan, 107-0052
    • Taisei Clinic ( Site 1109)
  • Tokyo, Japan, 144-0051
    • Medical Corporation Mori to Umi Tokyo Tokyo Kamata Hospital ( Site 1112)
  • Tokyo, Japan, 158-0097
    • Naoko Dermatology Clinic ( Site 1107)
  • Tokyo, Japan, 160-0017
    • Medical Corporation Shinanokai Shinanozaka Clinic ( Site 1106)
  • Tokyo, Japan, 160-0022
    • Medical Corporation Iseikai My City Clinic ( Site 1108)
  • Tokyo, Japan, 171-0014
    • Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 1102)
  • Tokyo, Japan, 175-0092
    • Kusunoki Clinic ( Site 1110)
  • Tokyo
    • Hachioji, Tokyo, Japan, 192-0071
      • P-One Clinic, Keikokai Medical Corp. ( Site 1101)
• Korea, Republic of
  • Seoul, Korea, Republic of, 03312
    • The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 0954)
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital ( Site 0953)
  • Seoul, Korea, Republic of, 07441
    • Hallym University Kangnam Sacred Heart Hospital ( Site 0951)
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital ( Site 0950)
  • Kyonggi-do
    • Ansan-si, Kyonggi-do, Korea, Republic of, 15355
      • Korea University Ansan Hospital ( Site 0952)
• Mexico
  • Cdmx, Mexico, 06700
    • Arke Estudios Clinicos S.A. de C.V. ( Site 0203)
  • Chihuahua, Mexico, 31000
    • Icaro Investigaciones en Medicina S.A. de C.V. ( Site 0200)
  • Veracruz, Mexico, 91910
    • ARKE Estudios Clinicos S.A de C.V ( Site 0211)
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62100
      • Instituto Nacional de Salud Publica ( Site 0202)
• Peru
  • Lima, Peru, 07006
    • Policlinico Universidad Nacional Mayor de San Marcos ( Site 0257)
  • Lima, Peru, 15046
    • Investigaciones Medicas en Salud - INMENSA ( Site 0255)
  • Lima, Peru, 15423
    • Instituto de Investigacion Nutricional - Anexo Huascar ( Site 0251)
  • Lima, Peru, LIMA 01
    • Asociacion Via Libre ( Site 0250)
  • Loreto
    • Iquitos, Loreto, Peru, 16000
      • Asociacion Civil Selva Amazonica ( Site 0252)
• Spain
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0755)
    • Centelles, Barcelona, Spain, 08540
      • CAP Centelles ( Site 0751)
    • L Hospitalet De Llobregat, Barcelona, Spain, 08090
      • ICO L Hospitalet ( Site 0754)
• Taiwan
  • Kaohsiung, Taiwan, 833
    • Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1003)
  • Tainan, Taiwan, 70403
    • National Cheng Kung University Hospital ( Site 1002)
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital ( Site 1000)
  • Taoyuan, Taiwan, 333
    • Chang Gung Medical Foundation.Linkou Branch ( Site 1001)
• Thailand
  • Chiang Mai, Thailand, 50200
    • Research Institute for Health Sciences ( Site 1053)
  • Krung Thep Maha Nakhon
    • Bangkok, Krung Thep Maha Nakhon, Thailand, 10400
      • Armed Forces Research Institute of Medical Sciences ( Site 1051)
    • Bangkok, Krung Thep Maha Nakhon, Thailand, 10400
      • Vaccine Trial Center Faculty of Tropical Medicine ( Site 1052)
    • Bangkok, Krung Thep Maha Nakhon, Thailand, 10700
      • Faculty of Medicine Siriraj Hospital ( Site 1050)
• United States
  • California
    • Northridge, California, United States, 91325
      • Valley Clinical Trials Inc. ( Site 0002)
    • Rialto, California, United States, 92377
      • Inland Empire Clinical Trials, LLC ( Site 0025)
    • Simi Valley, California, United States, 93065
      • Alta California Medical Group ( Site 0031)
    • Spring Valley, California, United States, 91978
      • Encompass Clinical Research ( Site 0028)
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc ( Site 0042)
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Clinical Research of South Florida ( Site 0036)
    • Miami, Florida, United States, 33142
      • Acevedo Clinical Research Associates ( Site 0001)
    • Tampa, Florida, United States, 33617
      • Moffitt Cancer Center ( Site 0017)
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University ( Site 0010)
  • Idaho
    • Meridian, Idaho, United States, 83646
      • Solaris Clinical Research, LLC ( Site 0003)
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton-O'Neil Clinical Research Center ( Site 0044)
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates, LLC ( Site 0034)
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Kentucky Pediatric/Adult Research Inc ( Site 0011)
  • Missouri
    • Hazelwood, Missouri, United States, 63042
      • Healthcare Research Network LLC ( Site 0035)
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Alliance for Multispecialty Reseach, LLC ( Site 0021)
  • New York
    • Cortland, New York, United States, 13045
      • Certified Research Associates ( Site 0041)
    • New York, New York, United States, 10011
      • Laser Surgery Care ( Site 0018)
    • New York, New York, United States, 10065
      • Weill Cornell Medicine ( Site 0046)
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc. ( Site 0008)
  • North Carolina
    • Salisbury, North Carolina, United States, 28144
      • PMG Research of Salisbury ( Site 0009)
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Rapid Medical Research, Inc. ( Site 0037)
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15236
      • Preferred Primary Care Physicians ( Site 0032)
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center ( Site 0043)
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group ( Site 0030)
  • Texas
    • Galveston, Texas, United States, 77555-1115
      • University of Texas Medical Branch at Galveston ( Site 0038)
    • Houston, Texas, United States, 77081
      • Texas Center For Drug Development ( Site 0013)
    • Victoria, Texas, United States, 77901
      • Crossroads Clinical Research LLC ( Site 0027)
  • Utah
    • Salt Lake City, Utah, United States, 84121
      • J Lewis Research Inc/Foothill Family Clinic South ( Site 0006)
    • South Jordan, Utah, United States, 84095
      • J Lewis Research Inc/Jordan River Family Medicine ( Site 0023)
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research Center, LLC ( Site 0007)
    • Newport News, Virginia, United States, 23606
      • Health Research of Hampton Roads, Inc. ( Site 0015)
    • Richmond, Virginia, United States, 23226
      • Clinical Research Partners, LLC. ( Site 0004)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 human papillomavirus (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, 7, 10, 15, or 18 are met.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 9vHPV vaccine; Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6	Biological: 9vHPV Vaccine; 9-valent human papillomavirus vaccine (9vHPV) is an aluminum-adjuvanted recombinant protein vaccine prepared from the highly purified virus-like particles (VLPs) 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 Names: GARDASIL®9; V503
Placebo Comparator: Placebo; Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6	Other: Placebo (Saline for Injection); 0.9% sodium chloride given as a 0.5-mL intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Human Papillomavirus (HPV)16/18/31/33/45/52/58-related 6-month Persistent Oral Infection	A 6-month persistent infection is defined to have occurred if a participant, after completion of the Month 7 visit, is positive for the same human papillomavirus (HPV) type by the HPV polymerase chain reaction (PCR) assay to at least 1 common gene in Oral Rinse and Gargle (ORG) samples obtained at 2 or more consecutive visits at 6 months (+/-1 month visit window) apart.	Up to Month 42

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Human Papillomavirus (HPV) 6/11-related 6-month Persistent Oral Infection	A 6-month persistent infection is defined to have occurred if a participant, after completion of the Month 7 visit, is positive for the same human papillomavirus (HPV) type by the HPV polymerase chain reaction (PCR) assay to at least 1 common gene in Oral Rinse and Gargle (ORG) samples obtained at 2 or more consecutive visits at 6 months (+/-1 month visit window) apart.	Up to Month 42
Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 Antibodies	Serum antibodies to HPV types are measured with competitive Luminex immunoassay (cLIA). Geometric mean titers of antibodies to HPV types will be calculated by exponentiating the mean estimates of natural logarithm of the anti-HPV titers.	1 month postdose 3 (Month 7)
Percentage of Participants who Seroconvert to Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, and 58	Seroconversion is defined as changing a participant's serostatus from seronegative at Day 1 to seropositive by 4 weeks postdose 3. A participant with anti-HPV competitive Luminex immunoassay (cLIA) titer at or above the serostatus cutoff of the cLIA for a given HPV type is considered seropositive for that HPV type.	1 month postdose 3 (Month 7)
Percentage of Participants with at Least 1 Solicited Injection-site Adverse Event (AE)	An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the 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 redness/erythema, swelling, and tenderness/pain at the injection site will be recorded.	Up to 5 days after any vaccination
Percentage of Participants with Elevated Temperature (Fever)	Participants are asked to record oral body temperatures. The percentage of participants with elevated temperature (≥37.8°C or 100.0°F) will be assessed.	Up to 5 days after any vaccination
Percentage of Participants Who Report at Least 1 Systemic Adverse Event	An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the 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.	Up to 15 days after any vaccination
Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)	A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is another important medical event deemed such by medical or scientific judgment.	Up to 15 days after any vaccination
Percentage of Participants who Experience at Least 1 Serious Vaccine-Related Adverse Event	A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is another important medical event deemed such by medical or scientific judgment. An SAE that is considered by an investigator (a qualified physician) to be vaccine-related will be reported during entire study period.	Up to Month 42

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Giuliano AR. Initiation of three complementary international studies investigating prevalence of oral HPV infection, burden of HPV-related head and neck disease, and efficacy of 9-valent HPV vaccination against oral HPV persistent infection. Contemp Clin Trials. 2022 Apr;115:106629. doi: 10.1016/j.cct.2021.106629. Epub 2021 Nov 24. No abstract available.
• Morais E, Kothari S, Roberts C, Yen G, Chen YT, Lynam M, Pedros M, Mirghani H, Alemany L, Pavon MA, Waterboer T, Mehanna H, Giuliano AR. Oral human papillomavirus (HPV) and associated factors among healthy populations: The design of the PROGRESS (PRevalence of Oral hpv infection, a Global aSSessment) study. Contemp Clin Trials. 2022 Apr;115:106630. doi: 10.1016/j.cct.2021.106630. Epub 2021 Nov 25.
• Giuliano AR, Wilkin T, Bautista OM, Cheon K, Connor L, Dubey S; Thomas Group; Luxembourg A, Rawat S, Shaw A, Velicer C, Vendetti N, Tu Y. Design of a phase III efficacy, immunogenicity, and safety study of 9-valent human papillomavirus vaccine in prevention of oral persistent infection in men. Contemp Clin Trials. 2022 Apr;115:106592. doi: 10.1016/j.cct.2021.106592. Epub 2021 Oct 19.

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2020
• Primary Completion (Estimated): September 21, 2026
• Study Completion (Estimated): September 21, 2026

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Urogenital Diseases; Genital Diseases; Infections; Communicable Diseases; Papillomavirus Infections; Persistent Infection
• Other Study ID Numbers: V503-049 (Other Identifier: Merck); 2019-003236-23 (EudraCT Number: EudraCT Number); 205346 (Registry Identifier: JAPIC-CTI); 2022-501974-21-00 (Other Identifier: EudraCT Number)

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.: No