Papillomavirus InfectionsPhase 3NCT04199689
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 study testing 9vHPV Vaccine in people with Papillomavirus Infections, run by Merck Sharp & Dohme LLC at 103 sites in 16 countries.
Trial 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)… Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Papillomavirus Infections
- What is being tested?
- 9vHPV Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,033 participants
- Where
- 103 sitesin 16 countries
- Study dates
- 27 Feb 2020to 13 Aug 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
103 sites in 16 countries.
103 sites in 16 countries
United States32 sites
Augusta University ( Site 0010)
Augusta, Georgia, 30912
Kentucky Pediatric/Adult Research Inc ( Site 0011)
Bardstown, Kentucky, 40004
Charlottesville Medical Research Center, LLC ( Site 0007)
Charlottesville, Virginia, 22911
Rapid Medical Research, Inc. ( Site 0037)
Cleveland, Ohio, 44122
Clinical Research of South Florida ( Site 0036)
Coral Gables, Florida, 33134
Certified Research Associates ( Site 0041)
Cortland, New York, 13045
University of Texas Medical Branch at Galveston ( Site 0038)
Galveston, Texas, 77555-1115
Healthcare Research Network LLC ( Site 0035)
Hazelwood, Missouri, 63042
Texas Center For Drug Development ( Site 0013)
Houston, Texas, 77081
Holston Medical Group ( Site 0030)
Kingsport, Tennessee, 37660
Alliance for Multispecialty Reseach, LLC ( Site 0021)
Las Vegas, Nevada, 89119
Solaris Clinical Research, LLC ( Site 0003)
Meridian, Idaho, 83646
Acevedo Clinical Research Associates ( Site 0001)
Miami, Florida, 33142
Laser Surgery Care ( Site 0018)
New York, New York, 10011
Weill Cornell Medicine ( Site 0046)
New York, New York, 10065
Health Research of Hampton Roads, Inc. ( Site 0015)
Newport News, Virginia, 23606
Coastal Carolina Research Center ( Site 0043)
North Charleston, South Carolina, 29405
Valley Clinical Trials Inc. ( Site 0002)
Northridge, California, 91325
Preferred Primary Care Physicians ( Site 0032)
Pittsburgh, Pennsylvania, 15236
Inland Empire Clinical Trials, LLC ( Site 0025)
Rialto, California, 92377
Clinical Research Partners, LLC. ( Site 0004)
Richmond, Virginia, 23226
Rochester Clinical Research, Inc. ( Site 0008)
Rochester, New York, 14609
PMG Research of Salisbury ( Site 0009)
Salisbury, North Carolina, 28144
J Lewis Research Inc/Foothill Family Clinic South ( Site 0006)
Salt Lake City, Utah, 84121
Alta California Medical Group ( Site 0031)
Simi Valley, California, 93065
J Lewis Research Inc/Jordan River Family Medicine ( Site 0023)
South Jordan, Utah, 84095
Encompass Clinical Research ( Site 0028)
Spring Valley, California, 91978
Moffitt Cancer Center ( Site 0017)
Tampa, Florida, 33617
Cotton-O'Neil Clinical Research Center ( Site 0044)
Topeka, Kansas, 66606
Crossroads Clinical Research LLC ( Site 0027)
Victoria, Texas, 77901
Diablo Clinical Research, Inc ( Site 0042)
Walnut Creek, California, 94598
Heartland Research Associates, LLC ( Site 0034)
Wichita, Kansas, 67207
Japan15 sites
Sagiyama Urology Clinic ( Site 1116)
Fukuoka, 810-0001
Souseikai PS Clinic ( Site 1103)
Fukuoka, 812-0025
P-One Clinic, Keikokai Medical Corp. ( Site 1101)
Hachiōji, Tokyo, 192-0071
Souseikai Nishikumamoto Hospital ( Site 1104)
Kumamoto, 861-4157
Medical Corporation Heishinkai OPHAC Hospital ( Site 1105)
Osaka, 532-0003
Nomura Clinic Namba ( Site 1114)
Osaka, 542-0076
Medical Corporation Seiwakai Hayakawa Clinic ( Site 1113)
Osaka, 542-0086
Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 1111)
Tokyo, 101-0041
Taisei Clinic ( Site 1109)
Tokyo, 107-0052
Medical Corporation Mori to Umi Tokyo Tokyo Kamata Hospital ( Site 1112)
Tokyo, 144-0051
Naoko Dermatology Clinic ( Site 1107)
Tokyo, 158-0097
Medical Corporation Shinanokai Shinanozaka Clinic ( Site 1106)
Tokyo, 160-0017
Medical Corporation Iseikai My City Clinic ( Site 1108)
Tokyo, 160-0022
Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 1102)
Tokyo, 171-0014
Kusunoki Clinic ( Site 1110)
Tokyo, 175-0092
France5 sites
CHU Dijon Bourgogne - Hopital F. Mitterrand ( Site 0223)
Dijon, Cote-d Or, 21079
Hopital Saint Eloi ( Site 0504)
Montpellier, Herault, 34295
CHU Nantes - Hopital Hotel Dieu ( Site 0510)
Nantes, Loire-Atlantique, 44093
Hopital Cochin ( Site 0506)
Paris, Île-de-France Region, 75014
C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0507)
Rennes, Ille-et-Vilaine, 35033
Italy5 sites
Azienda Ospedaliera Policlinico di Bari ( Site 0550)
Bari, 70124
AOU Policlinico Vittorio Emanuele ( Site 0552)
Catania, 95123
Azienda Ospedaliera - Universita di Padova ( Site 0555)
Padova, Veneto, 35128
Universita di Roma "La Sapienza" ( Site 0553)
Roma, 00161
Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 0551)
Rome, Roma, 00144
Peru5 sites
Asociacion Civil Selva Amazonica ( Site 0252)
Iquitos, Loreto, 16000
Policlinico Universidad Nacional Mayor de San Marcos ( Site 0257)
Lima, 07006
Investigaciones Medicas en Salud - INMENSA ( Site 0255)
Lima, 15046
Instituto de Investigacion Nutricional - Anexo Huascar ( Site 0251)
Lima, 15423
Asociacion Via Libre ( Site 0250)
Lima, LIMA 01
South Korea5 sites
Korea University Ansan Hospital ( Site 0952)
Ansan-si, Kyonggi-do, 15355
The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 0954)
Seoul, 03312
Severance Hospital ( Site 0953)
Seoul, 03722
Hallym University Kangnam Sacred Heart Hospital ( Site 0951)
Seoul, 07441
Korea University Guro Hospital ( Site 0950)
Seoul, 08308
Czechia4 sites
Centrum ambulantni gynekologie a primarni pece ( Site 0401)
Brno, Brno-mesto, 602 00
G-CENTRUM Olomouc s.r.o. ( Site 0400)
Olomouc, 772 00
MediStar s.r.o. ( Site 0403)
Prague, 120 00
FN Motol ( Site 0402)
Prague, 150 06
Germany4 sites
Epimed GmbH ( Site 0450)
Berlin, 10787
Klinische Forschung Berlin ( Site 0454)
Berlin, 10787
Infektiologikum Frankfurt-Sachsenhausen ( Site 0456)
Frankfurt am Main, Hesse, 60596
Universitatsklinikum Hamburg-Eppendorf ( Site 0451)
Hamburg, 20246
Israel4 sites
Rambam Medical Center ( Site 0601)
Haifa, 3525408
Hadassah Medical Center. Ein Kerem ( Site 0600)
Jerusalem, 9112001
Meir Medical Center ( Site 0602)
Kfar Saba, Central District, 4428164
Maccabi Health Services Medical Center ( Site 0604)
Tel Aviv, Central District, 6789140
Mexico4 sites
Icaro Investigaciones en Medicina S.A. de C.V. ( Site 0200)
Chihuahua City, 31000
Instituto Nacional de Salud Publica ( Site 0202)
Cuernavaca, Morelos, 62100
Arke Estudios Clinicos S.A. de C.V. ( Site 0203)
Mexico City, Mexico City, 06700
ARKE Estudios Clinicos S.A de C.V ( Site 0211)
Veracruz, 91910
Taiwan4 sites
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1003)
Kaohsiung City, 833
National Cheng Kung University Hospital ( Site 1002)
Tainan, 70403
National Taiwan University Hospital ( Site 1000)
Taipei, 100
Chang Gung Medical Foundation.Linkou Branch ( Site 1001)
Taoyuan, 333
Thailand4 sites
Armed Forces Research Institute of Medical Sciences ( Site 1051)
Bangkok, Bangkok, 10400
Vaccine Trial Center Faculty of Tropical Medicine ( Site 1052)
Bangkok, Bangkok, 10400
Faculty of Medicine Siriraj Hospital ( Site 1050)
Bangkok, Bangkok, 10700
Research Institute for Health Sciences ( Site 1053)
Chiang Mai, 50200
Belgium3 sites
Universitair Ziekenhuis Gasthuisberg ( Site 0353)
Leuven, Vlaams-Brabant, 3000
Femicare VZW ( Site 0350)
Tienen, Vlaams-Brabant, 3300
University of Antwerp ( Site 0352)
Wilrijk, Antwerpen, 2610
Brazil3 sites
CPCLIN ( Site 0100)
Natal, Rio Grande do Norte, 59025-050
Hospital Santo Antonio - Obras Sociais Irma Dulce ( Site 0101)
Salvador, Estado de Bahia, 40415-006
Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0102)
São Paulo, 05402-000
Colombia3 sites
Clinica de la Costa Ltda. ( Site 0152)
Barranquilla, Atlántico, 080020
Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0156)
Chía, Cundinamarca, 250001
Fundacion Centro de Investigacion Clinica CIC ( Site 0153)
Medellín, Antioquia, 050021
Spain3 sites
Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0755)
Badalona, Barcelona, 08916
CAP Centelles ( Site 0751)
Centelles, Barcelona, 08540
ICO L Hospitalet ( Site 0754)
L'Hospitalet de Llobregat, Barcelona, 08090
About this 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
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.
- Conditions
- Papillomavirus Infections
- Being tested
- 9vHPV Vaccine, Placebo (Saline for Injection)
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9vHPV VaccineBiological
Also called GARDASIL®9, V503
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.
Placebo (Saline for Injection)Other
0.9% sodium chloride given as a 0.5-mL intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| 9vHPV vaccine | Experimental | Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6 Receives: Biological: 9vHPV Vaccine |
| Placebo | Placebo comparator | Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6 Receives: Other: Placebo (Saline for Injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of 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 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.
Measured: Up to Month 90
Secondary outcomes (8)
Incidence of 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 HPV type by the HPV PCR assay to at least 1 common gene in ORG samples obtained at 2 or more consecutive visits at 6 months (+/-1 month visit window) apart.
Measured: Up to Month 90
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.
Measured: 1 month postdose 3 (Month 7)
Percentage of Participants who Seroconvert to 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 cLIA titer at or above the serostatus cutoff of the cLIA for a given HPV type is considered seropositive for that HPV type.
Measured: 1 month postdose 3 (Month 7)
Percentage of Participants with 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 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.
Measured: 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.
Measured: Up to 5 days after any vaccination
Percentage of Participants Who Report at Least 1 Systemic AE
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.
Measured: Up to 15 days after any vaccination
Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)
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.
Measured: Up to 15 days after any vaccination
Percentage of Participants who Experience at Least 1 Serious Vaccine-Related AE
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.
Measured: Up to Month 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start27 Feb 2020
- Primary completion15 Jan 2027 (estimated)
- Study completion13 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Papillomavirus InfectionsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 6,033 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199689
- Sponsor's protocol ID
- V503-049
- Other IDs
- V503-049, 205346, 2022-501974-21-00, U1111-1275-8682, 2019-003236-23, 2019
- Status last verified
- Oct 2026
- First submitted
- 12 Dec 2019
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
PubMed 41276263Giuliano 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.
PubMed 34838718Morais 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.
PubMed 34838717Giuliano 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.
PubMed 34678491