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Clinical Trials in the USA / NCT04199689
Active, not recruiting Phase 3

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

NCT04199689 · tracked via the Priya Life Science USA tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2020-02-27
Last updated
2025-03-25

Condition(s) studied

Papillomavirus Infections

Investigational drug(s) / intervention(s)

9vHPV VaccinePlacebo (Saline for Injection)

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.

Placebo (Saline for Injection): 0.9% sodium chloride given as a 0.5-mL intramuscular injection

Study 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.

Eligibility

Sex
MALE
Min age
20 Years
Max age
45 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (103)

FacilityCityRegionStatus
Valley Clinical Trials Inc. ( Site 0002) Northridge California
Inland Empire Clinical Trials, LLC ( Site 0025) Rialto California
Alta California Medical Group ( Site 0031) Simi Valley California
Encompass Clinical Research ( Site 0028) Spring Valley California
Diablo Clinical Research, Inc ( Site 0042) Walnut Creek California
Clinical Research of South Florida ( Site 0036) Coral Gables Florida
Acevedo Clinical Research Associates ( Site 0001) Miami Florida
Moffitt Cancer Center ( Site 0017) Tampa Florida
Augusta University ( Site 0010) Augusta Georgia
Solaris Clinical Research, LLC ( Site 0003) Meridian Idaho
Cotton-O'Neil Clinical Research Center ( Site 0044) Topeka Kansas
Heartland Research Associates, LLC ( Site 0034) Wichita Kansas
Kentucky Pediatric/Adult Research Inc ( Site 0011) Bardstown Kentucky
Healthcare Research Network LLC ( Site 0035) Hazelwood Missouri
Alliance for Multispecialty Reseach, LLC ( Site 0021) Las Vegas Nevada
Certified Research Associates ( Site 0041) Cortland New York
Laser Surgery Care ( Site 0018) New York New York
Weill Cornell Medicine ( Site 0046) New York New York
Rochester Clinical Research, Inc. ( Site 0008) Rochester New York
PMG Research of Salisbury ( Site 0009) Salisbury North Carolina
Rapid Medical Research, Inc. ( Site 0037) Cleveland Ohio
Preferred Primary Care Physicians ( Site 0032) Pittsburgh Pennsylvania
Coastal Carolina Research Center ( Site 0043) North Charleston South Carolina
Holston Medical Group ( Site 0030) Kingsport Tennessee
University of Texas Medical Branch at Galveston ( Site 0038) Galveston Texas
Texas Center For Drug Development ( Site 0013) Houston Texas
Crossroads Clinical Research LLC ( Site 0027) Victoria Texas
J Lewis Research Inc/Foothill Family Clinic South ( Site 0006) Salt Lake City Utah
J Lewis Research Inc/Jordan River Family Medicine ( Site 0023) South Jordan Utah
Charlottesville Medical Research Center, LLC ( Site 0007) Charlottesville Virginia
Health Research of Hampton Roads, Inc. ( Site 0015) Newport News Virginia
Clinical Research Partners, LLC. ( Site 0004) Richmond Virginia
University of Antwerp ( Site 0352) Wilrijk Antwerpen
Universitair Ziekenhuis Gasthuisberg ( Site 0353) Leuven Vlaams-Brabant
Femicare VZW ( Site 0350) Tienen Vlaams-Brabant
Hospital Santo Antonio - Obras Sociais Irma Dulce ( Site 0101) Salvador Estado de Bahia
CPCLIN ( Site 0100) Natal Rio Grande do Norte
Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0102) São Paulo Brazil
Fundacion Centro de Investigacion Clinica CIC ( Site 0153) Medellín Antioquia
Clinica de la Costa Ltda. ( Site 0152) Barranquilla Atlántico

+ 63 more sites — see the full list on the official registry below.

More Merck Sharp & Dohme LLC trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04199689 on ClinicalTrials.gov ↗ ← All trials in the USA