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

Merck Sharp & Dohme LLC103 sites in 6 countries6,033 target enrollmentFebruary 27, 2020

ConditionsPapillomavirus Infections

Interventions9vHPV Vaccine Placebo (Saline for Injection)

Drugs9vHPV Vaccine

Overview

Phase: Phase 3
Intervention: 9vHPV Vaccine
Conditions: Papillomavirus Infections
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 6033
Locations: 103
Primary Endpoint: Incidence of HPV 16/18/31/33/45/52/58-related 6-month Persistent Oral Infection
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 27, 2020

End Date

August 31, 2028

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

9vHPV vaccine

Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6

Intervention: 9vHPV Vaccine

Placebo

Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6

Intervention: Placebo (Saline for Injection)

Outcomes

Primary Outcomes

Incidence of HPV 16/18/31/33/45/52/58-related 6-month Persistent Oral Infection

Time Frame: Up to Month 90

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.

Secondary Outcomes

Incidence of HPV 6/11-related 6-month Persistent Oral Infection(Up to Month 90)
Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 Antibodies(1 month postdose 3 (Month 7))
Percentage of Participants who Seroconvert to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58(1 month postdose 3 (Month 7))
Percentage of Participants with at Least 1 Solicited Injection-site Adverse Event (AE)(Up to 5 days after any vaccination)
Percentage of Participants with Elevated Temperature (Fever)(Up to 5 days after any vaccination)
Percentage of Participants Who Report at Least 1 Systemic AE(Up to 15 days after any vaccination)
Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)(Up to 15 days after any vaccination)
Percentage of Participants who Experience at Least 1 Serious Vaccine-Related AE(Up to Month 90)