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A Phase 1, Randomized, Double-Blind, Comparator-Controlled, Dose-Escalation Trial to Evaluate, Tolerability, and Immunogenicity of V540D in Healthy Adults.
Researchers are looking for new ways to prevent cancers related to human papillomavirus (HPV). HPV is a common virus that can cause an infection. There are many different types of HPV. Most people's immune system can fight HPV infection and it goes away without treatment. For some people, HPV infections can last longer and may cause cancer years later. A standard vaccine to prevent HPV-related cancers is GARDASIL®9 (G9). G9 protects against 9 types of HPV but it does not protect against other types of HPV. The study vaccine (called V540D) is designed to protect against the same HPV types that G9 protects against plus other HPV types. The main goal of this study is to learn about the safety of V540D in healthy adults and if people tolerate it.
Age
18 - 45 years
Sex
ALL
Healthy Volunteers
Yes
Research Centers of America ( Hollywood ) ( Site 0001)
Hollywood, Florida, United States
Velocity Clinical Research, Savannah ( Site 0005)
Savannah, Georgia, United States
Alliance for Multispecialty Research, LLC ( Site 0003)
Kansas City, Missouri, United States
Alliance for Multispecialty Research, LLC ( Site 0004)
Knoxville, Tennessee, United States
Start Date
December 20, 2024
Primary Completion Date
November 30, 2026
Completion Date
November 30, 2026
Last Updated
March 13, 2026
72
ESTIMATED participants
V540D
BIOLOGICAL
GARDASIL®9
BIOLOGICAL
Lead Sponsor
Merck Sharp & Dohme LLC
NCT07310264
NCT06290258
Data Source & Attribution
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