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ACTIVE NOT RECRUITING
NCT06623409
PHASE1

Safety and Immunogenicity of V540B in Healthy Adults (V540B-002).

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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 V540B) 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 V540B in healthy adults and if people tolerate it.

Official title: A Phase 1, Randomized, Double-Blind, Comparator-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of V540B in Healthy Adults.

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2024-11-12

Completion Date

2026-11-20

Last Updated

2025-08-03

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

GARDASIL®9 (G9)

Suspension administered via intramuscular (IM) injection

BIOLOGICAL

V540B

Experimental vaccine and adjuvant administered via IM injection

Locations (5)

Anaheim Clinical Trials ( Site 0002)

Anaheim, California, United States

California Clinical Trials Medical Group managed by PAREXEL ( Site 0008)

Glendale, California, United States

Velocity Clinical Research, Hallandale Beach ( Site 0003)

Hallandale, Florida, United States

Research Centers of America ( Hollywood ) ( Site 0001)

Hollywood, Florida, United States

Velocity Clinical Research, Omaha ( Site 0005)

Omaha, Nebraska, United States