NCT06623409

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	GARDASIL®9 (G9)	Suspension administered via intramuscular (IM) injection
BIOLOGICAL	V540B	Experimental vaccine and adjuvant administered via IM injection

Timeline

• Start date: 2024-11-12
• Primary completion: 2026-11-20
• Completion: 2026-11-20
• First posted: 2024-10-02
• Last updated: 2025-08-03

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study