NCT06655324

A Study to Evaluate Safety, Tolerability, and Immunogenicity of V350A and V350B in Healthy Participants (V350-001).

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V350A and V350B in Healthy Participants.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 12 Years – 30 Years
• Healthy volunteers: Accepted

Summary

Epstein Barr virus (EBV) is a virus which can cause infectious mononucleosis and is associated with certain kinds of cancer and multiple sclerosis. Researchers are looking for new ways to prevent disease related to EBV and have developed a new study vaccine (V350A and V350B). The main goal of this study is to learn about the safety and tolerability of V350A and V350B in healthy adults.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	V350A	Vaccination administered via intramuscular injection
BIOLOGICAL	V350B	Vaccination administered via intramuscular injection
BIOLOGICAL	Placebo	Vaccination administered via intramuscular injection

Timeline

• Start date: 2024-12-05
• Primary completion: 2028-07-17
• Completion: 2028-07-17
• First posted: 2024-10-23
• Last updated: 2026-04-13

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study