Safety and Immune Response Study of V350A and V350B Vaccines in Healthy People Aged 12 to 30

What this Trial Is About

Researchers are evaluating the safety and immune response of two new vaccines, V350A and V350B, which target the Epstein Barr virus EBV. EBV can cause infectious mononucleosis and is linked to certain cancers and multiple sclerosis. This Phase 1 trial focuses on healthy individuals aged 12 to 30 to assess how well these vaccines are tolerated and their safety profiles. Participants will be randomly assigned to receive either the V350A vaccine, the V350B vaccine, or a placebo. Each participant will get vaccinations on Day 1, Month 2, and Month 6, all given by intramuscular injection. The study uses a triple-blind design to ensure unbiased results, and it follows a sequential study model. During the trial, participants will be monitored for adverse events at the injection site and systemic reactions up to six months post-vaccination. Other safety assessments include monitoring for serious and medically attended adverse events up to eighteen months. Researchers will also measure immune responses by analyzing antibody levels against EBV over approximately eighteen months. The total participation duration extends to about eighteen months with regular safety and immune system evaluations.

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