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.
Merck Sharp & Dohme LLC
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.
Eligibility
- Age range
- 12–30 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Is in good health before randomization. * Has a body mass index between 18 and 38 kg/m\^2, inclusive, for adults 18-30; has a body mass index between 15 and 38 kg/m\^2, inclusive, for adolescents 12-17. Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * Has a confirmed or suspected case of infectious mononucleosis within 12 months prior to enrollment. * Has any immunosuppressive medical condition or receive any immunosuppressive therapy.
Interventions
- BiologicalV350A
Vaccination administered via intramuscular injection
- BiologicalV350B
Vaccination administered via intramuscular injection
- BiologicalPlacebo
Vaccination administered via intramuscular injection
Locations (9)
- California Clinical Trials Medical Group managed by PAREXEL ( Site 0011)Glendale, California
- QPS-MRA, LLC ( Site 0012)Miami, Florida
- Alliance for Multispecialty Research, LLC ( Site 0008)Kansas City, Missouri
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0016)Springfield, Missouri
- Velocity Clinical Research Lincoln ( Site 0004)Lincoln, Nebraska
- Velocity Clinical Research, Omaha ( Site 0005)Omaha, Nebraska