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
Location: See all (9) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 30
Healthy Volunteers: t
View:
⁃ The key inclusion criteria include but are not limited to the following:
• Is in good health before randomization.
• Has a body mass index ≥18 and ≤38 kg/m\^2, inclusive.
Locations
United States
California
California Clinical Trials Medical Group managed by PAREXEL ( Site 0011)
COMPLETED
Glendale
Florida
QPS-MRA, LLC ( Site 0012)
ACTIVE_NOT_RECRUITING
Miami
Missouri
Alliance for Multispecialty Research, LLC ( Site 0008)
RECRUITING
Kansas City
Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0016)
RECRUITING
Springfield
Nebraska
Velocity Clinical Research Lincoln ( Site 0004)
RECRUITING
Lincoln
Velocity Clinical Research, Omaha ( Site 0005)
RECRUITING
Omaha
Ohio
Remington-Davis, Inc. ( Site 0017)
RECRUITING
Columbus
Oklahoma
Lynn Health Science Institute ( Site 0010)
RECRUITING
Oklahoma City
Tennessee
Alliance for Multispecialty Research, LLC ( Site 0009)
RECRUITING
Knoxville
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2024-12-05
Estimated Completion Date: 2027-07-16
Participants
Target number of participants: 200
Treatments
Experimental: V350A
Participants will receive V350A vaccinations on Day 1, Month 2, and Month 6.
Experimental: V350B
Participants will receive V350B vaccinations on Day 1, Month 2, and Month 6.
Placebo_comparator: Placebo
Participants will receive placebo vaccinations on Day 1, Month 2, and Month 6.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC