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

Purpose

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.

Condition

  • Healthy

Eligibility

Eligible Ages
Between 18 Years and 30 Years
Eligible Sex
All
Accepts 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 ≥18 and ≤38 kg/m^2, inclusive.

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Basic Science
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
V350A 		Participants will receive V350A vaccinations on Day 1, Month 2, and Month 6.
  • Biological: V350A
    Vaccination administered via intramuscular injection
Experimental
V350B 		Participants will receive V350B vaccinations on Day 1, Month 2, and Month 6.
  • Biological: V350B
    Vaccination administered via intramuscular injection
Placebo Comparator
Placebo 		Participants will receive placebo vaccinations on Day 1, Month 2, and Month 6.
  • Biological: Placebo
    Vaccination administered via intramuscular injection

Recruiting Locations

Alliance for Multispecialty Research, LLC ( Site 0008)
Kansas City 4393217, Missouri 4398678 64114
Contact:
Study Coordinator
816-943-0770

Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0016)
Springfield 4409896, Missouri 4398678 65802
Contact:
Study Coordinator
417-831-2048

Velocity Clinical Research Lincoln ( Site 0004)
Lincoln 5072006, Nebraska 5073708 68510
Contact:
Study Coordinator
308-365-8900

Remington-Davis, Inc. ( Site 0017)
Columbus 4509177, Ohio 5165418 43215
Contact:
Study Coordinator
614-487-2560

Lynn Health Science Institute ( Site 0010)
Oklahoma City 4544349, Oklahoma 4544379 73112
Contact:
Study Coordinator
405-602-3939

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com