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

Last updated: April 17, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

V350A

V350B

Placebo

Clinical Study ID

NCT06655324
V350-001
  • Ages 18-30
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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 (BMI) ≥18 and ≤35 kg/m^2, inclusive.

Exclusion

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 priorto enrollment.

  • Has any immunosuppressive medical condition or receive any immunosuppressivetherapy.

Study Design

Total Participants: 200
Treatment Group(s): 3
Primary Treatment: V350A
Phase: 1
Study Start date:
December 05, 2024
Estimated Completion Date:
November 21, 2026

Connect with a study center

  • California Clinical Trials Medical Group managed by PAREXEL ( Site 0011)

    Glendale, California 91206
    United States

    Active - Recruiting

  • QPS-MRA, LLC ( Site 0012)

    Miami, Florida 33143
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research, LLC ( Site 0008)

    Kansas City, Missouri 64114
    United States

    Active - Recruiting

  • Velocity Clinical Research Lincoln ( Site 0004)

    Lincoln, Nebraska 68510
    United States

    Active - Recruiting

  • Velocity Clinical Research, Omaha ( Site 0005)

    Omaha, Nebraska 68134
    United States

    Active - Recruiting

  • Lynn Health Science Institute ( Site 0010)

    Oklahoma City, Oklahoma 73112
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research, LLC ( Site 0009)

    Knoxville, Tennessee 37909
    United States

    Active - Recruiting

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