RecruitingPhase 1NCT06655324

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

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.


Sponsor

Merck Sharp & Dohme LLC

Enrollment

250 participants

Start Date

Dec 5, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 YearsMax Age: 30 Years

Inclusion Criteria2

  • 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 Criteria2

  • 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.

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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, United States

QPS-MRA, LLC ( Site 0012)

South Miami, Florida, United States

Alliance for Multispecialty Research, LLC ( Site 0008)

Kansas City, Missouri, United States

Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0016)

Springfield, Missouri, United States

Velocity Clinical Research Lincoln ( Site 0004)

Lincoln, Nebraska, United States

Velocity Clinical Research, Omaha ( Site 0005)

Omaha, Nebraska, United States

Remington-Davis, Inc. ( Site 0017)

Columbus, Ohio, United States

Lynn Health Science Institute ( Site 0010)

Oklahoma City, Oklahoma, United States

Alliance for Multispecialty Research, LLC ( Site 0009)

Knoxville, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT06655324


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