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

NCT ID: NCT06655324

Last Updated: 2026-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-05

Study Completion Date

2028-07-17

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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V350A

Participants will receive V350A vaccinations on Day 1, Month 2, and Month 6.

Group Type EXPERIMENTAL

V350A

Intervention Type BIOLOGICAL

Vaccination administered via intramuscular injection

V350B

Participants will receive V350B vaccinations on Day 1, Month 2, and Month 6.

Group Type EXPERIMENTAL

V350B

Intervention Type BIOLOGICAL

Vaccination administered via intramuscular injection

Placebo

Participants will receive placebo vaccinations on Day 1, Month 2, and Month 6.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Vaccination administered via intramuscular injection

Interventions

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V350A

Vaccination administered via intramuscular injection

Intervention Type BIOLOGICAL

V350B

Vaccination administered via intramuscular injection

Intervention Type BIOLOGICAL

Placebo

Vaccination administered via intramuscular injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Is in good health before randomization.
* Has a body mass index ≥18 and ≤38 kg/m\^2, inclusive.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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

Glendale, California, United States

Site Status COMPLETED

QPS-MRA, LLC ( Site 0012)

Miami, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Alliance for Multispecialty Research, LLC ( Site 0008)

Kansas City, Missouri, United States

Site Status RECRUITING

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

Springfield, Missouri, United States

Site Status RECRUITING

Velocity Clinical Research Lincoln ( Site 0004)

Lincoln, Nebraska, United States

Site Status RECRUITING

Velocity Clinical Research, Omaha ( Site 0005)

Omaha, Nebraska, United States

Site Status ACTIVE_NOT_RECRUITING

Remington-Davis, Inc. ( Site 0017)

Columbus, Ohio, United States

Site Status RECRUITING

Lynn Health Science Institute ( Site 0010)

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Alliance for Multispecialty Research, LLC ( Site 0009)

Knoxville, Tennessee, United States

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States

Central Contacts

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Toll Free Number

Role: CONTACT

1-888-577-8839

Facility Contacts

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Study Coordinator

Role: primary

816-943-0770

Study Coordinator

Role: primary

417-831-2048

Study Coordinator

Role: primary

308-365-8900

Study Coordinator

Role: primary

614-487-2560

Study Coordinator

Role: primary

405-602-3939

Related Links

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https://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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V350-001

Identifier Type: -

Identifier Source: org_study_id

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