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Study of V350A and V350B Vaccines for Epstein-Barr Virus

This study is testing two new vaccines, V350A and V350B, to see how safe they are and how well people tolerate them. These vaccines aim to prevent diseases caused by the Epstein-Barr virus (EBV), which can lead to conditions like infectious mononucleosis, certain cancers, and multiple sclerosis. You might be able to join if you are a healthy person between 12 and 30 years old. Participants will receive either V350A, V350B, or a placebo (an inactive shot). The main goal is to track any side effects at the injection site or in the body for about 6 months after vaccination. This study plans to enroll about 250 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment (V350A, V350B, or placebo). It plans to include about 250 healthy participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects for up to approximately 6 months after vaccination.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06655324

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

Recruiting
PHASE1Ages 12–30InterventionalBasic science
Merck Sharp & Dohme LLC
~250 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:V350AV350BPlacebo

At a glance

Recruiting sites
5 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Solicited Injection Site Adverse Events (AEs)
Measured over Up to approximately 6 months
+6 more outcomes measured

Conditions

Healthy

Explore related trials

Healthy

Where it's being run

9 sites across 7 states
Missouri2
Nebraska2
California1
Florida1
Ohio1
Oklahoma1
Tennessee1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of Participants with Solicited Injection Site Adverse Events (AEs)Up to approximately 6 months

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection site AEs will be recorded on a vaccination report card (VRC).

  • Number of Participants with Solicited Systemic AEsUp to approximately 6 months

    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs will be recorded on a VRC.

  • Number of Participants with Immediate AEs Following VaccinationsUp to approximately 6 months

    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Participants will be observed following vaccination for immediate AEs.

  • Number of Participants with Unsolicited AEsUp to approximately 7 months

    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Unsolicited AEs will be recorded on a VRC.

  • Number of Participants with Serious AEsUp to approximately 18 months

    A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event.

  • Number of Participants with Medically Attended Adverse Events (MAAEs)Up to approximately 18 months

    A MAAE is an AE in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Routine visits are not considered MAAEs.

  • Number of Participants with Events of Clinical Interest (ECIs)Up to approximately 18 months

    ECIs are selected serious and nonserious AEs are defined as an overdose of Sponsor's product, drug-induced liver injury events, or potential immune-mediated diseases (pIMDs).