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NCT Number: NCT06655324

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

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.

Recruiting

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Key information

Conditions

Healthy

Age range

12 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

California Clinical Trials Medical Group managed by PAREXEL ( Site 0011), Glendale, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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 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.

Treatment and study plan

V350A

Biological

Vaccination administered via intramuscular injection

V350B

Biological

Vaccination administered via intramuscular injection

Placebo

Biological

Vaccination administered via intramuscular injection

Primary outcomes

  1. Number of Participants with Solicited Injection Site Adverse Events (AEs)

    Time frame: 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).

  2. Number of Participants with Solicited Systemic AEs

    Time frame: Up 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.

  3. Number of Participants with Immediate AEs Following Vaccinations

    Time frame: Up 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.

  4. Number of Participants with Unsolicited AEs

    Time frame: Up 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.

  5. Number of Participants with Serious AEs

    Time frame: Up 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.

  6. Number of Participants with Medically Attended Adverse Events (MAAEs)

    Time frame: 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.

  7. Number of Participants with Events of Clinical Interest (ECIs)

    Time frame: 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).

Secondary outcomes

  1. Geometric Mean Titers (GMT) of Immunoglobulin G (IgG) Antibodies Response Against Vaccine-matched Epstein Barr Virus (EBV) Antigens

    Time frame: Up to approximately 18 months

    The GMT of EBV antigen antibody titers will be measured with a multiplex ligand binding assay (LBA).

  2. Geometric Mean Fold Rise (GMFR) of IgG Antibody Response against Vaccine-matched EBV Antigens

    Time frame: Baseline and up to approximately 18 months

    The GMFR of EBV antigen antibody titers will be measured with a multiplex LBA.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 23, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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