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

NCT06655324 | Recruiting Phase 1 FDA Drug

• 1 other identifier: V350-001
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

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

  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).

  Up to approximately 6 months

• Number of Participants with Solicited Systemic AEs

  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.

  Up to approximately 6 months

• Number of Participants with Immediate AEs Following Vaccinations

  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.

  Up to approximately 6 months

• Number of Participants with Unsolicited AEs

  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.

  Up to approximately 7 months

• Number of Participants with Serious AEs

  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.

  Up to approximately 18 months

• Number of Participants with Medically Attended Adverse Events (MAAEs)

  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.

  Up to approximately 18 months

• Number of Participants with Events of Clinical Interest (ECIs)

  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).

  Up to approximately 18 months

Secondary Outcomes (2)

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

  Up to approximately 18 months

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

  Baseline and up to approximately 18 months

Study Arms (3)

V350A

EXPERIMENTAL

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

Biological: V350A

V350B

EXPERIMENTAL

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

Biological: V350B

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

V350A BIOLOGICAL

Vaccination administered via intramuscular injection

V350A

V350B BIOLOGICAL

Vaccination administered via intramuscular injection

V350B

Placebo BIOLOGICAL

Vaccination administered via intramuscular injection

Placebo

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (9)

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

Glendale, California, 91206, United States

COMPLETED

QPS-MRA, LLC ( Site 0012)

South Miami, Florida, 33143, United States

ACTIVE NOT RECRUITING

Alliance for Multispecialty Research, LLC ( Site 0008)

Kansas City, Missouri, 64114, United States

RECRUITING

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

Springfield, Missouri, 65802, United States

RECRUITING

Velocity Clinical Research Lincoln ( Site 0004)

Lincoln, Nebraska, 68510, United States

RECRUITING

Velocity Clinical Research, Omaha ( Site 0005)

Omaha, Nebraska, 68134, United States

ACTIVE NOT RECRUITING

Remington-Davis, Inc. ( Site 0017)

Columbus, Ohio, 43215, United States

RECRUITING

Lynn Health Science Institute ( Site 0010)

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Alliance for Multispecialty Research, LLC ( Site 0009)

Knoxville, Tennessee, 37909, United States

ACTIVE NOT RECRUITING

Related Links

• Merck Clinical Trials Information

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: December 5, 2024
• Primary Completion (Estimated): July 17, 2028
• Study Completion (Estimated): July 17, 2028
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (9)