A Study to Evaluate Safety, Tolerability, and Immunogenicity of V350A and V350B in Healthy Participants (V350-001).
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT06655324
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
The key inclusion criteria include but are not limited to the following:
- Is in good health before randomization.
- Has a body mass index (BMI) ≥18 and ≤35 kg/m^2, inclusive.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description V350A V350A Participants will receive V350A vaccinations on Day 1, Month 2, and Month 6. V350B V350B Participants will receive V350B vaccinations on Day 1, Month 2, and Month 6. Placebo Placebo Participants will receive placebo vaccinations on Day 1, Month 2, and Month 6.
- Primary Outcome Measures
Name Time Method 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 AEs 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.
Number of Participants with Immediate AEs Following Vaccinations 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.
Number of Participants with Unsolicited AEs 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.
Number of Participants with Serious AEs 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.
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).
- Secondary Outcome Measures
Name Time Method Geometric Mean Titers (GMT) of Immunoglobulin G (IgG) Antibodies Response Against Vaccine-matched Epstein Barr Virus (EBV) Antigens Up to approximately 18 months The GMT of EBV antigen antibody titers will be measured with a multiplex ligand binding assay (LBA).
Geometric Mean Fold Rise (GMFR) of IgG Antibody Response against Vaccine-matched EBV Antigens Baseline and up to approximately 18 months The GMFR of EBV antigen antibody titers will be measured with a multiplex LBA.
Trial Locations
- Locations (7)
California Clinical Trials Medical Group managed by PAREXEL ( Site 0011)
🇺🇸Glendale, California, United States
QPS-MRA, LLC ( Site 0012)
🇺🇸Miami, Florida, United States
Alliance for Multispecialty Research, LLC ( Site 0008)
🇺🇸Kansas City, Missouri, United States
Velocity Clinical Research Lincoln ( Site 0004)
🇺🇸Lincoln, Nebraska, United States
Velocity Clinical Research, Omaha ( Site 0005)
🇺🇸Omaha, Nebraska, United States
Lynn Health Science Institute ( Site 0010)
🇺🇸Oklahoma City, Oklahoma, United States
Alliance for Multispecialty Research, LLC ( Site 0009)
🇺🇸Knoxville, Tennessee, United States