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

Condition(s) studied

Investigational drug(s) / intervention(s)

V350A: Vaccination administered via intramuscular injection

V350B: Vaccination administered via intramuscular injection

Placebo: Vaccination administered via intramuscular injection

Study 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.

Eligibility

Primary outcome measure(s)

• 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).

Trial sites (9)

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