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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Biological: V350A; Biological: Placebo; Biological: V350B

Study type: Interventional

Funder types: Industry

Identifiers

NCT06655324

V350-001

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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 (BMI) ≥18 and ≤35 kg/m^2, inclusive.

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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200 participants in 3 patient groups, including a placebo group

V350A

Experimental group

Description:

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

Treatment:

Biological: V350A

V350B

Experimental group

Description:

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

Treatment:

Biological: V350B

Placebo

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo