Clinical trial NCT06655324: A Study to Evaluate Safety, Tolerability, and Immunogenicity of V350A and V350B in Healthy Participants (V350-001).
Official 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-10-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Solicited Injection Site Adverse Events (AEs)
timeFrame: Up to approximately 6 months
measure: Number of Participants with Solicited Systemic AEs
timeFrame: Up to approximately 6 months
measure: Number of Participants with Immediate AEs Following Vaccinations
timeFrame: Up to approximately 6 months
measure: Number of Participants with Unsolicited AEs
timeFrame: Up to approximately 7 months
measure: Number of Participants with Serious AEs
timeFrame: Up to approximately 18 months
measure: Number of Participants with Medically Attended Adverse Events (MAAEs)
timeFrame: Up to approximately 18 months
measure: Number of Participants with Events of Clinical Interest (ECIs)
timeFrame: Up to approximately 18 months
Secondary outcomes:
measure: Geometric Mean Titers (GMT) of Immunoglobulin G (IgG) Antibodies Response Against Vaccine-matched Epstein Barr Virus (EBV) Antigens
timeFrame: Up to approximately 18 months
measure: Geometric Mean Fold Rise (GMFR) of IgG Antibody Response against Vaccine-matched EBV Antigens
timeFrame: Baseline and up to approximately 18 months
Other outcomes:
Locations:
city: Glendale
country: United States
facility: California Clinical Trials Medical Group managed by PAREXEL ( Site 0011)
state: California
city: Miami
country: United States
facility: QPS-MRA, LLC ( Site 0012)
state: Florida
city: Kansas City
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0008)
state: Missouri
city: Lincoln
country: United States
facility: Velocity Clinical Research Lincoln ( Site 0004)
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research, Omaha ( Site 0005)
state: Nebraska
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute ( Site 0010)
state: Oklahoma
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0009)
state: Tennessee
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: