Menu
Recruiting NCT06655324

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

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: V350A, V350B, Placebo.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 12 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

Interventions

  • Biological V350A
    Vaccination administered via intramuscular injection
  • Biological V350B
    Vaccination administered via intramuscular injection
  • Biological Placebo
    Vaccination administered via intramuscular injection

Primary outcome measures

  • Number of Participants with Solicited Injection Site Adverse Events (AEs) [Time frame: Up to approximately 6 months]
  • Number of Participants with Solicited Systemic AEs [Time frame: Up to approximately 6 months]
  • Number of Participants with Immediate AEs Following Vaccinations [Time frame: Up to approximately 6 months]
  • Number of Participants with Unsolicited AEs [Time frame: Up to approximately 7 months]
  • Number of Participants with Serious AEs [Time frame: Up to approximately 18 months]
  • Number of Participants with Medically Attended Adverse Events (MAAEs) [Time frame: Up to approximately 18 months]
  • Number of Participants with Events of Clinical Interest (ECIs) [Time frame: Up to approximately 18 months]
Secondary outcome measures (2)
  • Geometric Mean Titers (GMT) of Immunoglobulin G (IgG) Antibodies Response Against Vaccine-matched Epstein Barr Virus (EBV) Antigens [Time frame: Up to approximately 18 months]
  • Geometric Mean Fold Rise (GMFR) of IgG Antibody Response against Vaccine-matched EBV Antigens [Time frame: Baseline and up to approximately 18 months]

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 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Triple blind
Primary purpose
Basic science

Study locations

United States · 9 centers
  • California Clinical Trials Medical Group managed by PAREXEL ( Site 0011) — Glendale
  • QPS-MRA, LLC ( Site 0012) — South Miami
  • Alliance for Multispecialty Research, LLC ( Site 0008) — Kansas City
  • Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0016) — Springfield
  • Velocity Clinical Research Lincoln ( Site 0004) — Lincoln
  • Velocity Clinical Research, Omaha ( Site 0005) — Omaha
  • Remington-Davis, Inc. ( Site 0017) — Columbus
  • Lynn Health Science Institute ( Site 0010) — Oklahoma City
  • … and 1 more center

Identifiers

NCT: NCT06655324 · V350-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗