NCT05683834View on ClinicalTrials.gov

Trial Evaluating the Immunogenicity and Safety of an Adjuvanted Epstein-Barr Virus (EBV) Glycoprotein 350 Vaccine in EBV-seronegative Persons

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

September 22, 2023

Primary Completion Date

April 1, 2026

Study Completion Date

April 1, 2027

Conditions
Epstein-Barr Virus InfectionInfectious MononucleosisHerpesvirus
Interventions
DRUG

Matrix-M1 Adjuvant

Matrix-M1 is composed of 2 types of 40 nm-sized particles each with a different saponin fraction (fraction A and fraction B) combined with cholesterol and phospholipid.

DRUG

EBV gp350-Ferritin Vaccine

The EBV gp350-Ferritin vaccine is composed of Helicobacter pylori non-heme ferritin fused to EBV gp350 which self-assembles to form a nanoparticle. The vaccine is supplied in single-use vials at a concentration of 250 micrograms/mL in 1.7 mM KH2PO4, 5 mM Na2HPO4, 150 mM NaCl, 5% sucrose, pH 7.4 (diluent).

OTHER

Placebo Comparator

Normal Saline

Trial Locations (2)

20892

National Institutes of Health Clinical Center, Bethesda

55455

University of Minnesota, Minneapolis

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT05683834 - Trial Evaluating the Immunogenicity and Safety of an Adjuvanted Epstein-Barr Virus (EBV) Glycoprotein 350 Vaccine in EBV-seronegative Persons | Biotech Hunter | Biotech Hunter