EBV Vaccine for EBV Infection

Phase 1 & 2

Waitlist Available

Led By Jessica R Durkee-Shock, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up year 2

Summary

This trial tests a vaccine against EBV infection. Healthy 18-22 year olds will receive either a vaccine or placebo, plus physical exams and record any side effects. Follow-ups over 2 years.

Who is the study for?

Healthy individuals aged 18 to 22 who've never had EBV infection, can consent, and commit to the study for about 18 months. They must avoid certain vaccines before/after receiving the study vaccine and use effective contraception if applicable. Excluded are pregnant/breastfeeding individuals, those on recent immunosuppressants or with serious health conditions.

What is being tested?

The trial is testing an adjuvanted EBV gp350-Ferritin Vaccine against a placebo in preventing infectious mononucleosis. Participants will receive two injections a month apart and have follow-ups up to two years to monitor effectiveness and any potential onset of EBV infection.

What are the potential side effects?

Possible side effects include reactions at the injection site, general symptoms like fever or fatigue, allergic responses, or other immune-related issues that could arise from vaccination. Specific side effects of this new vaccine will be closely monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~year 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and year 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in mean EBV neutralizing antibody from Day 0 to 30 days after the third dose of study vaccine in EBV gp350 Ferritin vaccine recipients as compared with placebo.

Secondary study objectives

Reduction EBV related infectious mononucleosis as defined by signs and symptoms consistent with infectious mononucleosis with laboratory evidence for new EBV infection for up to 2 years post-vaccination as compared with placebo

Reduction in EBV infection as measured by new anti-EBV VCA IgG or IgM or new EBV viremia for up to 2 years post-vaccination as compared with placebo

Reduction of viremia measured by qPCR in EBV gp350 vaccine recipients as compared with placebo in participants who become infected with EBV

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: InterventionalExperimental Treatment2 Interventions

The gp350-Ferritin vaccine will be delivered intramuscularly into the deltoid muscle at Days 0, 30, and between 60 and 90. Each vaccine dose will consist of 50 micrograms of EBV gp350-Ferritin combined with 49 micrograms of Matrix-M1 adjuvant.

Group II: ControlPlacebo Group1 Intervention

The placebo will be delivered intramuscularly into the deltoid muscle at Days 0, 30, and between 60 and 90. Each dose will consist of 0.4mL normal saline.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Matrix-M1 Adjuvant

2017

Completed Phase 2

~300

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