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Virus Therapy

EBV Vaccine for EBV Infection

Phase 1

Waitlist Available

Led By Jeffrey I Cohen, 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

Contraceptive requirements: Because the effects of EBV gp350-Ferritin vaccine on the developing human fetus are unknown, sexually active female participants of childbearing potential must agree to use highly effective contraception as outlined below before study entry and until 60 days after the last dose of vaccine. Females of childbearing potential must have a negative pregnancy test before receiving each dose of the EBV gp350-Ferritin vaccine. During the course of the study, if a participant becomes pregnant or suspects they are pregnant, then they should inform the study staff and their primary care physician immediately. Acceptable forms of contraception are: Intrauterine device (IUD) or equivalent, Hormonal contraceptive (e.g. consistent, timely, and continuous use of contraceptive pill, patch, ring, implant, or injection that has reached full efficacy prior to dosing). If the participant uses a contraceptive pill, path, or ring, then a barrier method (e.g. male/female condom, cap or diaphragm plus spermicide) must also be used at the time of potentially reproductive sexual activity, A stable, long-term monogamous relationship with a partner who does not pose any potential pregnancy risk, e.g. has undergone a vasectomy at least 6 months prior to the first dose of vaccine or is of the same sex as the participant, A hysterectomy and/or a bilateral tubal ligation or bilateral oophorectomy.

18 to 29 years old

Must not have

- Asthma that is not well-controlled or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous steroids

- Malignancy that is active or treated malignancy for which there is no reasonable assurance of sustained cure or malignancy that is likely to recur during the study period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up reactogenicity during the 7-day period after each dose; unsolicited adverse events up to 30 days after each dose; serious adverse events through 1 month after the third dose:; neutralizing antibody response one month after third dose

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new EBV vaccine to see if it is safe and if it causes an immune response. Healthy adults 18-29 can participate. There are 4 in-person visits and 6 telephone calls over 18 months.

Who is the study for?

Healthy adults aged 18-29 can join this trial to test a new EBV vaccine. They must be in good health, not planning to receive other live vaccines around the study period, and willing to use effective contraception. People with severe reactions to vaccines, certain chronic diseases like uncontrolled asthma or diabetes, or those on immunosuppressive drugs cannot participate.

What is being tested?

The trial is testing the safety and immune response of an Epstein-Barr Virus (EBV) gp350-Ferritin nanoparticle vaccine with Matrix-M1 adjuvant in healthy young adults. Participants will get three doses of the vaccine over several months and have follow-ups for about 18 months.

What are the potential side effects?

Possible side effects include reactions at the injection site, fever, fatigue, muscle pain, headache or nausea after vaccination. Participants will track any side effects using a diary card or electronic system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am using or agree to use effective birth control during and 60 days after the vaccine study.

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I am between 18 and 29 years old.

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I have had a hysterectomy or my fallopian tubes or ovaries removed.

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I have had a hysterectomy or my fallopian tubes or ovaries removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My asthma has been severe, needing emergency care or steroids in the last 2 years.

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My cancer is active or likely to come back during the study.

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I do not have a functioning spleen.

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I have a diagnosed bleeding disorder that needs special care.

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I have had Guillain-Barre Syndrome in the past.

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I have type 1 or type 2 diabetes, but not gestational diabetes.

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I have a form of angioedema, whether it's inherited, acquired, or of unknown cause.

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I have a serious autoimmune disease or immunodeficiency.

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My high blood pressure is not well-controlled.

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My thyroid condition is not under control.

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I haven't received any live vaccines in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ reactogenicity during the 7-day period after each dose; unsolicited adverse events up to 30 days after each dose; serious adverse events through 1 month after the third dose:; neutralizing antibody response one month after third dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~reactogenicity during the 7-day period after each dose; unsolicited adverse events up to 30 days after each dose; serious adverse events through 1 month after the third dose:; neutralizing antibody response one month after third dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and reactogenicity during the 7-day period after each dose; unsolicited adverse events up to 30 days after each dose; serious adverse events through 1 month after the third dose:; neutralizing antibody response one month after third dose for reporting.