EBV Vaccine for EBV Infection

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byJessica R Durkee-Shock, M.D.

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Trial Summary

What is the purpose of this trial?

Background: Epstein-Barr virus (EBV) causes most cases of infectious mononucleosis (mono). Mono can cause fatigue that lasts more than 6 months, and some people can have severe complications. EBV infection may also contribute to some cancers and autoimmune diseases. Currently, there are no approved therapies or vaccines for EBV infection. Objective: To test a vaccine against EBV. Eligibility: Healthy people aged 18 to 25 years. Design: Participants will be screened in 2 parts. They will have a blood test. If that test shows they have never had an EBV infection, they will have a second clinic visit. They will have a physical exam, with blood and urine tests. A cotton swab will be rubbed on their gums to collect saliva. Participants will receive 2 injections into a shoulder muscle. Some will receive the EBV vaccine. Others will receive a placebo; this contains harmless salt water with no vaccine. Participants will not know which one they are getting. The 2 injections will be 30 days apart. Participants will be asked to record any side effects or symptoms they have between visits. They can do this on paper or online. Participants will return for a follow-up visit 60 days after the first injection. They will have follow-up visits by phone or telehealth after 5 and 8 months. They will return for a physical exam after 13 months. They may come back for an optional physical exam after 2 years. Participants will come to the clinic if they become ill with an EBV infection during the study.

Research Team

Jessica R Durkee-Shock, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria

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.

Inclusion Criteria

White blood cell count and differential within institutional normal reference range, or if not, then deemed not clinically significant by PI or designee

Willing to allow samples and data to be stored for future secondary research

Total lymphocyte count (lymphocyte absolute) >800 cells/microliters

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Exclusion Criteria

Has significant bruising or bleeding difficulties with intramuscular injections or blood draws

Has idiopathic urticaria within the past year

Has clinically significant autoimmune disease or immunodeficiency

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Treatment Details

Interventions

EBV gp350-Ferritin Vaccine (Cancer Vaccine)
Matrix-M1 Adjuvant (Adjuvant)
Placebo Comparator (Other)

Trial OverviewThe 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.

Participant Groups

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.