EBV Vaccine for EBV Infection

Recruiting in Palo Alto (17 mi)

Overseen by Jessica R Durkee-Shock, M.D.

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

Background: Epstein-Barr virus (EBV) causes most cases of infectious mononucleosis (mono). Up to 1 in 10 people who get mono can have fatigue that lasts more than 6 months. One out of 100 people can have severe complications. EBV is also associated with several types of cancer. Researchers want to test an EBV vaccine. Objective: To test the safety of and immune response to a new vaccine against EBV. Eligibility: Healthy adults ages 18-29 Design: Participants will be screened with a medical history and physical exam. They will give a blood sample. Screening tests will be repeated during the study. Participants will get a dose of the study vaccine as an injection in a muscle in the upper arm. They will be observed for 30 to 60 minutes. Blood pressure, heart rate, breathing rate, and temperature will be checked. The injection site will be examined. Participants will get a diary card. They will write down any side effects they have after the vaccine dose, or they may use an electronic diary card. Participants will be asked to write down or enter any important medical events that may occur at any time during the study. Participants will get a vaccine dose at 2 more study visits. They will have 4 follow-up visits at different times after a vaccine dose. Participants will have 6 telephone calls in between the in-person visits. They will also have 1 telephone call 1 year after the third dose of vaccine. If possible, this visit can occur in person. Participation will last about 18 months. There is an optional in-person visit or telephone call 2 years after the third dose of vaccine.

Research Team

Jessica R Durkee-Shock, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria

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.

Inclusion Criteria

My partner uses effective birth control or has had surgery to prevent pregnancy.

I use hormonal birth control and a barrier method during sex.

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

Exclusion Criteria

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

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

I haven't taken strong immune system medications or cancer drugs in the last month.

Treatment Details

Interventions

• EBV gp350-Ferritin Nanoparticle Vaccine (Virus Therapy)

Trial Overview 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.

Participant Groups

Group I: EBV gp_350 Ferritin Vaccination Experimental Treatment 2 Interventions

Adult participants with or without prior EBV infection will receive 3 doses of vaccine

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Dr. Jeanne Marrazzo

National Institute of Allergy and Infectious Diseases (NIAID)

Chief Executive Officer since 2023

MD, MPH

Dr. H. Clifford Lane

National Institute of Allergy and Infectious Diseases (NIAID)

Chief Medical Officer

MD