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

A 50 micrograms dose of EBV gp350-Ferritin vaccine will be administered intramuscularly for each vaccination at Days 0, 30, and 180 to all participants.

EBV gp350-Ferritin Vaccine

Each vaccine dose will consist of 50 micrograms of EBV gp350-Ferritin combined with 49 micrograms of Matrix-M1.

Matrix-M1

Jessica R Durkee-Shock, M.D.

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.

Study Description:

Phase 1 study to evaluate the safety and immunogenicity of a 3-dose vaccination regimen of an adjuvanted EBV gp350-Ferritin nanoparticle vaccine. Based on data reported in animal studies, our hypothesis is that this EBV vaccine will be safe and will induce a potent EBVgp350-specific immune response. Twenty EBV seropositive participants and 20 EBV seronegative participants will receive 3 doses of vaccine at 0, 1, and 6 months. Subjects will be followed until 12 months after the third dose of vaccine with an option to be followed for an additional year.

Objectives:

Primary objective:

To determine the safety and immunogenicity of an adjuvanted EBV gp350- Ferritin vaccine administered as 3 intramuscular injections to healthy adults with or without prior EBV infection.

Secondary objective: To further evaluate the immunogenicity of an adjuvanted EBV gp350-Ferritin vaccine administered to healthy adults.

Endpoints:

Primary endpoint consists of:

* Local and systemic reactogenicity signs and symptoms during the 7-day period after each vaccination
* Unsolicited adverse events up to 30 days after each vaccination
* Serious adverse events through Day 210
* Change in log10 antibody response to EBV from baseline to 1 month after the third dose of vaccine (Day 210) as measured by neutralization assay

Secondary endpoints:

* Change in log10 antibody response to EBV gp350 from baseline to Day 210 as measured by luciferase immunoprecipitation system (LIPS) assay
* Change in log10 CD4 T cell response to EBV gp350 from baseline to Day 210 as measured by intracellular cytokine staining

Safety and Immunogenicity of an Epstein-Barr Virus (EBV) gp350-Ferritin Nanoparticle Vaccine in Healthy Adults With or Without EBV Infection

Phase 1 Study of the Safety and Immunogenicity of an Epstein-Barr Virus (EBV) gp350- Ferritin Nanoparticle Vaccine in Healthy Adults With or Without EBV Infection

.We will return results from CLIA approved testing done in the department of laboratory medicine to participants. Based on results and clinical judgement, we will manage and refer patients appropriately. Non-FDA approved research assay results will not be shared with patients.

-Local reactogenicity: pain, tenderness, redness, bruising, swelling; Systemic reactogenicity symptoms: headache, muscle pain, fatigue, chills, oral temperature, joint pain, nausea/ vomiting, diarrhea; Change in log10 antibody response to EBV from baseline to 1 month after third dose of vaccine(Day 210) as measured by neutralization assay.

-Change in log10 antibody response to EBV from baseline to 1 month after third vaccine dose measured by a luciferase immunoprecipitation assay; --Change in log10 CD4+ T cell response from baseline to one month after third dose measured by an intracellular cytokine staining assay.

Spots Global Cancer Trial Database for cd4+ t cell response