Background:
Epstein-Barr virus (EBV) is the primary cause of infectious mononucleosis, commonly known as mono. EBV infects more than 90% of the world s population. Mono can be serious, and it can lead to severe illnesses like cancer and autoimmune diseases. Researchers want to test vaccines that may help prevent EBV and associated diseases.
Objective:
To test two EBV vaccines: EBV gH/gL/gp42-ferritin and EBV gp350-ferritin.
Eligibility:
Healthy EBV-negative or EBV-positive people aged 18 to 29.
Design:
Participants will be screened. They will have a physical examination. They will give blood and saliva samples.
They will receive 3 doses of the study vaccine as an injection in the shoulder muscle. They will get either one vaccine or a combination of both vaccines.
Participants will get their first dose of the vaccine at visit 1, the second dose about 30 days later, and the final dose about 90 days after that.
Participants will be given a memory aid so they can record any symptoms and side effects between visits. This can be done either on paper or online through a link that is emailed to them.
There are 6 required in-person visits. There are also 2 optional visits. In between the in-person visits are 7 telehealth visits or phone calls. Each visit may take up to 4 hours.
The study will last for about 17 months. Participants will have the option of staying in the study for an additional year.
18 to 29 years old.
Able to provide informed consent.
Willingness to allow storage of blood and saliva for future research.
In good general health as evidenced by medical history, physical examination, and laboratory screening results.
Pregnant, breastfeeding, or planning to become pregnant while participating through 60 days after the last dose of vaccine.
More than 10 days of systemic immunosuppressive medications (>=10 mg prednisone dose or its equivalent) or cytotoxic medication within the 30 days prior to first dose of vaccine or immunomodulating therapy within 180 days prior to first dose of vaccine.
Blood products, including immunoglobulin products, within 120 days prior to first dose of vaccine.
Investigational research agents within 30 days prior to first dose or planning to receive investigational products while on study.
Parallel
EBV gp350-ferritin vaccine with ALFQ adjuvant
Biological/VaccineThe adjuvanted gH/gL/gp42-ferritin nanoparticle vaccine is given with gp350-ferritin intramuscularly into the deltoid muscle at 0, 1, and 4 months.
EBV gH/gL/gp42-ferritin nanoparticle vaccine with ALFQ adjuvant
Biological/VaccineThe adjuvanted gH/gL/gp42-ferritin nanoparticle vaccine is given with gp350-ferritin intramuscularly into the deltoid muscle at 0, 1, and 4 months.
Local and systemic reactogenicity signs and symptoms during the 7-day period after each vaccination. Unsolicited AEs up to 30 days after each vaccination and SAEs through Day 150.
To determine the safety of an adjuvanted EBV gH/gL/gp42-ferritin nanoparticle vaccine with or without gp350-ferritin nanoparticle in seronegative and seropositive healthy adults.
Change in log10 antibody response to EBV from baseline to 30 days after the last dose of vaccine (Day 150) as measured by the B cell neutralization assay.
To evaluate the immunogenicity via neutralization assay of an EBV gH/gL/gp42-ferritin nanoparticle vaccine with or without gp350-ferritin nanoparticle in seronegative and seropositive healthy adults.
Change in log10 antibody response to EBV from baseline to 30 days after the last dose of vaccine (Day 150) as measured by the epithelial cell neutralization assay.
To further evaluate the immunogenicity of the adjuvanted EBV gH/gL/gp42-ferritin nanoparticle vaccine with or without gp350-ferritin.
ELISA-determined dilution for for antibodies to H. pylori and/or human ferritin on Day 0, Day 30, Day 60, and Day 150.
To determine whether the vaccine causes production of antibodies to H. pylori and/or human ferritin.
Click on the lead sponsor to view all of their trials.
