EBV Vaccine for EBV Infection
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot have taken certain medications like systemic immunosuppressive drugs or live vaccines shortly before the trial starts.
What data supports the effectiveness of the EBV gp350-Ferritin Nanoparticle Vaccine treatment for EBV infection?
How does the EBV gp350-Ferritin Nanoparticle Vaccine differ from other treatments for EBV infection?
The EBV gp350-Ferritin Nanoparticle Vaccine is unique because it uses a nanoparticle design to present multiple copies of the gp350 protein, which is a major target for neutralizing antibodies, potentially offering stronger protection against EBV infection compared to traditional monomeric vaccines. This approach is novel as there are currently no vaccines or treatments available for EBV infection.12678
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 18-29Design: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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Vaccination
Participants receive 3 doses of the EBV gp350-Ferritin nanoparticle vaccine at 0, 1, and 6 months
Follow-up
Participants are monitored for safety and immune response, including local and systemic reactogenicity, adverse events, and antibody response
Long-term Follow-up (optional)
Participants have the option to be followed for an additional year to monitor long-term safety and immune response
Treatment Details
Interventions
- EBV gp350-Ferritin Nanoparticle Vaccine
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor