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Clinical Trials associated with EBV gp350-Ferritin Vaccine(NIAID) / Not yet recruitingPhase 1IIT Phase 1 Study of the Safety of an Epstein-Barr Virus (EBV) gH/gL/gp42-Ferritin Nanoparticle Vaccine With or Without gp350-Ferritin in Healthy Adults With or Without EBV Infection
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.
/ Active, not recruitingPhase 1/2IIT A Phase 1/2 Randomized, Double-Blinded, Placebo-Controlled Trial Evaluating the Immunogenicity and Safety of an Adjuvanted Epstein-Barr Virus (EBV) Glycoprotein 350 Vaccine in EBV-Seronegative Persons
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.
/ Active, not recruitingPhase 1IIT 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
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.
100 Clinical Results associated with EBV gp350-Ferritin Vaccine(NIAID)
100 Translational Medicine associated with EBV gp350-Ferritin Vaccine(NIAID)
100 Patents (Medical) associated with EBV gp350-Ferritin Vaccine(NIAID)
100 Deals associated with EBV gp350-Ferritin Vaccine(NIAID)
