Safety and Immunogenicity of an Epstein-Barr Virus (EBV) gp350-Ferritin Nanoparticle Vaccine in Healthy Adults With or Without EBV Infection
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|ClinicalTrials.gov Identifier: NCT04645147|
Recruitment Status : Recruiting
First Posted : November 27, 2020
Last Update Posted : September 17, 2021
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.
To test the safety of and immune response to a new vaccine against EBV.
Healthy adults ages 18-29
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.
|Condition or disease||Intervention/treatment||Phase|
|EBV Epstein-Barr Virus Infection Infectious Mononucleosis||Biological: EBV gp350-Ferritin Vaccine Other: Matrix-M1||Phase 1|
This is a phase 1, open-label study to evaluate the safety and immunogenicity of an Epstein-Barr virus (EBV) gp350-Ferritin nanoparticle vaccine adjuvanted with Matrix-M1. Forty healthy volunteers will be enrolled and dosed in this trial: 20 EBV seropositive participants and 20 EBV seronegative. Each participant will receive 3 intramuscular doses of vaccine on Days 0, 30, and 180. Follow-up visits will occur after each dose of vaccine either in person or by telephone contact. In addition to vaccine dosing days, mandatory in-person visits will occur in the first week after the first dose of vaccine, 1 month after the second and third doses of vaccine, and 6 months after the third dose of vaccine. The primary endpoint is assessment of safety and includes solicited injection site and systemic reactions related to vaccination that occur in the 7-day period after each vaccination, unsolicited adverse events occurring up to 30 days after each vaccination, and serious adverse events through 1 year after the third dose of vaccine. A mandatory telephone, optional in-person, contact will occur 1 year after the third dose of vaccine (Day 540) to collect information about medically attended events and significant new medical conditions to assess for possible autoimmune disease that may be related to the adjuvant, Matrix-M1. An optional visit may occur 2 years after the third dose of vaccine (Day 900) to collect similar medical information and possibly assess durability of immune responses to vaccination. The primary endpoint for immunogenicity is the change in log10 antibody responses to EBV from baseline to 1 month after the third vaccine dose as measured by an neutralization assay. Secondary immunogenicity endpoints are the change in log10 antibody responses to
EBV gp350 from baseline to 1 month after the third vaccine dose as measured by a luciferase immunoprecipitation assay and the change in log10 CD4 T cell responses to EBV gp350 from baseline to 1 month after the third dose as measured by an intracellular cytokine staining assay. The estimated duration of this study will be about 4 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||September 22, 2021|
|Estimated Primary Completion Date :||July 1, 2025|
|Estimated Study Completion Date :||July 1, 2025|
Experimental: EBV gp_350 Ferritin Vaccination
Adult participants with or without prior EBV infection will receive 3 doses of vaccine
Biological: EBV gp350-Ferritin 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.
Each vaccine dose will consist of 50 micrograms of EBV gp350-Ferritin combined with 49 micrograms of Matrix-M1.
- Local and systemic reactogenicity; unsolicited adverse events; serious adverse events; change in neutralizing antibody responses to EBV [ Time Frame: Reactogenicity during the 7-day period after each dose; unsolicited adverse events up to 30 days after each dose; serious adverse events through 1 month after the third dose:; neutralizing antibody response one month after third dose ]-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 antibody responses to EBV gp350; change in CD4+ T cell responses to EBV gp350 [ Time Frame: Change in antibody responses and change in CD4 T cell responses at 1 month after third dose of vaccine ]-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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04645147
|Contact: Kayla D Morgan||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Jeffrey I Cohen, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|