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NCT04645147 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of an Epstein-Barr Virus (EBV) gp350-Ferritin Nanoparticle Vaccine in Healthy Adults With or Without EBV Infection
A Phase 1 study of Epstein-Barr Virus Infection and EBV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Phase 1
- Development phase
- 83
- Enrollment target
- 1
- Study location
NCT04645147: Active Phase 1 study of Epstein-Barr Virus Infection and EBV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04645147 is a Phase 1 study of Epstein-Barr Virus Infection and EBV that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 83 participants, below the 471-participant average among 6 other Epstein-Barr Virus Infection trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04645147, a Phase 1 study of Epstein-Barr Virus Infection and EBV, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 83 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Number of participants with at least one solicited local adverse events occurring within seven days of each vaccine dose administration. Local reactogenicity included injection site pain, injection site redness, injection site bruising, and injection site swelling. Adverse events were captured by investigator examination and history from participants.
Conditions Studied
Interventions
- BIOLOGICAL EBV gp350-Ferritin Vaccine
- OTHER Matrix-M1
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2022-03-29 |
| Est. Completion | 2026-07-01 |
| Phase | Phase 1 |
What the registry record for NCT04645147 still lists
NCT04645147 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 471-participant average among 6 other Epstein-Barr Virus Infection trials with a reported enrollment target (82% lower).
The record links to 3 conditions, with Epstein-Barr Virus Infection appearing as the primary indexed condition, and to 2 interventions - of which EBV gp350-Ferritin Vaccine is the first listed.
NCT04645147 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04645147 about?
NCT04645147 is a clinical study titled "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 ...
What is the current status of trial NCT04645147?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 83 participants. The study started on 2022-03-29. Estimated completion is 2026-07-01.
What conditions does trial NCT04645147 study?
This clinical trial studies the following conditions: Epstein-Barr Virus Infection, EBV, Infectious Mononucleosis.
What interventions are being tested in trial NCT04645147?
The interventions under investigation include: EBV gp350-Ferritin Vaccine (BIOLOGICAL), Matrix-M1 (OTHER).
Who is sponsoring clinical trial NCT04645147?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04645147 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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