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NCT05683834 · ClinicalTrials.gov registry record · Phase 1
Trial Evaluating the Immunogenicity and Safety of an Adjuvanted Epstein-Barr Virus (EBV) Glycoprotein 350 Vaccine in EBV-seronegative Persons
A Phase 1 study of Epstein-Barr Virus Infection and Infectious Mononucleosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 2
- Study locations
NCT05683834: Active Phase 1 study of Epstein-Barr Virus Infection and Infectious Mononucleosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05683834 is a Phase 1 study of Epstein-Barr Virus Infection and Infectious Mononucleosis that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 25 participants, below the 480-participant average among 6 other Epstein-Barr Virus Infection trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05683834, a Phase 1 study of Epstein-Barr Virus Infection and Infectious Mononucleosis, 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
- 25 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
To evaluate the safety and immunogenicity of the adjuvanted EBV gp350-Ferritin vaccine administered to healthy EBV-seronegative adults.
Conditions Studied
Interventions
- OTHER Placebo Comparator
- DRUG Matrix-M1 Adjuvant
- DRUG EBV gp350-Ferritin Vaccine
Study Locations (2)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2023-09-22 |
| Est. Completion | 2027-04-01 |
| Phase | Phase 1 |
What the registry record for NCT05683834 still lists
NCT05683834 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 480-participant average among 6 other Epstein-Barr Virus Infection trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Epstein-Barr Virus Infection appearing as the primary indexed condition, and to 3 interventions - of which Placebo Comparator is the first listed.
NCT05683834 reports a single indexed study location in Maryland, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05683834 about?
NCT05683834 is a clinical study titled "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...
What is the current status of trial NCT05683834?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2023-09-22. Estimated completion is 2027-04-01.
What conditions does trial NCT05683834 study?
This clinical trial studies the following conditions: Epstein-Barr Virus Infection, Infectious Mononucleosis, Herpesvirus.
What interventions are being tested in trial NCT05683834?
The interventions under investigation include: Placebo Comparator (OTHER), Matrix-M1 Adjuvant (DRUG), EBV gp350-Ferritin Vaccine (DRUG).
Who is sponsoring clinical trial NCT05683834?
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 NCT05683834 being conducted?
This trial has 2 study locations across Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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