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NCT06908096 · ClinicalTrials.gov registry record · Phase 1
Epstein-Barr Virus (EBV) gH/gL/gp42-Ferritin Nanoparticle Vaccine With or Without gp350-Ferritin 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).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 750
- Enrollment target
- 1
- Study location
NCT06908096: Recruiting Phase 1 study of Epstein-Barr Virus Infection and EBV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT06908096 is a Phase 1 study of Epstein-Barr Virus Infection and EBV that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 750 participants, above the 360-participant average among 6 other Epstein-Barr Virus Infection trials with a reported enrollment target (108% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06908096, a Phase 1 study of Epstein-Barr Virus Infection and EBV, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 750 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
To determine the safety of an adjuvanted EBV gH/gL/gp42-ferritin nanoparticle vaccine with or without gp350-ferritin nanoparticle in seronegative and seropositive healthy adults.
Conditions Studied
Interventions
- BIOLOGICAL EBV gp350-ferritin vaccine with ALFQ adjuvant
- BIOLOGICAL EBV gH/gL/gp42-ferritin nanoparticle vaccine with ALFQ adjuvant
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 750 participants |
| Start Date | 2025-05-29 |
| Est. Completion | 2028-10-01 |
| Phase | Phase 1 |
What NCT06908096 shows while recruiting
NCT06908096 is an interventional study that assigns participants to a tested intervention. The registered 750 participants enrollment target is mid-sized for trials with a published cap, above the 360-participant average among 6 other Epstein-Barr Virus Infection trials with a reported enrollment target (108% higher).
The record links to 4 conditions, with Epstein-Barr Virus Infection appearing as the primary indexed condition, and to 2 interventions - of which EBV gp350-ferritin vaccine with ALFQ adjuvant is the first listed.
NCT06908096 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06908096 about?
NCT06908096 is a clinical study titled "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 ma...
What is the current status of trial NCT06908096?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 750 participants. The study started on 2025-05-29. Estimated completion is 2028-10-01.
What conditions does trial NCT06908096 study?
This clinical trial studies the following conditions: Epstein-Barr Virus Infection, EBV, Infectious Mononucleosis, Mono.
What interventions are being tested in trial NCT06908096?
The interventions under investigation include: EBV gp350-ferritin vaccine with ALFQ adjuvant (BIOLOGICAL), EBV gH/gL/gp42-ferritin nanoparticle vaccine with ALFQ adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT06908096?
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 NCT06908096 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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