NCT06908096

Epstein-Barr Virus (EBV) gH/gL/gp42-Ferritin Nanoparticle Vaccine With or Without gp350-Ferritin in Healthy Adults With or Without EBV Infection

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 29 Years
• Healthy volunteers: Accepted

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.

Detailed description

Study Description: This is a phase 1 study to evaluate the safety of a 3-dose vaccination regimen of an adjuvanted EBV gH/gL/gp42-ferritin nanoparticle vaccine with or without gp350-ferritin. Based on data reported in animal studies, our hypothesis is that this EBV vaccine will induce a potent immune response that neutralizes EBV infection of B cells and epithelial cells. There will be an initial dose escalation phase comprised of 9 EBV-seropositive individuals followed by a randomization phase comprised of 24 EBV-seropositive individuals and an additional 30 EBV-seronegative individuals. In each group, the vaccine will be given at 0, 1, and 4 months, and participants will be followed until at least 12 months after the third dose of vaccine with an option to be followed for an additional year. Some individuals will receive only the EBV gH/gL/gp42-ferritin nanoparticle vaccine; others will receive EBV gH/gL/gp42-ferritin nanoparticle vaccine plus the gp350-ferritin nanoparticle vaccine. Participants will know which vaccine they have received during the study. Objectives: Primary objective: 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. Key secondary objective: To evaluate the immunogenicity of an adjuvanted EBV gH/gL/gp42-ferritin nanoparticle vaccine with or without gp350-ferritin nanoparticle in seronegative and seropositive healthy adults. Endpoints: Primary endpoints: * Local and systemic vaccine side effects during the 7-day period after each vaccination * All symptoms and diagnoses up to 30 days after each vaccination * Serious medical events (SAEs) through 30 days after the last dose of study vaccine. Key secondary endpoints: -Production of EBV neutralizing antibody after the vaccination series, as measured by B cell and epithelial cell neutralization assays.

Conditions

• EBV
• Epstein-Barr Virus Infection
• Infectious Mononucleosis
• Mono

Interventions

Type	Name	Description
BIOLOGICAL	EBV gp350-ferritin vaccine with ALFQ adjuvant	The adjuvanted gH/gL/gp42-ferritin nanoparticle vaccine is given with gp350-ferritin intramuscularly into the deltoid muscle at 0, 1, and 4 months.
BIOLOGICAL	EBV gH/gL/gp42-ferritin nanoparticle vaccine with ALFQ adjuvant	The adjuvanted gH/gL/gp42-ferritin nanoparticle vaccine is given with gp350-ferritin intramuscularly into the deltoid muscle at 0, 1, and 4 months.

Timeline

• Start date: 2025-05-29
• Primary completion: 2027-10-01
• Completion: 2028-10-01
• First posted: 2025-04-03
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study