Phase 1 Study to Assess Safety of Two Epstein-Barr Virus Vaccines in Healthy Adults Aged 18 to 29

What this Trial Is About

Researchers are investigating two vaccines designed to prevent Epstein-Barr virus EBV infection and related illnesses such as infectious mononucleosis, cancer, and autoimmune diseases. This phase 1 study aims to assess the safety and immune response triggered by a 3-dose vaccination regimen of an EBV gHgLgp42-ferritin nanoparticle vaccine, with or without the gp350-ferritin vaccine, in healthy adults aged 18 to 29 who may or may not already have EBV infection. Participants will receive three injections into the shoulder muscle at the start of the study, about one month later, and again around four months after the first dose. The study includes an initial dose escalation phase with different dosing levels and combinations to determine the best dose for the randomization phase. The vaccines are given with an adjuvant to potentially enhance the immune response. The randomization phase will assign participants to receive either the gHgLgp42-ferritin vaccine alone or combined with gp350-ferritin. During the approximately 17-month study, participants will attend six required in-person visits and up to two optional visits, along with seven telehealth or phone follow-ups. Each visit may last up to four hours. Participants will provide blood and saliva samples and record any symptoms or side effects using a memory aid available on paper or online. The researchers will monitor safety by tracking reactions and adverse events after each vaccination and will measure immune responses to the vaccines. Participants may opt to continue in the study for an additional year to further assess safety and immune response.

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