Clinical Research Directory

A Study to Evaluate INT101 in Healthy Adults for the Prevention of Norovirus Gastroenteritis

This study is being conducted to evaluate the safety and immunogenicity of INT101, an investigational vaccine intended to prevent norovirus gastroenteritis, in healthy adults. INT101 contains multivalent norovirus antigens (GII.3, GII.4, and GII.17) and is administered as an intramuscular injection. Participants will receive either INT101 or a placebo, given three times at 4-week intervals. This is a single-center, single-blind, randomized, dose-escalation, placebo-controlled, multiple-dose, Phase 1 clinical trial. Approximately 30 healthy adult participants will be enrolled and randomly assigned to receive either a low dose or high dose of INT101, or a matching placebo, in a 2:1 ratio within each dose group. The primary objective is to evaluate the safety of multiple intramuscular doses of INT101 compared to placebo. The secondary objective is to evaluate the immunogenicity (antibody response) of INT101 compared to placebo. Participants will be followed for approximately 6 months after their last dose to monitor safety and immune response.