Phase 1 Study to Assess Safety and Immune Response of IVT Shigella-04 Vaccine in Healthy Adults Aged 18 to 49

What this Trial Is About

Researchers are conducting a phase 1 clinical trial to study the safety and immune response of a new vaccine called IVT Shigella-04 in healthy young adults aged 18 to 49 years. This study compares five different dose levels of the vaccine, given with or without an adjuvant, to a placebo. The goal is to evaluate how well the vaccine stimulates the immune system and to monitor any side effects. Participants will be randomly assigned to one of six groups to receive two intramuscular injections of either the IVT Shigella-04 vaccine at varying doses or a placebo saline 28 days apart. The vaccine formulations include low, medium, and high doses, some combined with an adjuvant to potentially enhance the immune response. The study is double-blind, meaning neither participants nor researchers know who receives the vaccine or placebo. During the trial, participants will attend scheduled visits for health assessments, blood tests, and monitoring of any reactions for up to six months after the second dose. Researchers will track immediate vaccine reactions, adverse events, and immune responses by measuring specific antibodies against Shigella. The total study duration for each participant includes screening, vaccination, and follow-up to ensure safety and gather detailed immune data.

First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults