Phase I Trial of MVA Strain Monkeypox Live Vaccine Evaluating Safety and Immune Response in Adults 18 and Older

What this Trial Is About

Researchers are conducting a randomized, double-blind, placebo-controlled phase I clinical trial to evaluate the safety and immune response of two doses of the MVA strain monkeypox attenuated live vaccine in adults aged 18 years and older. The study aims to assess how well this vaccine works and its safety in different groups, including healthy individuals, men who have sex with men, and people living with HIV. Participants are also categorized based on whether they have previously received a smallpox vaccine. Participants will be randomly assigned to one of three groups low-dose vaccine, high-dose vaccine, or placebo, with equal distribution among these groups. Each participant will receive two doses, one on day 0 and another on day 28. The study includes groups with and without prior smallpox vaccination history. The trial is designed to carefully compare responses and side effects across these groups. During the study, participants will be monitored closely for immediate and delayed adverse events after each vaccination. Safety assessments include tracking any serious or special interest adverse events for up to 12 months after the last dose. Participants will attend follow-up visits, complete diaries or contact cards, and undergo physical exams and laboratory tests to evaluate vaccine safety and immune response over time. The total study duration includes the vaccination phase and long-term safety monitoring.

A Study Evaluating the Safety and Immunogenicity of MVA Strain Monkeypox Attenuated Live Vaccine