Phase I Study to Evaluate Safety, Tolerability, and Immune Response of the JT118 Monkeypox Protein Vaccine in Healthy Adults Aged 18 to 59

What this Trial Is About

Researchers are conducting a Phase I randomized, double-blind, placebo-controlled trial to study the Monkeypox recombinant protein vaccine JT118. This first-in-human study aims to evaluate the vaccines safety, how well participants tolerate it, and the immune response it generates in healthy adults aged 18 to 59. The trial also explores different vaccination schedules to understand the best approach for this vaccine. The study involves administering the JT118 vaccine or a placebo by subcutaneous injection. It progresses sequentially from a low-dose group to a high-dose group, with participants divided into subgroups based on prior Smallpox vaccination history. The trial will test single-dose, two-dose, and three-dose vaccination regimens in about 180 healthy adults. Participants will be monitored closely throughout the study, including during a follow-up period lasting up to 416 days. Researchers will track adverse events, laboratory test results, and serious side effects. They will also assess immune responses, including cellular immunity and antibody levels. The study includes regular health assessments, physical exams, and laboratory tests to ensure safety and measure outcomes.

A Clinical Trial Evaluating the Monkeypox Recombinant Protein Vaccine