A Clinical Trial Evaluating the Monkeypox Recombinant Protein Vaccine

This study is a randomized, double-blind, placebo-controlled Phase I clinical trial representing the first-in-human (FIH) investigation of the Monkeypox recombinant protein vaccine JT118. The primary objectives are to evaluate the safety, tolerability, and immunogenicity of two doses of JT118 in healthy adults and to conduct preliminary exploration of vaccination regimens. The study will sequentially proceed from the low-dose group to the high-dose group with Subgroup 1 (participants without prior Smallpox vaccination history) and Subgroup 2 (participants with prior Smallpox vaccination history) being conducted concurrently within each dose group. It will explore single-dose, two-dose, and three-dose vaccination regimens with approximately 180 healthy adult participants planned for enrollment.

NCT Number	NCT07495202
Lead Sponsor	Shanghai JunTop Biosciences Co., LTD
Conditions	Health Volunteer
Enrollment	180 participants
Start Date	2026-05-18
Primary Completion	2027-11-07 (estimated)
Study Completion	2027-11-07 (estimated)
Updated on ClinicalTrials.gov	2026-06-05