NCT07495202

A Clinical Trial Evaluating the Monkeypox Recombinant Protein Vaccine

A Phase I Randomized Double-blind Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Recombinant Monkeypox Protein Vaccine JT118 in Healthy Adults.

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Shanghai JunTop Biosciences Co., LTD · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Health Volunteer

Interventions

Type	Name	Description
BIOLOGICAL	JT118 experimental group	The vaccine was administered by Subcutaneous Injection
BIOLOGICAL	JT118 placebo group	The vaccine was administered by Subcutaneous Injection

Timeline

• Start date: 2026-03-30
• Primary completion: 2027-11-07
• Completion: 2027-11-07
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: China