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A Clinical Trial Evaluating the Monkeypox Recombinant Protein Vaccine

NCT07495202 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-06-05

No results posted yet for this study

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

BIOLOGICAL

JT118 experimental group

The vaccine was administered by Subcutaneous Injection

BIOLOGICAL

JT118 placebo group

The vaccine was administered by Subcutaneous Injection

Sponsors & Collaborators

  • Shanghai JunTop Biosciences Co., LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-18
Primary Completion
2027-11-07
Completion
2027-11-07

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07495202 on ClinicalTrials.gov