NCT06771479

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

A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial Evaluating the Safety and Immunogenicity of MVA Strain Monkeypox Attenuated Live Vaccine for Individuals Aged 18 and Above

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shanghai Institute Of Biological Products · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double blinded, controlled phase I clinical study. To evaluate the safety and immunogenicity of receiving two doses of MVA strain monkeypox attenuated live vaccine in individuals aged 18 years and above.

Detailed description

This is a randomized, double blinded, controlled phase I clinical study. The study plans to recruit 120 participants aged 18 years and above. The experimental vaccine MVA strain monkeypox attenuated live vaccine has two different doses (low dose and high dose). The ratio of low-dose experimental group, high-dose experimental group, and placebo group is 1:1:1. Participants will be divided into three groups: healthy individuals, men who have sex with men, and HIV infected individuals, with a ratio of 2:1:1. Different groups will be divided into individuals with a history of vaccination against smallpox and those without a history of immunization, based on whether each population has a history of vaccination against smallpox. Each participant will receive one dose of the experimental vaccine or placebo on day 0 and day 28, respectively.

Conditions

• Monkeypox

Interventions

Type	Name	Description
BIOLOGICAL	MVA strain monkeypox attenuated live vaccine (low dose)	Low dose MVA strain monkeypox attenuated live vaccine
BIOLOGICAL	MVA strain monkeypox attenuated live vaccine (high dose)	High dose MVA strain monkeypox attenuated live vaccine
OTHER	Placebo	Vaccine excipient

Timeline

• Start date: 2025-01-22
• Primary completion: 2026-01-30
• Completion: 2026-05-30
• First posted: 2025-01-13
• Last updated: 2025-10-03

Locations

1 site across 1 country: China