Actively Recruiting
A Study Evaluating the Safety and Immunogenicity of MVA Strain Monkeypox Attenuated Live Vaccine
Led by Shanghai Institute Of Biological Products · Updated on 2025-10-03
120
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study Evaluating the Safety and Immunogenicity of MVA Strain Monkeypox Attenuated Live Vaccine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 18 years or older at enrollment
- Those born before 1980 if they have a history of smallpox vaccination
- Able to provide legal proof of identity
- Capable of understanding the study and signing informed consent
- Able to attend all follow-up visits and comply with study procedures
- Body temperature less than 37.3 6C (axillary) on enrollment day
- Men and women of childbearing age who agree to avoid pregnancy for 6 months and use effective contraception
You will not qualify if you...
- History of smallpox, monkeypox, or close contact with monkeypox
- Allergy to eggs, vaccines, or substances used in vaccine production
- Use of immunoglobulin or blood products within 3 months or planned during the trial
- Current or planned long-term use of salicylate drugs during the trial
- Use of experimental or unregistered products within 1 month or planned during the trial
- Received inactivated vaccine within 14 days or attenuated live vaccine within 30 days before trial vaccine
- Chronic diseases in acute or progressive phase
- Long-term immunosuppressant or immunomodulatory drug use within 6 months prior to vaccination
- History of chemotherapy, radiation, or organ/bone marrow transplantation
- Immune dysfunction diseases or related medical treatments
- Moderate or severe acute illness or fever on vaccination day
- History of thrombocytopenia or coagulation disorders
- Serious cardiovascular, liver, kidney disease, or uncontrolled diabetes
- History of mental or neurological disorders or family history
- Active infectious, suppurative, or allergic skin diseases
- Women pregnant, lactating, or with positive pregnancy test
- Planning to move or be away during trial visits
- Abnormal blood, urine, ECG, or heart disease indicators before vaccination (unless minor)
- Conditions affecting study evaluation as judged by researchers
- Active tuberculosis
- HIV-infected with plasma HIV-1 RNA 60 copies/mL, or positive for hepatitis B, C, or syphilis
- Healthy or men having sex with men positive for hepatitis B, C, syphilis, or HIV
- Severe allergic reaction after first vaccine dose
- Serious adverse events definitely related to first vaccine dose
- New conditions post-first dose that do not meet inclusion/exclusion criteria, with researcher decision
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Henan Infectious Disease Hospital
Zhengzhou, Henan, China
Actively Recruiting
Research Team
H
Hao Zhou, Bachelor
CONTACT
L
Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
6
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