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RecruitingMonkeypox

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

Eligible age

18+ yrs

Accepts

All genders

Locations

0 states

Healthy volunteers

Yes

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About this study

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.

Sponsor: Shanghai Institute Of Biological Products

You may qualify if…

  • ✓ On the day of enrollment, individuals aged 18 years or older with a history of smallpox vaccination must have been born before 1980;
  • ✓ Can provide legal proof of identity;
  • ✓ Be able to understand the experimental procedure and sign a written informed consent form, expressing agreement to participate in the experiment;
  • ✓ Be able to participate in all planned follow-up visits and comply with all trial procedures (such as completing diary/contact cards and being able to return for visits);
  • ✓ On the day of enrollment, the body temperature was less than 37.3 ℃ (axillary temperature);
  • ✓ Men and women of childbearing age who have no plans to have children within 6 months and agree to take effective contraceptive measures within 6 months after receiving the experimental vaccine.

You may not qualify if…

  • ✕ Individuals with a history of smallpox, monkeypox, or close contact with monkeypox in the past;
  • ✕ Individuals who are allergic to any ingredients of eggs, vaccines, or substances used in production processes, or have a history of other severe allergies;
  • ✕ Use immunoglobulin and/or any blood products within 3 months prior to administering the trial vaccine, or plan to use them during the trial period;
  • ✕ Currently using salicylate drugs or planning long-term use during the trial period;
  • ✕ Have used any experimental or unregistered products within one month prior to administering the trial vaccine, or plan to use them during the trial period;
  • ✕ Administer inactivated vaccine within 14 days before administering the experimental vaccine or attenuated live vaccine within 30 days before administering the experimental vaccine;
  • ✕ Chronic disease patients are in the acute or progressive phase of chronic disease;
  • ✕ Long term use of immunosuppressants or other immunomodulatory drugs within 6 months prior to vaccination with the experimental vaccine;

Source: ClinicalTrials.gov · NCT06771479 · last updated 2025-10-03

A Study Evaluating the Safety and Immunogenicity of MVA Strain Monkeyp · TrialPath