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

ConditionMonkeypox
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Institute Of Biological Products

About this trial

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.

Eligibility criteria

Qualifiers

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);

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • MVA strain monkeypox attenuated live vaccine (low dose)
  • MVA strain monkeypox attenuated live vaccine (high dose)
  • Placebo

Treatment groups

120 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.