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.
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);
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;
Parallel
MVA strain monkeypox attenuated live vaccine (low dose)
Biological/VaccineLow dose MVA strain monkeypox attenuated live vaccine
MVA strain monkeypox attenuated live vaccine (high dose)
Biological/VaccineHigh dose MVA strain monkeypox attenuated live vaccine
Placebo
Other interventionVaccine excipient
6
Treatment groupsSee each treatment group below.
Immediate adverse events
The occurrence of any adverse events within 60 minutes after each dose of vaccine immunization.
Solicited Adverse Events
Adverse events defined by the protocol that occurred to the participant during 0-14 days after each dose of vaccination.
Unsolicited Adverse Events
Other adverse events that occurred among participants within 0-28/30 days after each vaccination, in addition to the solicited adverse events.
Abnormal incidence rate of electrocardiogram
Abnormal electrocardiogram after 14 days of vaccination with each dose.
Geometric Mean Titer (GMT) of neutralizing antibodies
GMI of neutralizing antibodies against monkeypox virus in the experimental vaccine groups and the placebo group.
Seroconversion rate of neutralizing antibodies
The neutralizing antibody seroconversion rate against monkeypox virus in the experimental vaccine groups and the placebo group.
Seropositive rate of neutralizing antibodies
The neutralizing antibody seropositive rate against monkeypox virus in the experimental vaccine groups and the placebo group.
GMT of binding antibody
GMI of binding antibody against monkeypox virus in the experimental vaccine groups and the placebo group.
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