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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
120
Low dose MVA strain monkeypox attenuated live vaccine
High dose MVA strain monkeypox attenuated live vaccine
Vaccine excipient
Henan Infectious Disease Hospital
Zhengzhou, Henan, China
RECRUITINGImmediate adverse events
The occurrence of any adverse events within 60 minutes after each dose of vaccine immunization.
Time frame: 60 minutes after each dose of vaccination
Solicited Adverse Events
Adverse events defined by the protocol that occurred to the participant during 0-14 days after each dose of vaccination.
Time frame: 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.
Time frame: 28 or 30 days after each dose of vaccination
Abnormal incidence rate of electrocardiogram
Abnormal electrocardiogram after 14 days of vaccination with each dose.
Time frame: 14 days after each dose of vaccination
Serious Adverse Events (SAE)
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Time frame: 12 months after the last dose
Adverse Event of Special Interest (AESI)
Adverse events that require special attention as specified in the experimental protocol.
Time frame: 12 months after the last dose
Li
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