A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial Evaluating the Safety and Immunogenicity of MVA Strain Monkeypox Attenuated Live Vaccine for Individuals Aged 18 and Above
Overview
- Phase
- Phase 1
- Intervention
- MVA strain monkeypox attenuated live vaccine (low dose)
- Conditions
- Monkeypox
- Sponsor
- Shanghai Institute Of Biological Products
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Immediate adverse events
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
- •Having undergone chemotherapy or radiation therapy or organ and bone marrow transplantation related treatments for cancer or other diseases;
- •Diseases or medical measures that lead to immune dysfunction, such as congenital immunodeficiency, organ and bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma or malignant tumors, etc;
Arms & Interventions
Experimental group 1
Participants without a history of immunization against smallpox
Intervention: MVA strain monkeypox attenuated live vaccine (low dose)
Experimental group 2
Participants without a history of immunization against smallpox
Intervention: MVA strain monkeypox attenuated live vaccine (high dose)
Experimental group 3
Participants with a history of immunization against smallpox
Intervention: MVA strain monkeypox attenuated live vaccine (low dose)
Experimental group 4
Participants with a history of immunization against smallpox
Intervention: MVA strain monkeypox attenuated live vaccine (high dose)
Control group 1
Participants without a history of immunization against smallpox
Intervention: Placebo
Control group 2
Participants with a history of immunization against smallpox
Intervention: Placebo
Outcomes
Primary Outcomes
Immediate adverse events
Time Frame: 60 minutes after each dose of vaccination
The occurrence of any adverse events within 60 minutes after each dose of vaccine immunization.
Solicited Adverse Events
Time Frame: 14 days after each dose of vaccination
Adverse events defined by the protocol that occurred to the participant during 0-14 days after each dose of vaccination.
Unsolicited Adverse Events
Time Frame: 28 or 30 days after each dose of vaccination
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
Time Frame: 14 days after each dose of vaccination
Abnormal electrocardiogram after 14 days of vaccination with each dose.
Serious Adverse Events (SAE)
Time Frame: 12 months after the last dose
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Adverse Event of Special Interest (AESI)
Time Frame: 12 months after the last dose
Adverse events that require special attention as specified in the experimental protocol.