To evaluate the safety and immunogenicity of the MVA-SIBP vaccine using a double-blind, randomized, controlled, age de-escalation design conducted in Kinshasa, Democratic Republic of the Congo (DRC).
Adults: 18 to 45 years inclusive at the time of informed consent. Adolescents: 12 to 17 years inclusive at the time of consent/assent. Children: 2 to 11 years inclusive at the time of consent/assent.
Participant is in good general health as determined by medical history, targeted physical examination, and clinical judgment of the investigator.
Adults: Able to read and understand the written informed consent, and willing to comply with all study procedures and availability for the entire study duration. Adolescents: Parent(s) or legally acceptable representative(s) able and willing to provide written informed consent; participant able and willing to provide appropriate assent per local regulations and IRB requirements. Children: Parent(s) or legally acceptable representative(s), with the relationship to the child similarly verified and documented on the consent form, and able and willing to provide written informed consent.
Willing and able to comply with all study procedures, visit schedule, and follow-up requirements as judged by the investigator.
Any prior smallpox or mpox vaccination. History of confirmed or suspected infection with monkeypox, cowpox, or vaccinia virus.
Close contact, as defined by WHO.
Known or suspected immunocompromised state as specified in the protocol.
Acute febrile illness (≥38.0°C) or clinically significant infection within 72 hours prior to vaccination. Any acute illness requiring systemic therapy or hospitalization within 14 days prior to enrollment.
Parallel
MVA-SIBP low dose
Biological/VaccineParticipants received one subcutaneous dose of 0.5ml MVA-SIBP low dose on days 0 and 28, respectively, for a total of two doses.
MVA-SIBP high dose
Biological/VaccineParticipants received one subcutaneous dose of 0.5ml MVA-SIBP high dose on days 0 and 28, respectively, for a total of two doses.
MVA-BN
Biological/VaccineParticipants received one subcutaneous dose of 0.5ml MVA-BN low dose on days 0 and 28, respectively, for a total of two doses.
Unsolicited adverse events
An unsolicited AE is any AE reported in addition to those solicited during the clinical study.
Solicited local adverse events
That is frequency of occurrence of events pain, erythema, swelling, induration, pruritus at injection site and recorded by memory aid.
Solicited systemic adverse events
That is frequency of occurrence of events headache, fatigue, myalgia, fever, chills, nausea and recorded by memory aid.
Serious Adverse Events(SAEs)
To evaluate the incidence of SAE after vaccination.
Plaque Reduction Neutralization Test(PRNT) Geometric Mean Titers(GMT) of vaccinia
Neutralizing antibody titer by PRNT against vaccinia virus.
PRNTest GMTof mpox
Neutralizing antibody titer by PRNT against mpox virus.
Seroconversion rate of vaccinia
Seroconversion rate is ≥4-fold rise in PRNT titer vs. baseline.
Seroconversion rate of mpox
Seroconversion rate is ≥4-fold rise in PRNT titer vs. baseline.
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