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).
Given the urgent need for pediatric data and the high burden of mpox in the DRC, this trial will evaluate the safety and immunogenicity of the MVA-SIBP vaccine using a double-blind, randomized, controlled, age de-escalation design conducted in Kinshasa, DRC. The trial is designed to generate critical data to support regulatory approval and broader access to affordable, stable, and scalable mpox vaccines for Africa.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
180
Participants received one subcutaneous dose of 0.5ml MVA-SIBP low dose on days 0 and 28, respectively, for a total of two doses.
Participants received one subcutaneous dose of 0.5ml MVA-SIBP high dose on days 0 and 28, respectively, for a total of two doses.
Participants 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.
Time frame: Day 28 after each dose
Solicited local adverse events
That is frequency of occurrence of events pain, erythema, swelling, induration, pruritus at injection site and recorded by memory aid.
Time frame: Day 8 after each dose
Solicited systemic adverse events
That is frequency of occurrence of events headache, fatigue, myalgia, fever, chills, nausea and recorded by memory aid.
Time frame: Day 8 after each dose
Serious Adverse Events(SAEs)
To evaluate the incidence of SAE after vaccination.
Time frame: Day 365 after the first dose
Adverse Events of Special Interest(AESIs)
To evaluate the incidence of AESI after vaccination.
Time frame: Day 365 after the first dose
Medically Attended Adverse Events(MAAEs)
To evaluate the incidence of MAAE after vaccination.
Time frame: Day 365 after the first dose
Grade 3+ related adverse events
Grade 3+ incidence of adverse events related to vaccination.
Time frame: Day 28 after each dose
Plaque Reduction Neutralization Test(PRNT) Geometric Mean Titers(GMT) of vaccinia
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Neutralizing antibody titer by PRNT against vaccinia virus.
Time frame: Day 0, 28, 56, 181, 365
PRNTest GMTof mpox
Neutralizing antibody titer by PRNT against mpox virus.
Time frame: Day 0, 28, 56, 181, 365
Seroconversion rate of vaccinia
Seroconversion rate is ≥4-fold rise in PRNT titer vs. baseline.
Time frame: Day 28, 56, 181, 365
Seroconversion rate of mpox
Seroconversion rate is ≥4-fold rise in PRNT titer vs. baseline.
Time frame: Day 28, 56, 181, 365