This is a randomised, double-blind, placebo-controlled Phase 1/2 clinical trial to evaluate the safety, tolerability and immunogenicity of recombinant respiratory syncytial virus in participants aged 18 years and older.
Three dose-levels of SCTV02 will be evaluated in participants aged 18 years and older. Solicited adverse events within 7 days post study vaccination and unsolicited adverse events within 30 days post study vaccination will be collected. Immunogenicity including Neutralizing antibody against RSV-A and RSV-B will be tested 14, 30, 90, 180 and 365 days post study vaccination will be assessed. T cell response will be tested 30 days post study vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
480
Hebei Zhongshiyou Central Hospital
Langfang, Hebei, China
RECRUITINGLuzhou Center for Disease Control and Prevention
Luzhou, Sichuan, China
NOT_YET_RECRUITINGIncidence and severity of solicited adverse events within 7 days post study vaccination.
Incidence and severity of solicited adverse events within 7 days post study vaccination.
Time frame: Day o to Day 7
Geometric mean titer (GMT) of neutralizing antibodies (nAb) against RSV-A and RSV-B subtypes 30 days post vaccination
Geometric mean titer (GMT, Live Virus Neutralization Test) of neutralizing antibodies (nAb) against RSV-A and RSV-B subtypes 30 days after study vaccination.
Time frame: Day 30
GMT of nAb against RSV-A and RSV-B subtypes 14 days after study vaccination.Immunogenicity 14 days post vaccination
GMT of nAb against RSV-A and RSV-B subtypes 14 days after study vaccination.
Time frame: Day 14
GMT of nAb against RSV-A and RSV-B subtypes 90 days post vaccination
GMT (Live Virus Neutralization Test) of neutralizing antibodies (nAb) against RSV-A and RSV-B subtypes 90 days after study vaccination.
Time frame: Day 90
GMT of nAb against RSV-A and RSV-B subtypes 180 days post vaccination
GMT (Live Virus Neutralization Test) of neutralizing antibodies (nAb) against RSV-A and RSV-B subtypes 180 days after study vaccination.
Time frame: Day 180
GMT of nAb against RSV-A and RSV-B subtypes 365 days post vaccination
GMT (Live Virus Neutralization Test) of neutralizing antibodies (nAb) against RSV-A and RSV-B subtypes 365 days after study vaccination.
Time frame: Day 365
T cell response
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Number of T cell subsets activated by interferon-γ (for Th1) and interleukin-4 (for Th2) 30 days after study vaccination.
Time frame: Day 30
Incidence and severity of unsolicited adverse events within 30 days
Incidence and severity of unsolicited adverse events within 30 days after study vaccination.
Time frame: Day to Day 30
Incidence and severity of Serious adverse events and adverse events of special interest within 365 days
Incidence and severity of Serious adverse events and adverse events of special interest within 365 days after study vaccination.
Time frame: Day 0 to Day 365