This is a randomized, double-blinded, placebo-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine in subjects ( aged 6 months to 59 years ).
This is a single-center, randomized, double-blinded, placebo-controlled phase I clinical trial in which three dose levels of the Enterovirus Type71 -Coxsackievirus Type A16 bivalent vaccine will be evaluated the safety and preliminary immunogenicity in subjects aged 6 months to 59 years. A total of 144 participants will be enrolled, including 48 adults (aged 18-59 years), 48 adolescents (aged 6-17 years), and 48 children (aged 6 months-5 years). Participants will be randomized into vaccine group and placebo group in a 3:1 ratio, and receive two doses of vaccine or placebo according to the 0- and 28-day immunization schedule.The dose escalation principle within each age group is from low to high doses, and the sequential enrollment principle between different age groups is from adults to children. Primary endpoints are the occurrence of safety events after vaccination including the incidence of adverse events within 30 minutes/7 days/28 days after each dose, as well as the incidence of serious adverse events within 12 months after the final dose which will be defined as the secondary safety endpoint. Besides, the secondary immunogenicity endpoints are the geometric mean titers, geometric mean fold increases, seropositive rates, and seroconversion rates of anti-EV71 neutralizing antibodies and anti-CA16 neutralizing antibodies 28 days after the final dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
144
Low-dose vaccine,dosage and immunization procedure: 0.1 ml/dose, 2 doses, 28-day interval
Medium-dose vaccine,dosage and immunization procedure: 0.1 ml/dose, 2 doses, 28-day interval
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Safety index - incidence of adverse events
Incidence of adverse events after each dose vaccination
Time frame: 0- 30 minutes/Day 0 to 7 days/Day 0 to 28 days after each dose
Safety index - incidence of serious adverse events
Incidence of serious adverse events/adverse reactions after vaccination
Time frame: From the beginning of the vaccination up to12 months after the last vaccination completed
Immunogenicity index-Seroconversion rates
The seroconversion rates of anti-EV71 neutralizing antibodies and anti-CA16 neutralizing antibodies after the end of the entire vaccination course.
Time frame: Between baseline and Day 28 after full vaccination
Immunogenicity index - Geometric mean titer (GMT)
The GMT of anti-EV71 neutralizing antibodies and anti-CA16 neutralizing antibodies 28 days after the end of the entire vaccination course.
Time frame: Day 28 after full vaccination
Immunogenicity index - Geometric mean fold increases (GMFI)
The GMFI of anti-EV71 neutralizing antibodies and anti-CA16 neutralizing antibodies after the end of the entire vaccination course.
Time frame: Between baseline and Day 28 after full vaccination
Immunogenicity index-Seropositive rates
The seropositive rates of anti-EV71 neutralizing antibodies and anti-CA16 neutralizing antibodies 28 days after the end of the entire vaccination course.
Time frame: Day 28 after full vaccination
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High-dose vaccine,dosage and immunization procedure: 0.1 ml/dose, 2 doses, 28-day interval
Placebo,dosage and immunization procedure: 0.1 ml/dose, 2 doses, 28-day interval