This is a phase I, randomized, observer-blinded study to evaluate the safety, tolerability, and immunogenicity of BV211(a herpes zoster vaccine) in Adult Volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
40
0.5mL, Intramuscular
0.5mL, Intramuscular
0.5mL, Intramuscular
Safety in terms of adverse reactions/events
Incidence rates of adverse reactions/events (ADRs/AEs)
Time frame: 30 mins, 0-7 days, 8-30 days and 0-30 days
Safety in terms of laboratory-based AEs
Incidence rates of abnormal laboratory indicators
Time frame: 3 days after each vaccination
Safety in terms of SAEs
Incidence rates of SAEs
Time frame: Within 6 months after full vaccination
Safety in terms of Adverse Events of Special Interest
Incidence rates of AESI
Time frame: Within 6 months after full vaccination
Immunogencity in terms of GMT by ELISA or FAMA
GMC of anti-gE antibody and GMT of anti-VZV antibody
Time frame: Days 1, 30, 60, 90 and 240
Immunogencity in terms of Seroconversion Rates
Seroconversion rates of anti-gE and anti-VZV antibody responses
Time frame: Days 30, 60, 90 and 240
Immunogencity in terms of Geometric Mean Fold Increase
GMFI of anti-gE and anti-VZV antibody responses
Time frame: Days 30, 60, 90 and 240
Immunogencity in terms of Cellular immunity
Frequency of CD4+ and CD8+T cells that express at least one cytokine
Time frame: Days 1, 90 and 240
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