A Phase I clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in adults aged 18 years and older. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, controlled Phase I clinical trial.
A phase I clinical trial of the study of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV24) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in Chinese adults aged 18 years and older. The trial is a randomized, double-blind and active controlled study. The objective of this study is to evaluate the safety and immunogenicity of PCV24 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine is the Pneumovax® manufactured by MSD. The placebo is 0.9%NaCl solution. A total of at least 168 participants will be enrolled, including 84 adults aged 18-59 years and 84 elderly people aged ≥60 years. Participants will be randomized in a 2:2:2:1 ratio to receive one dose of PCV24 formulation 1, PCV24 formulation 2, Pneumovax® or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
170
One dose of Sinovac PCV24 formulation 1(0.5mL)
One dose of Sinovac PCV24 formulation 2(0.5mL)
One dose of Pneumovax® (0.5 mL) contains 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F saccharides.
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, China
Incidence of adverse reactions
Incidence of adverse reactions within 30 days after vaccination
Time frame: 0-30 days after vaccination
Incidence of adverse reactions
Incidence of adverse reactions within 7 days after vaccination
Time frame: 0-7 days after vaccination
Incidence of serious adverse events (SAE)
Incidence of SAE during the period of safety monitoring
Time frame: 0-6 months after vaccination
Incidence of clinically significant abnormality in laboratory examination tests
Incidence of clinically significant abnormality in blood routine, blood biochemistry and urine routine test results within 3 days after vaccination
Time frame: 0-3 days after vaccination
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)
IgG GMC 30 days after vaccination
Time frame: 30 days after vaccination
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)
IgG GMI 30 days after vaccination
Time frame: 30 days after vaccination
Proportion of pneumococcal serotype-specific IgG antibody concentration increase≥4
Proportion of IgG antibody concentration increase≥four folds 30 days after vaccination
Time frame: 30 days after vaccination
Pneumococcal serotype-specific opsonophagocytic assay (OPA) geometric mean titer (GMTs)
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0.5 mL of 0.9%NaCl solution (normal saline)
OPA GMT 30 days after vaccination
Time frame: 30 days after vaccination
Pneumococcal serotype-specific OPA GMI
OPA GMI 30 days after vaccination
Time frame: 30 days after vaccination
Proportion of pneumococcal serotype-specific OPA antibody titer increase≥4
Proportion of OPA antibody titer increase≥four folds 30 days after vaccination
Time frame: 30 days after vaccination