Streptococcus pneumoniae infections often cause serious health problems, especially in infants and the elderly. Failure to cover all polysaccharide types of vaccines is a greater problem for adults than for children. The purpose of this study was to preliminarily evaluate the safety and immunogenicity of a recombinant pneumococcal protein vaccine applied to adults aged 50 years and older to provide a basis for subsequent clinical trial design.
The risk of Streptococcus pneumoniae infection varies widely with age, underlying disease, and living environment. Worldwide, infants and the elderly are at high risk for pneumococcal disease. Disease from pneumococcal infections can affect multiple organ systems and lead to multiple disease syndromes. This vaccine has a higher coverage rate, capable of reaching more than 94%. With the high coverage rate, it can effectively prevent the occurrence of serotype substitution and the outbreak of antibiotic-resistant pneumococcal-associated diseases. This clinical trial is a Phase Ib clinical trial in adults aged 50 years and older based on the Phase Ia clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
Lancang Lahu Autonomous County Center for Disease Control and Prevention
Puer, Yunnan, China
Incidence of adverse reactions 0~7 days after vaccination
Time frame: 0~7 days after vaccination
Incidence of adverse reactions 0~30 days after vaccination
Time frame: 0~30 days after vaccination
Positive (4-fold change) rate of serum Pneumococcal surface protein A(PspA)-RX1, PspA-3296, PspA-5668 and PlyLD protein antibodies at day 30, 3 months and 6 months after vaccination
Time frame: Day 30, 3 months and 6 months after vaccination
Incidence of adverse reactions within 30 minutes after vaccination
Time frame: 30 minutes after vaccination
Incidence of adverse events within 30 days after vaccination
Time frame: 30 days after vaccination
Incidence of Serious Adverse Event (SAE) within 6 months after vaccination
Time frame: 6 months after vaccination
Evaluation of the incidence of abnormal laboratory hematology values, including hemoglobin, white blood cell count, alanine aminotransferase (AT), aspartate AT, total bilirubin, creatine phosphokinase , before and on day 8 of the subject's exemption
Time frame: Before and on day 8 of the subject's exemption
Serum PspA-RX1, PspA-3296, PspA-5668, PlyLD protein antibody Geometric Mean Titer (GMT) at 30 days, 3 months and 6 months before and after vaccination
Time frame: 30 days, 3 months and 6 months before and after vaccination
Serum PspA-RX1, PspA-3296, PspA-5668, PlyLD protein antibody Geometric Mean Increase (GMI) at 30 days, 3 months and 6 months before and after vaccination
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Time frame: 30 days, 3 months and 6 months before and after vaccination
Serum Ply antibody neutralization test activity at 30 days, 3 months and 6 months before and after vaccination
Time frame: 30 days, 3 months and 6 months before and after vaccination
GMT of serotype specific Multiplexed Opsonophagocytic Killing Assay (MOPA) at 30 days, 3 months and 6 months before and after vaccination
Time frame: 30 days, 3 months and 6 months before and after vaccination
Positive conversion rate of serotype specific Multiplexed Opsonophagocytic Killing Assay (MOPA) at 30 days, 3 months and 6 months before and after vaccination
Time frame: 30 days, 3 months and 6 months before and after vaccination
GMI of serotype specific Multiplexed Opsonophagocytic Killing Assay (MOPA) at 30 days, 3 months and 6 months before and after vaccination
Time frame: 30 days, 3 months and 6 months before and after vaccination