Infections with Streptococcus pneumoniae often cause serious health problems, especially for infants and the elderly.Failure to cover all polysaccharide types is an even greater problem with adults than with children. The aim of the study is to preliminary evaluate the safety and immunogenicity of PBPV vaccine compared to placebo,in order to provide a basis for subsequent clinical trial design.
The polysaccharide vaccine protected 60% of elderly adults who were at risk for pneumococcal infection.However, pneumococci are highly diverse with respect to their capsular types , and the polysaccharide-protein conjugate vaccines will not protect against strains of the many capsular types not included in the vaccine.This experimental vaccine was covered 70% of all pneumococcal types, Subjects will receive three doses of PBPV vaccine on day 0,60 and 120 with different contents of 20μg,50μg,100μg each antigen in 18 to 49 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
120
0.2mL,Intramuscular other name:PBPV
0.2mL,Intramuscular other name:PBPV placebo
0.5mL,Intramuscular other name:PBPV
Suixian Center for Disease Control and Prevention
Shangqiu, Henan, China
Safety indexes of solicited and unsolicited adverse reactions
Occurrence of solicited and unsolicited reactions post each vaccination
Time frame: within 30 minutes,0-7 days,0-30 days post-vaccination
Safety indexes of lab measures
Occurrence of abnormal changes of hematological examination,clinical chemistry test,urine test and vital signs
Time frame: day 3 and 8 post the first vaccination
Safety indexes of lab measures
Occurrence of abnormal changes of CK-MB,CTN,urine test and vital signs
Time frame: day 14 and 30 post each vaccination
safety indexes of SAE
Occurrence of SAE
Time frame: within 180 days post vaccination
immunogencity indexes of GMC and GMI by ELISA
Geometric mean concentration(GMC) and Geometric mean increase(GMI)of anti-PspA-RX1 , anti-PspA-3296, anti-PspA-5668 and anti-PlyLD antibodies in serum
Time frame: day 8, 14,30,60 post each vaccination
immunogencity indexes of the seropositivity rates by ELISA
the seropositivity rates of anti-PspA-RX1 , anti-PspA-3296, anti-PspA-5668 and anti-PlyLD antibodies in serum
Time frame: day 8, 14,30,60 post each vaccination
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0.5mL,Intramuscular other name:PBPV placebo
1.0mL,Intramuscular other name:PBPV
1.0mL,Intramuscular other name:PBPV placebo