An Early Phase 1 interventional study of Protein based pneumococcal vaccine(Low dose) and Protein based pneumococcal vaccine placebo(Low dose) in Pneumonia, Respiratory Tract Diseases and Respiratory Tract Infections, sponsored by CanSino Biologics Inc.. Completed at 1 site in China. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-04.
Sponsored by CanSino Biologics Inc. · Early Phase 1, Interventional, and Prevention
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.
1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.
This study's enrollment of 120 is below the median of 199 across 698 interventional studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →CanSino Biologics Inc. is the lead sponsor of 41 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects received three doses of PBPV with 20μg each antigen
Biological: Protein based pneumococcal vaccine(Low dose)
Subjects received three doses of placebo
Biological: Protein based pneumococcal vaccine placebo(Low dose)
Subjects received three doses of PBPV with 50μg each antigen
Biological: Protein based pneumococcal vaccine(Middle dose)
Subjects received three doses of placebo
Biological: Protein based pneumococcal vaccine placebo(Middle dose)
Subjects received three doses of PBPV with 100μg each antigen
Biological: Protein based pneumococcal vaccine(High dose)
Subjects received three doses of placebo
Biological: Protein based pneumococcal vaccine placebo(High dose)
0.2mL,Intramuscular other name:PBPV
0.2mL,Intramuscular other name:PBPV placebo
0.5mL,Intramuscular other name:PBPV
0.5mL,Intramuscular other name:PBPV placebo
1.0mL,Intramuscular other name:PBPV
1.0mL,Intramuscular other name:PBPV placebo
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
immunogencity indexes of GMT and GMI by Opsonophagocytic assay (OPA)
Geometric mean titer(GMT) and Geometric mean increase（GMI）of antibodies in serum
Time frame: day30,60 post each vaccination
immunogencity indexes of neutralization test
neutralization test activity of anti-Ply antibody in serum
Time frame: day30,60 post each vaccination
Plan to share: No — In order to maintain the rights of the subject, do not open the IPD
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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CanSino Biologics Inc.