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| Name | Class |
|---|---|
| Henan Center for Disease Control and Prevention | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose Group A | Experimental | Subjects received three doses of PBPV with 20μg each antigen |
|
| Low-dose Group B | Placebo Comparator | Subjects received three doses of placebo |
|
| Middle-dose Group A | Experimental | Subjects received three doses of PBPV with 50μg each antigen |
|
| Middle-dose Group B | Placebo Comparator | Subjects received three doses of placebo |
|
| High-dose Group A | Experimental | Subjects received three doses of PBPV with 100μg each antigen |
|
| High-dose Group B | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein based pneumococcal vaccine(Low dose) | Biological | 0.2mL,Intramuscular other name:PBPV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety indexes of solicited and unsolicited adverse reactions | Occurrence of solicited and unsolicited reactions post each vaccination | 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 | 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 | day 14 and 30 post each vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| safety indexes of SAE | Occurrence of SAE | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| immunogencity indexes of GMT and GMI by Opsonophagocytic assay (OPA) | Geometric mean titer(GMT) and Geometric mean increase（GMI）of antibodies in serum | day30,60 post each vaccination |
| immunogencity indexes of neutralization test |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xia Shengli | Henan Province Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suixian Center for Disease Control and Prevention | Shangqiu | Henan | 450016 | China |
In order to maintain the rights of the subject, do not open the IPD
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Subjects received three doses of placebo |
|
| Protein based pneumococcal vaccine placebo(Low dose) | Biological | 0.2mL,Intramuscular other name:PBPV placebo |
|
| Protein based pneumococcal vaccine(Middle dose) | Biological | 0.5mL,Intramuscular other name:PBPV |
|
| Protein based pneumococcal vaccine placebo(Middle dose) | Biological | 0.5mL,Intramuscular other name:PBPV placebo |
|
| Protein based pneumococcal vaccine(High dose) | Biological | 1.0mL,Intramuscular other name:PBPV |
|
| Protein based pneumococcal vaccine placebo(High dose) | Biological | 1.0mL,Intramuscular other name:PBPV placebo |
|
| 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 | day 8, 14,30,60 post each vaccination |
neutralization test activity of anti-Ply antibody in serum
| day30,60 post each vaccination |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012140 | Respiratory Tract Diseases |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D008171 | Lung Diseases |
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