Pneumonia, Respiratory Tract Diseases, Respiratory Tract Infections
Conditions
Keywords
Vaccnie, PspA, Pneomolysin
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALProtein based pneumococcal vaccine(Low dose)
0.2mL,Intramuscular other name:PBPV
BIOLOGICALProtein based pneumococcal vaccine placebo(Low dose)
0.2mL,Intramuscular other name:PBPV placebo
BIOLOGICALProtein based pneumococcal vaccine(Middle dose)
0.5mL,Intramuscular other name:PBPV
BIOLOGICALProtein based pneumococcal vaccine placebo(Middle dose)
0.5mL,Intramuscular other name:PBPV placebo
BIOLOGICALProtein based pneumococcal vaccine(High dose)
1.0mL,Intramuscular other name:PBPV
BIOLOGICALProtein based pneumococcal vaccine placebo(High dose)
1.0mL,Intramuscular other name:PBPV placebo
Sponsors
Henan Center for Disease Control and Prevention
CanSino Biologics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers aged 18 to 49 years old; * Willing to provide proof of identity; * Able to understand and sign the informed consent; * Able and willing comply with the requirements of the protocol
Exclusion criteria
* Hypertensive volunteers with uncontrollable medications (on-site measurement: systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg); * Abnormal changes of laboratory measures (with clinical significance); * Woman is pregnant and lactating (by urine pregnancy test) * Suffered from pneumonia in the past three years; * Invasive diseases caused by Streptococcus pneumoniae (such as meningitis, bacteremia, pericarditis, peritonitis, etc.) in the past three years; * Allergic person; * Any prior administration of blood products in last 3 month; * Any prior administration of other research medicines in last 1 month; * Plans to participate in or is participating in any other drug clinical study; * Any prior administration of attenuated live vaccine in last 14 days; * Any prior administration of subunit or inactivated vaccines in last 7 days; * Had fever before vaccination, volunteers with temperature \>37.0℃ on axillary setting; * According to the investigator's judgment, the volunteers have any otherfactors that make them unfit to participate in the clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety indexes of solicited and unsolicited adverse reactions | within 30 minutes,0-7 days,0-30 days post-vaccination | Occurrence of solicited and unsolicited reactions post each vaccination |
| Safety indexes of lab measures | day 3 and 8 post the first vaccination | Occurrence of abnormal changes of hematological examination,clinical chemistry test,urine test and vital signs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| immunogencity indexes of the seropositivity rates by ELISA | day 8, 14,30,60 post each vaccination | the seropositivity rates of anti-PspA-RX1 , anti-PspA-3296, anti-PspA-5668 and anti-PlyLD antibodies in serum |
| immunogencity indexes of GMC and GMI by ELISA | day 8, 14,30,60 post each vaccination | 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 |
| safety indexes of SAE | within 180 days post vaccination | Occurrence of SAE |
Other
| Measure | Time frame | Description |
|---|---|---|
| immunogencity indexes of GMT and GMI by Opsonophagocytic assay (OPA) | day30,60 post each vaccination | Geometric mean titer(GMT) and Geometric mean increase（GMI）of antibodies in serum |
| immunogencity indexes of neutralization test | day30,60 post each vaccination | neutralization test activity of anti-Ply antibody in serum |
Countries
China
Outcome results
None listed