Phase Ⅰa Clinical Trial of a Pneumococcal Vaccine
- Conditions
- Respiratory Tract DiseasesRespiratory Tract InfectionsPneumonia
- Interventions
- Biological: Protein based pneumococcal vaccine placebo(Middle dose)Biological: Protein based pneumococcal vaccine(Low dose)Biological: Protein based pneumococcal vaccine placebo(Low dose)Biological: Protein based pneumococcal vaccine(Middle dose)Biological: Protein based pneumococcal vaccine placebo(High dose)Biological: Protein based pneumococcal vaccine(High dose)
- Registration Number
- NCT04087460
- Lead Sponsor
- CanSino Biologics Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Middle-dose Group B Protein based pneumococcal vaccine placebo(Middle dose) Subjects received three doses of placebo Low-dose Group A Protein based pneumococcal vaccine(Low dose) Subjects received three doses of PBPV with 20μg each antigen Low-dose Group B Protein based pneumococcal vaccine placebo(Low dose) Subjects received three doses of placebo Middle-dose Group A Protein based pneumococcal vaccine(Middle dose) Subjects received three doses of PBPV with 50μg each antigen High-dose Group B Protein based pneumococcal vaccine placebo(High dose) Subjects received three doses of placebo High-dose Group A Protein based pneumococcal vaccine(High dose) Subjects received three doses of PBPV with 100μg each antigen
- Primary Outcome Measures
Name Time Method 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 14 and 30 post each vaccination Occurrence of abnormal changes of CK-MB,CTN,urine test and vital signs
- Secondary Outcome Measures
Name Time Method safety indexes of SAE within 180 days post vaccination Occurrence of SAE
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
Trial Locations
- Locations (1)
Suixian Center for Disease Control and Prevention
🇨🇳Shangqiu, Henan, China