A Phase Ⅰa Randomized,Double-Blind, Placebo-controlled Clinical Trial to Preliminary Evaluate the Safety and Immunogenicity of Protein Based Pneumococcal Vaccine（PBPV） in Healthy People Aged Between 18 and 49 Years Old
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Safety indexes of solicited and unsolicited adverse reactions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Safety indexes of solicited and unsolicited adverse reactions
时间窗: 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
时间窗: day 14 and 30 post each vaccination
Occurrence of abnormal changes of CK-MB,CTN,urine test and vital signs
次要结局
- safety indexes of SAE(within 180 days post vaccination)
- immunogencity indexes of the seropositivity rates by ELISA(day 8, 14,30,60 post each vaccination)
- immunogencity indexes of GMC and GMI by ELISA(day 8, 14,30,60 post each vaccination)