A Randomized, Double-blind, Positive Controlled Phase Ib/II Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Adults Aged ≥18 Years
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 385
- 试验地点
- 1
- 主要终点
- Incidence of adverse reactions
研究概览
简要总结
A Phase Ib/II clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24)developed by Sinovac Life Science Co., Ltd will be conducted in adults aged ≥18 years.
The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, Positive Controlled phase Ib/II clinical trial.
详细描述
A phase Ib/II clinical trial of the study of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV24) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in Chinese adults aged ≥18years.
The trial is a randomized, double-blind, positive controlled study. The objective of this study is to evaluate the safety and immunogenicity of PCV24 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine is Pneumovax® manufactured by MSD.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged ≥18 years, who can provide legal identification documents
- •Fully understand and agree to sign the informed consent form
- •Willing and able to follow all study procedures and stay in contact during the study
排除标准
- •Received any pneumococcal vaccine;
- •History of invasive pneumococcal diseases or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
- •History of allergy or serious adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioedema and anaphylactic shock;
- •Congenital malformations or developmental disorders, genetic defects, severe malnutrition;
- •Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases, metabolic diseases, hematological diseases,liver and kidney diseases, digestive diseases, respiratory diseases , malignant tumors and major functional organ transplantation history;
- •Autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis,autoimmune thyroid disease, asplenia, functional asplenia, HIV infection);
- •Abnormalities in coagulation function (such as deficiency of coagulation factors, coagulation disorders, and abnormalities of platelets);
- •Have/have suffered from a serious neurological disorder (epilepsy , convulsions or seizures) or mental illness or have a family history of such diseases;
- •Long-term alcohol or drug abuse;
- •Have received > 14 days of immunosuppressive or other immunomodulatory therapy((such as prednisone ≥20 mg/day, or an equivalent dose)) in the past 6 months, or cytotoxic therapy, or plan to receive such therapy during the study period;
- •Received immunoglobulin or other blood products within 3 months before receiving the l vaccine, or plan to receive such treatment during the study period;
- •Received other investigational drugs or vaccines within 30 days before receiving the vaccine, or plan to receive such drugs or vaccines during the study;
- •Received live attenuated vaccine within 14 days before receiving the vaccine;
- •Received subunit or inactivated or other vaccine within 7 days before receiving the vaccine;
- •Acute diseases or acute onset of chronic diseases within the past 7 days , or known or suspected active infection;
- •Women who are breastfeeding or pregnant, or women of childbearing potential who plan to become pregnant or have egg donation plans from the time of signing the informed consent form until 6 months after the study intervention;
- •Participants who have a fever on the day of the planned trial vaccine, with an axillary temperature >37.0°C before vaccination;
- •Abnormalities in clinical laboratory indicators that exceed reference range and are clinically significant(Applicable only to phase Ib)
- •In the investigator's judgment, the participant has any other factors that make him or her unfit to participate in the clinical trial.
研究组 & 干预措施
Low-dosage PCV24 (phase Ib)
12 Participants aged 18-49years and 12 Participants aged ≥50years will receive Sinovac Low-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose
干预措施: Sinovac Low-dosage PCV24 (Biological)
Middle-dosage PCV24(phase Ib)
12 Participants aged 18-49 years and 12 Participants aged ≥50years will receive Sinovac Middle-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose
干预措施: Sinovac Middle-dosage PCV24 (Biological)
High-dosage PCV24(phase Ib)
12 Participants aged 18-49years will receive Sinovac High-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose
干预措施: Sinovac High-dosage PCV24 (Biological)
Pneumovax®(phase Ib)
12 Participants aged 18-49years and 6 Participants aged ≥50years will receive Pneumovax®(PPV23) . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose
干预措施: Pneumovax® (Biological)
Low-dosage PCV24(phase II)
50 Participants aged 18-49years and 50 Participants aged ≥50years will receive Sinovac Low-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose
干预措施: Sinovac Low-dosage PCV24 (Biological)
Middle-dosage PCV24(phase II)
50 Participants aged 18-49years and 50 Participants aged ≥50years will receive Sinovac Middle-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose
干预措施: Sinovac Middle-dosage PCV24 (Biological)
Pneumovax®(phase II)
50 Participants aged 18-49years and 50 Participants aged ≥50years will receive Pneumovax®(PPV23) . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose
干预措施: Pneumovax® (Biological)
结局指标
主要结局
Incidence of adverse reactions
时间窗: 0-30 days after vaccination
Incidence of adverse reactions of different doses of PCV24 in adults aged ≥18 years within 30 days after vaccination
Pneumococcal serotype-specific opsonophagocytic assay (OPA) geometric mean titer (GMT) (phase II)
时间窗: 30 days after vaccination
OPA GMT 30 days after vaccination
Proportion of pneumococcal serotype-specific OPA antibody titer increase≥4-fold(phase II)
时间窗: 30 days after vaccination
Proportion of OPA antibody titer increase≥four folds 30 days after vaccination
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)(phase II)
时间窗: 30 days after vaccination
IgG GMC 30 days after vaccination
Proportion of pneumococcal serotype-specific IgG antibody concentration increase≥4-fold(phase II)
时间窗: 30 days after vaccination
Proportion of IgG antibody concentration increase≥four folds 30 days after vaccination
次要结局
- Incidence of clinically significant abnormality in laboratory examination tests(phase Ib)(0-3 days after vaccination)
- Incidence of adverse reactions(0-7 days after vaccination)
- Incidence of serious adverse reactions(SAE)(0-6 months after vaccination)
- Pneumococcal serotype-specific OPA GMI(phase II)(30 days after vaccination)
- Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)(phase II)(30 days after vaccination)