A Seamless Phase II/III, Observer-blind, Multi-centre, RandomizedClinical Trial to Evaluate Immunogenicity and Safety of BBV87, anInactivated Chikungunya Virus Vaccine in Healthy Subjects 12-65Years of Age
试验速览
- 阶段
- 2/3 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 8
- 主要终点
- Immunogeneity
研究概览
简要总结
Study Title: A Seamless Phase II/ III, Double-blind, Multi-centre, Randomized Clinical Trial to Evaluate Immunogenicity and Safety of BBV87, an Inactivated Chikungunya Virus Vaccine in Healthy Subjects 12-65 Years of Age
Protocol ID: BBIL/CHIKV/II-III/2019
Clinical Development Phase: Phase II/III
Study Indication: Active immunization for prevention of Chikungunya virus (CHIKV) infection
Number of Study Sites: The study will be conducted at approximately 8 sites across India
Name of the Investigational Vaccine: Inactivated Chikungunya Virus Vaccine (BBV87)
Name of Control Vaccine: Phase II and Phase III: Placebo
Phase II
Study Design: The current study is designed as a seamless Phase II/III study in healthy subjects, with Phase II being an age de-escalation, dose finding study followed by a Phase III study, which is aimed at evaluation of safety, immunogenicity and lot-to-lot consistency of BBV87. The immunogenicity and safety data of 600 subjects randomized in Phase II study receiving BBV87 low dose /BBV87 high dose/placebo in a two-dose schedule, will be presented to the Data and Safety Monitoring Board (DSMB). Post approval from DSMB, the dose strength of BBV87 to be used in the Phase III study will be selected and the Phase III study will be initiated to randomize approximately 1000 subjects.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male and female subjects aged between 12 to 65 years (both inclusive).
- •Subject or Subject’s Parent should be willing to give voluntary written informed consent and/or assent prior to inclusion in the study.
- •Must be able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary.
- •Willing to consent to the storage and future use of biological samples for CHIKV related research.
- •Male subjects who are sexually active or married and female subjects who are sexually active or married and are of child-bearing potential should be willing to follow effective birth control methods for at least 3 months after the last dose of vaccine.
排除标准
- •History of rheumatoid arthritis and moderate or severe arthritis or arthralgia within past 90 days prior to Screening visit. -Subject a known case of diabetes mellitus (Type 1 and 2). -History of degenerative neurological disease (e.g. Guillain Barre Syndrome, Multiple Sclerosis). -Any clinically significant laboratory values or illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints. -History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine. -Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature ≥ 38°C or ≥ 100.4 °F) within 48 hours prior to vaccination. -Subject has history of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease (e.g. Systemic Lupus Erythematosus, autoimmune thyroid disease). -Subject has history of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease (e.g. Systemic Lupus Erythematosus, autoimmune thyroid disease). -Subjects who are pregnant or breast feeding. -Prior major surgery or any radiation therapy within 4 weeks of Screening visit. -Positive serologic test for HIV 1 and 2, hepatitis B surface antigen (HBsAg); or any potentially communicable infectious disease as determined by the Investigator. -Current (within 14 days prior to Screening visit) or anticipated concomitant immune-modifying or immunosuppressive therapy (excluding inhaled, topical skin or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day). -Receipt of licensed vaccines within 30 days prior to first vaccination. -Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation 90 days prior to screening visit.
- •Active addictive drug or alcohol use or dependence that, in the opinion of the Investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints. -Participating in another clinical trial within 30 days prior to Screening visit or planning to participate during the study -History of participation in Investigational Chikungunya virus vaccine trial. -Any other condition which in the opinion of the Investigator may affect subject’s safety or participation.
结局指标
主要结局
Immunogeneity
时间窗: Immunogeneity | 1.Immune Response following two doses: | Geometric mean titres of CHIKV antibodies estimated by PRNT50 | 2.Safety and Tolerability: | a. occurring up to 7 days following each vaccination. | b. occurring up to 28 days following Dose 2 (Visit 3) | c. occurring post Visit 3 and up to end of study
1.Immune Response following two doses:
时间窗: Immunogeneity | 1.Immune Response following two doses: | Geometric mean titres of CHIKV antibodies estimated by PRNT50 | 2.Safety and Tolerability: | a. occurring up to 7 days following each vaccination. | b. occurring up to 28 days following Dose 2 (Visit 3) | c. occurring post Visit 3 and up to end of study
Geometric mean titres of CHIKV antibodies estimated by PRNT50
时间窗: Immunogeneity | 1.Immune Response following two doses: | Geometric mean titres of CHIKV antibodies estimated by PRNT50 | 2.Safety and Tolerability: | a. occurring up to 7 days following each vaccination. | b. occurring up to 28 days following Dose 2 (Visit 3) | c. occurring post Visit 3 and up to end of study
2.Safety and Tolerability:
时间窗: Immunogeneity | 1.Immune Response following two doses: | Geometric mean titres of CHIKV antibodies estimated by PRNT50 | 2.Safety and Tolerability: | a. occurring up to 7 days following each vaccination. | b. occurring up to 28 days following Dose 2 (Visit 3) | c. occurring post Visit 3 and up to end of study
a.Occurrence, relationship and severity of local and systemic solicited adverse events (AE)
时间窗: Immunogeneity | 1.Immune Response following two doses: | Geometric mean titres of CHIKV antibodies estimated by PRNT50 | 2.Safety and Tolerability: | a. occurring up to 7 days following each vaccination. | b. occurring up to 28 days following Dose 2 (Visit 3) | c. occurring post Visit 3 and up to end of study
b. Occurrence, relationship and severity of unsolicited AEs and serious adverse events (SAE)
时间窗: Immunogeneity | 1.Immune Response following two doses: | Geometric mean titres of CHIKV antibodies estimated by PRNT50 | 2.Safety and Tolerability: | a. occurring up to 7 days following each vaccination. | b. occurring up to 28 days following Dose 2 (Visit 3) | c. occurring post Visit 3 and up to end of study
c.Occurrence, relationship and severity of related unsolicited AEs, all SAEs and AEs- arthralgia, myalgia
时间窗: Immunogeneity | 1.Immune Response following two doses: | Geometric mean titres of CHIKV antibodies estimated by PRNT50 | 2.Safety and Tolerability: | a. occurring up to 7 days following each vaccination. | b. occurring up to 28 days following Dose 2 (Visit 3) | c. occurring post Visit 3 and up to end of study
次要结局
- Immunogenicity:(1.a.Immune Response following two doses: Percentage of subjects achieving seroconversion of CHIKV antibodies.)