A Randomized Control, Double Blinded, Non-inferiority Trial to Evaluate the Immunogenicity and Safety of Typhoid Vi Conjugate Vaccine 'Typhocon' in Bangladeshi Healthy Population
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 630
- 试验地点
- 1
- 主要终点
- Proportion of participants developing adverse events and serious adverse events
研究概览
简要总结
This is a double blinded, randomized-controlled, non-inferiority trial of a typhoid conjugate vaccine, Typhocon (Vi- polysaccharide conjugated to diphtheria toxoid, Vi-DT), manufactured by a local company, Incepta Vaccine Limited. The vaccine will be tested among individuals from 6 months to 60 years of age residing in Mirpur area of Dhaka city. The Typbar-TCV (Vi-polysaccharide conjugated to tetanus toxoid, Vi-TT), manufactured by Bharat Biotech International Limited will be used as a reference vaccine in this study.
In Phase I the Typhocon vaccine will be tested in 30 adults. Safety and immunogenicity data of the vaccine for 30 adults will be submitted to the Data Safety Monitoring Board (DSMB), IRB and Directorate General of Drug Administration (DGDA). Upon receiving approval letter, the investigators will initiate the Phase II study including 600 individuals. The Phase II study will be conducted in age de-escalation manner (6-23 months, 2-5 years, 6-17 years and 18-60 years). Equal number of participants of all age groups will be enrolled for vaccination. Blood specimens will also be collected for carrying out the clinical chemistry (complete blood count with differential for white blood count, hemoglobin, absolute neutrophil count, platelet count, serum alanine transaminase, serum creatinine) on day -7 to day -2 for screening of participants before vaccination and on day 28, postvaccination. Based on blood reports of clinical chemistry, 600 participants will be randomized in a 1:1 ratio to allocate Typhocon or Typbar-TCV vaccine. Memory aid will be used to collect solicited adverse events following vaccination (AEFI) data up to day 7. Data on unsolicited AEFI and serious adverse events (SAEs) will be collected up to 28 days after vaccination. All study update including adverse events and serious adverse events will be reported to the DSMB. Blood specimen will be obtained on day 0 before vaccination, and day 28 for carrying out Enzyme-linked Immunosorbent Assay (ELISA) to determine anti-Vi-IgG antibody.
详细描述
A double blinded, randomized-controlled, non-inferiority trial of a typhoid conjugate vaccine, Typhocon (Vi- polysaccharide conjugated to diphtheria toxoid, Vi-DT), manufactured by a local company, Incepta Vaccine Limited will be conducted. The vaccine will be tested among individuals from 6 months to 60 years of age residing in Mirpur area of Dhaka city. The Typbar-TCV (Vi-polysaccharide conjugated to tetanus toxoid, Vi-TT), manufactured by Bharat Biotech International Limited will be used as a reference vaccine in this study.
Hypothesis:
Locally produced typhoid conjugate vaccine 'Typhocon' is non-inferior in terms of safety and immunogenicity among healthy Bangladeshi population as compared to 'Typbar-TCV'.
Objectives:
- To evaluate and compare the safety of locally produced 'Typhocon' with 'Typbar- TCV'.
- To evaluate and compare the immunogenicity of 'Typhocon' with 'Typbar-TCV' in healthy population in Bangladesh.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a randomized double-blind study. Study investigators along with study staff involved in safety evaluation and laboratory analysis will be blinded regarding the assigned treatment of the participant. The vaccine administration team will be un-blinded to the treatment assignment list. The vaccine administrator team members will not be involved in the evaluation of vaccine safety and laboratory analysis. The DSMB will be responsible for un-blinding the randomization number codes in the event of severe putative vaccine reactions. Otherwise, the codes will not be revealed until the end of the trial and until the computerized dataset has been frozen. If the intervention assignment is un-blinded, all study collaborators will be notified immediately. If deemed necessary, the DSMBs will recommend unblinding to the IRB and contact the study statistician responsible for providing information on the vaccine received by the individual in question.
入排标准
- 年龄范围
- 6 Months 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide informed written consent from participants or if minor from their parent/legal guardian
- •Healthy participants aged 6 months to 60 years
- •Family does not have any plan to move from the study area during study period.
排除标准
- •History of hypersensitivity reaction to any component of the study vaccines.
- •History of typhoid vaccination within the last three years.
- •Fever of any origin or infections of more than 3 days within the past month.
- •Subjects with febrile illness (temperature >37.9 C) at the time of enrollment.
- •History of any vaccination within the past 30 days.
- •Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder.
- •Participants with abnormalities in screening hematological and biochemical tests will be excluded for vaccination
- •Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy.
- •Known case of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy.
- •Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study.
- •Urine dipstick pregnancy test verified as positive
- •Pregnant* and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization).
- •Urine pregnancy test (UPT) will be performed in all married females prior to vaccination
研究组 & 干预措施
Test vaccine group
300 participants will receive Typhoid Vi polysaccharide-diphtheria toxoid conjugate vaccine (Vi-DT)
Trade name: Typhocon®, Incepta Vaccine Ltd.
干预措施: Typhoid Vi polysaccharide-diphtheria toxoid conjugate vaccine (Vi-DT) (Biological)
Reference vaccine group
300 participants will receive Vi polysaccharide-tetanus toxoid conjugate vaccine (Vi-TCV)
Trade name: Typbar-TCV®, Bharat-Biotech International Limited.
干预措施: Typhoid Vi polysaccharide-diphtheria toxoid conjugate vaccine (Vi-DT) (Biological)
结局指标
主要结局
Proportion of participants developing adverse events and serious adverse events
时间窗: 28 days
Proportion of participants developing adverse events following immunization (AEFI) and serious adverse events (SAE). To estimate the proportion of safety data, the investigators will use memory aid, and AEFI and SAE forms to collect the data.
次要结局
- Immune response induced in vaccinees(6 months)