Study of Field Application of Oral Cholera Vaccine, Shanchol for Use in Developing Country Settings
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,015
- 试验地点
- 1
- 主要终点
- Immunogenicity of Shanchol cholera vaccine
研究概览
简要总结
Background:
Cholera is a public health problem globally and in Bangladesh and its prevention is important. Despite recent availability of an effective and affordable oral cholera vaccine (OCV), its field application remains a challenge and needs to be addressed in carefully conducted research studies.There is lack of information on temperature sensitivity and resulting immunogenicity of Shanchol OCV and it is not known if administration of two doses of OCVs, one month apart, instead of currently recommended 14 days, to improve success of vaccination programme will be effective;also if one dose of the vaccine, instead of currently recommended two doses, would result in adequate immune response in population exposed to V. cholerae in an endemic country like Bangladesh.
Objectives:
To determine immunogenicity of Shanchol in adults. when:
- the vaccine is stored at three defined temperatures(25 oC ,37 oC and 42oC) for 14 days, before putting back in cold box for administration in the field and compare them with the response when the vaccine is stored under currently recommended temperatures.
- two doses of the vaccine administered one month apart and compared vaccines administered at currently recommended interval of 14 days.
- a single dose is administered and compare them with responses after recommended two doses.
Methods: The study will be conducted among adults living in the Mirpur community in urban Dhaka, the capital of Bangladesh.Studying safety and acute and long-term immune responses over a period of one year.
Outcome measures/variables:
- Objective 1: safety and immunogenicity of vaccine in adults after its storage at three defined temperatures (25oC ,37oC and 42oC) by measuring vibriocidal antibody responses and compare them with the findings when the vaccine is stored at currently recommended temperature of 2-8oC (recommended by manufacturer, Shantha Biotechnic).
- Objective 2: compare vibriocidal responses following administration of two doses of the vaccine one month apart and compare them with vaccination 14 days apart over a period of one year, with study of the memory responses over a one year period as a secondary outcome.
- Objective 3: compare acute immune responses (vibriocidal antibody) following one and two doses of vaccine, and compare memory response as a secondary outcome measure, over a one year period.
The above information is needed urgently for developing effective vaccination strategies for prevention and control of cholera in endemic countries.
详细描述
Cholera remains a major cause of morbidity and mortality in Bangladesh and many other endemic countries in the world.The WHO recommends using the cholera vaccine in both epidemic and endemic areas to control outbreaks.An affordable oral vaccine is now available for use in endemic settings; however, successful vaccination remains challenging and expensive due to the need for temperature-controlled distribution systems, which is difficult in most developing countries.Therefore, it would be important to test heat stability of the current vaccines without significantly compromising its safety and efficacy.
In cholera endemic populations their baseline immune responses and memory to the pathogen already exists. Therfore, a single dose of cholera vaccine could act as booster dose eliminating the need for the second dose, saving costs but more importantly significantly improving its delivery to large number of people within a very short time. However, that needs study in endemic countries, such as Bangladesh, to examine both acute and memory responses following a single dose and to determine how long they persist.
In the developing countries such as in Bangladesh, vaccination with two doses can be problematic, with logistic and cost issues. It is also difficult to administer two doses of the vaccine after an interval of 14 days - increasing the interval to one month would be more practical and that would improve coverage of large number of populations. It would, therefore, be important to examine if immunogenicity could be increased when the second dose is administered 30 days following the first dose.
Adult males and females living in the Mirpur community in urban Dhaka will be recruited in the study.The community will be informed by the field staff and interested persons will be recruited according to the inclusion/exclusion criteria.
Eligible participants will receive Shanchol vaccine according to study design. The vaccine comes in single-dose vials and is 1.5 mL in volume.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy individuals
- •Age: 18-45 years
- •Sex: Both male and female
- •Consent: Written informed consent form for participation in the study
排除标准
- •History of chronic illness, such as TB, hypertension, chronic asthma, diabetes
- •Gastrointestinal disorder such as abdominal pain or cramps, loss of appetite, nausea, vomiting or diarrhoea in the past 7 days
- •Intake of any anti-diarrheal medicine in the past one week or antimicrobial therapy in the past two weeks.
- •Any febrile illness in the past 7 days.
- •Receiving killed oral cholera vaccine any time in the past, and any other live or killed enteric vaccine in the last 4 weeks.
- •Immunocompromising condition or receipt of blood or blood products or parenteral immunoglobulin preparation in the past 3 months.
- •Females of reproductive age who are pregnant at the time of vaccination and follow up (determined by verbal screening e.g last menstrual period (LMP)).
研究组 & 干预措施
Shanchol stored at 2-8oC
Vaccines will be stored at 2-8oC before administration.
干预措施: Shanchol (Drug)
Shanchol stored at 25oC
Vaccines will be stored at 25oC for 14 days before administration.
干预措施: Shanchol (Drug)
Shanchol stored at 37oC
Vaccines will be stored at 37oC for 14 days before administration.
干预措施: Shanchol (Drug)
Shanchol stored at 42oC
Vaccines will be stored at 42oC for 14 days before administration.
干预措施: Shanchol (Drug)
结局指标
主要结局
Immunogenicity of Shanchol cholera vaccine
时间窗: 1 year
Immunogenicity of Shanchol vaccine will be measured by vibriocidal response in adults storing the vaccine at 2-8 0 c, 25 oC, 37 oC and 42oC
次要结局
- Immunogenicity by vibriocidal response(1 year)
- Acute and memory B and T cell responses(1 year)