Vellore Typhoid Vaccine Impact Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72,400
- 试验地点
- 1
- 主要终点
- Total effect
研究概览
简要总结
This cluster randomised trial will examine the impact of introducing TyphiBEV, a typhoid conjugate vaccine licensed in India, on the incidence of typhoid fever in a high burden urban setting in South India.
详细描述
TyphiBEV®, a typhoid conjugate vaccine from Biological E, has been licensed by the Central Drugs Standard Control Organaisation in India based on immunogenicity and safety data. A similar typhoid conjugate vaccine has been demonstrated in large clinical trials to provide 80% vaccine efficacy in Nepal and Bangladesh. The TyphiBEV® has not been similarly evaluated. The demonstration of the impact of a city-scale typhoid conjugate vaccine introduction on the burden of typhoid will aid policy decisions on the use of typhoid conjugate vaccines in the national immunisation program.
After written informed consent, the investigators will establish stimulated passive surveillance in 72,000 individuals between 1 and 30 years of age within the Vellore Demographic Surveillance System to determine the incidence of blood-culture confirmed typhoid fever. Thirty-six thousand surveillance participants between 1 year and 30 years residing in the 30 clusters (areas) randomised to receive the vaccine will receive the vaccine at the beginning of the trial. Those in other areas will receive the same at the end of two years. Using a stimulated passive surveillance approach, those with acute febrile illness will be encouraged to visit study surveillance hospitals. Participants will be evaluated for blood-culture confirmed typhoid fever if they are eligible. The incidence of typhoid among those living in areas assigned to vaccination compared to those whose residence is in areas not designated for vaccination will be used to calculate the impact of the vaccine on disease burden.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The control arm will not receive a vaccine, however the investigator and the outcome assessors will be trained not to seek history of vaccination. The clusters selected for vaccination and their boundaries will not be accessible to the investigators and outcome assessors.
入排标准
- 年龄范围
- 1 Year 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For adults, 18 years and over - they must be willing and competent to provide informed consent
- •For those aged under 18 years, the parent/guardian is willing and competent to provide informed consent, and if the participant is 11 to 18 years of age, informed assent will also be sought,
- •Between 1 and 30 years (i.e., up to 29 years 364 days) at time of recruitment into the surveillance
- •Currently living within the study catchment area with no plans to leave the study area in the next 24 months
排除标准
- •For fever surveillance
- •o Medical reasons that prevent the participant from complying with study requirements including follow up and testing during illness
- •For vaccination
- •Has received a typhoid vaccine in the previous three years
- •Is known to have an allergy to any vaccine component
- •Nursing mothers, Pregnancy or planning pregnancy around vaccination
- •Receipt of any other vaccine in the past 30 days (temporary exclusion)
- •Febrile illness in the 24 hours before vaccination (temporary exclusion)
研究组 & 干预措施
Vaccinated arm
Typhoid Conjugate Vaccine (TyphiBEV) 0.5 ml as a single dose given intramuscularly to consenting, eligible residents of vaccine clusters
干预措施: Typhoid conjugate Vaccine (Biological)
Control arm
No vaccination in the control clusters
结局指标
主要结局
Total effect
时间窗: at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters.
Number of blood culture confirmed typhoid fever episodes in vaccinated participants from vaccine clusters compared to the number of blood culture confirmed typhoid fever episodes in unvaccinated participants from non-vaccine clusters
次要结局
- Overall effect(at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters.)
- Effect on all febrile illness requiring healthcare visits(at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters.)
- Safety outcomes(Seven days after vaccine receipt)
- Effect in children 1 to 14 years(at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters.)
研究者
Jacob John
Professor
Christian Medical College, Vellore, India