Epidemiology division at NICED, has been involved in research projects on epidemiology of diarrhoea - observational, intervention and operational research projects like micronutrient supplementation and albendazole administration to children and its impact on growth and diarrhoeal incidence.
NICED in collaboration with International Vaccine Institute, Seoul, Korea initiated a project titled “Surveillance for typhoid fever and cholera in eastern Kolkata, West Bengal, India” in 2002, to generate accurate epidemiologic, socio-behavioral, and economics data on typhoid fever and cholera in impoverished slum area populations of eastern Kolkata in preparation for field trials of vaccines against these two diseases. It is basically a healthcare facility-based passive surveillance; nested case-control studies done among urban slum population (60,000) of Kolkata in ward 29 and 30.
It was followed by the typhoid (Vi) vaccination trial titled “Randomized controlled evaluation of protection by the Vi polysaccharide vaccine against typhoid fever in eastern Kolkata, West Bengal, India” among 60, 000 urban slum population in 2004 with a coverage of 69%. The study population was followed up for 2 years to estimate the effectiveness of the vaccine. The study ended in 2007.
Simultaneously NICED -IVI undertook a phase II trial to study the safety and immunogenicity of the bivalent whole cell killed oral cholera vaccine in Kolkata among healthy volunteers aged 1 year and above. It was proven to safe and immunogenic.
This was followed by a Phase III study on the same vaccine titled “A Randomized Controlled Trial of The Bivalent Killed Whole Cell Oral Cholera Vaccine in Eastern Kolkata, West Bengal, India” among 110,000 urban slum populations in ward 29, 30 and 33 of Kolkata Municipal Corporation. It was a double dose vaccine with 2 weeks gap in between the doses. The coverage was 61% for the two doses. The vaccination ended in September 2006. Post vaccination surveillance will continue for 3 years.
In built in these trials were socio-behavioral and economic studies on typhoid fever and cholera to estimate the economic costs of cholera and typhoid fever in the community as also community perception about these diseases. In 2007, NICED-IVI conducted a trial to compare the immune response of the cholera vaccine after one dose as against the regular two doses. Preliminary results show significant rise in vibriocidal titre after one dose of the vaccine which may pave the way for introducing this vaccine in public health program of India especially in endemic areas to combat cholera epidemics.
NICED has already undertaken a large community based randomized placebo-controlled blinded trial to study the efficacy of probiotic in preventing diarrhoeal diseases among the children 1-5 years of age, in collaboration with Yakult Honsha, Japan. The diarrhoea episodes were followed up in the community. The study included anthropometric measurements of the children, identification of causative organisms and intestinal microflora assessment. Final analysis is underway.
A multi centric diarrhoeal diseases burden study among under 5 years children, is already on, in collaboration with University of Maryland. It is a large community based case control study among 2,00,000 populations who are urban slum dwellers in Kolkata. The study includes identification and stool sample collection of severe diarrhoea cases and matched controls and finally isolation of diarrhoeal pathogens in both groups. Later a phase II trial is to be conducted with the same cholera vaccine among the infants to ensure safety and immunogenicity in that age group.
In the coming years the Epidemiology division of NICED is planning to undertake several vaccine trials mainly in collaboration with IVI. A phase II trial with live oral typhoid vaccine (ZH09) among children aged 2-17 years to see the safety, immunogenicity will be followed by large scale community based phase III trial with the same vaccine.
NICED is also planning a phase II safety trial of a live oral cholera vaccine (VA 1.4) in collaboration with Society for Applied Studies funded by Department of Biotechnology followed by a large scale Phase III study on 1,30,000 populations.
Other studies in the pipeline include phase II trial of Peru 15 (live oral cholera vaccine), mass vaccination project with the oral killed cholera vaccine in endemic areas keeping another set of population as reference population, efficacy study of one dose of the same cholera vaccine in collaboration with International Vaccine Institute.