IVI and India
IVI Member State
On 1 May 2012, India deposited an instrument of accession to the IVI Establishment Agreement with the United Nations, becoming IVI’s 35th state party.
The government of India is represented on the IVI Board of Trustees by Dr. Balram Bhargava.
Secretary of the Department of Health Research & Director General of the Indian Council of Medical Research.
On August 21, 2017, India agreed to become IVI’s 3rd state funder.
India contributes $500,000 USD annually to IVI in non-earmarked core budget support in order to facilitate the advancement of the UN Sustainable Development Goals and India’s development policy.
IVI Collaborating Center
In 2021, IVI and the Indian Council of Medical Research (ICMR) signed a memorandum of understanding to guide the establishment of an IVI Collaborating Center within ICMR. The IVI Collaborating Center will enable joint research, development, and capacity-building activities in vaccine research to achieve regional health objectives as well the UN Sustainable Development Goals.
Chikungunya Vaccine Development
IVI’s Global Chikungunya vaccine Clinical Development Program (GCCDP) is advancing the clinical development of Bharat Biotech International Ltd’s (BBIL) Chikungunya vaccine candidate (BBV87) through a Phase II/III randomized, controlled trial to evaluate the safety and immunogenicity of a 2-dose regimen of BBV87 Chikungunya vaccine in healthy adults at 9 clinical trial sites across 5 countries (Colombia, Costa Rica, Dominican Republic, Guatemala, Panama, and Thailand) with endemic Chikungunya. GCCDP is in partnership with BBIL and funded by the Coalition for Epidemic Preparedness Innovations (CEPI) with support from the Ind-CEPI mission of the Department of Biotechnology, India.
GCCDP seeks to develop and manufacture an affordable Chikungunya vaccine with the aim of achieving WHO prequalification to enable its distribution in low- and middle-income countries, consistent with CEPI’s core commitment to equitable access, affordability and sustainability. As needed, CEPI or BBIL may propose a third-party for manufacturing of a stockpile of investigational product to be used for further clinical trials in outbreak conditions to advance vaccine development, or pursuant to an emergency use authorization in emergency situations based on national or international guidance (such as by the WHO).
Oral Cholera Vaccine Technology Transfer
IVI is transferring the technology of its Oral Cholera Vaccine (OCV) to Bharat Immunologicals and Biologicals Corporation Limited (BIBCOL) in India. By increasing the number of OCV manufacturers, IVI can ensure sufficient supplies for the global OCV stockpile. As part of the technology transfer, IVI is providing training to BIBCOL staff and will conduct a phase III clinical trial of the vaccines to secure domestic licensure in India as well as WHO prequalification.
Supporting Typhoid Conjugate Vaccine Introduction
IVI’s Policy and Economic Research (PER) team is supporting the introduction of typhoid conjugate vaccine (TCV) as a routine immunization in India by conducting an economic evaluation of TCV vaccination in Navi Mumbai. The resultant cost of illness and cost-effectiveness analysis will help Indian policymakers understand the costs associated with TCV introduction, as well as the economic benefits derived by protecting communities from typhoid fever.
In 2008, in collaboration with India’s National Institute of Cholera and Enteric Diseases (NICED) in Kolkata, IVI established a laboratory to monitor immune responses to candidate vaccines in young children and infants. IVI and NICED worked together closely to locate, design, build, and equip that laboratory so it meets GCLP requirements. The joint IVI-NICED immune-monitoring laboratory is the first of its kind- a state of the art laboratory situated in one of the world’s largest urban slums that provides real-time analyses of immune responses induced by candidate vaccines in people living in this impoverished setting. The lab’s inauguration took place in spring 2009.
With support from the Bill and Melinda Gates Foundation (BMGF), IVI launched a 4-year study that explored the effects of chronic environmental enteropathy (CEE) in children in India and Bangladesh. IVI utilized the NICED Laboratory to follow approximately 600 children residing in an urban slum of Kolkata before and after vaccination with oral polio vaccine (OPV) and rotavirus vaccines during their first year of life.
Cholera Vaccine Development
Starting in 2004, IVI’s Diseases of the Most Impoverished (DOMI) initiative began investigating cholera in India. In collaboration with India’s NICED, IVI carried out a large scale cholera surveillance and phase II trial of the oral cholera vaccine in a Kolkata slum with approximately 60,000 residents. IVI arranged a technology transfer between Vabiotech and Shantha Biotechnics of Hyderabad in which Shantha obtained the technology to produce Vabiotech’s cholera vaccine. IVI and Shantha worked together on clinical trials and securing WHO prequalification for the new Shanchol vaccine. IVI and Shantha’s cholera vaccine is only one of three vaccines to have ever been developed through a product development partnership and receive WHO prequalification.
With a grant from BMGF, IVI a conducted Japanese Encephalitis disease burden study between 2000 and 2001 in Andhra Pradesh. The Hospital-based surveillance was conducted at two field sites in collaboration with the Indian Council of Medical Research (ICMR), the National Institute of Virology, and the state government of Andhra Pradesh.
North Korea Program
India’s NICED participated in IVI’s North Korea program by assisting with a two week “training of trainers” workshop in Vietnam in January 2010. This program helped build a sustainable training capacity in North Korea in such areas as epidemiology, disease surveillance, data management, diagnostic test, and vaccine evaluation.
Pediatric Dengue Vaccine Initiative (PDVI)
From 2008 to 2015, IVI carried a number of research projects on Dengue in India. In 2008, PDVI conducted face-to-face surveys of policymakers and other stakeholders regarding their views about dengue and the future introduction of dengue vaccines in India and Sri Lanka. In all, 54 officials from health ministries, major hospitals, research institutes, professional associations, municipal governments and Indian vaccine producers were interviewed. The study found that dengue is a major concern and a top infectious disease priority among both local and national governments, and there is generally a high interest among policymakers in introducing dengue vaccines once they become available. In 2009, the Field Site Consortium supported by IVI introduced a Laboratory Information Management System (LIMS), into the PDVI field site in Kolkata India.
IVI received a contract from Wyeth Vaccines (later Pfizer) in 2007 to support PneumoNet, a multi-country, hospital-based disease burden study in Asia designed to better define the incidence and serotype distribution of pneumococcal disease. This study, conducted jointly with Quintiles, Quest laboratories, and local hospitals, established sites in 5 countries (China, India, Indonesia, the Philippines, and Thailand). In 2009, IVI established 3 hospital sites in Bangalore, India for 2 years of prospective surveillance. The Bangalore site enrolled over 8,800 patients hospitalized with meningitis, pneumonia, or sepsis. Patient enrollment at the hospitals in Bangalore, India ended in 2011 and data from these field sites were presented at the European Society for Infectious Diseases (ESPID) meeting at The Hague, The Netherlands in June 2011.
With funding from the BMGF, IVI and India’s NICED conducted an observational study to see if there is a relationship between children with tropical enteropathy and those who do not respond well to oral polio and rotavirus vaccines. The study also identified if maternal breast milk has a role in the child’s immune response to vaccines, and how a child’s nutritional status is related to this problem. From 2012 to 2015, the study enrolled 372 infants at the hospital study site in Kolkata, India. All infants, as part of their routine immunization, received the EPI vaccines, as well as the oral rotavirus vaccine (Rotarix). For the polio vaccine, infants were randomized into two groups with one group receiving the injectable polio vaccine (IPV) and the other group receiving the oral polio vaccine. All of the lab tests were conducted at the IVI /NICED immune-monitoring laboratory.
Rotavirus Diarrhea Vaccine Program
From 2008 to 2011, IVI completed a surveillance study supported by the U.S. National Institutes of Health for rotavirus diarrhea among children under five years of age in Kerala’s Kolenchery city, India to estimate the disease burden of rotavirus and to determine if the two currently available rotavirus vaccines adequately protect against the various viral strains circulating in this area. In collaboration with the ICMR and the National Rotavirus Reference Laboratory in Vellore, Tamil Nadu, India, IVI established a surveillance system using a data collection form that was created by IVI and has now been adapted for use by the WHO in national rotavirus surveillance programs across Asia.
Along with the surveillance study’s paper-based data collection forms, mobile smartphones were pilot-tested as a method of data collection. The phone-based system, created in collaboration with IVI’s Biostatistics and Medical Geographic Unit, mirrors the paper-based data form and involves local physicians and nurses entering information into a data form visible on the phone’s touch screen. The system underwent evaluation by investigators in Kerala to understand the feasibility of implementation, acceptability among end-user clinicians, and potential for sustainability and application in public health programs when scaled-up across a larger geographic area.
Typhoid Vaccination Campaign
In November 2004, IVI launched a massive vaccination campaign with Vi-PS typhoid vaccine in Kolkata, India. 37,686 persons 2 years and older received the typhoid vaccine in a community-based trial. Following two years of disease surveillance after the vaccination campaign, IVI completed an analysis of the vaccine’s effectiveness for a post-licensure clinical trial in Kolkata. The results showed that the vaccine was highly effective in 2–4-year-olds.