IVI and Nepal
Member State Relations
On 30 May 1997, Ambassador of Nepal to the United Nations, H.E. Narendra Bikram Shah signed the Establishment Agreement of the International Vaccine Institute at UN headquarters in New York.
Ongoing Collaboration
Nepal Health Research Council (NHRC)
On 12 March 2021, IVI and the Nepal Health Research Council (NHRC) signed an MOU during a virtual ceremony, laying the foundation for the two organizations to build research and development capacity in Nepal and jointly pursue opportunities to improve public health in the region. As part of the MOU, IVI-NHRC collaborative efforts may include Good Clinical Practice and Good Clinical Laboratory Practice trainings at medical schools and hospitals, and vaccinology courses to train young scientists, healthcare workers, and researchers.
Enhancing Cholera Control (ECHO) – Nepal
Since 2020, IVI’s ECHO program has been conducting a major cholera control and prevention project in Nepal, which included oral cholera vaccine (OCV) vaccination campaigns combined with Water, Sanitation, and Hygiene (WASH) activities, disease surveillance, and the development and approval of a National Cholera Control Plan.
In 2024, the project made substantial progress completing surveillance activities in Nepal.
IVI works in close collaboration with the Ministry of Health and Population, the National Public Health Laboratory, Seti Zonal Hospital, Nepal Medical College, New Era, and the Department of Health Services in Nepal. This program is made possible with funding from the Korean International Cooperation Agency’s Global Disease Eradication Fund, LG Electronics, and the Korean Support Committee for IVI.
RSV Clinical Trial
IVI supports a Phase III multi-country study designed to evaluate the efficacy, immunogenicity, and safety of Sanofi Pasteur’s respiratory syncytial virus (RSV) vaccine in infants and toddlers. The trial aims to enroll 6,300 infants and toddlers worldwide, with IVI leading trial operations in Nepal, where 900 participants have been enrolled as of September 2024. There is a parallel focus on strengthening clinical trial research capabilities in Nepal.
This trial is done in collaboration with Dhulikhel Hospital, Kanti Children’s Hospital, and Nepalgunj Medical College with funding from Sanofi.
Global HPV Burden Study
In late 2022, the Bill & Melinda Gates Foundation granted $14.99 million USD to an IVI-proposed HPV global disease burden study with $1 million in cofounding from the Swedish government through IVI’s European Regional Office.
This harmonized, multi-country and multi-site study will estimate the prevalence of high-risk HPV genotype infections among representative samples of girls and women aged 9-50 years, and among specific sub-populations, to better understand the incidence of persistent HPV infection in girls and women in low- and lower middle-income countries in Asia and sub-Saharan Africa. Project host countries include Bangladesh, Nepal, Pakistan, the Democratic Republic of the Congo, Ghana, Sierre Leone, Tanzania, and Zambia.
During the tenure of this program, 33 substudies of four types, including cross-sectional surveys in general populations, longitudinal studies, special population studies, and qualitative studies will be launched.
Data will also be collected on girls’ and women’s knowledge, attitudes, and beliefs about HPV and vaccination, and on risk factors for HPV infection and explore barriers to prevention, screening and treatment access for girls and women.
The results of this study will enable a more accurate understanding of the HPV disease burden as well as barriers to effective interventions at the country and global level, will better inform policymakers and health program designers, and encourage prioritization of research and development efforts towards those with the greatest potential public health impact.
In Nepal, IVI works with Dhulikhel Hospital, B.P. Koirala Institute of Health Sciences, and New Era.
Shigella Surveillance Study
IVI’s prospective surveillance study will estimate the burden of shigellosis, a disease caused by the Shigella bacterium, in Nepal in children under five. By generating data on the proportion of cases, disease severity, antimicrobial resistance profile, and serotype distribution among children with diarrhea in the country, this study will help funders, public health officials, and policymakers allocate resources effectively and promote the development of vaccines and other strategies to control shigellosis.
In Nepal, IVI works with Kanti Children’s Hospital, B.P Koirala Institute of Health Sciences, and Nepalgunj Medical College, with funding from the Government of Sweden through the IVI Europe Regional Office.
Capturing data on Antimicrobial resistance Patterns and Trends in Use in Regions of Asia (CAPTURA)
The IVI-led CAPTURA project played a pivotal role in expanding historical and current datasets on AMR and antimicrobial usage through extensive data collection efforts across Southeast and South Asia. Building on its successes, CAPTURA II aims to further improve the quality, quantity, analysis, and dissemination of AMR data. This phase focuses on refining methodologies in data collection, stronger monitoring of how surveillance systems are performing, better data management practices, and supporting sustainable improvements in these surveillance systems.
The project runs from 2023 through 2025, directly informing national and regional initiatives to help:
- Improve AMR surveillance
- Promote antimicrobial stewardship
- Shape evidence-based policy
Countries: Bangladesh, Bhutan, Indonesia, Laos, Nepal, Pakistan, Papua New Guinea, Sri Lanka, Viet Nam
Strengthening External Quality Assurance for AMR in Asia (EQAsia)
The Technical University of Denmark is leading a consortium with IVI and the Veterinary Faculty at Chulalongkorn University in Thailand with the Strengthening External Quality Assurance for AMR in Asia (EQAsia) project. During the first phase, the consortium identified and mapped coverage of external quality assurance programs on the continent, providing seven rounds of services and relevant trainings to National Reference Laboratories and Centers of Excellence across One Health sectors. In the next phase, launched in 2023, partners provide four additional rounds of external quality assurance to more than 80 laboratories and centers in Asia and support two countries in establishing national external quality assurance programs to build up their capacity to independently conduct One Health-focused external quality assurance.
Regional Antimicrobial resistance Data Analysis for Advocacy, Response and policy (RADAAR)
This initiative improves regional data sharing and analysis for use in AMR planning, policy, and advocacy. The project laid the groundwork to strengthen the capacities of low- and middle-income countries to translate AMR knowledge – from data and evidence to effective policies. In 2024, RADAAR initiated the Evidence-Informed Policy Network with the World Health Organization in Bhutan, hosted a series of policy webinars, initiated online training modules, and conducted a systematic literature review on the economic evaluations of AMR.
Countries: Bangladesh, Bhutan, Cambodia, Cameroon, Eswatini, Ghana, Indonesia, Kenya, Laos, Malawi, Nepal, Nigeria, Pakistan, Papua New Guinea, Senegal, Sierra Leone, Tanzania, Timor-Leste, Uganda, Vietnam, Zambia, Zimbabwe
Technical Assistance for Clinical Engagement – Asia (TACE Asia)
The TACE Asia project focuses on providing technical support to improve the use of laboratory services and generation of good quality and representative AMR and antimicrobial use data in the human health sector. This will be done through support for clinical engagement and training on the use of simplified protocols to generate AMR burden data in select Fleming Fund priority countries. Launched in 2024, the program is contributing to the use of data on clinical practice and decision-making, improving rational use of antimicrobials, promoting antimicrobial stewardship, and shaping evidence-based practice.
Countries: Bangladesh, Bhutan, Indonesia, Laos, Nepal, Pakistan, Papua New Guinea, Sri Lanka, Timor-Leste, Viet Nam
Technical Assistance for Data and Evidence Use (TADEU)
The TADEU project was launched to provide technical assistance to support data production and improve the use of AMR data and evidence, with a particular focus on the economic evaluations of AMR.
In 2024, the project:
- Developed a micro-costing tool to help governments plan future AMR surveillance by informing financial implications, sustainability, and outcomes of AMR surveillance.
- Developed protocols and tools to measure the impact of antimicrobial stewardship programs as well as the economic burden of AMR.
- Completed literature reviews on existing methodologies and frameworks for econometric modeling and quantifications for AMR economic burden and impact measurements of stewardship programs.
- Developed a technical guide for the Political Economy Analysis framework.
Countries: Bangladesh, Indonesia, Laos, Nepal, Pakistan, Papua New Guinea, Timor-Leste, Viet Nam
International Vaccinology Course
Since 2000, Over 30 Nepalese health officials have received training in IVI’s International Vaccinology Course.
Previous Collaboration
COVID Vaccine Clinical and Operational Alliance (COCOA)-H
IVI is collaborating with SK bioscience through the COCOA consortium to advance the development of SK’s COVID-19 recombinant protein nanoparticle vaccine with funding from CEPI. The funding for COCOA-H was awarded in June 2022, and IVI is responsible for leading the phase III heterologous booster clinical trial.
The study title is “A Phase III, Placebo-controlled, Randomized, Observer-blinded, Multi-national, Multi-center Study to Assess the Safety, Reactogenicity, and Immunogenicity of Heterologous Booster Vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) adjuvanted with AS03 in Adults Aged 18 Years and Older’’.
The primary objective is to assess and compare the immune responses against the original strain prior to and post heterologous dose of GBP510 25µg adjuvanted with AS03 and demonstrate superiority in adults aged 18 years and older without prior of SARS-CoV-2 infection. Another primary objective is to assess the immune response against circulating variants of concern (i.e., Omicron variant) induced by a single heterologous booster dose of GBP510 25µg adjuvanted with AS03 (a subset of at least approximately 10% participants may be randomly selected from the Test and Placebo groups in each cohort).
Participants will have to receive 2 doses of primary vaccination from 6 predefined cohort at least 12 weeks before being recruited and will be followed up for 12 months after recruitment. The participants will be unblinded after 4 weeks of recruitment and Placebo group population will be advised to receive booster vaccine that are available in their country.
The consortium agreement was executed in June 2022, and we identified our partner CRO(s) as well as study sites.
Recruitment is completed in both Nepal and Colombia in early August 2023. The 3rd DSMB meeting was completed in July 2023 and no safety concern was raised. Preparation for interim analysis is ongoing and will be completed in early 2024. Study activities are ongoing in both countries without any major roadblocks.
COVID-19 Vaccine Development
IVI and Nepal are contributing to a global Phase III trial to evaluate the efficacy of Sanofi and GSK’s vaccine candidate targeting the original SARS-CoV-2 virus as well as circulating variants. The trial expects to enroll 4,000 volunteers across 3 study sites in Nepal. In addition to generating local data to support the global clinical trial, the study will continue to build capacity and infrastructure for vaccine research and development in Nepal.
Typhoid Vaccine Development
IVI developed a a new-generation typhoid conjugate vaccine (TCV) that distinguishes itself from other typhoid vaccines with its immunogenicity in young children. IVI transferred the technology to SK bioscience of South Korea, Bio Farma of Indonesia, and Incepta of Bangladesh, and is currently working with SK bioscience and Bio Farma on clinical development for licensure and WHO prequalification, currently targeted for the end of 2022.
Large-scale Phase III studies with a single dose of Vi-DT started in the Philippines and Nepal in 2020. While the Philippines study is nearing completion, a pivotal trial involving four hospitals in Kathmandu, Dhulikhel, Dharan, and Nepalgunj has shown that the Vi-DT test vaccine was safe, immunogenic, and non-inferior to the WHO prequalified Vi polysaccharide-tetanus toxoid (Vi-TT) Typbar TCV vaccine in individuals aged 6 months to 45 years.
Oral Cholera Vaccine (OCV) Reformulation
In 2019, IVI received a grant from the Bill & Melinda Gates Foundation to explore a reformulation of OCV that could lower the cost of Euvichol production by 20% and increase production capacity of Euvichol by 35%. The clinical trial to compare the lower cost formulation to Shanchol began enrollment in Nepal in October 2021 with expected completion in September 2022 and a final study report in 1Q1 2023.
Hepatitis E
As part of the Enhancing Cholera Control (ECHO) cholera surveillance program, IVI and its partners in Nepal began an HEV epidemiological survey in 2021. The survey involves door-to-door visits to conduct interviews and collect blood samples among select cluster populations. The results will be used to determine the seroprevelance of HEV across age groups and ecological zones, help understand the associated risk factors for HEV seropositivity, and help inform public health decision makers on strengthening the national waterborne disease surveillance system and the future introduction of HEV vaccines.
In November 2015, IVI sponsored and supported a Hepatitis E Symposium in Kathmandu, Nepal that was organized by the Nepali government. Following the massive earthquakes that struck Nepal earlier in the year, there were concerns about outbreaks of waterborne diseases such as cholera, typhoid, and hepatitis E. While cholera and typhoid were well-known, less was known about hepatitis E. The symposium aimed to present and share Hepatitis E data among local public health and medical professionals and government officials and to discuss how to prevent, control and manage the disease in Nepal. Topics such as Hepatitis E epidemiology and surveillance, diagnostics, clinical presentation and management, impact on pregnant women, and preventive measures and vaccination were presented.
Typhoid Vaccination
IVI vaccination campaigns led to over 140,000 Nepalese school children receiving the Vi-PS typhoid vaccine. In collaboration with MITRA Samaj and with funding from the Bill & Melinda Gates Foundation, the 2011 vaccination campaigns introduced an innovative cross-subsidization financing system, in which a $2.50 user fee from workers in the tourism sector funded free vaccinations for school children in Lalitpur and Bakhtapur districts. More than 2,000 tourism sector workers were immunized, and the school-based campaign immunized 140,873 students in the two districts.
Case-control studies ran from 2012 to 2013 in Kathmandu to assess the impact of vaccination, and in 2012 the National Committee on Immunization Practices (NCIP) convened a seminar with IVI, local media, policymakers, and stakeholders in Kathmandu to share findings from the vaccination campaign and to discuss strategies on typhoid control. The meeting culminated in an endorsement by the Health Secretary on the use of typhoid vaccines and a commitment by the local government to expand the vaccination campaign to high-risk areas and groups in Kathmandu.
Cholera Vaccination
Using the IVI-developed Oral Cholera Vaccine, IVI conducted vaccination campaigns in Nepal against endemic and epidemic cholera. In response to the 2015 earthquake, IVI provided its cholera vaccine to 9,000 people in Dhading and Nuwakot, and a 2017 initiative saw 27,000 people in Banke receive IVI’s cholera vaccine.
Supporting Independent Immunization and Vaccine Advisory Committees (SIVAC)
The Government of Nepal signed an agreement with IVI for its SIVAC team to provide technical assistance to the country’s National Committee on Immunization practice (NCIP), which was established in 2008. Working with the WHO Nepal county office, the WHO Southeast Asia regional office (SEARO), and the US CDC, SIVAC assisted the NCIP in developing a concept paper for its charter. In 2013, SIVAC co-organized a study tour in Canberra, Australia for a delegation from Nepal to observe the Australian Technical Advisory Group on Immunization.