June 14, 2022 – SEOUL, Republic of Korea – A new study jointly conducted by the International Vaccine Institute (IVI) and collaborators shows multidose and single-dose formulations of Vi-DT typhoid conjugate vaccine (TCV) are immunologically equivalent and safe for use in infants as young as 6 months to adults 45 years of age. The results of this study, published in The Lancet Regional Health – Western Pacific, provide critical evidence in supporting the use of alternative dosing formulations to facilitate flexible vaccine roll-out in settings with endemic and epidemic typhoid.
The first of its kind, this Phase 3, randomized, controlled, multicenter equivalence trial adds to the available evidence on the efficacy of TCVs in controlling and potentially eliminating typhoid in high-burden settings. With additional vaccine delivery options, Vi-DT TCV has the potential to protect more people through mass vaccination campaigns and the Expanded Programs on Immunization (EPI), a WHO initiative to ensure access to life-saving vaccines for all populations.
“Typhoid is a significant public health issue in several low- and middle-income countries and Vi-DT will make a vital difference in protecting vulnerable people—especially young children—from a serious but vaccine-preventable disease. Multi-dose vials play a crucial role in mass vaccination campaigns and this study paves the way for usage of Vi-DT in these campaigns,” said Dr. Sushant Sahastrabuddhe, Head of IVI’s Typhoid Program.
“Not only do the results of this study add to the body of evidence supporting the safety and efficacy of Vi-DT TCV in persons aged 2 years and older, the immune equivalence of multidose and single-dose formulations in infants as young as 6 months greatly enhances the ability to protect more people from typhoid. We’re grateful to our clinical trial site partners in the Philippines for their collaboration and to our vaccine manufacturing partner SK bioscience,” said Dr. Birkneh Tilahun Tadesse, Project Technical Lead and co-author of the study.
Vi-DT was developed at IVI and its technology was transferred to SK bioscience in 2013 for manufacturing and commercialization. Following a Phase 1 safety trial with participants aged 2-45 years and a Phase 2 trial with infants under 2 years in the Philippines, large-scale Phase 3 studies with a single dose of Vi-DT launched in the Philippines and Nepal in 2020. Vi-DT was shown to be safe in all trial participants and met its primary endpoints by the end of the year. On May 18, 2022, IVI and SK bioscience announced that the Korean Ministry of Food and Drug Safety granted an export license for SK bioscience’s TCV, SKYTyphoid. In collaboration with IVI, SK bioscience will seek WHO PQ certification for SKYTyphoid to begin supplying the vaccine globally as early as next year.
This article describes the Phase 3 clinical trial of Vi polysaccharide conjugated with diphtheria toxoid (Vi-DT), a new-generation TCV, among 1,800 healthy Filipino individuals between the ages of 6 months to 45 years. The Phase 3 trial was conducted by IVI in collaboration with four medical centers in the Philippines: University of the East Ramon Magsaysay Memorial Medical Center, Asian Hospital and Medical Center, Tropical Disease Foundation’s Medical Research Unit, and University of the Philippines Manila-National Institutes of Health, in partnership with SK bioscience and with support from the Bill & Melinda Gates Foundation.
About the International Vaccine Institute (IVI)
The International Vaccine Institute (IVI) is a nonprofit inter-governmental organization established in 1997 at the initiative of the United Nations Development Programme (UNDP). IVI has 39 countries and the World Health Organization (WHO) on its treaty, including Korea, Sweden, India, and Finland as state funders.
Our mandate is to make vaccines available and accessible for the world’s most vulnerable people. We focus on infectious diseases of global health importance such as cholera, typhoid, shigella, salmonella, schistosomiasis, chikungunya, group A strep, Hepatitis A, HPV, TB, HIV, MERS, COVID-19, as well as antimicrobial resistance. For more information, please visit https://www.ivi.int
Aerie Em, Global Communications & Media Specialist
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