July 26, 2021 – SEOUL, Republic of Korea – The International Vaccine Institute (IVI) announced today the start of a cluster-randomized, controlled Phase IV trial to assess the effectiveness of Typbar® typhoid conjugate vaccine (TCV) in preventing typhoid infection in children in Asante Akim, Ghana conducted in collaboration with the Kwame Nkrumah University of Science and Technology (KNUST) and other partners. As part of the Typhoid Conjugate Vaccine Introduction in Africa (THECA) program, the Typhoid Conjugate Vaccine Effectiveness in Ghana (TyVEGHA) study aims to generate evidence to support critical decision-making for introduction of TCV into routine immunization programs in African countries with endemic typhoid.
A total of 23,000 eligible children and adolescents aged 9 months to <16 years will be vaccinated against typhoid, 11,500 with Typbar®-TCV and 11,500 with the control vaccine MenAfriVac. As the first cluster-randomized typhoid study in Africa, TyVEGHA will measure both individual- and population-level vaccine effectiveness, which are key data for estimating the real-life impact and cost-effectiveness of TCVs and ultimately supporting national introduction and uptake.
Dr. Florian Marks, Deputy Director General at the International Vaccine Institute (IVI) and Principal Research Associate at the University of Cambridge, said: “The start of the TyVEGHA study is an incredible milestone in the effort to prevent typhoid, generating key data to depict the full public health value of TCV and support the introduction of TCVs in national immunization programs. Congratulations to Dr. Ellis Owusu-Dabo and the KNUST team for paving the way for impact studies in high-burden African settings, and thank you to all THECA members and funders, including the European and Developing Countries Clinical Trial Partnership and the Bill & Melinda Gates Foundation, for their sustained collaboration to prevent and eliminate typhoid.”
Dr. Ellis Owusu-Dabo, Principal Investigator and Pro Vice-Chancellor of KNUST, said: “Our responsibility to this and future generations is to aspire to inspire before we expire, while leaving legacies for the next generation through collaborative research.”
Dr. Andrea Haselbeck, Senior Research Scientist at IVI and TyVEGHA Technical Lead, said: “Measuring the real-world effectiveness of Vi-TT in Asante Akim is a significant step forward in guiding TCV introduction in Ghana and other typhoid-endemic countries to protect more children from a vaccine-preventable disease.”
Earlier this month, IVI and KNUST commissioned an international collaborating center on the premises of the Agogo Presbyterian Hospital to conduct joint typhoid research such as the TyVEGHA study. In addition to serving as the main site for vaccination and follow-up activities of the immunogenicity subgroup, the KNUST-IVI Collaborating Center will remain a research and training site to implement ongoing and new collaborative projects, including disease surveillance and other vaccine clinical development and health economics studies, while developing the next generation of leaders in epidemiology and vaccine science.
The TyVEGHA study leverages collected epidemiological data from a typhoid surveillance network established in the Asante Akim District of Ghana as well as several other sub-Saharan African countries through the IVI-led Typhoid Surveillance in Africa Program (TSAP), which was completed in 2014, and the Severe Typhoid in Africa (SETA) program, which is ongoing. Data from both studies demonstrate high incidence of typhoid fever, particularly in children under 15, with steady transmission over the last 10 years.
With the Ghana FDA’s recent approval of Vi-TT for use in public health programs and the country’s extensive clinical trial experience, Ghana is well poised to demonstrate the benefit of TCV introduction in the region. In parallel, the THECA program will conduct a mass vaccination campaign in the Democratic Republic of Congo (DRC) and vaccine effectiveness will be assessed through a prospective cohort design.
Both THECA studies in Ghana and the DRC will complement ongoing TCV trials in Malawi, Bangladesh, and Nepal conducted by the University of Maryland-led TyVAC consortium to generate a robust understanding of indirect protection from TCV, long-term effectiveness, and cost-effectiveness. Learn more about global efforts to take on typhoid here.
About Typhoid Conjugate Vaccine Effectiveness in Ghana (TyVEGHA)
The TyVEGHA study is a participant- and observer-blinded cluster-randomized Phase IV trial with clusters randomized to receive Typbar®, a Vi-polysaccharide conjugated to a tetanus-toxoid protein carrier (Vi-TT), or MenAfriVac, a group A meningococcal polysaccharide-tetanus toxoid conjugate vaccine (MCV-A), to evaluate the effectiveness and safety of Vi-TT in Ghanaian children. The cluster-randomized design enables an assessment of individual-level effectiveness and population-level effectiveness including herd protection of vaccination for children aged 9 months to <16 years living in the Asante Akim District of Ghana for a period of 3 years.
Typhoid fever is an invasive water-borne bacterial infection caused by Salmonella enterica serovar Typhi (S. Typhi) presenting with mild to severe symptoms and even resulting in death. Typhoid is most often contracted through ingestion of food or drink contaminated by bacteria shed by infected people. It is usually characterized by fever, headache, constipation, and malaise, though diagnosis can be difficult due to symptoms common to other febrile illnesses. Figures for burden of disease vary due to this difficulty, however the World Health Organization estimates that 128,000-161,000 people die every year from typhoid fever with 11-21 million annual cases. Typhoid surveillance studies report that a quarter to more than half of all invasive cases are found in children under 5.
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 36 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
About Kwame Nkrumah University of Science and Technology (KNUST)
Established in 1951, KNUST is Ghana’s leading public tertiary institutions. The campus is situated about eight kilometres away from the centre of Kumasi, the Ashanti regional capital, and covers an area of about eighteen square kilometres. The School of Public Health is one of the five schools/faculties within the college of health sciences.
It works closely with the department of clinical microbiology of the School of Medicine and Dentistry and has established laboratories for the conduct of research. One such laboratory is located at the Agogo Presbyterian Hospital, where the KNUST-IVI collaborating center is located. The laboratories are equipped with state-of-the-art equipment to enable the smooth conduct of research. These holistic laboratories boast of microscopes, autoclaves, biosafety hoods, incubators, cooled centrifuges, ELISA readers, thermal cyclers, agarose gel electrophoresis set-up, transilluminator and Real time PCR machines.
Aerie Em, Global Communications & Media Specialist
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