IVI and South Africa

 

Ongoing Collaboration

 

Oral Cholera Vaccine Technology Transfer

In 2022, IVI initiated the technology transfer of OCV-S to South Africa’s Biovac to expand production while establishing and demonstrating Good Manufacturing Practice capacity for end-to-end vaccine manufacturing in Africa, for Africa. The project has entered an extension phase to support scale-up efforts, chemistry, manufacturing, and controls development; stability testing; clinical trial document preparation; and Investigational New Drug submission. 

 

Advancing Hepatitis E Control

IVI is generating critical epidemiological and clinical data to support the expanded use of Hecolin®, a hepatitis E virus vaccine approved for use in China and Pakistan. A Phase II clinical trial in Pakistan is evaluating the safety and immunogenicity of the vaccine in women to support WHO prequalification and other policymaking. In South Africa, a Phase IIb trial is assessing the safety and immunogenicity of the vaccine in children and adults. With about 860 participants enrolled in 2024, the study’s data will address critical evidence gaps, particularly regarding the inclusion of children in vaccine use recommendations and the administration of the vaccine to people living with HIV/AIDS. 

 

In the South African clinical trial, IVI is collaborating with Ardent Consulting, the Medunsa Clinical Research Unit, the Newtown Clinical Research Unit, OnQ Research, and Cytespace Africa Laboratories. 

 

This project is made possible by funding from the Gates Foundation, Open Philanthropy, and the Thrasher Research Fund. 

 

Establishment of assays for immunogenicity assessment of Rift Valley fever vaccines

In 2023, IVI began developing assays to assess Rift Valley fever vaccine immunogenicity. In 2024, IVI progressed in the production of Rift Valley fever glycoprotein complex-pseudovirus and the optimization of protein lengths for secretion in mammalian cells. These processes are integral to developing reliable and effective vaccine assays and will ensure that the immune response generated in Rift Valley fever vaccines is both strong and specific to the virus.

In South Africa, IVI is collaborating with Afrigen Biologics and Vaccines. 

 

This project is funded by the government of Sweden.

 

Previous Collaboration

 

Typhoid Surveillance in sub-Saharan Africa Program (TSAP)

From 2010 to 2014, IVI’s The Typhoid Fever Surveillance in Africa Program (TSAP) obtained comparable incidence data on typhoid fever and invasive nontyphoidal Salmonella (iNTS) disease in sub-Saharan Africa through standardized surveillance in ten countries (Burkina Faso, Ethiopia, Ghana, Guinea-Bissau, Kenya, Madagascar, Senegal, South Africa, Sudan, and Tanzania).

 

In South Africa, TSAP ran from 2012 to 2014, conducting surveillance in the Pietermaritzburg area in collaboration with the National Institute for Communicable Diseases, a division of the National Health Laboratory Service located in Johannesburg, which provided supplemental laboratory and technical support and the management of specimens.

 

Each TSAP site conducted passive surveillance for bloodstream infections among febrile patients to isolate and identify aerobic bacteria from the patients’ blood. Healthcare utilization surveys were conducted to adjust population denominators in incidence calculations for differing healthcare utilization patterns and improve comparability of incidence rates across sites. The results of TSAP indicated that enteric fever caused by Salmonella Typhi and non-typhoidal Salmonella are significant problems in Africa and that the prevalence of multi-drug resistance may limit appropriate treatment options.

 

Along with its new disease burden discoveries, TSAP and its collaborators strengthened local surveillance capacities at multiple sites across sub-Saharan Africa, creating a system that has improved bacterial disease diagnostics, disease surveillance, reporting, and analysis systems in the region.