In an effort to produce vaccines where they are needed most, IDRI (Infectious Disease Research Institute) is collaborating with the Cape Town, South Africa, based biotechnology startup company Afrigen Biologics, founded by the Industrial Development Corporation of South Africa Limited and IDRI, and its production partner the Biovac Institute (Biovac), a vaccine manufacturer also located in Cape Town, to produce a vaccine for tuberculosis.
IDRI’s TB vaccine, ID93 + GLA-SE, is composed of a recombinant fusion-protein antigen, ID93, plus IDRI’s proprietary adjuvant, GLA-SE. In 2018, IDRI released results from a Phase 2a clinical trial in South Africa, which demonstrated that the vaccine was well tolerated, had an acceptable safety profile and induced a specific immune response, supporting further development and clinical testing. The vaccine candidate is now being developed, in conjunction with the Wellcome Trust, European Union and India’s Department of Biotechnology for a therapeutic application.
This work is part of a worldwide effort to develop a new vaccine for the control of TB. There are 1.7 billion people across the globe who are already infected with TB; therefore, a vaccine that blocks progression from the precursor phase of TB (latent infection) to active disease, is critical. Each year, more than 10 million people develop TB disease and 1.7 million die from TB.
A vaccine produced on site in Africa has a number of potential advantages. Making a vaccine in sub-Saharan Africa can increase local trust in receiving the immunization, enhance preparedness for disease outbreaks, reduce the cost of production, and expedite local regulatory review. Afrigen Biologics is the first ever adjuvant formulation laboratory in Africa and has acquired the manufacturing and distribution rights for ID93 for Africa. Afrigen Biologics has partnered with Biovac, which formulates, fills, finishes and distributes vaccines already produced in bulk. Biovac was recently awarded a manufacturing license by a South African regulator, taking it one step closer to producing vaccines in Africa. IDRI has transferred technology for producing ID93 + GLA-SE to Afrigen Biologics and Biovac; the materials produced by the two South African companies showed good results.
