A new paper details the GMP manufacturing and formulation process of a semi-synthetic Shigella glycoconjugate vaccine candidate from the Institut Pasteur.
Intravacc has published the Good Manufacturing Practices (GMP) manufacturing and formulation process for a monovalent semi-synthetic conjugate vaccine candidate against Shigella flexneri 2a (SF2a), developed at the Institut Pasteur in France.
The candidate vaccine is being developed to combat shigella SF2a, a species of enteric bacteria that causes shigellosis, which is associated with diarrhea, in humans. About 250 million cases of shigellosis occur each year in low- and middle-income countries, causing more than 212,000 deaths. Children acquire shigella at the highest rate.
The newspaper, published in AEC Core Sciences, discloses the feasibility of the GMP synthesis of conjugate vaccines featuring a single homogeneous synthetic glycan hapten refined to protect against an infectious disease. The large-scale feasibility of the bioconjugation step under GMP conditions resulted in a high-yield process and a reproducible and controllable SF2a vaccine production process, according to Intravacc.
Pre-clinical and clinical batches of polysaccharide conjugate vaccines and (non) compendial tests, compliant with ICH guidelines and World Health Organization (WHO) recommendations, have been produced. The resulting synthetic glycan conjugate vaccine met all criteria related to toxicity, was immunogenic in rabbits, and elicited bactericidal antibodies against SF2a in mice. Induced serum IgG antibodies recognized a wide panel of circulating SF2a strains.
The results of the first human trial of the semi-synthetic conjugate vaccine candidate based on SF2a glycans suggest that it is safe and immunogenic. The development achievements of this SF2a vaccine candidate are part of Stopenterics, a European consortium that received funding from the European Community’s Seventh Framework Program (FP7/2007-2013).
An age-declining phase IIa trial to investigate the safety and immunogenicity of this SF2a vaccine candidate in the target child population in endemic countries was initiated in 2020 (NCT04602975). The estimated completion date is scheduled for the third quarter of 2023.
Dr. Jan Groen, President and CEO of Intravacc, commented: “This is Intravacc’s second successful development of a GMP manufacturing process for a tetanus conjugate vaccine. Our first Haemophilus influenza type b (Hib) conjugate vaccine has been transferred to international partners around the world and has been on the market for several years now.