Development of Broadly Protective Filovirus Vaccines

Description

Objectives Development of multivalent Filovirus vaccines CEPI intends to support the development of broadly reactive Filovirus vaccines that are based on multiple valences. These vaccines should be suitable for the preventive use in at-risk populations in regions where one or multiple Filovirus outbreaks can occur, and therefore be able to contribute to epidemic preparedness. Creation and evaluation of a vaccine library for a range of Filoviruses with outbreak potential, from human or animal origin. CEPI seeks to support the generation of antigens for the Filovirus family and their evaluation in preclinical and/or clinical studies. It is expected that computational prediction will be used to create a collection of immunogen designs for multiple selected viruses within the Filovirus family, and if possible, to design cross-protective antigens. These designs should then be evaluated for expression, antigenicity, and stability. Selected immunogen designs should be combined with vaccine platforms to generate exemplar vaccine candidates that can be further tested in in vitro and in-vivo preclinical experiments. The most promising pre-clinical exemplar vaccine candidates should then be advanced into translational development up to the end of phase I clinical trials. Scope of the Call Development of multivalent Filovirus vaccines In addition to the licenced Ebola Zaire vaccines, there are different other candidate vaccines under development for Ebola viruses and Marburg virus; their combination into multivalent vaccines could provide the desired breadth of protection against the Filoviruses that have caused the majority of outbreaks in humans. The intent is to support the translational and clinical development of multivalent vaccine candidates up to the end of phase II clinical trials and explore pathways to licensure (ideally based on immuno-bridging approaches). Multivalent vaccines or individual monovalent vaccines on the same platform will ideally have an established preclinical proof-of-concept (PoC) as well as initial clinical safety and immunogenicity data. Creation and evaluation of a vaccine library for a range of Filoviruses The CfP intends to consider and evaluate application proposals for the use of computational methods for immunogen design and to support experimentally based methods (where applicable) for immunogen verification against several members of the Filovirus family. The desired outcome from this effort is to have the resultant immunogen designs combined with and tested in various vaccine technology platforms, contributing to a Filovirus vaccine library (i.e., consisting of a knowledge-base, working seed materials and reagents, and/or candidate formulations) that are either ready and available to be used in future Filovirus outbreaks or that create a solid base for the rapid generation of new vaccines for emerging Filoviruses. Immunogen designs should be generated through state-of-the-art computational and structural methods, and tested for their ability to present the right epitopes to maximize the adequate immune response, to be properly expressed in the chosen vaccine technology platform, to generate a protective immune response in animal models, and if possible, to be amenable to early clinical proof=of-concept of safety and immunogenicity. Antigens that are broadly protective against multiple filoviruses are preferred. CEPI encourages applications from consortia that can tackle the different aspects of vaccine library development, as well as preclinical and clinical testing. CEPI has the capability to support development through its centralised laboratory network and animal models network, and/or adjuvant library (that can be screened for optimal adjuvants for a particular candidate) where applicable. Applicants must discuss these opportunities with CEPI staff prior to application submission. Applicants based in the Global South and/or partnerships that include developers in the Global South are encouraged to apply. Applications by consortia of partners with complementary competences are encouraged.

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