The Coalition for Epidemic Preparedness Innovations (CEPI) has launched a call for proposals for the Broadly Protective Betacoronavirus (BPBC) Vaccine to involve the research and development of novel immunogens and platform technologies and should have a minimal Target Product Profile (TPP) that aims to protect against disease caused by the known Betacoronaviruses that already pose a significant epidemic or pandemic risk.
The primary objective of this call is the research and development of novel immunogens and platform technologies with the demonstration of preclinical and clinical POC, taking into account prerequisite regulatory requirements. Given that field efficacy trials against certain known Betacoronaviruses (e.g. MERS) and novel threatening lineages are not feasible, and a correlate of protection likely impossible across the genus, clinical POC is provisionally defined as follows:
Safety demonstrated in phase 1 / 2 trials in vaccinees applicable for the TPP.
Robust neutralization titers in a high proportion of vaccinees (e.g. 80% or more) against a panel of viruses applicable for the TPP with supportive additional immunological read-outs.
An overall clinical package confirming that the concept of the new vaccine is feasible and that further late development is warranted and supportive of any subsequent steps towards regulatory approval.
The TPP for a BPBC vaccine seeks the following indications: in outbreaks, the active immunization of at-risk individuals, based on specific risk factors, to prevent disease and mortality, and ideally to prevent infection and viral transmission. In the long-term, active immunization of at-risk persons to prevent disease and infection.
- The CfP seeks novel immunogen design based, for example, on one or more of the following scientific approaches:
- Appropriate platform technology to deliver the vaccine immunogen(s) in a manner that elicits a broad immune response.
- Multivalent immunogens.
- Computationally designed immunogens using state-of-the-art methods to derive consensus sequences and/or the identification of highly conserved epitopes. Here, additionally, iterative design supported by machine learning tools could inform a translational science approach to optimal immunogen design.
- Monoclonal antibody driven immunogen design to direct antigen selection in terms of identifying broadly protective conserved / cryptic epitopes across the Betacoronavirus genus
- Any other vaccine and immunogen design approaches that address the objectives of the CfP.
To be eligible the applicants need to fulfil the following criteria:
- Applicants must be legal entities, or consortia comprised of legal entities.
- At least one of the partners in the applicant organisations or consortia of partnering organisations should have experience in human vaccine development and have a track record of bringing vaccine candidates through to human clinical trials in the past 5 years.
- Have a Target Product Profile (TPP) clearly stipulating the intended indication that drives subsequent immunogen design and R&D plans. Accompanying the TPP, have rationale that justifies the desired breadth of protection being sought.
- Have access to an established or licensed vaccine technology platform that has at least early-stage clinical experience, or propose novel vaccine technology platforms that support development of broadly protective vaccines.
- Propose rationale and pathway for antigen design and selection such as a) multivalent immunogen, b) computational, and/or c) monoclonal antibody driven approaches.
- Appropriate R&D plans that support the immunogen strategy, including POC plans.
- Where applicable, leverage immunology biomarker understandings from SARS-COV-1/2 and MERS vaccine development to enable and support preclinical and clinical development
- Definition for a successful preclinical and clinical POC. Special attention is needed towards the panel of viruses that will be used to establish POC.
- Present plans to produce Good Manufacturing Practice (GMP) batch for clinical trial materials.
- Present plans to integrate preclinical and Phase I immunological testing which would utilize CEPI’s available central resources and Centralised Laboratory network, and apply for sample testing, by completing and submitting the Sample Analysis Request Form.
- Indicate willingness for data sharing and use of common assays
- Indicate willingness to commit to CEPI’s Equitable Access principles.
- Timelines: BPBC proposals should aim to demonstrate clinical proof of concept (POC) within 3-4 years.