Abstract
Non-human primates (NHPs) are used extensively in the development of vaccines and therapeutics for human disease. High standards in the design, conduct, and reporting of NHP vaccine studies are crucial for maximizing their scientific value and translation, and for making efficient use of precious resources. A key aspect is consideration of the 3Rs principles of replacement, reduction, and refinement. Funders of NHP research are placing increasing emphasis on the 3Rs, helping to ensure such studies are legitimate, ethical, and high-quality. The UK’s National Centre for the 3Rs (NC3Rs) and the Coalition for Epidemic Preparedness Innovations (CEPI) have collaborated on a range of initiatives to support vaccine developers to implement the 3Rs, including hosting an international workshop in 2019. The workshop identified opportunities to refine NHP vaccine studies to minimize harm and improve welfare, which can yield better quality, more reproducible data. Careful animal selection, social housing, extensive environmental enrichment, training for cooperation with husbandry and procedures, provision of supportive care, and implementation of early humane endpoints are features of contemporary good practice that should and can be adopted more widely. The requirement for high-level biocontainment for some pathogens imposes challenges to implementing refinement but these are not insurmountable.
Highlights
Non-human primates (NHPs) studies have been instrumental in gaining an understanding of the pathogenesis of various infectious diseases and have provided relevant models to develop new therapies
The international expert working group is evaluating which animal tests are recommended for the batch release and quality control testing of biologics, including vaccines, and what opportunities exist for better implementation of 3Rs principles and alternative test methods, generating recommendations to World Health Organization (WHO) on how this could be best achieved [23]
It is well established that social housing is crucial for the welfare of NHPs, including macaques, marmosets, and other species used in bioscience research [25,26,27]
Summary
Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations. By acting as an honest broker for cross-sector data sharing, and analyzing data on over 100 biologics from 15 companies, the Centre has identified opportunities to halve the number of non-human primates used in a typical mAb development program from 144 to 64, whilst supporting patient safety [20,21] This collaborative work has changed company practice and influenced the addendum to the ICH S6 guidelines on the nonclinical safety evaluation of biotechnology-derived pharmaceuticals [22]. Explore opportunities for refinement of CEPI-funded NHP vaccine development studies, in order to optimize animal welfare and scientific outcomes; better align CEPI-funded studies with the NC3Rs NHP guidelines and deliver on public commitments to the 3Rs; share relevant data and experience from international laboratories; and provide a platform for follow-up work on important concepts such as refinement and standardization of humane endpoints. We share key findings and best practice, and summarize the full recommendations from the workshop to help support other funders, regulators, researchers and laboratory staff to refine NHP vaccine studies and facilitate better animal wellbeing, research quality, data integrity, and public support
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