Mind the gap from research laboratory to clinic: Challenges and opportunities for next-generation assays in human diseases

M Patricia D'Souza; Amy C Palin; Thomas Calder; Hana Golding; Steven H Kleinstein; Erin L Milliken; David O'Connor; Georgia Tomaras; Jon Warren; Cesar Boggiano

doi:10.1016/j.vaccine.2021.07.071

Mind the gap from research laboratory to clinic: Challenges and opportunities for next-generation assays in human diseases

Vaccine. 2021 Aug 31;39(37):5233-5239. doi: 10.1016/j.vaccine.2021.07.071. Epub 2021 Aug 6.

Authors

Affiliations

¹ Vaccine Clinical Research Branch, Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA. Electronic address: pdsouza@niaid.nih.gov.
² Vaccine Clinical Research Branch, Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.
³ Office of the Director, Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.
⁴ Division of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
⁵ Interdepartmental Program in Computational Biology and Bioinformatics, Yale University, New Haven, CT, USA; Department of Pathology and Department of Immunobiology, Yale School of Medicine, New Haven, CT, USA.
⁶ NOVA Research Company, Silver Spring, MD, USA.
⁷ Department of Pathology and Laboratory Medicine, University of Wisconsin-Madison, Madison, WI, USA.
⁸ Duke Human Vaccine Institute, Duke University, Durham, NC, USA.
⁹ Pre-clinical Research and Development Branch, Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.

Abstract

Modern vaccinology has experienced major conceptual and technological advances over the past 30 years. These include atomic-level structures driving immunogen design, new vaccine delivery methods, powerful adjuvants, and novel animal models. In addition, utilizing advanced assays to learn how the immune system senses a pathogen and orchestrates protective immunity has been critical in the design of effective vaccines and therapeutics. The National Institute of Allergy and Infectious Diseases of the National Institutes of Health convened a workshop in September 2020 focused on next generation assays for vaccine development (Table 1). The workshop focused on four critical pathogens: severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) and human immunodeficiency virus (HIV)-which have no licensed vaccines-and tuberculosis (TB) and influenza-both of which are in critical need of improved vaccines. The goal was to share progress and lessons learned, and to identify any commonalities that can be leveraged to design vaccines and therapeutics.

Keywords: Assay; HIV; Influenza; SARS-CoV-2; Technology; Tuberculosis; Vaccine.

Publication types

Clinical Conference
Research Support, N.I.H., Extramural

MeSH terms

Animals
COVID-19*
Humans
Laboratories
SARS-CoV-2
Tuberculosis* / prevention & control
United States
Vaccinology

Grants and funding

UM1 AI068618/AI/NIAID NIH HHS/United States