NEW YORK – The US Department of Health and Human Services' Biomedical Advanced Research Development Authority (BARDA) this week issued a solicitation for proposals for the research and development of immune assays to evaluate responses to COVID-19 vaccines. An enquiry period for the solicitation is open until April 10.
The limited-term solicitation comes from BARDA's Influenza and Emerging Infectious Diseases Division, or IEIDD. The division is seeking submissions to develop assays for the analysis of clinical study samples to evaluate immune responses to COVID-19 vaccines and quantify responses relevant to ancestral SARS-CoV-2 as well as circulating variants of concern.
According to documents issued on April 3, assays of interest include SARS-CoV-2 variant-specific lentivirus-based S-pseudotyped virus neutralization tests, multiplexed SARS-CoV-2 antigen panels for human antibody quantification by electrochemiluminescence, IgG and IgA multiplex meso scale discovery (MSD) antibody binding assays to SARS-CoV-2 proteins, MSD-based multiplexed angiotensin-converting enzyme 2 (ACE2) receptor blocking assays to the SARS-CoV-2 spike and receptor binding domain antigens, and a multiparameter intracellular staining (ICS) assay to identify and quantify SARS-CoV-2 spike-specific T cells.
BARDA also seeks proposals for methods and devices for the collection of clinical samples for use in these immune assays.
Developers will be responsible for establishing high-throughput laboratory testing capability for the assays, and data from the assays should meet regulatory requirements and may be used to support a US Food and Drug Administration Emergency Use Authorization or Biological License Application, BARDA said.
The assays will in turn help BARDA with continuing support for the assessment of the impact of variants on vaccine protection and the analysis of immune correlates of protection.
The enquiry period for the solicitation is open until 4:30 p.m. EST, April 10, and written responses to collected inquiries from respondents will be provided after the open enquiry period has concluded, BARDA said, and posted as a subsequent amendment to the solicitation. The solicitation will be open until May 3 at 4:30 p.m. EST.