DBT Invites Research Proposals To Strengthen Development Of Vaccines For Epidemic Potential

Mumbai, 21 April 2020:

The Department of Biotechnology (DBT) has invited Coalition for Epidemic Preparedness Innovations (CEPI’s) call for proposals for centralized laboratory for measurement of immune responses elicited by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine candidates to strengthen development of vaccines for the diseases of epidemic potential in India.

In order to reduce some of this complexity, better compare the immunological profile of each vaccine candidate, and to provide robust assays for regulatory purposes, CEPI is planning to measure the immune response elicited by different vaccine in preclinical studies as well as phase I and II clinical studies in the same (centralised) laboratory, establishing a common protocol or providing the data package which allows formal bridging to a common protocol and information sharing.

To prepare for such studies CEPI is launching a Request for Proposals (RfP) to identify and select potential partners. The types of studies that pre-approved providers might be asked to perform could include, but are not limited to, ELISA assays, Wild type (BSL-3) and pseudo-virus neutralisation assays (BSL-2) and T-cells ELISPOT assays.

The comparing immune responses against different vaccine candidates intended for the prevention of the coronavirus and SARS-CoV-2, is challenging given the global complexity in the number of institutions now focusing on developing SARS-CoV-2 vaccines. Biological variation and technical differences (how and where specimens are collected, transported, stored, and analysed) impacts the quality and usefulness of the data produced and makes comparisons between measurements in individual laboratories difficult.

The RfP is open to any laboratory worldwide that are able to perform one or more vaccine-relevant immunological assays for SARS-CoV-2 for preclinical and/or human samples under GLP/GCLP conditions.

The applicants must have the assays proposed already in place and be willing to run comparability studies with other laboratories in different geographical regions or able to fast tech transfer the assays from other laboratories.

Last date for submitting the application is May 10, 2020. Pharmabiz