Virus World

All COVID-19 vaccine developers can use the network of five laboratories working together as part of centralised network to reliably assess and compare immunological responses generated by COVID-19 vaccine candidates.   Five laboratories initially selected to work together as part of centralised network to reliably assess and compare immunological responses generated by COVID-19 vaccine candidate. Global group will minimise variation between individual lab analyses to enable uniform way of evaluating and identifying the most successful candidates. All COVID-19 vaccine developers (both CEPI-funded and non-CEPI funded) can use the network. In order to monitor interest and adjust the testing capacity, we are requesting that all COVID-19 vaccine developers interested in using CEPI’s centralised laboratory network complete this short survey. For any COVID-19 vaccine developer ready to submit their samples to the network, please complete our Sample Analysis Request Form. 

2 October 2020, Oslo, Norway –The Coalition for Epidemic Preparedness Innovations (CEPI) has today announced partnerships with five clinical sample testing laboratories to create a centralised global network to reliably assess and compare the immunological responses generated by COVID-19 vaccine candidates. Located across multiple regions globally, the laboratories initially selected for this vaccine-assessment network are: Nexelis (Canada) and Public Health England (PHE, UK), VisMederi Srl (Italy), Viroclinics-DDL (The Netherlands), icddr,b (formerly International Centre for Diarrhoeal Disease Research, Bangladesh), and Translational Health Sciences and Technological Institute (THSTI, India). The network will use the same testing reagents—originating in the labs of Nexelis and PHE—and follow common protocols to measure the immunogenicity of multiple COVID-19 vaccine candidates (both CEPI-funded and non-CEPI funded developers). This approach will ensure uniformity in assessment and informed identification of the most promising vaccine candidates. CEPI is actively negotiating with additional laboratories to participate in this network.

Advantages of centralising immunological response assessment

Typically, the immunogenicity of potential candidate vaccines is assessed through individual laboratory analyses, aiming to determine whether biomarkers of immune response—such as antibodies and T-cell responses—are produced after clinical trial volunteers receive a dose(s) of a vaccine candidate. However, withover 320 vaccine candidates against COVID-19 currently in development, there are likely to be numerous differences in data collection and evaluation methods. This includes potential variation in the range of correlates of immunity being measured by laboratories. Technical differences in how and where samples are collected, transported and stored can also occur, impacting the quality and usefulness of the data produced and making comparisons between measurements in individual laboratories difficult. In addition, with the wide range of COVID-19 vaccine approaches and technologies currently being deployed (e.g., recombinant viral vectors, live attenuated vaccines, recombinant proteins and nucleic acids), standard evaluation of the true potential of these vaccine formulations becomes very complex.

Through centralising the analysis of samples obtained from trials of COVID-19 vaccine candidates, the new clinical-sample-testing network will minimise variation in results obtained, which could otherwise arise due to such technical differences when carrying out independent analysis. The samples from participating vaccine developers will instead be tested in the same group of laboratories using the same methods, therefore, removing much of the inter-laboratory variability and allowing for head-to-head comparisons of immune responses induced by multiple vaccine candidates.

Supporting global COVID-19 vaccine development

Through this new network, up to the limit of programme funding, eligible COVID-19 vaccine developers (both CEPI-funded and non-CEPI funded developers) can use the laboratories, without per sample charges, to analyse the immune response elicited by their COVID-19 vaccine candidates in preclinical, Phase I and Phase IIa studies. Data obtained on the immunogenicity of CEPI-funded vaccine candidates will be used to inform and advance CEPI’s COVID-19 vaccine portfolio by providing quick and accurate evaluation of its candidate vaccines. By opening the sample testing network to other COVID-19 vaccine programmes, CEPI also aims to ensure that all eligible developers—regardless of their size—can benefit from this analysis. Certain commitments may be required for eligibility, such as making timely publication of sample testing results and sharing data that will be produced on the immunogenicity of COVID-19 vaccine candidates to facilitate future regulatory decisions. The number of samples available for testing per developer may be limited depending on response...

How many COVID-19 cases have gone undetected? And are those who had mild cases of the disease—perhaps so mild they dismissed it as a cold or allergies—immune to new infections? If so, they could slow the spread of the burgeoning pandemic. Answering those questions is crucial to managing the pandemic and forecasting its course. But the answers won’t come from the RNA-based diagnostic tests now being given by the tens of thousands. They look for the presence of viral genes in a nose or throat swab, a sign of an active infection. But scientists also need to test a person’s blood for antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Such tests can detect active infections, too, but more importantly, they can tell whether a person has been infected in the past because the body retains antibodies against pathogens it has already overcome.

Labs and companies around the world have raced to develop antibody tests, and a few have been used in small studies and received commercial approval, including several from China. But so far, large-scale data from such tests—for example showing what fraction of people in the hard-hit city of Wuhan, China, might now be immune—is still lacking or at least not public. Scientists hope that will soon change as more tests become available. A new recipe could offer labs an alternative to waiting for or buying commercial tests. Florian Krammer, a virologist at the Icahn School of Medicine at Mount Sinai, and his colleagues posted a preprint yesterday describing a SARS-CoV-2 antibody test they have developed, and directions for replicating it. It’s one of the first such detailed protocols to be widely distributed, and the procedure is simple enough, he says, that other labs could easily scale it up “to screen a few thousand people a day,” and quickly amass more data on the accuracy and specificity of the test. Together with increased availability of commercial tests, that means some important answers about immunity to COVID-19, the disease caused by the novel coronavirus, may be available soon, he says.

To create the test, the researchers began by designing a slightly altered version of the “spike” protein on SARS-CoV-2’s outer coat. (The alterations made the protein more stable for use in the lab.) That protein helps the virus enter cells, and it is a key target in the immune reaction against the virus, as the body churns out antibodies that recognize the protein and tag the virus for destruction. They also isolated the short piece of the spike protein called the receptor-binding domain (RBD), which the virus uses to attach to cells it tries to invade. They then used cell lines to produce large quantities of the altered spike proteins and RBDs....

Preprint Published in medRxiv (March 18, 2020):

https://doi.org/10.1101/2020.03.17.20037713

Globally, the COVID-19 pandemic has had extreme consequences for the healthcare system and calls for diagnostic tools to monitor and understand the transmission, pathogenesis and epidemiology, as well as to evaluate future vaccination strategies.

Here we have developed novel flexible ELISA-based assays for specific detection of SARS-CoV-2 antibodies against the receptor-binding domain (RBD): An antigen sandwich-ELISA relevant for large population screening and three isotype-specific assays for in-depth diagnostics. Their performance was evaluated in a cohort of 350 convalescent participants with previous COVID-19 infection, ranging from asymptomatic to critical cases. We mapped the antibody responses to different areas on protein N and S and showed that the IgM, A and G antibody responses against RBD are significantly correlated to the disease severity. These assays-and the data generated from them-are highly relevant for diagnostics and prognostics and contribute to the understanding of long-term COVID-19 immunity.