Services and deliverable data for a serologic study of immunity to endemic coronaviruses (OC43, HKU1, NL63) and SARS-CoV-2 before and during the COVID-19 pandemic in children in Cebu, Philippines

PRE-SOLICITATION NOTICE NOI-NIAID-2081365 NAICS - 541380 This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with the University of the Philippines-Manila (UPM) to procure services and deliverable data for a serologic study of immunity to endemic coronaviruses (OC43, HKU1, NL63) and SARS-CoV-2 before and during the COVID-19 pandemic in children in Cebu, Philippines. This study will be the first seroprevalence study of SARS-CoV-2 in the Philippines and will prospectively follow children with COVID-19 cases in the cohort. It will test the association between immunity to endemic coronaviruses before the COVID-19 pandemic and antibody response following SARS-CoV-2 infection. NIH will evaluate whether prior or recent infection with specific endemic coronaviruses (OC43, HKU1, 229E, NL63) is associated with the probability of being SARS-CoV-2 seropositive after the start of the COVID-19 pandemic. NIH will determine whether pre-pandemic endemic coronavirus infections induce cross-reactive anti-SARS-CoV-2 spike antibodies that are associated with probability of being SARS-CoV-2 seropositive during the pandemic. NIH will evaluate how SARS-CoV-2 infection changes the response to binding antibodies to the spike of endemic coronaviruses. NIH is currently shipping the viral proteins (RBD and spike) for OC43, HKU1, 229E, NL63, and SARS-CoV-2 to Manila, along with anti-SARS-CoV-2 convalescent plasma and monoclonal antibodies for establishing serological assays (Premkumar et al. 2020 Science Immunology). UPM will manage all logistics for blood sampling of healthy/febrile study participants in the COVID-19 project including specimen collection, storage, transport, staff honoraria. They will also perform calibration/maintenance of all equipment needed for sample processing and data collection. UPM staff will also conduct nasopharyngeal swab collection for all study participants meeting criteria for COVID-19, including patient renumeration, staff honoraria, specimen materials, transportation, and COVID RT-PCR testing. UP-Manila will ensure maintenance of laboratory facilities and utilities, accounting and bookkeeping, personnel support services for this project to ensure data and specimens are collected in accordance with best laboratory practice. This collaboration is part of a core part of the NIH research program. NIH has worked closely with UPM on other longitudinal cohort studies, and has already completed a smaller project on this same study, thus this is a continuation of an ongoing COVID-19 study. UPM has already established the required protocols and approvals for initiating this study of COVID-19 and are ready to immediately begin the study as soon as this service is purchased. Given the urgency of COVID-19 research, working with an established team is an absolute necessity for the success of this scientific investigation The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide comparable services may submit a capability statement that will be considered by email (subject line to reference NOI-NIAID-2081365 to Dana Monroe at contact@example.gov by 5:00pm PDST Wednesday, June 23, 2021. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.