Inactive

PRE-SOLICITATION NOTICE **NOTICE OF INTENT TO SOLE SOURCE NOI-NIAID-24-2231383 NAICS – 541380, Testing Services This is a Notice of Intent, not a request for proposal. The National Institute of Allerg... PRE-SOLICITATION NOTICE **NOTICE OF INTENT TO SOLE SOURCE NOI-NIAID-24-2231383 NAICS – 541380, Testing Services 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 Curia Bio Inc of San Carlos, CA to procure ongoing sample preparation services relating to DENV and ZIKN viruses for the NIAID Laboratory of Infectious Disease (LID). LID is focusing on testing the hypothesis that quaternary ‘super-antibodies’ bind epitopes across viral envelope proteins and are mechanistic immune correlates of protection against dengue virus infection and disease. These antibodies are considered a key part of enduring protection and are an important benchmark for dengue and Zika vaccines. LID proposes to test this hypothesis using multiple studies of both naturally infected and vaccinated individuals participating in clinical trials and longitudinal cohort studies in Nicaragua, Ecuador, the Philippines, Thailand, and Cambodia, among other sites. This study provides a unique opportunity to interrogate protective secondary DENV immunity. To study these populations of antibodies in a large number of serological samples, LID requires numerous antibody reagents that enable them to perform immunostain protocols to identify immunofoci/plaques. The antibodies 4G2 and 2H2 are well known antibodies used for staining. Large quantities of these antibodies are needed for performing hundreds of immunofocus/plaque assays as required for their research. The other antibodies, including 1F4, 2D22, 5J7, 5H2, 14C10, B7, C8, C10, E3-A-10C and D1-G-10F are in fact among the only ‘super-antibodies’ that have been identified against dengue and Zika viruses and are critical reagents and controls for all of the experiments. They will be used in numerous ways to understand the genetic basis of super-antibody neutralization as well as to help interrogate super-antibodies in polyclonal antisera from dengue and Zika virus immune individuals living in endemic areas. Measurement of and neutralizing antibodies is a core component of epidemiological studies as well as studies to identify the population of antibodies that serve as immune correlates of protection. The antibodies 4G2 and 2H2 are essential for resolving plaque assays and measuring neutralizing antibodies. The antibodies 1F4, 2D22, 5J7, 5H2, 14C10, B7, C8, C10, E3-A-10C and D1-G-10F are themselves ‘super-antibodies’ and will enable LID to measure other populations of super antibodies in naturally infected and vaccinated individuals, a core part of their research program. LID has previous experience with these antibodies produced by Curia Bio Inc and it is imperative to retain them for the follow-on for continuity in results. While other companies produce 4G2 and 2H2, Curia Bio Inc meets the requirement of producing sufficiently potent antibodies that are reliably able to stain a diverse range of dengue virus isolates and other ‘super’ antibodies cannot be directly purchased elsewhere to source large amounts of antibodies needed for this experimental work. Curio Bio Inc has also optimized their antibody production protocols specifically to meet NIAID’s immunostain and experimental protocols. 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-22-2231383) to Dana Monroe at dana.monroe@nih.gov, by 5:00pm ET, Wednesday, July 17, 2024. 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.