Analysis services on Crimean Congo Hemorrhagic Fever Virus (CCHFV) Non-Human Primate samples

PRE-SOLICITATION NOTICE ** NOTICE OF INTENT NOI-NIAID-24-2206591 NAICS – 541380, Testing Laboratories 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 SeromYx Systems, Inc of Woburn, MA, to procure sample analysis services on Crimean Congo Hemorrhagic Fever Virus (CCHFV) Non-Human Primate samples for ongoing studies to develop an efficacious vaccine to prevent CCHFV disease.

The Laboratory of Virology (LV) Disease Modeling and Transmission Section (DMTS) conducts research to investigate emerging and re-emerging viral pathogens that cause serious illness in humans. Among these are the Crimean Congo Hemorrhagic Fever Virus (CCHFV), a serious viral infection that has a fatality rate of up to 30%.

Although naturally spread by the bites of ticks, humans can acquire CCHFV during butchering of infected livestock and hospital workers have acquired CCHFV during the care of CCHFV-infected patients. Human disease is characterized by a sudden onset of fever, headache and myalgia that can progress into a hemorrhagic phase in which patients can exhibit large hematomas and bleeding from the nose, gastrointestinal system, urinary tract and lungs.

The expanding range of the natural tick host and the ability of the ticks to be transmitted by migratory birds threatens to introduce CCHFV into non-endemic areas. Currently there are no approved vaccines for CCHFV and the only recommended antiviral, ribavirin, has unclear efficacy. Therefore, an efficacious vaccine is critically needed to prevent CCHFV disease.

In this project DMTS is evaluating a vaccine platform in which a self-replicating RNA is delivered by a formulation that delivers the RNA to target cells leading to protein expression and immune responses to the protein. This vaccine platform has shown significant protection in mouse and non-human primate models of CCHF. In order to evaluate the efficacy of this vaccine, NHP sample analysis is required.

Required specifically are high throughput assays that characterize antigen-specific antibody effector functions, supported by a machine learning computational biology platform, collectively Systems Serology. A requirement for this project, met through SeromYx, is the capacity to assay tens of thousands of samples in a single run and conduct multiple large-scale runs weekly. 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-24-2206591 to Dana Monroe at dana.monroe@nih.gov, by 5:00 pm eastern standard time January 10, 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.