Inactive 8(a) Sole Source (FAR 19.8)

1. Introduction: The Naval Medical Research Unit No. 6, Clinical Trials Unit, engages in research on influenza disease as one important threat to healthcare personnel worldwide. Research conducted by ... 1. Introduction: The Naval Medical Research Unit No. 6, Clinical Trials Unit, engages in research on influenza disease as one important threat to healthcare personnel worldwide. Research conducted by Clinical Trials Unit for the study: “Randomized trial to evaluate the immunogenicity of a high dose influenza vaccine among health care personnel - Part I Cohort” requires performing complex sample analysis. Belomed S.R.L. is the sole distributor of Themo Fisher Scientific, Life Technologies laboratory reagents. NAMRU6 has used these reagents in the past and it is part of multiple ongoing NAMRU6 research studies at different settings and lab infrastructure. These reagents also provide high quality results as well as cost reduction because it helps to process RT-PCR testing to identify influenza respiratory viruses. 2. Background: NAMRU-6 has been awarded with CDC Influenza Division funding to continue working in an important field or research related to Influenza disease as well as related to the measures to prevent and control its transmission specifically in target risk groups like for instance health care workers. There is enough evidence showing that besides health care personnel frequently receive annual influenza vaccination, a substantive proportion of them might have attenuated or no response to additional standard dose influenza vaccines. In contrast, other studies have shown a significantly improved immunogenicity and seroconversion among adults who received Adjuvanted influenza vaccine (AD) when compare with a non-adjuvanted standard dose vaccine (SD). Then, in health care workers that are seasonally exposed to influenza illnesses and repeatedly vaccinated using standard dose vaccines, adjuvanted influenza vaccines might elicit a better immunity than the typically used standard dose vaccines. Therefore, NAMRU6 together with US CDC will conduct a double-blinded randomized controlled vaccine trial among health care personnel to determine if AD influenza vaccines generate superior seroprotection against influenza than SD vaccines particularly among previous sub-optimal responders. As part of this effort, it will be also important to know how many people became infected by influenza virus that highly affect this important target population. NAMRU6 will be leading this effort and will be in charge to the study implementation and execution in all the study sites. 3. General Requirements: The requested reagents must be delivered in a timely manner following submission of the contract, and before the end of FY21. 4. Performance Requirements: Timely communication must be maintained until all materials are delivered. If the requested materials cannot be delivered in a timely manner, notification of the delay in delivery, the reason for the delay, and an estimated time of delivery must be provided. 5. Deliverables: The reagents specifically listed and requested must be delivered in a timely manner and in good condition, according to the delivery specifications of each item with respect to shipping temperature.