Inactive

Introduction: The Naval Medical Research Unit No. 6, Clinical Trials Unit, engages in research on influenza as well as COVID19 diseases as major threats to healthcare personnel worldwide. Research con... Introduction: The Naval Medical Research Unit No. 6, Clinical Trials Unit, engages in research on influenza as well as COVID19 diseases as major threats to healthcare personnel worldwide. Research conducted by the Clinical Trial Unit for protocol NAMRU6.2019.0011 “Randomized controlled trial, double blind, phase III, to evaluate the immunogenicity of a high dose influenza vaccine among healthcare personnel (EDUCATE), which includes Part I: Sub-study: Effectiveness of Influenza Vaccines in Preventing Influenza Virus Infection, Missed Work, and Patient Exposure: A Prospective Cohort Study of Healthcare Personnel in the context of COVID-19 pandemic”; requires performing complex sample analysis. Biofire is the manufacturer and sole distributor of FilmArray panels. NAMRU6 has used these panels in the past and it is part of multiple ongoing NAMRU6 research studies at different settings with minimal requirements of trained personnel and lab infrastructure. These panels not only provide high quality results but also allows a cost reduction identifying simultaneously 19 respiratory viruses and 4 respiratory bacteria. These panels now include the identification of SARS-CoV2 in addition to the other pathogens. One additional characteristic of this platform is the timely report, which is even more important in hospitalized settings as it has been proved in the US. 2. Background: NAMRU-6 has been awarded with CDC Influenza Division funding to continue working in an important field or research related to Influenza and COVID19 diseases as well as related to the measures to prevent and control their 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 is conducting 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, the surveillance activities included are important to support a regular systematic COVID-19 testing with ongoing repeated assessment of exposure and risk factors to know what the other respiratory viruses are that co-circulate during influenza season and could affect this important target population in the context of the current pandemic. NAMRU6 is leading this effort and is in charge of the study implementation and execution in all the study sites. 3. General Requirements: The requested Biofire panels must be delivered in a timely manner following submission of the contract, and before the end of FY23. 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 panels 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. Long expiration date is strongly desired.