Notice Number: NOT-AI-17-043
Key Dates
Release Date: September 21, 2017
Response Date: December 5, 2017
None
Issued by
National Institute of Allergy and Infectious Diseases (NIAID)
Purpose
NIAID is seeking information related to prospective, longitudinal cohort studies on influenza infections. The primary goal of this request is to gather information about existing community-based, prospective, longitudinal cohort studies of influenza, or other acute respiratory infections that may allow assessment of influenza immunity from banked samples. Also of interest are longitudinal cohort studies examining the effectiveness of influenza vaccination.
NIAID seeks to understand the breadth of existing cohort studies including cohort characteristics (e.g., the size, participant population, ages, location, and period of time the cohort has been studied); the types of samples that have been collected; and the quantity of samples banked for future use. Of particular interest are cohorts (including international cohorts) that might be leveraged to examine gaps in understanding how immunity develops to influenza, especially in the context of vaccination vs natural infection. Information from this RFI will be used in developing a research agenda.
Background
Seasonal influenza outbreaks occur each year and cause significant morbidity and mortality. Despite the substantial disease burden, current licensed vaccines provide suboptimal protection against seasonal influenza, and offer limited protection against new emerging strains of influenza. To address this issue NIAID convened a workshop in June 2017, “Pathway to a Universal Influenza Vaccine,” which brought together global influenza experts to identify the knowledge gaps hindering progress towards improving influenza vaccine effectiveness. Among the gaps identified were: an incomplete understanding of how immunity to influenza infection develops over time (from both natural infections and in response to vaccinations); limited understanding of the impact of prior exposure(s) to influenza on protective immunity (imprinting); and the limited availability of long-term, natural history studies of repeat exposures to influenza. Prospective cohort studies were highlighted as a valuable tool to address these knowledge gaps.
Information Requested
Organizations, including international sites, are invited to provide information that describes their community-based, prospective, longitudinal cohort(s); the number of influenza seasons in which the cohorts have been followed; and the clinical samples that have been collected and may be available for future collaborative studies. Organizations that conducted longitudinal cohorts that were prospectively studied as part of vaccine efficacy studies and for which clinical samples are available are also of interest. For this RFI, information requested includes but is not limited to:
- The purpose of the study and a description of the cohort, including:
- Overall study objectives and the study design (e.g., observational, test-negative design, etc.);
- Location(s) of the cohort(s);
- When the cohort was initiated and number of consecutive influenza seasons the cohort was followed (or will be followed if ongoing);
- The cohort population(s), including age ranges; and any special populations (e.g., infants, elderly, pregnant women, immunocompromised individuals);
- Case definition for influenza;
- Number of individuals confirmed to have influenza infection and the method(s) used to confirm infection;
- Availability of epidemiologic data, including receipt of prior influenzas vaccine(s) and the method of documentation (e.g., medical records, immunization registry, self-report);
- The vaccine status of individuals over time.
- A description of the types of samples collected, including but not limited to:
- The types of samples collected and the time period of collection (e.g., sera, PBMCs, nasal wash, etc.);
- Whether control samples are available;
- Any testing that has already been completed on the samples;
- Whether the samples have been consented for future use, and whether any are available for collaborative research.
- A list of publication references involving the cohort.
While the primary interest is in multi-year cohorts in which the incidence of influenza has been the primary focus, information on non-influenza specific cohorts may also be of interest provided the samples can provide insights into acquired influenza immunity.
Responses
Please note, this request is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government or the NIH. The NIH does not intend to make any awards based on responses to this RFI Notice or to otherwise pay for the preparation of any information submitted or for the Government's use of such information. The NIH will use the information submitted in response to this RFI Notice at its discretion and will not provide comments to any responder’s submission. The information provided will be analyzed and may appear in reports. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, and/or sensitive information should be included in a response. The NIH and the Government reserve the right to use any non-proprietary technical information in any future solicitation(s).
Responses should be sent to Lillian Abbey (labbey@niaid.nih.gov).
Inquiries
Please direct all inquiries to:
Diane Post, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3348
Email: postd@niaid.nih.gov
and Human Services (HHS)
