Effectiveness of Rotavirus Vaccine in Preventing Rotavirus Gastroenteritis

The announcement is amended as follows:

The Centers for Disease Control and Prevention (CDC), National Center for Immunizations and Respiratory Diseases (NCIRD), Division of Viral Disease is actively seeking a qualified health care organization or business concern to:
1. Assess the duration of pentavalent rotavirus vaccine protection among children 1 - 3 years of age.
2. Determine the vaccine effectiveness of mixed receipt of monovalent and pentavalent rotavirus vaccine among children 15 days - 12 months of age.
3. Evaluate vaccine effectiveness against the most commonly detected strain during the 2009 season.
The vendor shall provide all labor, equipment, supplies, and facilities necessary to 1) conduct active surveillance in the emergency department and inpatient wards to identify children under three years of age presenting with acute gastroenteritis, 2) collect immunization information from all enrolled children, and 3) enroll control patients under three years of age presenting with acute respiratory illness. All collected data including clinical histories of diarrhea patients, rotavirus test results, and immunization records from all cases and controls- to include a brief report with information deemed to be relevant for data analysis and interpretation - shall be delivered to the appointed CDC Project Officer. Additionally, aliquots of serum, plasma, and stool specimens shall be sent to the viral gastroenteritis laboratory at CDC. Data shall be submitted in Access, Excel, or other similar flat file format. The period of performance will not exceed one year or 12 consecutive months following award of a U.S. Government Purchase Order. SEE THE ATTACHED STATEMENT OF WORK FOR FURTHER DETAILS.

MINIMUM VENDOR QUALIFICATIONS:
The vendor must have a large patient population (at least 750 cases of acute gastroenteritis among children <2 years of age seen in the emergency department per year for the past two years) that will ensure collection of adequate numbers of specimens (at least 70 rotavirus positive stool specimens) to calculate vaccine effectiveness during a dampened rotavirus season. In a rotavirus vaccine effectiveness evaluation performed, 90 rotavirus positive cases were indentified which enabled vaccine effectiveness to be estimated.

The vendor must have knowledge of vaccine coverage rates to assess vaccine impact and access to an immunization registry to obtain immunization status of enrolled participants as well as established relationships and protocols with area physicians to collect immunization data on patients not included in the registry.
The vendor must have established protocols for data collection that will enable rapid and efficient collection of data during an abbreviated rotavirus season.

RESPONSES DUE: Interested vendors should submit a Capability Statement to include the business classification (e.g. not for profit hospital, university, small business concern), Dun & Bradstreet Number (DUNS), and demonstrated expertise and qualifications in performing the work requirements as stated above. Please include any prior project experience as it relates to this study.

Examples should include a narrative of the work performed to include: project title, location, size (dollar value), if the firm acted as a prime or sub contractor, and contract type (Firm Fixed Price or Cost Reimbursement). Submissions in response to this Sources Sought Announcement should not exceed 10 typed pages in MS Word and/or Excell. Capability Statements shall be submitted to Russell Oxford no later than 5:00 p.m. EST on April 4, 2009. Responses received after this date will not be considered. Questions may be e-mailed to the contract specialist at roxford@cdc.gov. Please reference the Project Title and Solicitation Number in all written correspondence: 2009-Q-11285 Effectiveness of Rotavirus Vaccine in Preventing Rotavirus Gastroenteritis. This request is for information and planning purposes and is not to be construed as a commitment by the U.S. Government. Information received will be considered solely for the purpose of conducting a competitive procurement. Respondents will assume all financial costs for preparing a response to this notice. The U.S. Government assumes no financial obligation for the preparation and distribution of prepared responses. Respondents will not be notified of the results of the evaluation.