SOLICITATION NOTICE
B -- Identification, recruitment, interviewing and sampling of control subjects for Lyme Vaccine Safety Study
- Notice Date
- 5/23/2002
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Division of Construction and Agency Support Contracting, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 223-02-1433
- Response Due
- 7/15/2002
- Archive Date
- 7/30/2002
- Point of Contact
- Paul Scarborough, Contract Specialist, Phone (301) 827-7168, Fax (301) 827-7103,
- E-Mail Address
-
pscarbor@oc.fda.gov
- Description
- The Food and Drug Administration has a requirement to provide a control study center (CSC), from which matched controls can be identified and recruited to participate in a case-control study. The study will in part, determine if there is a possible association between arthritis following LYMErix vaccination and biological factors including genetic factors found to be associated with Treatment Resistant Lyme Arthritis and immune system responses. The contractor shall serve as the CSC for the identification and recruitment of controls for the study, obtain informed consent from controls, and collect peripheral blood samples from those controls and ship them for laboratory analysis. Controls will be matched based on gender, age, and ethnicity to approximately 50 to 75 cases identified by FDA. There are three groups of controls required for this study: 1) Lyme vaccine naive patients with recent onset inflammatory arthritis, 2) Lyme vaccine recipients without a history of adverse events following vaccination, and 3) vaccine naive patients without a history of inflammatory arthritis. The contractor shall provide staff capable of reviewing medical records from the center's subject population, make necessary arrangements for each control subject to have peripheral blood samples drawn for use in the study, and schedule a brief telephone interview to be conducted by CSC staff. The contractor shall also administer a questionnaire provided by FDA during the phone interview. RFP available on or about 7/15/02.
- Record
- SN00082224-W 20020525/020523213128 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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