SOURCES SOUGHT
A -- Seroimmunity to Poliomyelitis in the US
- Notice Date
- 4/12/2010
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2010-N-12097
- Point of Contact
- Cherie J. Katin, Phone: 770-488-2652, Nancy M. Norton, Phone: 770-488-2056
- E-Mail Address
-
chk5@cdc.gov, ftg8@cdc.gov
(chk5@cdc.gov, ftg8@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- SOURCES SOUGHT NOTICE SEROIMMUNITY TO POLIOMYELITIS IN THE US SOURCES SOUGHT - MARKET RESEARCH NOTICE Notice Number: 2010-N-12097 Project Title: Seroimmunity to Poliomyelitis in the United States Background Recent outbreaks of vaccine-preventable diseases for which indigenous elimination has occurred highlights the concern of potentially growing susceptible populations in the United States due to a lack of vaccination. The last indigenous case of poliomyelitis in the United States occurred in 1979; however the risk of importation from global endemic areas persists. The risk of transmission of poliovirus from an importation into a population is not known due, in part, to a lack of information regarding susceptible sub-populations in a community. Epidemics of poliomyelitis due to the 3 types of poliovirus occurred prior to the advent of vaccine. In the United States, inactivated poliovirus vaccine (IPV) was introduced in 1955 followed by a transition to oral poliovirus vaccine (OPV) in the early 1960's. Utilization of these two vaccines led to a rapid decrease and eventual elimination of wild-type poliomyelitis. The Western Hemisphere was certified as free from indigenous wild poliovirus in 1994. In order to decrease the risk of vaccine-associated paralytic poliomyelitis (VAPP) associated with the use of OPV, the routine all-OPV schedule was replaced with a sequential IPV followed by OPV schedule in 1997. This was followed by an all-IPV schedule which has been routinely recommended since 2000. No OPV has been distributed in the United States since 1999. The most recent serosurvey to evaluate immunity in the United States was done from 1997-2001 during the transition from OPV to IPV. This study was done in four urban areas in children aged 19-35 months and concluded that the transition to IPV did not negatively impact the seroprevalence of anti-poliovirus antibody in that age group (1). Previously, a serosurvey in two inner city populations during the all-OPV era among children age 12-47 months found that secondary OPV exposure played a modest role in providing seroprotection (2). A study of sera collected in 1966 and 1971 in the United States found that 1) the proportion of susceptibles was increased in older age groups; 2) susceptibility to type 3 poliovirus was highest; and 3) self-reported vaccine coverage was non-informative for predicting serologic immunity (3). Serosurveys to evaluate population protection for poliomyelitis have been conducted in other countries without endemic disease. For countries utilizing OPV at the time of the surveys, lower levels of seroprotection to type 3 poliovirus was a consistent finding (4, 5, 6, 7, 8). While some studies found differences in seroprotection rates for some age cohorts, this was not a consistent finding and could vary depending on vaccine and disease history in the country evaluated. For IPV-only countries, GMT's generally were lower with time since last vaccination, but high protective antibody prevalence was found across ages (9, 10, 11). Purpose and Objectives The gaps in knowledge regarding the U.S. population's susceptibility to poliomyelitis requires the following three questions be addressed: 1. Ten years from the transition from OPV to IPV, what is the seropositivity rate for the age cohort that has received IPV with no exposure to environmental OPV? 2. What are the seroimmunity profiles in other age cohorts who have different disease and vaccine exposures over time including 1) those vaccinated during the transition from OPV to IPV; 2) those vaccinated during the all-OPV era; and 3) those vaccinated in the early IPV era with a lower potency formulation and those mostly unvaccinated, both with potential wild-type poliovirus exposure. 3. In an all-IPV era, is there a growing immunity gap with increasing age potentially due to waning immunity potentially as a result of a lack of secondary OPV boosting? Anticipated Performance Period A cost reimbursement contract is anticipated with an award date on or about September 1, 2010 and a period of performance for six months. The associated NAICS code is 541712. Capability Statement CDC is interested in soliciting capability statements from all qualified Offerors demonstrating their ability to perform this research effort. At a minimum, Offerors must document capabilities in the following areas. A. Access to clinical/hospital facilities with sufficient capacity to routinely acquire blood/serum samples from all age cohorts in the study with a demographic population base representative of the surrounding community. This would include a minimum of 1,000 outpatient visits for routine blood draws per month covering all age groups. B. Ability to recruit sufficient number of participants for each study age cohort (100 persons in each of the following age cohorts: age 2-3 years; 6-10 years; 11-15 years; 16-50 years, >50 years) within a 6 month time period. C. Ability to have participants complete a brief (~2 page) questionnaire on demographic information as well as relevant vaccine and disease history and obtain informed consent. D. Ability to obtain serologic specimens of 2-3mL in all age cohorts included in the study including ability to have adequate phlebotomy staffing and available supplies. E. Ability to identify and recruit participants in sub-populations with lower vaccine coverage (<85%) due to vaccine exemptions, particularly for the younger cohorts. F. Documented experience in performing and participating in clinical trial studies. Special attention should be given to discussion of previous experience of a similar size and complexity to this project. G. Adequate facilities to properly store, batch, and ship vaccine to CDC for analysis including documented cold-chain requirements and sample pedigree. Response Guidelines This notice will expire 15 calendar days from its posting.(April 27, 2010) Respondents may provide written capability statements referencing the above Notice Number and detailing their ability to perform the efforts described above via email attachment to the Contract Specialist named herein. Respondents shall indicate their business size, specifically if theirs is a small business under one of the socioeconomic programs identified in FAR Subpart 19 and NAICS 541712. This is not a request for proposals and the Government is not required to award any contract as a result of this notice. Along with the Capability Statement, request the following be included: 1. DUNS 2. Complete Company Name and Address 3. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc) as validated via the Central Contractor Registration (CCR). All offerors must register on the CCR located at http://www.ccr.gov/index/asp 4. Company Point of Contact, phone and email address Provide responses via email to Cherie J. Katin at chk5@cdc.gov, Contract Specialist, CDC/Procurement and Grants Office. Questions must be in writing to the email address above. No telephone inquiries will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2010-N-12097/listing.html)
- Place of Performance
- Address: 2920 Brandywine Road, M/S K-14, Atlanta, Georgia, 30341, United States
- Zip Code: 30341
- Zip Code: 30341
- Record
- SN02119664-W 20100414/100412235116-7a9b356ff8f870818af09ecf0cc03ff0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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