SOLICITATION NOTICE
A -- Syphilis Specimen Collection
- Notice Date
- 4/19/2021 9:21:13 AM
- Notice Type
- Solicitation
- NAICS
- 541714
— Research and Development in Biotechnology (except Nanobiotechnology)
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIAID BETHESDA MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N93021R00005
- Response Due
- 7/1/2021 12:00:00 PM
- Archive Date
- 07/16/2021
- Point of Contact
- Aytaj Vily, Phone: 301-761-5131, Jonathan Bryan, Phone: 240-669-5180
- E-Mail Address
-
aytaj.vily@nih.gov, jonathan.bryan@nih.gov
(aytaj.vily@nih.gov, jonathan.bryan@nih.gov)
- Description
- Introduction The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. �The NIAID, Enteric and Sexually Transmitted Infections Branch (ESTIB) has a requirement for the design and performance of a longitudinal, multisite clinical study that will enroll untreated patients who have primary, secondary or early latent syphilis. Description Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (HHS) strives to understand, treat and ultimately prevent the myriad of infectious and allergic diseases that threaten millions of human lives. �The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by infectious agents. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics, which are funded through a variety of research grants and contracts. The NIAID Enteric and Sexually Transmitted Infections Branch supports research in bacterial enteric pathogens and sexually transmitted infections (STIs).� Syphilis is an STI caused by the bacterial pathogen Treponema pallidum.� The number of syphilis cases, especially congenital syphilis, has significantly increased nationally in the last five years. The CDC reported over 100,000 cases of syphilis in the U.S. in 2018, which is a 14% increase from 2017, and that year there was also a 40% rise in cases of congenital syphilis.� Therefore, urgent efforts are needed to design and implement control and preventive measures for syphilis.� Suboptimal syphilis diagnostics and insufficient information on the human immune response to T. pallidum infection pose a critical barrier to syphilis efforts.� Most cases of syphilis are diagnosed by using a screening algorithm involving multiple serum antibody tests, all with imperfect specificity and sensitivity.� Although these tests have been used in some fashion since the 1930s, they have well-known limitations including the inability to reliably distinguish between current and past infections, and difficulty in determining cure after antibiotic administration.� In the past few decades, modern molecular techniques such as nucleic acid amplification systems and platforms, transcriptomics, proteomics and metabolomics have been developed and successfully applied to diagnosis of infectious diseases.� However, developers of potential syphilis diagnostics have little to no access to high-quality syphilis patient specimens for advancing product development.� This RFP is intended to fill this gap and facilitate efforts towards syphilis control, prevention and ultimately elimination. � The 16-month contract Base will include protocol development, activation of multiple clinical sites, protocol implementation and the collection and delivery of specimens from a minimum of 50 patients with confirmed syphilis, or possibly have serofast status, who complete the protocol. �Three 10-month Options will be for the collection of specimens from a minimum of 75 syphilis patients per option. �The number and identity of participating clinical sites shall be determined by the contractor. The contractor also shall institute a panel of syphilis experts that will evaluate each patient�s clinical data and adjudicate the final diagnosis and stage of disease (primary, secondary or early latent syphilis, along with a subset of serofast patients if proposed). The contractor shall send specimens to an NIAID-supported repository from patients who have completed the study along with all metadata that includes, but is not limited to, the adjudication of the expert panel and results from all syphilis-related and other pertinent diagnostic/medical tests.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/da5661eb81ba44cd849e2f482eaca659/view)
- Record
- SN05976125-F 20210421/210419230108 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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