Targeted Clinical Research to Address Select Viral Infections

Identification of Herpes Simplex Virus (HSV) Shedding in the Female Genital Tract of Pregnant and Nonpregnant Women by GeneXpert PCR, Standard PCR, and Culture

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TARGETED CLINICAL RESEARCH TO ADDRESS SELECT VIRAL INFECTIONS

BAA NUMBER NIAID-DMID-NIHAI2010101

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, Division of Microbiology and Infectious Diseases, has an interest in identifying innovative approaches to effectively treat viral infections.

Description
The primary objective of this solicitation is to support clinical trials and clinical studies to further the development of therapies for select rare and emerging viral diseases. This solicitation targets the evaluation of new or existing therapies (alone or in combination) in a variety of underserved or special patient populations (e.g., immunosuppressed patients (non-HIV); pediatric patients, elderly patients). Because many of the targeted diseases may not be clinically well characterized, appropriate natural history studies may be necessary. When appropriate, the use of innovative or adaptive clinical trial designs, particularly in cases where the disease incidence is rare or the patient population presents unique challenges, is encouraged.

Contracts to be awarded under this BAA will support a variety of clinical study approaches, including natural history studies (e.g., the design and conduct of natural history studies to characterize the clinical presentation of the viral illness as a way to identify and validate potential clinical surrogate markers for future antiviral efficacy trials), retrospective analysis of existing data (either in patient charts or other databases), and interventional clinical trials (Phase I, II and IV only; contracts awarded under this BAA will not support Phase III clinical trials). Adaptive clinical trial designs are encouraged, when appropriate. The assessment of laboratory surrogate markers for clinical response, enhanced use of existing therapies, evaluation of new therapeutic drugs and the development of resistance to important antiviral drugs are important aspects and may be included in any study proposed.

For the purposes of this BAA, the disease areas/study types that will be supported are limited to the following:

• Serious herpesvirus diseases (particularly CMV and EBV), serious adenovirus infections, and BK virus infections in immunocompromised (non-HIV) hosts;
• Serious herpesvirus diseases (CMV and HSV) and enterovirus disease in pediatric patients;
• Herpesvirus infections, particularly post-herpetic neuralgia and West Nile virus in elderly patients;
• Flavivirus infections in the general population; and
• Natural history studies for any of the diseases listed above to identify biomarkers that may be useful in the design of future therapeutic studies.

Eligible clinical trials/studies include:

• Trials of therapeutic safety and effectiveness (particularly in underserved populations);
• Assessment of the natural history of the diseases listed above to assist in the design of treatment trials with useful endpoints;
• Validation of biomarkers (including pharmaco-genetic biomarkers) of clinical responses and safety in antiviral therapy;
• Validation of diagnostic tests for predicting clinical response to therapy;
• Proof of principle studies to further product development;
• Exposure/exposure-response studies (using pharmacokinetic and pharmacokinetic /pharmacodynamic approaches) to optimize therapies;
• Assessment of the emergence of resistance to antiviral therapies; or
• Analysis of existing databases or patient charts.

It is anticipated that contracts consisting of Staged Options may be awarded for multiple offerors

The NIAID estimates that multiple contracts may be issued with funds available to not exceed more than $5.5 million per year. However, it is anticipated that the total cost for the award(s) may vary depending upon the scope of the project and the technical objectives of the award(s). The length of time for each stage by an offeror shall not exceed five (5) years.

All responsible sources may submit a proposal which shall be considered by the Agency. This BAA will be available electronically on/about 10 days and may be accessed through FedBizOpps http://www.fbo.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.