A request for applications (RFA) with set aside is proposed, entitled “Enhancing the capacity for biomedical research on Tuberculosis for HIV-infected mothers and children in India” using the R01 Research Project grant mechanism.
The purpose of this initiative is to enhance biomedical and clinical research capacity for the study of the interaction of HIV and Tuberculosis (TB) in children and pregnant women in India. Longitudinal cohorts of TB patients and their contacts along with fundamental research laboratories have been established in India by NIAID through collaborations between the U.S. and Indian governments, investigators, and institutions. NICHD funds will ensure the capacity of these cohorts to achieve scientific aims specific to both HIV-infected and uninfected children and pregnant women with TB that will have the potential to be applied on a global scale.
NIAID has determined that the research laboratory TB (“Centers of Excellence” they are funding (RePORT-India) does not fall under the new Indian Clinical Trial Liability rules, as the Centers include longitudinal studies and not clinical trials as defined by India (India definition “Systematic study of new drug(s) in human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic) and/or adverse effects with the objective of determining safety and / or efficacy of the new drug”). Therefore NIAID has moved forward with funding of these centers, and have written in the Notice of Grant Award (NOGA) that interventional components are not allowed in these grants and that given these are purely observational studies, that it is expected that they fall outside of the realm of the new clinical regulations. NICHD will include similar information in the NOGA.
Grantees will establish and maintain longitudinal cohorts consisting of TB infected/exposed pediatric and obstetric patients with and without HIV co-infection and establish a repository of specimens. These cohorts are an integral part of an effort to enhance biomedical and clinical research capacity in the field of TB and are designed to form the basis for studies of comprehensive basic science and pathogenesis that will employ state of the art research tools.
Research areas of particular interest include, but are not limited to: characterization of immune responses in pregnant women and children with TB disease or latent TB infection with and without co-existing HIV infection; studies of novel biomarkers that help identify persons with the highest risk of progression to active TB disease after TB infection; identification of the host and microbial factors that determine the clinical presentation of TB; identification of host and/or microbial markers that indicate the presence of paucibacillary bacterial infection (most common in children and patients with HIV co-infection); identification of host factors (genetic and other) that correlate with protective immunity; and identification of host and microbial factors responsible for the development of antimicrobial drug resistance.
Carol J. Worrell, MD
Maternal and Pediatric Infectious Disease Branch
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