A large clinical trial to assess treatments for preventing people at high risk from developing multidrug-resistant tuberculosis (MDR-TB) has begun. The study is comparing the safety and efficacy of a new MDR-TB drug, delamanid, with the decades-old TB drug isoniazid for preventing active MDR-TB disease in children, adolescents and adults at high risk who are exposed to adult household members with MDR-TB.
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The Therapeutic Development Services program offers a collection of preclinical services to support the development of products intended for use in the cure, mitigation, diagnosis, or treatment of disease caused by a pathogen or certain toxins.
This is one of several programs provided by NIAID's Division of Microbiology and Infectious Diseases to support infectious disease product developers.
The Tuberculosis Research Units operate as a collaborative network designed to improve the understanding of Mycobacterium tuberculosis (Mtb)-host interactions. During the past 20 years, there has been significant progress in tuberculosis (TB) research to better understand host-pathogen interactions, but much remains to be learned. Effective management of TB continues to be hampered by a limited understanding of the different stages of this complex disease, as well as the mechanisms that control these stages. An improved understanding of the host and pathogen mechanisms underlying heterogeneity, latency and persistence has the potential to inform novel assays to identify persons at increased risk for progression to active disease, new drugs to shorten the duration of treatment, and other interventions to prevent or improve disease outcome. Finally, some comorbidities including diabetes, hypertension, malnutrition and tobacco smoking are risk factors for TB and for poor TB treatment outcomes, and inflammation in the lung is recognized as an important factor for TB pathogenesis. It is therefore important to understand how these comorbidities and inflammation impact TB progression to improve co-management.
Each TBRU has been established as part of a multi-disciplinary consortium of investigators and institutions with expertise in clinical research, animal models, microbiology, epidemiology, pharmacology, immunology as well as data and statistical management to characterize bacterial and host determinants that are relevant during stages of infection, disease and transmission, and the impact of bacterial and host heterogeneity on disease outcomes.
For more information about the TBRU network, please contact NIAIDTBRU@mail.nih.gov.
European and Developing Countries Clinical Trials Partnership (EDCTP) funds research for prevention and treatment of HIV/AIDS, tuberculosis, malaria, and neglected infectious diseases in sub-Saharan Africa.
Read more about this network: European and Developing Countries Clinical Trials Partnership
The EDCTP has offices in The Hague, The Netherlands, and Cape Town, South Africa.
EDCTP regularly solicits proposals. Visit the EDCTP website for more information.
The NIAID Genomic Centers for Infectious Diseases (GCID) provide insights into the biology of microbes, their role in pathogenesis, and their interactions with the host, including the microbiome, by supporting a diverse set of genomic capabilities, such as high-throughput sequencing and related genomic technologies.
The Center for Advancing Genomic, Transcriptomic and Functional Approaches to Combat Globally Important and Emerging Pathogens
Principal Investigator/Director: Daniel Neafsey, Ph.D.
Institute: Broad Institute, Boston, Massachusetts
The Center for Integrated Genomics of Mucosal Infections
Principal Investigator/Director: Joseph Petrosino, Ph.D.
Institute: Baylor College of Medicine, Houston, Texas
The Michigan Infectious Disease Genomics (MIDGE) Center
Principal Investigator/Director: Adam Lauring, Ph.D.
Institute: The University of Michigan, Ann Arbor, Michigan
The University of Maryland Genomics Center (ends 2025)
Principal Investigator/Director: David Rasko, Ph.D.
Institute: The University of Maryland, Baltimore, Maryland
In 2014, NIAID established the Centers of Excellence for Translational Research (CETR) program. Supported translational activities will range from very early discovery-based efforts to late-stage preclinical development.
The CETR program builds on work of previous NIAID-supported research and development programs, including the Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE) program, and is intended to complement and enhance ongoing translational and product development activities.
Each multi-project Center is organized around specific themes that address development of a targeted medical countermeasure or technology, and related regulatory barriers.
The CRSTAL-ID program, formerly known as the Structural Genomics Centers, supports the characterization of the 3D structure of proteins of infectious disease pathogens. Each Center is a collaborative effort consisting of teams from multiple academic institutions/companies. Protein structures are requested by NIAID or the extramural research community and are made publicly available through online databases such as the Protein Data Bank. The structures help investigators better understand pathogen activity on a molecular level and assist in the identification of targets for drugs, vaccines, and other medical countermeasures.
Researchers funded through the CRSTAL-ID program have been at the forefront of basic and preclinical research activities for emerging infectious disease pathogens. For example, they have solved the structures of numerous SARS-CoV-2 proteins of high interest, including the spike protein, and have contributed substantially to the number of SARS-CoV-2 structures currently available in the Protein Data Bank. These efforts have provided critical insights into the molecular structure and mechanistic functions of SARS-CoV-2. In addition, CRSTAL-ID researchers have been active in efforts to identify and develop novel therapeutics, vaccines, and diagnostics for COVID-19. They have shown how different therapeutics bind to SARS-CoV-2 and have conducted preclinical screening to identify approved and candidate therapeutics with activity against SARS-CoV-2. They are using computational methods to facilitate the development of diagnostics and have been instrumental in structure-based vaccine design activities and efforts to determine correlates of protection for COVID-19.
For information on how to request services from the Centers, please see the CRSTAL-ID Resources for Researchers.
The Centers provide the research community with
NIAID-funded investigators at the SSGCID determined the structure and function of the SARS-CoV-2 spike glycoprotein. The findings were made available in the Protein Data Bank and published in Cell.
For more advances in research see CSGID Publications and SSGCID Publications.
The ACTG established and supports the largest Network of expert clinical and translational investigators and therapeutic clinical trials units in the world, including sites in resource-limited countries. These investigators and units serve as the major resource for HIV/AIDS research, treatment, care, and training/education in their communities.
The scientific priorities of the ACTG network include research to:
Read more about this network: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACT…
The Executive Committee provides oversight and resource allocation through its Scientific Agenda Steering Committee. The Transformative and Collaborative Science Groups, with input from and integration with the Resource Committees and the other committees, are empowered to develop, implement, and monitor the scientific agenda of the ACTG.
The ACTG has conducted more than 100 studies since 2006. These studies have led to more than 400 peer-reviewed publications. The results of some of these studies have been used to make changes to HIV/AIDS treatment guidelines.
From time to time, the ACTG publishes requests for application (RFA) from investigators to address special research questions that are of high priority to the network. In addition, the RFA may solicit applications to add additional non-Division of AIDS (DAIDS) funded Clinical Research Sites to a study if it is determined that they are needed to meet the required sample size.
The ACTG includes clinical research sites around the world.
The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network is a global collaboration of investigators, institutions, community representatives and other partners organized for the purpose of evaluating interventions to treat and prevent HIV infection and its consequences in infants, children, adolescents, and pregnant/postpartum women through the conduct of high quality clinical trials.
Read more about this network: IMPAACT Network
The Network is directed by a leadership group led by Chair, Sharon Nachman, MD, of the University of New York at Stony Brook, and Vice-Chair, James McIntyre, MD, of the Anova Health Institute and the University of Cape Town.
IMPAACT holds a meeting annually.