CIVICs is a network of research centers that works together in a coordinated, multidisciplinary effort to develop more durable, broadly protective and longer-lasting influenza vaccines. The CIVICs program includes three Vaccine Centers, one Vaccine Manufacturing and Toxicology Core, two Clinical Cores, and one Statistical, Data Management, and Coordination Center (SDMCC).
Read more about this network: NIAIDCIVICs.org
The Vaccine Centers focus on designing novel vaccine candidates and delivery platforms with an emphasis on cross-protective vaccine strategies that could be used in healthy adults as well as populations at high risk for the most serious outcomes of influenza, such as children, older adults, and pregnant women. The Vaccine Centers also focus on new ways to study influenza viruses and the human immune response to influenza through computer modeling, animal models and human challenge trials.
The most promising candidate vaccines will advance to clinical trials conducted by the Clinical Cores. The Vaccine Manufacturing and Toxicology Core will work with the Vaccine Centers to develop and manufacture the vaccine candidates for clinical testing. Vaccine candidates will first be evaluated for safety and immunogenicity in small Phase 1 clinical trials conducted among healthy adult participants. Successful vaccine candidates may eventually be advanced to larger Phase 2 clinical trials in healthy adults, or in specific age groups or at-risk populations.
The CIVICs Statistical, Data Management, and Coordination Center (SDMCC) provides assistance in designing statistically sound clinical trials. The SDMCC also performs clinical data analyses, curates pre-clinical data generated by the Vaccine Centers to ensure that results are available across the CIVICs program and deposited in publicly accessible databases, and provides a public portal for communication to the scientific community and general public about CIVICs program goals and accomplishments.
Primary contract awardees for the CIVICS Vaccine Centers, Vaccine Manufacturing & Toxicology Core, Clinical Core, and Statistical, Data Management, and Coordination Center.
The Immune Mechanisms of Protection Against Mycobacterium tuberculosis Centers (IMPAc-TB) program, established by NIAID in 2019, aims to elucidate the immune responses essential for protecting people against infection with Mycobacterium tuberculosis (Mtb). This program will lead to a better understanding of tuberculosis (TB) immunology, which is critical to guide the design and development of new and improved TB vaccines. The program aligns with the goals and objectives of the NIAID Strategic Plan for Tuberculosis Research.
The IMPAc-TB program aims to develop a comprehensive understanding of the immune responses required to prevent initial infection with Mtb, the establishment of latent infection, and transition to active TB disease. To accomplish these objectives, multidisciplinary research teams conduct immunological analyses of tissue-specific and systemic responses using human samples, combined with assessments using small animals, non-human primates (NHPs) and computational modeling. These integrated approaches are designed to identify the key immune responses needed for protection against Mtb; determine immunologic targets that can be used to improve TB vaccine strategies; determine the impact of human immunodeficiency virus (HIV) and nontuberculous mycobacteria (NTM) infections on relevant immune responses to Mtb infection or TB vaccines; and identify how bacterial immune evasion mechanisms subvert immune responses to Mtb.
Principal investigators: Sarah Fortune, M.D. (Harvard); Henry Boom, M.D. (Case Western Reserve University, Cleveland); JoAnne Flynn, Ph.D. (University of Pittsburgh)
Center objective: The goal of this Center is to identify factors that protect people from Mtb infection and to translate these findings into improved vaccine strategies. A multidisciplinary research team assesses samples from NHPs and human cohorts, in whom infection is suppressed, to learn how their immune responses protect them from Mtb infection. Investigators use computational modeling to predict the likely causes of suppressed infections, which is being tested in cellular and small animal models. Studies evaluate the effect of intravenous (IV) Bacille Calmette-Guerin (BCG) vaccination in rhesus macaques in response to Mtb challenge and the immune mechanisms responsible for controlling natural mycobacterial infection in cynomolgus macaques. Studies also examine the effect of Simian Immunodeficiency Virus/SIV infection on IV BCG vaccination using computational modeling and a systems biology approaches. Also, the research team compares the immune correlates of protection observed in the NHP studies with human responses. Human studies conducted by the Center also will also focus on exposed individuals that resist infection or that develop a transient infection response.
Principal investigator: Rhea Coler, Ph.D.
Center objective: This Center will identify the complex immune responses required to prevent Mtb infection or active TB disease by comparing and examining protective immune responses induced by natural mycobacterial infection or vaccines. The research team evaluates recombinant protein vaccines combined with adjuvants to identify and validate common protective correlates of immunity in well-established animal models for TB and human challenge clinical studies where participants are deliberately exposed to BCG (as a controlled human infection model) under carefully controlled conditions. The investigational vaccines being evaluated are ID93 and M72 formulated with GLA-SE and other adjuvants developed by Access to Advanced Health Institute (AAHI) and contractors supported by NIAID’s Division of Allergy, Immunology, and Transplantation’s (DAIT) adjuvant program. The studies also address how immunity from previous BCG vaccination and natural nontuberculous mycobacteria (NTM) infection affects the investigational vaccines’ effectiveness and ability to generate an immune response across species. The studies will provide crucial insights into the development of candidate vaccines that generate robust levels of durable, protective immunity against TB.
Principal investigator: Kevin Urdahl, M.D., Ph.D.
Center objective: The goal of this Center is to inform the design of an effective TB vaccine by identifying the immune responses capable of controlling and potentially eradicating Mtb. The research team is identifying and examining protective pathways in natural and vaccine-induced immunity by analyzing tissue-specific and systemic immunity in mice, NHPs, and humans. Investigators are focusing on immune correlates at three stages: the pre-infection immune stage; the early events after pulmonary infection; and the formation of granulomas (compact, organized structures of immune cells) during chronic infection. These studies will identify the immune responses required to protect the host from initial infection, establish latent infection, and prevent progression to active TB disease.
Dr. Que Dang, Division of AIDS (DAIDS)
Dr. Nancy Vázquez, Division of Allergy, Immunology, and Transplantation (DAIT)
Dr. Katrin Eichelberg, Division of Microbiology and Infectious Diseases (DMID)
Dang Q et al. Immune mechanisms of protection against Mycobacterium tuberculosis-centers. 2024 Oct 8:15:1429250. doi: 10.3389/fimmu.2024.1429250. eCollection 2024.
The NIAID-funded Bioinformatics Resource Centers provide data-driven, production-level, sustainable computational platforms to enable sharing and access to data, portable computational tools, and standards that support interoperability for the infectious diseases research community.
NIAID supports and conducts research to identify new vaccine candidates to prevent a variety of infectious diseases, including those for which no vaccines currently exist. NIAID-supported research also aims to improve the safety and efficacy of existing vaccines. Explore the links below to learn more about NIAID’s efforts to design, develop and evaluate new and improved vaccines to protect against specific infectious diseases.
NIAID-funded researchers at ATCC and Tufts University have developed SOPs for creating continuous in vitro culture systems for the intestinal parasite Cryptosporidium. Drug development has been hampered by limitations of methods to propagate the organism in vitro. The following SOPs describe procedures to establish and maintain Cryptosporidium hominis and Cryptosporidium parvum cultures.
Fungi include a wide range of organisms, such as mushrooms, molds, and yeast, that are common outdoors in water, soil and air; indoors on surfaces; and on our skin and inside our bodies. Mold can worsen breathing problems in people with allergies or asthma, while various types of fungi can infect nails and cause skin rashes.
Some fungal infections are more common in people with weakened immune systems or hospitalized individuals, while other fungal infections can infect anyone, including otherwise healthy people. There are only four classes of antifungal drugs, and fungal strains resistant to these drugs are emerging. Currently, there are no approved vaccines to prevent fungal infections.
NIAID conducts and supports basic research to understand how fungal pathogens cause disease and how the immune system responds to infection. NIAID is also conducting and supporting the science to find new ways to diagnose, treat and prevent fungal infections.
To learn about risk factors for fungal infections and current prevention and treatment strategies visit the MedlinePlus fungal diseases site.
Researchers are exploring how fungal susceptibility and infection impact the function of immune cells in clinical trials supported by NIAID.
The Trans-NIH Microbiome Working Group (TMWG) was established in 2012 by Dr. Lita Proctor (NHGRI) to provide a forum for coordinating NIH extramural research activities related to the human microbiome. TMWG membership is open to all extramural program staff from NIH institutes and centers (ICs) with an interest in the human microbiome. The TMWG meets monthly.
Below is a list of extramural program staff who have agreed to serve as the primary point of contact for their Institute for microbiome research related inquiries. They will address general questions and, if needed, will direct your inquiries to the appropriate program director in their Institute
| ICO | Program Staff |
|---|---|
| NIAID | Ryan Ranallo (Co-chair) |
| NCI | Phil Daschner (Co-chair) |
| NCCIH | Hye Sook Kim |
| NEI | Charles Wright |
| NHGRI | Lisa Chadwick |
| NCATS | Pablo Cure |
| NHLBI | Emmanuel Mongodin |
| NIA | Rebecca Fuldner |
| NIAAA | Joe Wang |
| NIAMS | Ricardo R. Cibotti |
| NICHD | Ashley Vargas |
| NIDA | Jag H. Khalsa |
| NIDCR | Tamara McNealy |
| NIDDK | Bob Karp |
| NIEHS | Anika Dzierlenga |
| NIGMS | Andrea Keane-Myers |
| NIMH | Nancy Desmond |
| NIMHD | Michael Sayre |
| ODS | Cindy Davis |