Research Program Accomplishments

Research on antimicrobial resistance, including antibacterial resistance, is a priority area for NIAID. In 2014, the Institute issued its report "NIAID's Antibacterial Resistance Program: Current Status and Future Directions" to describe the Institute's research portfolio and outline a combination of innovative approaches based on the latest scientific advances to be pursued.
This page provides recent progress and updates in the key research areas described in the report:

New Awards and Initiatives

  • Systems biology research. In 2016, NIAID made five awards under RFA-AI-14-064, Systems Biology and Antibacterial Resistance. These projects use a multi-disciplinary systems biology approach to study the molecular interaction networks of the pathogen and the host in association with antibacterial resistance or in response to treatment of antibacterial resistant infections. Additional information on Systems biology research is available here.
  • Non-traditional therapeutics for bacterial infections. In 2016, NIAID awarded approximately $5 million in funding for 24 research projects under RFA-AI-14-066, Non-Traditional Therapeutics that Limit Antibacterial Resistance. These grants provide funding to researchers developing early stage, non-traditional therapies that are less likely to develop resistance and eventually could complement or even replace currently available antibiotics that are losing effectiveness.
  • Novel strategies for Gram-negative infections. In 2015, NIAID made 14 awards for the discovery and early stage development of new antibacterial products under RFA-AI-14-026, Development of Novel Therapeutics for Select Pathogens, which focus on new therapeutics for Gram-negative pathogens. Many of these projects are dedicated to novel strategies to combat antibacterial resistance, such as anti-virulence, immune-based therapies, adjunctive therapies, and biofilm inhibitors.
  • Overcoming bottlenecks in therapeutics development. In 2015, NIAID awarded four product development contracts under BAA-NIAID-DMID-NIH-AI-2014007, Targeting Therapeutics Development to Relieve Bottlenecks. These awards support preclinical development leading to clinical candidate identification of broad-spectrum antibacterial therapeutics. Contracts were awarded for the development of antibacterial therapeutics including novel LpxC inhibitors, novel quorum sensing inhibitors, second generation polymyxins, and PolC polymerase inhibitors.

Basic Research

  • Identification of LpxC inhibitors against Neisseria gonorrhoeae. NIAID-supported researchers are targeting the enzyme LpxC in an effort to develop new therapeutics to treat gonorrhea.  LpxC is involved in the formation of the essential molecule lipid A. Inhibiting this enzyme blocks the formation of lipid A, leading to the death of the bacterium. LpxC-inhibiting drugs would be considered a novel class of antibiotics. (NIH Project R01AI094475)
  • Understanding host-pathogen interactions to design effective interventions. Staphylococcus aureus produces a toxin that targets a host protein, ADAM10. NIAID-supported scientists discovered that the toxin not only damages endothelial cells directly but also binds to ADAM10 to increase its enzymatic activity, leading to loss of specific cellular functions and increased pathology. Inhibiting ADAM10 provides a novel approach for treating sepsis caused by S. aureus that is less likely to increase AR. Additional information is available .
  • Identifying new antibacterial targets and finding ways to exploit old targets. NIAID-supported scientists have used the exquisite binding specificity of bacteriophage lysins to identify the enzyme 2-epimerase, which is required for bacterial growth. These findings led to the design of epimerox, a small-molecule inhibitor that prevents growth and lethality of several Gram-positive pathogens, including S. aureus and Bacillus anthracis. Importantly, resistance to epimerox was not detected in B. anthracis or S. aureus. Additional information is available here.
  • Identifying new anti-biofilm peptides. NIAID-supported researchers identified a small molecule that prevents bacteria from forming into biofilms, a highly-structured community of bacteria present in approximately two-thirds of all human infections. The anti-biofilm peptide, called 1018, prevented biofilms from forming, and works on Gram-positive and Gram-negative bacteria, including many resistant strains that cannot be treated by antibiotics. This finding represents a significant advance in identifying agents that specifically target biofilms. Additional information is available here.
  • Using genomics and related technologies to develop new diagnostics, therapeutics, and vaccines.
    • NIAID has made a significant commitment to supporting advanced technologies research to increase our knowledge of drug-resistant infections. For example, specific antibacterial resistance projects were completed by the Genomic Centers for Infectious Diseases examining Enterococcus, Klebsiella, Acinetobacter, Carbapenem-resistant Enterobacteriaceae (CRE) and several methicillin-resistant S. aureus (MRSA) collections. Sequence data from these efforts have been rapidly released into the public database GenBank and will contribute to the development of improved diagnosis, treatment, and understanding of the complexity of drug resistance.
    • NIAID-supported researchers are using genomics to analyze the emergence of resistance to Neisseria gonorrhoeae. For example, investigators are combining large-scale whole-genome sequencing and epidemiology to understand how antibiotic resistance spreads through the population. The goal of the project is to provide insights to help guide public health interventions, diagnostic approaches, and treatment regimens. (NIH Project K08AI10476)
    • The NIAID Structural Genomics Centers have generated more than 220 structures of proteins from pathogen species and genera associated with antimicrobial resistance, including Clostridium difficile, Acinetobacter, and Streptococcus pneumoniae, leading to new insights about the mechanisms of resistance. For example, the Center for Structural Genomics of Infectious Diseasesdescribed the structural basis for the evolution of vancomycin resistance in Enterococcus faecalis and E. gallinarum and illustrated the adaptability of the D,D-peptidase fold in response to antibiotic pressure, as a result of specific structural changes in its active site. Additional information is available here.
    • NIAID is expanding computational tool and method development for resistant bacteria. The NIAID-funded Genome Sequencing Centers are continuing to develop bioinformatics pipelines and tools for data management and comparative genome analysis. The NIAID-funded PathoSystems Resource Integration Center (PATRIC) provides the scientific community with free access to comprehensive bacterial genome sequence data, bioinformatics tools, workspaces, and other data sets relevant to genomic analysis and systems biology.
  • Improving treatment options for gonorrhea. Gonorrhea may become untreatable as it has progressively developed resistance to the antibiotic drugs prescribed to treat it. NIAID-supported investigators found that deleting the genes that encode efflux pumps in antibiotic-resistant strains of N. gonorrhoeae had a profound effect on the bacteria's ability to resist antibiotics. The data suggest that gonorrhea could be treated with antibiotics that are no longer recommended for use as long as the antibiotics are used in combination with a pump inhibitor. Additional information is available here.
  • Identifying protective bacteria for C. difficile infection. C. difficile infection (CDI) is the most common hospital-acquired infection in the United States. Looking at data from mice and hospitalized patients, NIAID-supported researchers found that susceptibility to CDI is related to distinct changes in the bacteria that naturally colonize the gut, including the loss of specific groups of bacteria. By combining this information with genomic analysis and mathematical modelling, the researchers identified a unique group of bacteria that restore these microbial communities in the gut and provide resistance to CDI. These findings may help inform the design of microbiome-based therapeutics and diagnostics. Additional information is available here.

Translational Research

Therapeutics and New Treatment Strategies

  • The Centers of Excellence for Translational Research program. In 2014, NIAID initiated the Centers of Excellence for Translational Research (CETR) program to advance discovery, preclinical development, production, licensure and/or use of new or improved medical countermeasures for emerging and re-emerging infectious diseases. Of the 14 CETRs awarded, 5 are engaged in discovery and/or development of new therapeutic approaches against bacterial pathogens, including drug-resistant organisms. In 2015, CETR investigators published a paper in Nature Chemical Biology describing the development of a versatile synthetic lethal approach for compound discovery and target identification in Staphylococcus aureus. In 2016, another team of CETR investigators published a paper in the Journal of the American Chemical Society on the mechanism of action of the potent antibiotic lysobactin.
  • New antibiotic classes and targets.
    • NIAID-supported researchers used an innovative method to screen uncultured bacteria from soil and identified a novel antibiotic, teixobactin. The drug inhibits bacterial cell wall synthesis by binding to a highly conserved lipid motif and shows activity against drug-resistant microbes in a mouse model of infection. The researchers suggest the properties of teixobactin may help identify a path toward antibiotics that are likely to avoid development of resistance. Additional information is available here. NIAID is currently supporting preclinical development of teixobactin (NIH Project R44AI118000).
    • Using in silico (computer) technology, NIAID-supported researchers discovered a new class of drugs that has shown promise in the treatment of methicillin-resistant S. aureus (MRSA) in mouse models of infection. The new class, called oxadiazoles, was also effective when taken orally. Additional information is available here.
    • NIAID-supported researchers also are pursuing new anti-virulence approaches to combat antibiotic resistance. One example is a project focused on the development of 2-aminomimidazole small molecules that will be used in combination with antibiotic treatment to enhance activity against multi-drug resistant bacterial pathogens and biodefense agents (NIH Project 272201500010C).
    • NIAID is advancing projects funded under RFA-AI-13-019, Drug Target Development and Validation for Antimicrobial-Resistant Pathogens, to translate basic research findings into the early stages of antimicrobial therapeutics discovery and development for bacterial pathogens where resistance threatens effective treatment.
  • Mechanisms of resistance to penicillin and beta-lactams. Penicillin and related beta-lactams target enzymes called penicillin-binding proteins (PBPs) that build the bacterial cell wall. NIAID-supported investigators have demonstrated that beta-lactams also induce a lethal malfunctioning of the bacterial cell wall synthesis machinery. The results provide insight into the mechanism of cell wall assembly and suggest how best to interfere with the process for future antibiotic development. Additional information is available here.
  • A novel beta-lactamase inhibitor to treat a variety of high priority bacterial pathogens. NIAID is supporting development of a highly potent and specific beta-lactamase inhibitor, VNRX-5133, for use in combination with a licensed beta-lactam antibiotic. They may be paired together as a potential treatment for a variety of bacterial infections including Burkholderia spp. and drug-resistant strains of a number of pathogens of public health concern including Klebsiella pneumoniae and Pseudomonas aeruginosa. NIAID is currently funding the preclinical development of this antibiotic candidate. (NIH Project 272201300019C)
  • New treatments for C. difficile. C. difficile is an infectious enteric pathogen that causes diarrhea, pseudomembranous colitis, toxic megacolon, and is associated with an estimated 29,000 annual deaths in the United States. Treatment is difficult, as infection returns in about 20 percent of patients. Through its preclinical services program, NIAID is supporting the development of new antibiotics, including Amixicile and GLS 262E, as well as new therapeutic strategies, such as MET-1, a microbiome-based treatment, to more effectively treat C. difficile infections.
  • Exploring bacteriophage therapy options. With the rise of antimicrobial resistance, NIAID-supported researchers are exploring phage therapy as an option to mitigate disease arising from antibiotic-resistant bacteria. NIAID is investing in research to understand the basic biology and lay the foundation for the development of phage therapy and phage-derived products. (NIH Projects R21AI113508, R21AI121531, R21AI121669, R21AI121689, R21AI121627, R21AI121552, R21AI121545, R21AI121662, AAI15021001)

Diagnostics

  • Rapid diagnostics to detect hospital-associated pathogens. In April 2015, NIAID awarded more than $11 million in first-year funding for nine research projects supporting enhanced diagnostics to rapidly detect antimicrobial-resistant bacteria. The awardee institutions will develop tools to identify certain pathogens that frequently cause infections in health care settings and, specifically, those that are resistant to most antimicrobials. Additional information is available here.
  • Rapid low-cost test screens patients for MRSA. With NIAID support, researchers are developing a rapid, user-friendly, and cost-effective diagnostic to screen patients for MRSA. The test uses digital imaging to count fluorescently labeled S. aureus cells and determine whether S. aureus cells from patient samples can grow in antibiotic-containing media. The fully automated device is highly sensitive and specific and produces results in less than 3.5 hours. (NIH Project 5R44AI080016)
  • Unique system identifies bacteria in less than 20 seconds. NIAID is supporting development of diagnostics that enable rapid identification of bacteria and drug-resistant strains from blood samples. This approach uses Raman microscopy, a laser-based device, along with an innovative approach for preparing samples by attaching them to a novel nanostructured substrate. Algorithms with exceptional analytical sensitivity and specificity are used to identify the bacteria. Preparing the sample takes about 20 minutes. Bacteria can then be detected in about 20 seconds, enabling prompt initiation of targeted antimicrobial therapy. (NIH Project R01AI090815)
  • Antibacterial Resistance Leadership Group tests novel diagnostic tools in clinical settings. The NIAID-supported Antibacterial Resistance Leadership Group (ARLG), in collaboration with industry, is developing and testing innovative diagnostic approaches, including a cost-efficient platform to rapidly identify antibiotic-resistant Gram-negative bacteria; a rapid test to detect carbapenem-resistant organisms directly in respiratory and urine samples; a rapid test to identify patients with lower respiratory tract infections who do not need antibiotics; and a diagnostics master protocol, in which the same patient specimens will be used to simultaneously validate multiple diagnostics. Additional information is available at the ARLG website.
  • Controlling drug-resistant gonorrhea with real-time PCR testing. The use of molecular assays for antimicrobial susceptibility determination has been successfully used to treat Mycobacterium tuberculosis and S. aureus infections, but not N. gonorrhoeae infections. NIAID-supported researchers are verifying a real-time PCR assay in the Los Angeles County Public Health Laboratory to allow determination of antibiotic susceptibility for gonorrheal infections. The goal of the project is to utilize a more tailored approach to treating gonorrhea infections and reduce drug resistance. (NIH Project R21AI109005)
  • Gene expression tests to identify source of respiratory infections. NIAID-supported researchers are developing a simple blood test that analyzes patterns of gene expression to determine if a patient’s respiratory symptoms stem from a bacterial infection, viral infection, or no infection at all. Current research is being conducted through the ARLG, building on research previously supported through the NIAID partnership program. Additional information can be found here.
  • Diagnostic prize competition. NIH is working in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to establish a prize for development of a rapid diagnostic test that can improve treatment of drug-resistant infections and facilitate antibiotic stewardship. NIH and BARDA are sponsoring a prize competition, and the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are contributing technical and regulatory expertise to develop the award evaluation process. Public input was solicited through the federal register and a stakeholder workshop was held in 2015.  Additional details concerning the prize competition are anticipated in 2016. 

Vaccines

  • NDV-3, a vaccine candidate. NIAID has provided consistent funding and support throughout basic research, discovery, and development stages of the vaccine candidate NDV-3. NIAID preclinical services supported scale-up, manufacture, and stability testing of this experimental Candida vaccine that also protects against S. aureus infection. NDV-3 is the first vaccine candidate to provide protective efficacy across kingdoms—from fungi and from bacteria. In industry-led Phase I clinical trials, the cross-protective vaccine was well tolerated, safe, and induced strong antibody and T-cell responses. An industry-sponsored Phase IB/IIA clinical trial is evaluating the ability of NDV-3 to prevent vaginal candidiasis in women with recurrent vulvovaginal candidiasis.
  • N. gonorrhoeae vaccine research. NIAID supports research on N. gonorrhoeae vaccine antigens, pathogenesis, and immune responses. NIAID-supported investigators have identified several potential vaccine antigens that are conserved among strains and have conducted initial preclinical development of vaccine candidates targeting some of them. The understanding that N. gonorrhoeae forms biofilms in humans has led to the discovery of targets for an anti-biofilm vaccine (NIH Project R01AI045728).
  • C. difficile vaccine approaches. NIAID is supporting a variety of vaccine approaches for C. difficile, including novel subunit vaccine candidates (NIH Project R01AI088748), novel adherence factors to be developed as potential subunit vaccine candidates (NIH Projects R03AI097953, R21AI113470 and R01AI095256), and live vector vaccines against C. difficile (NIH Projects R21AI105499 and R01AI095309). The first human clinical trial of a C. difficile toxoid vaccine was sponsored by NIAID. This vaccine, currently being developed by Sanofi Pasteur under the trade name Cdiffense, is the most clinically advanced candidate to date.

Clinical Research

Select examples of NIAID-supported antimicrobial (AR) clinical research activities are listed below. These include ongoing and recently supported trials and studies in development.

Antibacterial Resistance Leadership Group (ARLG)

  • In 2013, NIAID launched the ARLG, a major new clinical effort to address AR and complement other ongoing AR clinical research activities. The ARLG has published numerous journal articles and scientific meeting abstracts. A full list of ARLG-related news and publications can be found here. The ARLG is drawing on the creativity of the global research community by inviting concept submissions to identify and address AR priorities. Information on submitting protocol concepts, early stage investigator seed grants, ARLG fellowships, and other opportunities is available here.
  • In June 2015, the ARLG published a paper in Clinical Infectious Diseases outlining an innovative trial design that can be used to assess the risks and benefits of new strategies to optimize antibiotic use. Additional information can be found here.
  • The ARLG’s CRACKLE study is a multicenter consortium assessing Carbapenem-resistant Enterobacteriaceae (CRE), including Klebsiella pneumoniae, in hospitalized patients. While the incidence of CRE infections has increased dramatically in recent years, the epidemiology of CRE infection and colonization, and the longer term outcomes of patients colonized with CRE remain unclear. To help provide insight into these areas, CRACKLE is looking at clinical data, epidemiological data, CRE molecular characteristics, and patient outcomes.

A list of studies in progress, including studies that have been approved but are still in the planning stages, can be found here.

Enhancing Clinical Research Infrastructure

  • Comprehensive Clinical Research Resources. NIAID maintains a broad network of resources to support clinical research on infectious diseases, including drug-resistant infections. These programs include the Vaccine and Treatment Evaluation Units (VTEUs), the Sexually Transmitted Infectious Clinical Trials Group (STI CTG), and the Phase I Clinical Trial Units. In 2015, NIAID renewed its Phase I Clinical Trial Units program and increased the number of funded organizations from two to three, expanding capacity for conducting early safety testing of novel investigational drugs. These programs complement and enhance the capacity and capabilities of the ARLG for focused clinical studies. Additional information is available here.

Optimizing Use of Available Antimicrobials

  • Strategies to suppress resistance. NIAID supports research grants and contracts to identify new treatment strategies to optimize and preserve the use of currently available antimicrobial agents for hospital-associated and drug-resistant pathogens. Optimizing dosing levels, duration, route of administration, and use of combination drug therapy, according to current pharmacokinetic and pharmacodynamic principles, can suppress the emergence of resistance and minimize toxicity.
  • Preserving "last-line" drugs. Two Phase IIb clinical trials were conducted to evaluate whether oral "first-line" antibiotics, such as trimethoprim/sulfamethoxazole, clindamycin, and cephalexin, which are no longer under patent, can be used to effectively treat skin and soft-tissue infections caused by community-acquired methicillin-resistant S. aureus (CA-MRSA). The trials also evaluated whether certain forms of CA-MRSA can be managed without antibiotics (e.g., through drainage and wound care). These strategies may help preserve "last-line" drugs. Published results from these studies can be found here.
  • Reducing the length of treatment. Three Phase II clinical trials are studying whether the duration of therapy can be shortened for three different infections: staphylococcal bloodstream infections, including catheter-related infections; urinary tract infections in children; and acute otitis media infections in children. Shortened duration of therapy has the potential to reduce the emergence of resistance.
  • Optimal utilization of older antibiotics, such as colistin. In situations where commonly used antibiotics are no longer effective, healthcare providers are turning to some older antibiotics to treat drug-resistant bacterial infections. Colistin, an antibiotic approved in the late 1950s, is one of these older antibiotics that is getting a second look. Studies are underway to: determine the proper dosage of colistin; evaluate different formulations; and determine the efficacy of combination therapy.
  • Treating drug-resistant gonorrhea. As the bacteria that cause gonorrhea are becoming resistant to treatments, NIAID is studying new ways to treat and prevent the disease.
    • A Phase I trial evaluated the safety, drug absorption, distribution, and optimal dosage of extended duration high-dose cefixime for the treatment of reduced susceptibility gonorrhea.
    • In another clinical trial, two new antibiotic regimens using existing drugs—injectable gentamicin in combination with oral azithromycin and oral gemifloxacin in combination with oral azithromycin—successfully treated gonorrhea infections. The Phase IV trial was conducted by NIH and CDC to identify new treatment options in the face of growing antibiotic resistance. Additional information can be found here.
  • Improving treatment options for CRE. To improve therapeutic options for CRE, NIAID sponsored a Phase 1 trial to enable the clinical progression of intravenous (IV) fosfomycin. Fosfomycin IV is approved in Europe but not the United States. The trial was conducted through the NIAID Phase 1 Clinical Trial Units.
  • Treating complicated urinary tract infections (cUTIs). In January 2016, the NIAID-supported ARLG launched a Phase 1 trial, known as the PROOF study, to generate safety and pharmacokinetic data to inform future research on the expanded use of Monurol (oral fosfomycin) for outpatient treatment of cUTIs. The data generated by these studies will provide information on optimal dosing of Monurol for cUTIs, where rising fluoquinolone resistance rates are limiting oral treatment options.

New Antibacterial Products

NIAID supports a number of clinical trials to evaluate new products and approaches to address AR.

  • A novel topical antibacterial. Through the NIAID Phase I Clinical Trial Units, investigators are studying nasal decolonization of S. aureus using topical agent, XF-73. Compared with existing antibiotics, XF-73 has a novel structure and mechanism of action, kills S. aureus bacteria rapidly, and does not appear to generate resistance through genetic mutation. It is administered nasally.
  • Exploring new treatment options for gonorrhea. NIAID is supporting studies evaluating new ways to treat gonorrhea, including a Phase II trial of an investigational oral antibiotic and a Phase I trial assessing the pharmacokinetics of an oral next generation macrolide.
  • Studying a treatment for C. difficile. Two Phase I trials, conducted through the NIAID Phase I Clinical Trial Units, are studying a novel narrow-spectrum agent, CRS3123, for treatment of the intestinal bacterium C. difficile. Safety, drug absorption, distribution, and optimal dosage of the drug are being examined. 
  • Novel tetracyclines to treat numerous bacterial infections. In 2016, a new antibacterial candidate, TP271, advanced to Phase 1 clinical testing. TP271 is a novel tetracycline that is active against many Gram-negative and Gram-positive pathogens. Prepared using state-of-the-art chemistry developed by a NIAID-supported scientist, novel tetracyclines are synthetic compounds that are not subject to existing tetracycline resistance mechanisms, and therefore represent important new tools for the treatment of multidrug-resistant bacterial infections. For more information, please see DMID Scientific Success Stories, "Synthetic Tetracyclines to Combat Bacterial Infection."

Studies in Special Populations

  • NIAID-supported investigators are conducting a Phase II trial studying nasal decolonization of MRSA using a topical antibiotic in neonatal intensive care units (ICUs). The interventional trial is evaluating the safety, clinical acceptability and efficacy in eradicating S. aureus colonization in ICU infants receiving a 5-day course of mupirocin.
  • CRE infections carry high mortality, and solid organ transplant (SOT) recipients are highly vulnerable to infections, especially within the first 3 months post-transplant. It is unknown if CRE carriage by SOT recipients and donors is a risk factor for CRE infections following transplant. The NIAID-supported ARLG is conducting a multicenter study to assess hospitalized patient outcomes. Additional information can be found here.

Examining Optimal Vaccine Strategies

  • A Phase IIb trial, conducted through the VTEUs, is studying optimal dosage, safety, and immune response produced by two different doses of pneumococcal vaccine in older adults. In 2013, there were about 34,000 cases of invasive pneumococcal disease.  Available data show that pneumococcal bacteria are resistant to one or more antibiotics in 30% of cases, according to the CDC.

Meetings and Collaborative Activities

  • NIAID and the European Medicines Initiative's New Drugs for Bad Bugs program co-sponsored a one day meeting in early 2016 to explore barriers to efficient clinical trials of antibacterial drugs. BARDA and FDA also played key roles at this meeting.
  • NIAID and the Swedish Research Council co-sponsored a workshop in early 2016 to promote international collaboration among antibacterial resistance researchers.
  • In 2015, NIAID co-sponsored a workshop on “Bacteriophage Therapy: An Alternative Strategy to Combat Drug Resistance.” This workshop brought together members of the medical, academic, and commercial sectors, along with representatives of regulatory agencies, to discuss the potential of bacteriophages and related products for therapy and prevention of infectious disease. The goals of the workshop were to provide background on the historical and current uses of phage products in medicine and to identify key challenges and opportunities for development of phage-related products, particularly as they relate to strategies to mitigate antibacterial drug resistance. Additional information can be found here.
  • In 2015, NIAID sponsored the “Role of the Microbiota in Infectious Diseases” workshop to foster further collaboration between those performing basic research characterizing the microbiota/microbiome and the infectious disease research community; identify new and unique strategies for improving the translational pipeline of microbiome-infectious disease research; and discuss key challenges and opportunities for the development of microbiome-based products designed to mitigate infectious diseases. Additional information can be found here.
  • At the 2016 Global Forum for Vaccine and Immunization Research (GVIRF) in South Africa, NIAID organized a workshop on vaccines for antibacterial resistance. This session called attention to the potential for utilizing a vaccine approach to avoid the selective pressure that has taken such a toll on the available antibacterials for selected pathogens. In addition to a high level overview of the topic, the workshop included conceptual examples and current state of research for vaccines for S. aureus, Pseudomonas aeruginosa, and Neisseria gonorrhoeae.
  • In 2016, NIAID staff delivered a “Meet-the-Expert” presentation at the 26th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Amsterdam, Netherlands. This meeting brought together international researchers conducting basic, translational, and clinical research on infectious diseases to discuss contemporary topics, with an emphasis on antibacterial resistance. This meeting provided an opportunity for the international community to come together around these issues, and for the NIAID to reach out to international partners on needs and opportunities, as well as highlight NIAID accomplishments in this important arena.  A short video describing the NIAID antibacterial resistance program is available here.
  • In March 2015, the U.S. Department of Health and Human Services (HHS) announced the establishment of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). The Advisory Council provides advice, information, and recommendations to the HHS Secretary regarding programs and policies intended to support and evaluate the implementation of Executive Order 13676, including the National Strategy for Combating Antibiotic-Resistant Bacteria (Strategy) and the National Action Plan for Combating Antibiotic-Resistant Bacteria (Action Plan). NIAID liaisons provide updates on NIAID research activities and participate in PACCARB meetings as non-voting members.
  • The Transatlantic Taskforce on Antimicrobial Resistance (TATFAR) was created in 2009 with the goal of improving cooperation between the U.S. and the European Union (EU) in three key areas: (1) appropriate therapeutic use of antimicrobial drugs in medical and veterinary communities, (2) prevention of healthcare and community-associated drug-resistant infections, and (3) strategies for improving the pipeline of new antimicrobial drugs. NIAID collaborated with the European Commission’s Directorate General for Research and Innovation to organize the 2011 TATFAR workshop on the Challenges and Solutions in the Development of New Diagnostic Tests to Combat Antimicrobial Resistance. Through TATFAR, NIH coordinates with other U.S. government agencies and European funders to align international research activities within existing resources. U.S. representatives to TATFAR include the U.S. Department of Health and Human Services (co-chair), NIH (NIAID), CDC, FDA, and BARDA.
  • In 2012, NIAID sponsored a workshop entitled "Bridging the Gap: Overcoming Bottlenecks in the Development of Therapeutics for Infectious Diseases." The workshop brought together leaders in the field of therapeutics to review the current state of product development research; encourage collaboration between seasoned and new investigators and discuss innovative ways to address product development bottlenecks. Building on the momentum from this workshop, NIAID convened a second meeting in September 2014 entitled, "Overcoming Bottlenecks in Antibacterial Product Development." This workshop focused on the challenges of developing antibacterial products, with an eye toward finding ways to overcome those bottlenecks.
  • Immediately following the 2014 Bottlenecks workshop, NIAID sponsored a meeting in collaboration with FDA to explore the challenges, opportunities, and potential impact of rapid diagnostics on the development and use of therapeutics for infectious disease. The aim of the workshop, "Coordinated Development of Diagnostics and Therapeutics (2014)," was to identify strategies to advance the development of rapid diagnostics to enable more focused, streamlined development and rational use of such therapeutics. The topics discussed at both workshops were interrelated, sharing similar regulatory and commercialization challenges. The two meetings capitalized on the linked discussion and brought stakeholders together to address these critical areas of need. Additional information is available here.
  • Vaccines or other immunoprophylactics for hospital-acquired infections could significantly reduce the burden of disease in healthcare settings in a cost-effective manner if applied to selected populations. In June 2013, NIAID, along with the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), sponsored a one-day meeting to address the current challenges in the development of S. aureus vaccines. This meeting was a follow-up to the first Staphylococcal Vaccine Workshop held in May 2010 and brought together government, academic, non-profit, and industry stakeholders to discuss recent developments in staphylococcal vaccine design and to address mechanisms to overcome staphylococcal vaccine research challenges. The meeting report, “Overcoming Challenges in Staphylococcus aureus Vaccine Development - Meeting Summary, June 7, 2013,” can be viewed  here.

 

Content last reviewed on September 6, 2017