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Federal Tuberculosis Task Force Plan in Response to the Institute of Medicine Report, Ending Neglect: The Elimination of Tuberculosis in the United States

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The documents listed below are historical, archived information. The information contained in these documents, while accurate at the time of release, may not be the most current available.

Strategies and Action Steps

Domestic Federal Actions in Response to the Institute of Medicine Report on TB:
Ending Neglect: The Elimination of Tuberculosis in the United States

C. Activities for Developing New Tools

The goal of TB elimination cannot be reached with the tools that are currently available. TB elimination will require an increased investment in TB research to develop a more effective vaccine, as well as new diagnostic tools and drugs to more rapidly and reliably diagnose and shorten treatment for all persons with latent and active TB, including those afflicted with MDR TB.

IOM Recommendation 5.1: “To advance the development of tuberculosis vaccines...”

Strategies
Action Steps

1. Implement the Blueprint for Tuberculosis Vaccine Development.

Lead Agency: NIH

Collaborating Agencies: CDC, FDA

Start Date: FY 2002

Completion Date: FY 2012 - 2027

a) Conduct basic science research aimed at understanding host and bacterial factors associated with mycobacterial dormancy and disease, and identifying protective antigens and virulence genes.

  • Leads: NIAID, NHLBI
  • Collaborators: NCID, CBER
  • Start Date: FY 2002
  • Completion Date: FY 2002-2009

b) Expand the TB vaccine candidate screening program.

  1. Lead: NIAID
  2. Collaborator: None
  3. Start Date: FY 2002
  4. Completion Date: FY 2012

c) Standardize vaccine production and testing, including identification and validation of correlates of protective immunity for potential use in clinical trials.

  • Lead: NIAID
  • Collaborators: NHLBI, NCHHSTP
  • Start Date: FY 2002
  • Completion Date: FY 2012

d) Coordinate and conduct vaccine safety and immunogenicity studies.

  • Lead: NIAID
  • Collaborator: NHLBI
  • Start Date: FY 2002
  • Completion Date: FY 2014

e) Facilitate the development of vaccine efficacy endpoints.

  • Lead: CBER
  • Collaborators: NIAID, NCHHSTP
  • Start Date: FY 2002
  • Completion Date: FY 2012-2017

f) Facilitate and support public/private partnerships.

  • Lead: NIAID
  • Collaborator: NCHHSTP
  • Start Date: FY 2002
  • Completion Date: FY 2017-2022

g) Establish an international network of field sites for vaccine testing, including characterization of the target populations.

  • Lead: NIAID
  • Collaborator: NCSHTP
  • Start Date: FY 2002
  • Completion Date: FY 2007

h) Conduct clinical efficacy trials of new vaccines.

  • Lead: NIAID
  • Collaborator: NCHHSTP
  • Start Date: FY 2007
  • Completion Date: FY 2012-2027

i) Coordinate vaccine development efforts with other agencies and stakeholders.

  • Lead: NIAID
  • Collaborators: NCHHSTP, NHLBI, CBER
  • Start Date: FY 2002
  • Completion Date: 2017-2022

2. Facilitate related U.S. regulatory review and introduction of improved TB vaccines for use in the U.S.

Lead Agencies: FDA, CDC

Collaborating Agency: NIH

Start Date: 2002

Completion Date: 2012-2022

a) Assist researchers and manufacturers in the development of new TB vaccines that are pure, potent, safe, and effective; develop potency assays to test biologic activity of TB vaccines; provide guidance for the preclinical testing of TB vaccines; organize regulatory workshops to promote good manufacturing practices (GMPs) in vaccine production; and help develop protocols and standardized assays for human clinical investigation of TB vaccines.

  • Lead: CBER
  • Collaborators: NCHHSTP, NIAID
  • Start Date: FY 2002
  • Completion Date: FY 2012-2022

b) Undertake steps to introduce new vaccine(s) for use in target populations; conduct demonstration projects to identify impediments to uptake of new vaccine(s); issue guidelines on the use of new TB vaccine(s) through the CDC Advisory Committee for Immunization Practices and Advisory Council for the Elimination of Tuberculosis; support vaccine programs through CDC TB cooperative agreements; and support vaccine implementation programs in target populations.

  • Leads: NCHHSTP, NIP
  • Collaborators: CBER, NIAID
  • Start Date: Post vaccine
  • Completion Date: 5 years post-approval approval

IOM Recommendation 5.2: “To advance the development of diagnostic tests and new drugs for both latent infection and active disease, action plans should be developed and implemented...”

Strategies
Action Steps

1. Develop new diagnostics for TB infection including more specific tests to counter the problems of bacillus Calmette- Guerin (BCG) vaccination and nontuberculous mycobacteria (NTM) sensitization and methods
to identify those infected persons at highest risk of progression to active TB, including persons co-infected with HIV.

Start Date: FY 2002

Completion Date: 2010-2012

a) Explore and support mechanisms to increase private sector participation in developing improved TB latent diagnostics.

  • Lead: NIAID, NCHHSTP
  • Collaborators: CDRH, USAID
  • Start Date: FY 2002
  • Completion Date: FY 2010-2012

b) Improve and develop better molecular epidemiological tools for use in contact investigation.

  • Lead: NCHHSTP, NIAID
  • Collaborator: CDRH
  • Start Date: FY 2002
  • Completion Date: FY 2007


2. Develop and evaluate new and improved diagnostics for rapid and sensitive diagnosis of active TB, including the identification of drug-resistant strains and TB in HIV-infected persons.

Lead Agencies: NIH, CDC

Collaborating Agencies: FDA, USAID

Start Date: FY 2002

Completion Date: FY 2010-2012

a) Enable expedited FDA review of new diagnostics for latent and active TB and MDR TB, including those for use in different risk groups.

  • Lead: CDRH
  • Collaborator: CBER
  • Start Date: FY 2002
  • Completion Date: Ongoing

b) Develop “standard” animal models of latent and active TB infection.

  • Leads: NIAID, NHLBI
  • Collaborator: None
  • Start Date: FY 2002
  • Completion Date: FY 2007-2009

c) Conduct epidemiologic studies on immunologic and genetic markers of disease progression and protection.

  • Leads: NIAID, NHLBI, NCHHSTP
  • Collaborator: None
  • Start Date: FY 2002
  • Completion Date: 2007-2010

d) Conduct research aimed at the improvement of currently available diagnostic tests (e.g., smear microscopy, culture and susceptibility testing).

  • Leads: NCHHSTP, PHPPO, NIAID
  • Collaborator: USAID
  • Start Date: FY 2002
  • Completion Date: FY 2007

e) Support and conduct research and development (up to and including field tests and regulatory approval/ clearance) of diagnostic tools for latent and active TB, including MDR TB, with improved sensitivity and specificity in adults and children in both high and low endemic rate settings.

  • Leads: NIAID, NCHHSTP
  • Collaborators: NCID, NIOSH, CDRH, USAID
  • Start Date: FY 2002
  • Completion Date: FY 2010-1012

f) Assess and promote the most effective combinations/algorithms of new diagnostic tests for smear, culture, direct detection, and drug susceptibility testing.

  • Lead: PHPPO
  • Collaborators: NCID, NCHHSTP, CDRH, USAID
  • Start Date: FY 2002
  • Completion Date: Ongoing

3. Expand clinical research and evaluate the overall effectiveness
of current and novel treatments for latent TB, active TB, and MDR TB

Lead Agencies: NIH, CDC

Collaborating Agencies: FDA, USAID

Start Date: FY 2002

Completion Date: FY 2012

a) Identify shorter regimens to facilitate completion of treatment for TB disease and latent TB infection.

  • Leads: NCHHSTP, NIAID
  • Collaborators: NIDA, USAID
  • Start Date: prior to FY 2002
  • Completion Date: FY 2010

b) Expand use of non-human primates for research into vaccines and treatment of infection/disease.

  • Lead: NIAID
  • Collaborators: CBER, NHLBI, NCHHSTP
  • Start Date: FY 2003
  • Completion Date: FY 2010

c) Develop improved regimens for treatment of MDR TB and explore new and available agents not currently being used for TB (e.g., immunoregulation therapy and other delivery vehicles), including new indications for existing medications in the treatment of MDR TB.

  • Leads: NIAID, NHLBI, NCHHSTP
  • Collaborator: None
  • Start Date: FY 2002
  • Completion Date: FY 2010

d) Expand and support basic, preclinical and clinical development, and testing of novel TB therapeutic candidates.

  • Leads: NIAID, NCHHSTP
  • Collaborators: NIDA, NHLBI, CBER, CDER
  • Start Date: FY 2002
  • Completion Date: FY 2012

IOM Recommendation 5. 3: “To promote better understanding of patient and provider nonadherence with tuberculosis treatment recommendations and guidelines, a plan for a behavioral and social science research agenda should be developed and implemented”

Strategies
Action Steps

1. Conduct research to determine the best methods of educating health care providers to recognize TB cases.

Lead Agency: CDC

Collaborating Agencies: VA, OSHA, NIH, IHS, HRSA, SAMHSA, USAID

Start Date: FY 2002

Completion Date: FY 2005

a) Conduct research/demonstration projects with private and public health care providers to determine the most effective and efficient methods of education/intervention to lead to early/correct identification of TB cases.

  • Leads: NCHHSTP, NHLBI
  • Collaborators: NIOSH, VHA, OSHA, NIAID, NIDA, Fogarty International Center, IHS, BPHC, HAB, SAMHSA, USAID
  • Start Date: FY 2002
  • Completion Date: FY 2005

 

 

2. Conduct research on methods to maximize completion of therapy (and minimize relapse) for TB disease and maximize completion of treatment for latent TB infection.

Lead Agencies: NIH, CDC, INS

Collaborating Agencies: HRSA, USAID, DHHS/OGC/PHD

Start Date: FY 2002

Completion Date: FY 2004

a) Conduct cost effectiveness studies of utility/benefits of targeted tuberculin skin test (TST) programs in different populations.

  • Lead: NCHHSTP
  • Collaborators: NIAID, NIDA, BPHC, DIHS, NCID
  • Start Date: FY 2002
  • Completion Date: Ongoing

b) Conduct operational research of case management systems that take into account hard-to-reach popul boundaries, etc.

  • Lead: NCHHSTP
  • Collaborator: NTCA
  • Start Date: prior to FY 2002
  • Completion Date: Ongoing

c) Conduct public health law research on methods to maximize completion of therapy (and minimize relapse) for TB disease and to maximize completion of treatment for latent TB infection.

  • Leads: NCHHSTP, HQCOU, PHPPO
  • Collaborators: DHHS/OGC/PHD; D&R
  • Start Date: FY 2002
  • Completion Date: FY 2002


    1. Consult with DHHS and INS legal counsel on existing policies regarding mandatory TB treatment for immigrants seeking admission through legal processes.
      • Leads: CDC/OD/OGC, NCHHSTP, HQCOU
      • Collaborators: DHHS/OGC/PHD; NCID
      • Start Date: FY 2002
      • Completion Date: FY 2002


    2. Conduct legal and ethical research on issues related to mandatory completion of TB treatment of the detention populations and possibly other selected populations in the future.
      • Lead: HQCOU
      • Collaborators: DHHS/OGC/PHD, CDC/OD/OGC, NCHHSTP, D&R
      • Start Date: FY 2003
      • Completion Date: FY 2004

3. Conduct feasibility research to determine the costs, benefits, effectiveness, and utility of Targeted Testing and Treatment of Latent TB (TTTLTB) programs in different TB high-risk populations.

Lead Agency: CDC

Collaborating Agencies: NIH, HRSA, IHS, SAMHSA, DOJ, HUD

Start Date: FY 2002

Completion Date: FY 2004

a) Conduct evaluation of INS/DIHS teleradiology screening program for illegal aliens in INS detention facilities.

  • Lead: DIHS
  • Collaborator: None
  • Start Date: FY 2002
  • Completion Date: FY 2003

b) Evaluate methods and cost effectiveness of TB/HIV screening and related treatment of latent TB infection in populations at risk for both HIV and TB.

  • Lead: NCHHSTP
  • Collaborators: HAB, SAMHSA, NIDA, NTCA
  • Start Date: prior to FY 2002
  • Completion Date: FY 2003

c) Evaluate methods and cost effectiveness of TTTLTB programs for homeless populations.

  • Lead: NCHHSTP
  • Collaborators: BPHC, HUD, SAMHSA, NHLBI
  • Start Date: prior to FY 2002
  • Completion Date: FY 2003

d) Evaluate methods and cost effectiveness of TTTLTB programs for correctional facilities.

  • Lead: NCHHSTP
  • Collaborator: FBOP
  • Start Date: prior to FY 2002
  • Completion Date: FY 2003

e) Evaluate methods and cost effectiveness of TTTLTB programs among the following foreign-born populations at risk for TB: asylum applicants, newly arrived immigrants and refugees, students, and other TB at-risk foreign- born populations (to be identified).

  • Lead: NCHHSTP
  • Collaborators: NCID, D&R
  • Start Date: FY 2002
  • Completion Date: FY 2004

f) Evaluate methods and cost effectiveness of TTTLTB programs in drug treatment centers.

  • Leads: NCHHSTP, SAMHSA
  • Collaborators: NIDA, NTCA
  • Start Date: prior to FY 2002
  • Completion Date: FY 2004

g) Evaluate methods and cost effectiveness of TTTLTB programs in other high-risk populations including American Indians/Alaska Natives, migrant workers, and other minorities.

  • Leads: NCHHSTP, IHS, BPHC
  • Collaborators: Other agencies as appropriate.
  • Start Date: 2003
  • Completion Date: 2004

4. Develop and implement strategies to immediately translate evidence-based knowledge from research into clinical and public health practice.

Lead Agency: CDC

Collaborating Agencies: All

Start Date: FY 2002

Completion Date: FY 2007

a) Convene meeting of researchers in tuberculosis and related areas to develop implementation strategies based on evidence-based research.

  • Leads: NCHHSTP, NIAID, NHLBI, NIDA
  • Collaborator: None
  • Start Date: prior to FY 2002
  • Completion Date: FY 2002

b) Develop 5-year strategic plan for implementation of strategies (strategies defined in researchers
Federal TB Task Force Agencies meeting); include ongoing monitoring of implementation activities and yearly reconvening of lead researchers.

  • Leads: NCHHSTP, NIAID, NHLBI
  • Collaborators: All Federal TB Task Force members
  • Start Date: FY 2002
  • Completion Date: FY 2007

c) Develop criteria for evaluation and funding of key priority projects to implement identified strategies.

  • Leads: NCHHSTP, NIAID, NHLBI
  • Collaborator: None
  • Start Date: FY 2003
  • Completion Date: FY 2007

5. Support a career track for new TB investigators.

Lead Agency: NIH

Collaborating Agency: CDC

Start Date: FY 2003

Completion Date: 2013

a) Expand training support for early- and mid-career investigators pertinent to improving TB care.

  • Lead: NIAID
  • Collaborators: NHLBI, NCHHSTP
  • Start Date: FY 2003
  • Completion Date: 2013
 
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