Immune Mechanisms of Protection Against Mycobacterium tuberculosis Center (IMPAc-TB)

Awarded Vendors: Seattle Children's Research Institute. Contract Award Dollar Amount: $82,956,648. Contract Award Date: 2019-09-25.

Awarded Vendors: Infectious Disease Research Institute. Contract Award Dollar Amount: $44,827,505. Contract Award Date: 2019-09-24.

Introduction

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID Divisions of AIDS (DAIDS); Allergy, Immunology and Transplantation (DAIT); and Microbiology and Infectious Diseases (DMID) have a joint requirement for development of the Immune Mechanisms of Protection Against Mycobacterium tuberculosis center (IMPAc-TB) program to gain a comprehensive understanding of the nature, location and timing of protective immune responses required to prevent initial Mtb infection, development of stable latent infection, or transition to active TB disease.

Description

The goal of this program is to establish an integrated multi-disciplinary team of highly collaborative investigators that will plan and conduct iterative, in-depth immunologic analyses of tissue-specific and systemic responses in small animals, non-human primates (NHPs), and humans to identify the key immune responses needed for protection against Mtb; identify immunologic targets that can be used to improve TB vaccine strategies; determine the impact of HIV/SIV and Nontuberculous Mycobacteria (NTM) infection(s) on relevant immune responses to Mtb infection or TB vaccines; and identify how bacterial immune evasion mechanisms subvert immune responses to Mtb.

The IMPAc-TB team will be expected to develop Standard Operating Procedures and assay harmonization methods to be implemented by the center's members; conduct in-depth immunologic analyses of tissue-specific and systemic responses against Mtb/TB in small animals, non-human primates (NHPs), and humans, including examination of host responses to BCG or novel, promising vaccine candidates (pre- and/or post-exposure candidates); collaborate with existing NIAID-supported and other TB programs; and distribute positive and negative study results, reagents and other resources within a center, between centers (if applicable), to other NIAID-supported programs, and the broader research community to facilitate the development of improved TB vaccines.

To achieve the IMPAc-TB program goals, Contractors will be responsible for the following activities:

• Leadership structure: providing a Leadership Team to oversee center activities and be responsible for the planning and conduct of the IMPAc-TB center's proposed studies

• Data and resource management system used for the storage, retrieval and analysis of center-generated data; cataloging/reporting of all center-generated reagents and research resources; and sharing of positive and negative study results and research resources within the center, to other NIAID-supported programs, and the broader research community in a timely manner through existing NIAID-supported programs (e.g., ImmPort, the Bioinformatics Resource Centers (PATRIC), BEI Resources) or other public portals or repositories designated by NIAID.

• Conduct in-depth immunologic analyses to provide novel insights into the immune responses required to (1) protect a host from initial Mtb infection, (2) establish a latent infection, and/or (3) progress to active TB disease. These in-depth immune analyses should include a systemic analysis (i.e., not limited to a single component) of the immune system. Each IMPAc-TB team must examine at least two (2) of these three (3) Mtb/TB stages and conduct iterative immunologic studies using small animal models, non-human primate (NHP) and human studies. The immunologic studies should seek to move beyond analysis of single arms of the immune system and progress toward understanding how complex immune networks and interacting components generate a given biological outcome. The use of relevant small animal models that go beyond commonly used laboratory mouse strains is strongly encouraged. In addition, investigation of multiple clinically-relevant Mtb strains in animal challenge studies is encouraged.

It is anticipated that one to three (1-3) cost reimbursement, completion type contracts will be awarded with performance beginning on or about August 01, 2019.

NIAID anticipates funding up to $19.5M for all awards (direct and indirect costs combined) resulting from this BAA. Due to the inherent unknowns in a BAA (offeror developed SOW), it is difficult to determine the exact period of performance. The Government anticipates an initial, non-severable, completion portion of work. Dependent upon offeror's technical approaches and proposed milestones, the Government may also negotiate additional non-severable, completion options.

Any responsible offeror may submit a proposal which shall be considered by the Agency. This BAA will be available electronically on/about February 08, 2018, and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.

Where proposals will be received via the NIAID electronic Contract Proposal Submission (eCPS) website add the following:

For this solicitation, NIAID requires proposals to be submitted electronically via the electronic Contract Proposal Submission (eCPS) website at https://ecps.niaid.nih.gov.

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Introduction

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID Divisions of AIDS (DAIDS); Allergy, Immunology and Transplantation (DAIT); and Microbiology and Infectious Diseases (DMID) have a joint requirement for development of the Immune Mechanisms of Protection Against Mycobacterium tuberculosis center (IMPAc-TB) program to gain a comprehensive understanding of the nature, location and timing of protective immune responses required to prevent initial Mtb infection, development of stable latent infection, or transition to active TB disease.

Description

The goal of this program is to establish an integrated multi-disciplinary team of highly collaborative investigators that will plan and conduct iterative, in-depth immunologic analyses of tissue-specific and systemic responses in small animals, non-human primates (NHPs), and humans to identify the key immune responses needed for protection against Mtb; identify immunologic targets that can be used to improve TB vaccine strategies; determine the impact of HIV/SIV and Nontuberculous Mycobacteria (NTM) infection(s) on relevant immune responses to Mtb infection or TB vaccines; and identify how bacterial immune evasion mechanisms subvert immune responses to Mtb.

The IMPAc-TB team will be expected to develop Standard Operating Procedures and assay harmonization methods to be implemented by the center's members; conduct in-depth immunologic analyses of tissue-specific and systemic responses against Mtb/TB in small animals, non-human primates (NHPs), and humans, including examination of host responses to BCG or novel, promising vaccine candidates (pre- and/or post-exposure candidates); collaborate with existing NIAID-supported and other TB programs; and distribute positive and negative study results, reagents and other resources within a center, between centers (if applicable), to other NIAID-supported programs, and the broader research community to facilitate the development of improved TB vaccines.

To achieve the IMPAc-TB program goals, Contractors will be responsible for the following activities:

• Leadership structure: providing a Leadership Team to oversee center activities and be responsible for the planning and conduct of the IMPAc-TB center's proposed studies

• Data and resource management system used for the storage, retrieval and analysis of center-generated data; cataloging/reporting of all center-generated reagents and research resources; and sharing of positive and negative study results and research resources within the center, to other NIAID-supported programs, and the broader research community in a timely manner through existing NIAID-supported programs (e.g., ImmPort, the Bioinformatics Resource Centers (PATRIC), BEI Resources) or other public portals or repositories designated by NIAID.

• Conduct in-depth immunologic analyses to provide novel insights into the immune responses required to (1) protect a host from initial Mtb infection, (2) establish a latent infection, and/or (3) progress to active TB disease. These in-depth immune analyses should include a systemic analysis (i.e., not limited to a single component) of the immune system. Each IMPAc-TB team must examine at least two (2) of these three (3) Mtb/TB stages and conduct iterative immunologic studies using small animal models, non-human primate (NHP) and human studies. The immunologic studies should seek to move beyond analysis of single arms of the immune system and progress toward understanding how complex immune networks and interacting components generate a given biological outcome. The use of relevant small animal models that go beyond commonly used laboratory mouse strains is strongly encouraged. In addition, investigation of multiple clinically-relevant Mtb strains in animal challenge studies is encouraged.

It is anticipated that one to three (1-3) cost reimbursement, completion type contracts will be awarded with performance beginning on or about August 01, 2019.

NIAID anticipates funding up to $19.5M for all awards (direct and indirect costs combined) resulting from this BAA. Due to the inherent unknowns in a BAA (offeror developed SOW), it is difficult to determine the exact period of performance. The Government anticipates an initial, non-severable, completion portion of work. Dependent upon offeror's technical approaches and proposed milestones, the Government may also negotiate additional non-severable, completion options.

Any responsible offeror may submit a proposal which shall be considered by the Agency. This BAA will be available electronically on/about February 08, 2018, and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.

Where proposals will be received via the NIAID electronic Contract Proposal Submission (eCPS) website add the following:

For this solicitation, NIAID requires proposals to be submitted electronically via the electronic Contract Proposal Submission (eCPS) website at https://ecps.niaid.nih.gov.