Notice of NHLBI Participation in PAR-19-307, "Mechanisms of Mycobacterial-Induced Immunity in HIV-Infected and/or Uninfected Individuals to Inform Innovative Tuberculosis Vaccine Design (R01 Clinical Trial Not Allowed)" NOT-HL-19-745

Key Dates
Release Date: December 19, 2019

Related Announcements

PAR-19-307

Issued by

National Heart, Lung, and Blood Institute (NHLBI)

Purpose

The purpose of this Notice is to inform potential applicants of NHLBI's secondary participation in PAR-19-307 “Mechanisms of Mycobacterial-Induced Immunity in HIV-Infected and/or Uninfected Individuals to Inform Innovative Tuberculosis Vaccine Design (R01 Clinical Trial Not Allowed).” NHLBI's participation is intended to support research into understanding the host immune responses to mycobacterial infection and mycobacterial vaccination in HIV infected and HIV uninfected individuals, with the goal of improving development of innovative mycobacterial vaccines.

Background

Mycobacterium tuberculosis (MTB) has consistently been on the World Health Organization’s top 10 causes of death globally, in spite of availability of multidrug treatment regimens. Though HIV has moved off of the WHO’s top 10 causes of death worldwide, MTB infection is a major comorbidity in people living with HIV. Globally, the Bacillus Calmette-Guerin (BCG) vaccine is widely used in the pediatric population, but it does not provide lasting immunity to MTB and is thought to be variably efficacious based upon local mycobacterial exposure patterns that are as yet undefined. Moreover, HIV co-infection is known to modulate immune responses to MTB infection and to MTB vaccination, but the details of these immunomodulatory processes are only just beginning to be understood in detail.

The purpose of the parent PAR is to support basic, translational, and clinical studies (though not clinical trials) that seek to enhance understanding of immune responses to MTB infection and MTB vaccination in HIV+ and HIV- individuals, to allow for future development of more effective mycobacterial vaccines. Though the focus is on understanding host responses to MTB infection and MTB vaccination, the NHLBI recognizes that the spectrum of mycobacterial immune response is relevant for heart, lung, blood, and sleep (HLBS) diseases and HLBS co-morbidities in people living with HIV.

The following text has been added to reflect NHLBI's participation in this FOA:

Part 1. Overview Information

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)

National Heart, Lung, and Blood Institute (NHLBI)

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.855, 93.838

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

NHLBI Research Examples

• Selected examples of research topics of particular interest to NHLBI include, but are not limited to, the following:
• Elucidation of the specific role of mucosal adaptive immune responses within the lung, including signaling networks and regulatory mechanisms, throughout the course of mycobacterial infection and/or vaccination, and how HIV infection may alter these responses
• Definition of the specific roles of innate immune responses in the lung in the context of mycobacterial infection and/or vaccine response, and how these innate immune responses may be shaped by HIV infection
• Investigation of how HIV effects on bone marrow may shape systemic immune responses to mycobacterial infection and/or vaccination
• Studies investigating mechanisms of host response to mycobacterial exposure, through infection and/or through vaccination, that lead to granuloma formation, and the role of HIV infection in shaping granuloma formation and maintenance as it pertains to mycobacterial infection and/or vaccination responses
• Projects proposing to utilize existing resources such as the MACS/WHIS Combined Cohort Study, NHLBI BioLINCC, or other existing resources to address host responses to mycobacterial infection and/or vaccination in HIV+ and/or HIV- individuals

Part 2. Section VII. Agency Contacts

Cesar Boggiano, PhD
Division of AIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3038
Email: cesar.boggiano@nih.gov

Katrin Eichelberg, Ph D
Division of Microbiology and Infectious Diseases,
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2921
Email: keichelberg@nih.gov

Nancy Vázquez-Maldonado, Ph.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5044
Email: nvazquez@niaid.nih.gov

Josh Fessel, M.D., Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0222
Email: josh.fessel@nih.gov

Inquiries

Please direct all inquiries to:

Josh Fessel, M.D., Ph.D.
National Heart, Lung, and Blood Institute
Telephone: 301-435-0222
Email: josh.fessel@nih.gov