Clarification on NIH HIV/AIDS Clinical Network Responsibilities for the Use of Antibody-based Therapies for the Prevention and Treatment of HIV Infection

Notice Number: NOT-AI-12-035

Key Dates
Release Date: June 20, 2012

Affected Funding Opportunity Announcement

RFA-AI-12-001 Leadership Group for a Clinical Research Network on HIV/AIDS and HIV-associated Infections in Pediatric and Maternal Populations (UM1)

RFA-AI-12-011 Leadership Group for a Clinical Research Network on Integrated Strategies to Prevent HIV Infection (UM1) 

RFA-AI-12-008 Leadership Group for a Clinical Research Network on Microbicides to Prevent HIV Infection (UM1) 

RFA-AI-12-004 Leadership Group for a Clinical Research Network on Therapeutics for HIV/AIDS and HIV-associated Infections in Adults (UM1)

RFA-AI-12-012 Leadership Group for a Clinical Research Network on Vaccines to Prevent HIV infection (UM1)

Issued by
National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

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.

Given the advances in the field of immunoglobulin research, there is considerable optimism regarding applications of antibody-based therapies for the prevention and treatment of HIV infection.  NIAID recognizes that antibody-based interventions have the potential for broad application within the NIH supported HIV/AIDS Clinical Networks.  Collaboration across networks should optimize unique network capabilities, such as recruiting specific populations or conducting specialized laboratory assays in order to advance the best science supporting development of unique HIV therapies, vaccines and other prevention approaches.

The following Leadership Group (LG) lead assignments are appropriate based on scientific questions and network capabilities:

The LG for a Clinical Research Network on Vaccines to Prevent HIV infection may take responsibility for testing the strategy to determine if passive immunization with a particular type of antibody can protect against HIV. A positive outcome, with an immunological signature, will provide proof of concept for protection and may lead to further trials testing a potentially licensable vaccine that elicits similarly protective antibodies in vivo.

The LG for a Clinical Research Network on Integrated Strategies to Prevent HIV Infection may also lead on evaluating the use of antibodies themselves as potentially licensable biological products for pre- or post-exposure to prevent HIV acquisition in adult populations, including proof of concept studies that would lead to larger trials designed to support product licensure. It is anticipated that the LG for a Clinical Research Network on Vaccines to Prevent HIV infection would provide, if appropriate, integrated collaborative laboratory expertise for specialized assays to determine aspects of antibody performance such as persistence or distribution.

The LG for a Clinical Research Network on HIV/AIDS and HIV-associated Infections in Pediatric and Maternal Populations will take the lead on evaluating the use of antibodies as pre- or post-exposure prophylaxis to prevent HIV acquisition in pediatric and maternal populations.

The LG for a Clinical Research Network on Therapeutics for HIV/AIDS and HIV-associated Infections in Adults and the LG for a Clinical Research Network on HIV/AIDS and HIV-associated Infections in Pediatric and Maternal Populations will take the lead on evaluating effects of antibody therapy on HIV infection outcomes in their corresponding populations.

Inquiries

Please direct all inquiries for:
 
RFA-AI-12-001 Leadership Group for a Clinical Research Network on HIV/AIDS and HIV-associated Infections in Pediatric and Maternal Populations (UM1)
to
Judi Miller, BSN
Division of AIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Room 5227, MSC-7624
6700B Rockledge Drive
Bethesda, MD 20982-7624 (for Express Mail- 20817)
Telephone:  301-496-1189
FAX:  301-480-4582
Email: jmillera@niaid.nih.gov

RFA-AI-12-011 Leadership Group for a Clinical Research Network on Integrated Strategies to Prevent HIV Infection (UM1)
to
Mike Gilbreath, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Room 5249, MSC-7620
6700B Rockledge Drive
Bethesda, MD 20982-7624(for Express Mail- 20817)
Telephone:  301-451-2743 (office)
Email: gilbreathmj@niaid.nih.gov

RFA-AI-12-008 Leadership Group for a Clinical Research Network on Microbicides to Prevent HIV Infection (UM1)
to
Roberta Black, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Room 5117, MSC-7624
6700B Rockledge Drive
Bethesda, MD 20982-7624(for Express Mail- 20817)
Telephone:  301-496-8199 (office)
FAX: 301-402-3684
Email: rblack@niaid.nih.gov

RFA-AI-12-004 Leadership Group for a Clinical Research Network on Therapeutics for HIV/AIDS and HIV-associated Infections in Adults (UM1)
to
Ellen DeCarlo, BSN
Division of AIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Room 5229. MSC-7624
6700B Rockledge Drive
Bethesda, MD 20982-7624(for Express Mail- 20817)
Telephone: 301-496-8212
Email: decarloe@niaid.nih.gov

RFA-AI-12-012 Leadership Group for a Clinical Research Network on Vaccines to Prevent HIV infection (UM1)
to
Philip Renzullo, Ph.D., MPH
Division of AIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Room 5132, MSC-7624
6700B Rockledge Drive
Bethesda, MD 20892-7624 (for Express Mail – 20817)
Telephone: 301-451-2764 (office)
FAX: 301-402-3684
Email: prenzullo@niaid.nih.gov


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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