Notice of Change to PAR-18-319 "HIV Vaccine Research and Design (HIVRAD) Program (P01 Clinical Trial Not Allowed)"

Notice Number: NOT-AI-19-016

Key Dates
Release Date: December 11, 2018

Related Announcements

PAR-18-319


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

Purpose

The purpose of this Notice is to update the Objective for PAR-18-319 "HIV Vaccine Research and Design (HIVRAD) Program (P01 Clinical Trial Not Allowed)" to inform the applicant community of an additional area of interest by NIAID.

Part 2.Section I. Funding Opportunity Description

Objective

Current language:

The HIV Vaccine Research and Design (HIVRAD) program is designed to fund projects that further address hypotheses crucial to the design of an efficacious HIV/AIDS prophylactic vaccine. Applications for five years of support should include plans that have advanced past the exploratory stage and include preliminary data. Applications aimed at developing or optimizing a specific vaccine platform should lay out a research pathway with clear decision points. Extensive modeling of vaccine concepts in non-human primates may be included.

Applications may address, but need not be limited to:

  • Approaches to elicit durable and broadly neutralizing antibodies against HIV and/or SIV
  • Identifying correlates of vaccine-induced immune protection to HIV/AIDS
  • HIV structural studies as they relate to designing HIV immunogens
  • Induction and properties of protective non-neutralizing antibodies
  • Improved animal model systems (and challenge viruses) to address vaccine efficacy
  • Approaches to increase the immunogenicity of HIV antigens (e.g., novel adjuvants)
  • Vaccine design to better address the heterogeneity of HIV
  • Developing or improving viral or bacterial vaccine vectors
  • Determining how immune cells can be mobilized to the portal of infection
  • Investigations into the role of glycan structures on immunogenicity, antigenicity and infectivity
  • Investigations into innate immunity to alter the outcome of infection

Note:The following types of studies will not be supported under this FOA:

  • Clinical studies and clinical trials; however, studies utilizing clinical samples are permitted
  • Studies focused solely on therapeutic vaccines

Revised language:

The HIV Vaccine Research and Design (HIVRAD) program is designed to fund projects that further address hypotheses crucial to the design of an efficacious HIV/AIDS prophylactic vaccine. Applications for five years of support should include plans that have advanced past the exploratory stage and include preliminary data. Applications aimed at developing or optimizing a specific vaccine platform should lay out a research pathway with clear decision points. Extensive modeling of vaccine concepts in non-human primates may be included.

Applications may address, but need not be limited to:

  • Approaches to elicit durable and broadly neutralizing antibodies against HIV and/or SIV
  • Identifying correlates of vaccine-induced immune protection to HIV/AIDS
  • HIV structural studies as they relate to designing HIV immunogens
  • Induction and properties of protective non-neutralizing antibodies
  • Improved animal model systems (and challenge viruses) to address vaccine efficacy
  • Approaches to increase the immunogenicity of HIV antigens (e.g., novel adjuvants)
  • Vaccine design to better address the heterogeneity of HIV
  • Developing or improving viral or bacterial vaccine vectors
  • Determining how immune cells can be mobilized to the portal of infection
  • Investigations into the role of glycan structures on immunogenicity, antigenicity and infectivity
  • Investigations into innate immunity to alter the outcome of infection
  • Impact of pediatric immune ontogeny on vaccine responses

Note:The following types of studies will not be supported under this FOA:

  • Clinical studies and clinical trials; however, studies utilizing clinical samples are permitted
  • Studies focused solely on therapeutic vaccines
All other aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Alan Schultz, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-6169
Email:schultzam@niaid.nih.gov