Notice of Change to Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) (U19 Clinical Trial Not Allowed), PAR-23-033
Notice Number:
NOT-AI-24-004

Key Dates

Release Date:

November 8, 2024

Related Announcements

  • October 31, 2022 - Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) (U19 Clinical Trial Not Allowed). See NOFO PAR-23-033

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The purpose of this Notice is to alert potential applicants of a change to the Not Responsive parameters in PAR-23-033, Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) (U19 Clinical Trial Not Allowed).

Currently Reads:

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Applications Not Responsive to this FOA

Applications that propose to conduct research in the following areas will be considered non-responsive and will not be reviewed.

  • Studies proposing gp120 monomer immunogens either alone or in combination with other immunogens
  • Immunogens designed to primarily elicit binding or functional non-neutralizing antibodies other than bnAbs
  • Applications proposing only the CGMP manufacture of adjuvants
  • Development and manufacture of therapeutic interventions

Applications without the following will be considered non-responsive and will not be reviewed.

  • Product Development Plan
  • Milestone Plan
  • Clinical Development Plan
  • Product Storage and Stability Program 

Applicants are highly encouraged to contact the program official listed under Scientific/Research Contact(s) in Section VII to discuss their applications prior to submission.

Modified to Read (changes shown in bold italics):

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Applications Not Responsive to this FOA

Applications that propose to conduct research in the following areas will be considered non-responsive and will not be reviewed.

  • Studies proposing undefined boost immunogen (s) and / or those that are dependent on outcomes from clinical trials that are being planned or ongoing
  • Studies proposing gp120 monomer immunogens either alone or in combination with other immunogens
  • Immunogens designed to primarily elicit binding or functional non-neutralizing antibodies other than bnAbs
  • Applications proposing only the CGMP manufacture of adjuvants
  • Development and manufacture of therapeutic interventions

Applications without the following will be considered non-responsive and will not be reviewed.

  • Product Development Plan
  • Milestone Plan
  • Clinical Development Plan
  • Product Storage and Stability Program 

Applicants are highly encouraged to contact the program official listed under Scientific/Research Contact(s) in Section VII to discuss their applications prior to submission.

All other aspects of the NOFO remain unchanged.

Inquiries

Please direct all inquiries to:

Sujata Vijh, Ph.D.  
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7713
Email: sujata.vijh@nih.gov