Notice Number: NOT-AI-15-035

Key Dates
Release Date: May 8, 2015

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

Purpose

This Notice is to inform potential applicants that the NIAID is revising RFA-AI-15-005 "Molecular Mechanisms of Combination Adjuvants (MMCA) (U01)" to correct instructions under Section IV. Application and Submission Information PHS 398 Research Plan for preliminary studies.

The following change to this FOA is being made:

Section IV. Application and Submission Information

CURRENT LANGUAGE
2. Content and Form of Application Submission

PHS 398 Research Plan

Research Strategy: Within the research strategy, applicants must include the following:

• Preliminary studies demonstrating the ability of the proposed combination(s) of adjuvants to enhance vaccine induced immunity. Evidence of enhanced immune response may be provided as unpublished data or by referring to the published literature.
• Detailed plans for in vitro studies using human or other mammalian tissues, cells or molecules to determine the combination adjuvant’s mechanism(s) of action and obtain evidence consistent with enhanced efficacy.
• Plans for in vivo animal testing of adjuvant combinations used with one or more vaccines, to study pre-clinical safety (low or no reactogenicity) and efficacy, as well as to further elucidate mechanism of action of adjuvants.
• In addition to studying the mechanism of action of the combination adjuvant, some preliminary studies must be proposed to provide evidence of safety and efficacy using in vitro and animal model systems.
• A clear description of interim objectives and draft quantitative annual milestones to be achieved during the project for assessing progress and success.

NEW LANGUAGE
2. Content and Form of Application Submission

PHS 398 Research Plan

Research Strategy: Within the research strategy, applicants must include the following:

• Preliminary studies demonstrating the ability of each proposed individual adjuvant to enhance vaccine induced immunity. Evidence of enhanced immune response may be provided as unpublished data or by referring to the published literature.
• Detailed plans for in vitro studies using human or other mammalian tissues, cells or molecules to determine the combination adjuvant’s mechanism(s) of action and obtain evidence consistent with enhanced efficacy.
• Plans for in vivo animal testing of adjuvant combinations used with one or more vaccines, to study pre-clinical safety (low or no reactogenicity) and efficacy, as well as to further elucidate mechanism of action of adjuvants.
• In addition to studying the mechanism of action of the combination adjuvant, some preliminary studies must be proposed to provide evidence of safety and efficacy using in vitro and animal model systems.
• A clear description of interim objectives and draft quantitative annual milestones to be achieved during the project for assessing progress and success.

Inquiries

Please direct all inquiries to:

Wolfgang Leitner, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3575
Email: wleitner@niaid.nih.gov