Amendment 1.pdf
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- Solicitation number
- BAA-DAIT-75N93021R00008
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This document is an amendment to a Broad Agency Announcement soliciting research proposals for advancing vaccine adjuvant research for tuberculosis. The amendment responds to technical questions from potential offerors by clarifying that while a compound must have intrinsic adjuvant activity to qualify as an adjuvant, modulators that enhance adjuvant activity will be considered part of the adjuvant-vaccine formulation optimization. Offerors are required to propose three distinct adjuvants representing different categories that can be formulated with or without a modulator. The response date of August 10, 2021 at 3:00 PM EST remains unchanged. The National Institute of Allergy and Infectious Diseases within the Department of Health and Human Services National Institutes of Health issued this Broad Agency Announcement.
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| File | Type | Posted |
|---|---|---|
| Amendment 2.pdf | ||
| BAA-DAIT-75N93021R00008 Solicitation.pdf |
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BAA No.: BAA-DAIT-75N93021R00008 Page 1 of 2
Amendment No. 1
BROAD AGENCY ANNOUNCEMENT
BAA No.: BAA-DAIT-75N93021R00008
“Advancing Vaccine Adjuvant Research for Tuberculosis (TB)”
Amendment Number: One (1)
Amendment Issue Date: May 28, 2021
Response Date (Unchanged): August 10, 2021, at 3:00 PM, EST
Issued By: Emily Bannister
Contracting Officer
OA/DEA/NIAID/NIH/DHHS
5601 Fishers Lane, Room 3B55, MSC 9821 Rockville, Maryland 20852
Point of Contact: PRIMARY emily.bannister@nih.gov Emily Bannister, Contracting Officer Phone: 240-669-5135
Please note that we do NOT intend to extend the due date for submission of proposals as a result of this amendment. The date specified for receipt of proposals remains unchanged.
Offerors must acknowledge receipt of this amendment by identifying this amendment number and date of the amendment on each copy of the proposal submitted. Failure to receive your acknowledgement may result in the rejection of your proposal. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.
BAA No.: BAA-DAIT-75N93021R00008 Page 2 of 2
The purpose of Amendment #1 is to respond to questions by potential offerors.
QUESTIONS
Technical Questions
1. QUESTION: The BAA specifically calls for the selection of 3 adjuvants systems, however
(a) our modulators are specifically selected to work with any adjuvant, and (b) work to enhance adjuvant performance and have not adjuvanticity themselves. Would the modulators count as adjuvants or as formulations? I wanted to clarify that in the contract proposal, if we could propose these modulators separate from the adjuvant systems and as an alternative formulation approach to enhance the activity of each adjuvant
ANSWER: A compound that modulates an adjuvant-induced response does not qualify as an adjuvant when it does not have intrinsic adjuvant activity. However, since modulators can enhance/improve adjuvant activity, they are considered to be part of the adjuvant-vaccine/immunogen formulation optimization. According to attachment 5 of the BAA (Research and Technical Objectives), the offeror shall propose three (3) adjuvants representing different adjuvant categories (i.e., are chemically different and target different receptors or signaling pathways associated with adjuvanticity). Those distinct adjuvants can be formulated with or without a modulator as described in Attachment 5 under “Formulate adjuvant-vaccine/immunogen candidates.
END OF AMENDMENT NO. 1, BAA-DAIT-75N93021R00008
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