Amendment 2.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 proposals for advancing vaccine adjuvant research for tuberculosis. The amendment provides responses to technical questions from potential offerors. It clarifies that nucleic acid-based vaccine approaches encoding Mycobacterium tuberculosis antigens are within the scope of the solicitation. It also confirms that lipid nanoparticles may be considered as vaccine adjuvants when used in conjunction with at least two other adjuvants from different categories. The deadline for proposal submissions remains unchanged at August 10, 2021 at 3:00 PM Eastern Standard Time. The solicitation is seeking proposals to procure three Mtb immunogens formulated with three different adjuvants for testing under contract from the National Institute of Allergy and Infectious Diseases within the Department of Health and Human Services.
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| File | Type | Posted |
|---|---|---|
| Amendment 1.pdf | ||
| BAA-DAIT-75N93021R00008 Solicitation.pdf |
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BAA No.: BAA-DAIT-75N93021R00008 Page 1 of 2
Amendment No. 2
BROAD AGENCY ANNOUNCEMENT
BAA No.: BAA-DAIT-75N93021R00008
“Advancing Vaccine Adjuvant Research for Tuberculosis (TB)”
Amendment Number: Two (2)
Amendment Issue Date: July 7, 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 #2 is to respond to questions by potential offerors.
QUESTIONS
Technical Questions
1. QUESTION: Are RNA vaccine approaches within scope of this BAA? In other words, can an RNA delivery system such as a lipid nanoparticle be considered a vaccine adjuvant to be used with an RNA vaccine antigen?
ANSWER: The solicitation requires the offeror to procure three (3) Mtb immunogens but does not place any restrictions on the vaccine platform. Thus, the used of nucleic acid-based vaccines encoding Mtb antigens is acceptable based on the definition of an immunogen being “an agent that is specific to the target pathogen and is incorporated into a vaccine or vaccine candidate in order to induce an immune response.” The solicitation also requires the immunogen to be formulated with three (3) adjuvants, with each adjuvant representing a different adjuvant category. Since lipid nanoparticles (LNPs) provide adjuvant activity (in addition to serving as a delivery platform), they meet the definition of adjuvants as “agents added to, or used in conjunction with, vaccine immunogens to augment, potentiate, or modulate (and possibly target) specific immune responses to an immunogen”. Please note the requirement to test adjuvants representing different categories. Thus, different LNP formulations would not address this requirement, but LNPs may still be used in vaccine formulations (as a carrier and/or co-adjuvant) in which additional adjuvants are being evaluated.
END OF AMENDMENT NO. 2, BAA-DAIT-75N93021R00008
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