Amendment 2.pdf

BAA No.: BAA-DAIT-75N93020R00022 Page 1 of 5

Amendment No. 2

Broad Agency Announcement (BAA) No.: BAA-DAIT-75N93020R00022 “Adjuvant Comparison and Characterization”

Amendment Number: Two (2)

Amendment Issue Date: August 5, 2021

Response Date (Unchanged): September 16, 2021 by 3PM, Eastern Time

Issued By: George Ralis

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

5601 Fishers Lane, Room 3C19, MSC 9821 Rockville, Maryland 20852

Point of Contact: PRIMARY ralisg@niaid.nih.gov George Ralis, Contracting Officer Phone: 240-669-5146

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.

THE PURPOSE OF THIS AMENDMENT IS TO PROVIDE RESPONSES TO

QUESTIONS WHICH MAY BE USEFUL TO ALL POTENTIAL OFFERORS.

QUESTION/ISSUE 1:

Are applications limited to a certain number of submissions for each institution?

RESPONSE:

There are no limitations on the number of proposals that can be submitted by any one organization.

mailto:ralisg@niaid.nih.gov

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QUESTION/ISSUE 2:

The BAA mentions “clinically relevant vaccine/antigen” and the response to Amendment 1, Question 1 indicates “the offeror needs to select antigens/vaccines that have minimal impurities and other immune stimulators that would confound the analysis of adjuvant induced immune profiles.” Are applicants expected to use vaccines/antigens that are currently used in human vaccines or would an appropriately pure subunit antigen from a pathogen that is normally vaccinated against using a live attenuated virus be a suitable vaccine/antigen for this funding opportunity.

RESPONSE:

Applicants are not expected to use vaccines/antigens that are currently used in human vaccines.

An appropriately pure subunit antigen from a pathogen that is normally vaccinated against using a live attenuated virus would be a suitable vaccine/antigen for this funding opportunity.

QUESTION/ISSUE 3:

The response to Amendment 1, Question 2 indicates “the same adjuvant set of 3‐5 adjuvants, formulated to meet the requirements of the different delivery routes, can be used to establish immune profiles induced by the same adjuvant sets when given by different (clinically relevant) delivery routes”. Does the NIH expect all adjuvants (the two reference adjuvants and the 3‐5 test adjuvants) to be tested by both an injected route and a mucosal route? If the test adjuvants are designed to be delivered by a mucosal route, is it acceptable that the vaccine formulated with the test adjuvants are delivered by a mucosal route while the vaccine with the 2 reference adjuvants is delivered by an injection route?

RESPONSE:

NIAID does not expect all adjuvants being evaluated (i.e., the two reference adjuvants and the 3‐5 test adjuvants) to be delivered by both, an injected route and a mucosal route. The vaccination route should be the route that is most appropriate for the vaccine formulation and the adjuvant being used. However, it the delivery routes differ between the reference and all the test adjuvants, bridging studies are strongly encouraged to determine the impact of the delivery route on the immune profile. For example, if the test adjuvants are designed to be delivered by a mucosal route, it is acceptable that the vaccine formulated with the test adjuvants is delivered by a mucosal route while the vaccine with the 2 reference adjuvants is delivered intramuscularly. In this case, if feasible, some bridging studies should be included to deliver at least one of the test adjuvants by the intramuscular route to determine the impact of the delivery route on the immune profile. NIAID, however, recognizes that formulation characteristics or the mechanism‐of‐action of certain adjuvants may limit their delivery through different routes and such restrictions should be discussed in the proposal.

QUESTION/ISSUE 4:

Is there a budget cap per year or is it only based on the work proposed?

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RESPONSE:

Offerors will prepare their respective budgets based on the work they propose. Also note this is a competitive acquisition. As clarified in solicitation Amendment #1, posted on Sam.gov, NIAID plans to make between 1-4 awards. Furthermore, please note Attachment 3 of the solicitation which states, “NIAID estimates that the average annual total cost (direct and indirect costs combined) of the entire ACC program is $7.5 million, of which $5.5 million is dedicated to fund projects that include non-HIV vaccines/antigens, and $2 million to fund project(s) that include the HIV envelope antigen. It is anticipated that the total cost for the award(s) may vary depending upon the scope of the project and the technical objectives of the award(s).

QUESTION/ISSUE 5:

Page limits appear to be vague, can this be clarified or is it flexible?

RESPONSE:

Please see ‘Attachment 1’ (page 97) of the solicitation regarding formatting and page limits.

QUESTION/ISSUE 6:

Can there be multiple Co‐PIs at more than 2 institutions, if justified?

RESPONSE:

There are no restrictions on the number of PIs. However, please review section 2, on pages 56 and 57 of the solicitation, regarding ‘Multiple Principal Investigators”.

QUESTION/ISSUE 7:

The solicitation BAA‐DAIT‐75N93020R00022 specifically mentions infectious diseases and immune-mediated diseases as areas of interest and that it specifically excludes other areas (such as non‐viral cancer). Would an application be considered responsive to the BAA if the vaccine in the proposal were targeted toward a chronic disease of humans that is not an infectious disease, not an immune‐mediated disease, and not subject to any of the listed exclusions?

RESPONSE:

The BAA states that the intent of the ACC program is to generate data that will be made publicly available, enabling the rational selection of adjuvants and the future development of more effective vaccines against infectious diseases, and/or new vaccines to treat allergic or autoimmune diseases. Thus, offerors proposing to use a vaccine targeted toward a chronic disease of humans that is not an infectious disease or an immune‐mediated disease, even if it is not listed under exclusions, the proposal would not be responsive.

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In addition, once the contract(s) has been awarded, NIH reserves the right to issue contract change order modifications to contractors that have the capacity to screen adjuvants with vaccine/antigen(s) applicable to public health emergencies/pandemics and tumor‐associated antigens as the need arises.

QUESTION/ISSUE 8:

Question 8a:

Can one company or institution submit more than one application?

Response 8a:

Yes.

Question 8b:

More specifically, can one company submit two separate applications, one focusing on using non‐HIV antigen(s) and another focusing on HIV envelope antigen?

Response 8b:

Yes, an offeror can submit two separate applications, one focusing on using non‐HIV antigen(s) and another focusing on HIV envelope antigen OR the offeror may choose to submit one combined application that includes the HIV envelope antigen and non‐HIV antigen(s).

QUESTION/ISSUE 9:

[The BAA states on page 101: “ACC program will be expected to…… 2) screen additional adjuvants at the direction of NIAID…”].

QUESTION: If we don’t know how many adjuvants we would be expected to screen, how can we be expected to propose a realistic budget?

RESPONSE:

Please refer to ATTACHMENT 8: ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS AND UNIFORM COST ASSUMPTIONS, Section 4 ‐ Options, which outlines the budget considerations:

Specifically, provide the costs for the following:

1. The total costs per year for an additional Adjuvant Set (five [5] adjuvants and the two [2] reference adjuvants Alum and Addavax) to be tested with the proposed vaccine/antigen platforms; including estimated formulation costs.

2. The total costs per year to move an Adjuvant Set through the pipeline of immune profiling, challenge studies, and data analysis and computational modeling.

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QUESTION/ISSUE 10:

Do we have to propose in vitro studies?

RESPONSE:

In vitro studies are a requirement of the BAA because they will establish the correlation of the in vivo and in vitro results. In vitro studies in both animal and human immune cells will contribute to the adjuvants’ overall immune profile and establish whether innate immune profiles established in an animal model are also likely to be induced in humans.

QUESTION/ISSUE 11:

Does this program allow Human Clinical Trials?

RESPONSE:

Per ATTACHMENT 5: RESEARCH AND TECHNICAL OBJECTIVES, “the design and conduct of clinical trials” is specifically excluded.

QUESTION/ISSUE 12:

[The page limit of the statement of work (5 pages):] QUESTION: Does this include the technical discussion: immune profiling, pathogen challenge study, and computational modeling? Or is it just an overview and then section 4 describes all the technical discussion?

RESPONSE:

The SOW should provide detail on what you plan to do. The technical discussion section will be where you detail how you plan to do the work indicated in the SOW.

QUESTION/ISSUE 13:

Do we need CVs from companies listed as collaborators or just letters of support?

RESPONSE:

In addition to the ‘Letters of Support’ from collaborators, please include their CVs if they will serve as key personnel (i.e., PI, CO‐PI, CO‐Investigator) at the subcontractor level.

END OF AMENDMENT NO. 2