Amendment 1.pdf

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

Amendment No. 1

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

Amendment Number: One (1)

Amendment Issue Date: May 21, 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:

We have noted that the BAA excludes inactivated or live‐attenuated vaccines. We would like to know whether purified toxoid‐containing vaccines such as acellular pertussis vaccines are considered responsive.

RESPONSE:

The goal of the Adjuvant Comparison and Characterization (ACC) program is to support side-by- side comparison of adjuvants in combination with clinically relevant vaccine/antigen mailto:ralisg@niaid.nih.gov

BAA No.: BAA-DAIT-75N93020R00022 Page 2 of 5 platforms, and to establish both systemic and tissue-specific immunological profiles (“immune fingerprints”) of adjuvants that work through different mechanisms and have potential for a given antigen and/or disease target. The information obtained through the ACC program will inform the rational selection of such adjuvants moving forward, ultimately leading to the development of more effective vaccines in the future.

Inactivated or live-attenuated vaccines may contain endogenous adjuvants (e.g. significant impurities or naturally occurring or encoding immunostimulatory molecules), that may alter the effects of the adjuvants being compared &/or make the analysis of the profiles induced by the adjuvants less clear. Similarly, acellular pertussis vaccines or any licensed vaccine will likely contain an exogenous adjuvant, which would alter the effects of the adjuvants being compared &/or make the analysis of the profiles induced by the adjuvants less clear.

Thus, when proposing vaccines/antigens, 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.

QUESTION/ISSUE 2:

Question 2a:

For respiratory diseases, intranasal vaccination may be attractive to induce local immunity in the respiratory tract. However, different formulations may be required for intranasal administration compared to parenteral immunization. Is DAIT interested in intranasal or other alternative administration routes? Since different formulations may be required for different routes of immunization, how should the limitation on the number of adjuvants (the BAA states 3-5 adjuvants) be interpreted? Can a set of 5 adjuvants be proposed for the parenteral route and a different set of 5 adjuvants (or formulations) be proposed for the intranasal route?

Response 2a:

NIAID supports the development of vaccines delivered by different routes as a way to improve vaccine efficacy or simplicity of vaccine delivery, but recognizes that immune profiles obtained with adjuvanted vaccines given through different routes may change. While the BAA does not allow the use of multiple delivery routes with a vaccine formulated with the same adjuvant to circumvent the requirement to test a minimum of 3 distinct adjuvants, 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.

Offerors are advised to carefully consider the impact of pursuing multiple delivery routes on the budget of the proposal since optimization of aspects such as formulation and dose will be required for each route. Offerors are expected to propose a “broad range of

BAA No.: BAA-DAIT-75N93020R00022 Page 3 of 5 services [assays] for vaccine adjuvant testing” (see “Research and Technical objectives:

Scope”) to generate detailed immune profiles (innate and adaptive responses) of multiple adjuvants. The inclusion of different delivery routes should not come at the expense of the breadth of profiling assays.

Question 2b:

The BAA states that “adjuvants to be compared must have demonstrated adjuvant activity in the following: At least one animal model, which includes supporting data showing in vivo adjuvanticity, that indicates significant enhancement or modulation of the immune response in the periphery and relevant tissue sites induced with the adjuvanted vaccine/antigen compared to the vaccine/antigen alone, where the vaccines/antigens and adjuvants used have been tested across a range of doses and evaluated for safety, immunogenicity, and efficacy.” Does this mean that the 3-5 adjuvants proposed must have already been tested with the proposed antigen(s) for immunogenicity and efficacy? Or can the preliminary data have been obtained with different antigens that are not a part of the proposal? Likewise for HIV antigen(s): must the proposed antigen be the same antigen that was used to obtain the existing data immunogenicity/efficacy data, or can data with other antigens be used to justify the selection of the proposed adjuvants?

Response 2b:

The supporting data showing in vivo adjuvanticity can be for any antigen that the offeror has chosen to validate the efficacy of the adjuvants being proposed. The supporting data does not have to be for the proposed antigen/vaccines that will be tested through the ACC program. This applies to both non-HIV and HIV studies.

QUESTION/ISSUE 3:

Question 3a:

I am inquiring about a government solicitation with notice number BAA-DAIT- 75N93020R00022 to compare multiple adjuvants using various vaccine/antigen platforms. There are 3 focus areas listed: 1. omics; 2. T cell functional assay; 3. B cell and antibody profiles.

Response 3a:

To clarify, the 3 focus areas are: 1. Immuneprofiling of the innate and adaptive responses;

2. Pathogen/antigen challenge studies; 3. Data analysis & computational approaches to integrate data from #s 1 & 2.

Question 3b:

Are you looking for proposals to evaluate all 3 areas?

BAA No.: BAA-DAIT-75N93020R00022 Page 4 of 5

Response 3b:

Proposals must address all 3 focus areas described above. NIAID recognizes that a single organization or institution may not have the expertise and facilities required to perform all parts of the technical plan, and that it may be necessary for the contractor to subcontract portions of the work.

Question 3c:

Will using proteomics to evaluate vaccine/adjuvant-induced protein expression changes in murine models be appropriate or you are only looking for proposals related to human studies?

Response 3c:

Proteomics is one of the technologies listed in the technical approach section of the baa as being suitable for establishing immune profiles of innate and adaptive immune responses triggered by adjuvanted vaccine/antigen platforms. The immunoprofiling studies must be conducted in an animal model as well as in vitro, using primary human and animal cells. The selection of the animal model (mouse or other species) is determined by the choice of pathogen or antigen challenge studies (focus area 2).

QUESTION/ISSUE 4:

We have a question regarding the “Adjuvant Set” described in Attachment 5, Section III. e. of the Solicitation, where it states that:

e. “Adjuvant Set” is defined as a group of three (3) to five (5) distinct adjuvants and the two reference adjuvants, Alum and Addavax, that will be tested along with the vaccine/antigen platform(s) for comparison. Adjuvant Set #1 shall be proposed by the offeror in the proposal; inclusion of additional Adjuvant Sets will be identified by the NIAID or proposed by the Contractor and approved by the NIAID, and executed as contract Options at the discretion of the NIAID.

Can you please clarify if that means the set can have up to 7 groups total (i.e., 5 candidate adjuvants + alum control + Addavax)? Or if that means that the set can only have up to 5 groups total (i.e., 3 candidate adjuvants + alum control + Addavax)?

RESPONSE:

The adjuvant set proposed by the offeror can contain a maximum of 7 adjuvants being tested (ie.

5 distinct adjuvants plus 2 reference adjuvants). Additional Adjuvant Sets will be identified by the NIAID or proposed by the Contractor and approved by the NIAID, and executed as contract Options at the discretion of the NIAID.

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QUESTION/ISSUE 5:

If we are proposing to test non-HIV antigens and HIV envelope antigens, should the HIV envelope antigens component be submitted separately?

RESPONSE:

An offeror can propose a maximum of (3) platforms to test any combination of non-HIV antigens and HIV envelope antigens in one proposal. For example, platform 1 would use a non- HIV antigen and platform 2 would use an HIV envelope antigen.

QUESTION/ISSUE 6:

Currently there are four classes of effective laser adjuvant established to date. Would inclusion of laser adjuvants be applicable to this BAA?

RESPONSE:

This solicitation uses the U.S. Food and Drug Administration (FDA) definition of adjuvants, ie.

agents added to, or used in conjunction with, vaccine antigens to augment, potentiate, or modulate (and possibly target) specific immune responses to an antigen. Thus, the laser-based adjuvant is suitable for this solicitation. However, comparison of different laser wavelengths represents only one class of adjuvants and therefore the adjuvant set would be comprised of different formulations (eg. wavelengths) of the same adjuvant (laser adjuvant), which is an exclusion, and such a proposal would not be responsive to the BAA.

QUESTION/ISSUE 7:

How many awards are anticipated to be made regarding this BAA?

RESPONSE:

NIAID plans to make between 1-4 total awards.

END OF AMENDMENT NO. 1