Amendment_6_-_QA_and_Revisions_-_Research_Area_003.pdf

Amendment #6

Solicitation HHS-NIH-NIAID-BAA2018

AMENDMENT SIX (6)

OFFICE OF ACQUISITONS

National Institute of Allergy and Infectious Diseases (NIAID)

5601 Fishers Lane, Room 3D32, MSC 9821 Rockville, MD 20852

Solicitation Number: HHS-NIH-NIAID-BAA2018

Date of Solicitation Issuance: 06/01/2018

Date of Amendment No.1 Issuance: 07/03/2018

Date of Amendment No.2 Issuance: 07/03/2018

Date of Amendment No.3 Issuance: 07/20/2018

Date of Amendment No.4 Issuance: 07/24/2018

Date of Amendment No.5 Issuance: 08/02/2018

Date of Amendment No.6 Issuance: 08/31/2018

Number of Pages: 7

Attachment: HHS-NIH-NIAID-BAA2018 – Amendment 1 (Revised 08/31/2018)

Issued By:

George W. Kennedy, Contracting Officer

Email: kennedyg@mail.nih.gov

Phone: 240-669-5170

The hour and date specified for receipt of Offers remains unchanged.

Offerors must acknowledge receipt of the amendment by Amendment number(s) and date of the amendment. Include a statement of acknowledgement in your proposal submission. Failure of acknowledgement may result in rejection of your offer.

Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

PURPOSE OF SOLICITATION AMENDMENT

This amendment is applicable to RESEARCH AREA 003, “Collaborative Influenza Vaccine

Innovation Centers (CIVICs)”.

mailto:kennedyg@mail.nih.gov

The purpose of this amendment is to revise Section 3.2. of solicitation HHS-NIH-NIAID-

BAA2018 as described below; and respond to questions received in response to Research Area

003: Collaborative Influenza Vaccine Innovation Centers (CIVICs).

Section 3.2.2.1.1 – Budget and Award Information, is revised to include the following sentence:

“In addition to the information contained in this Section, the budget associated with proposed out year options should be commensurate with your technical approach.”

Section 3.2.2.1.3 – Technical Approach, Subsection 3.2.2.1.3.1 – Research Area 003

Component A: Vaccine Center, Item 3. Immunologic Analyses, is revised to add as the first bullet:

• Conduct evaluation of pre-existing immune responses to influenza antigens in human subpopulations, where such studies will inform design or optimization of proposed vaccine candidates. Human cohorts may be defined by variables that include, but are not limited to: age, race, gender, geographical location, vaccination history, and prior exposure to circulating influenza strains.

Section 3.2.2.1.3 – Technical Approach, Subsection 3.2.2.1.3.3 – Research Area 003

Component C: Clinical Core, the seventh bullet is revised to read as follows (the second sub-bullet is new):

• In collaboration with the CIVICs SDMCC:

• Prepare all data and documents from clinical trials and human challenge studies in accordance with FDA regulatory requirements and standards.

• Ensure that protection of data generated by the CIVICs program is consistent with NIAID Federal Information Management Security (FISMA) requirements and that all clinical systems of record are compliant with 21.CFR.11 and

ICHE6R2.

• Ensure that all protocols and data are submitted in a timely manner for internal management and for reporting to NIAID as directed. This includes clinical sample collection; processing and storage protocols; subject recruitment and retention information and meta-data; sample collection, processing, storage and availability; and all other relevant clinical trial and human challenge data (e.g., Adverse Events and Serious Adverse Events).

Section 3.2.3.1 – VACCINE CENTER, paragraph c. Immunologic Analyses, is revised to add as the first bullet:

• Plans for analysis of pre-existing immunity to influenza in human subpopulations, including:

o Description of each human research cohort(s) and explanation for how analysis of each cohort will inform vaccine design.

o Strategies for evaluation of prior natural exposure to influenza viruses and vaccination histories.

Section 3.2.3.4 – UNIFORM COST ASSUMPTIONS, paragraph c. Clinical Core, is revised to read as follows:

Clinical Core: Assume establishment of clinical sample repository in the first year and maintenance of repository in subsequent years. Assume design and planning activities for future clinical trials and human challenge studies in the first year. Assume conduct of two

(2) Phase I clinical trials in the second year and each year after. Assume conduct of one

(1) Phase II clinical trial in the second, fourth and sixth year. Assume conduct of one (1) human challenge study in the second, fourth and sixth year. For the purposes of these cost assumptions, the Phase II clinical trials should include no more than 200 subjects and the human challenge studies should include no more than 200 subjects.

QUESTIONS AND RESPONSES:

The Government’s responses to questions received regarding RESEARCH AREA 003, “Collaborative Influenza Vaccine Innovation Centers (CIVICs)” are as follows:

Question 1: Is the contractor required to have at least three unique vaccine candidates/platforms in hand at the time of submission or can this be developed during the contract period? Does comparison of different vaccine schemes or adjuvant use with existing vaccines count as “unique”?

Answer 1: Offeror(s) must have at least three unique vaccine candidate/platforms in hand at the time of submission. This may include different antigens, antigen/adjuvant combinations, or platforms.

Question 2: Can my research group be part of multiple independent applications? I was hoping you could give me clarity on if we can be included in multiple applications or if we need to pick one group.

Answer 2: Yes, you can be part of as many independent proposals as you would like.

Question 3: If we have two co-PIs from two different institutions, can the management team/costs also be split between the two institutions?

Answer 3: Since we anticipate cost reimbursement contract vehicles, all costs that are reasonable, allocable and allottable can be considered. Only one prime contractor is allowed.

All other sites will be subcontracts to the prime. Proposed subcontractors of course would be reimbursed by the prime for such costs.

Question 4: Should the composition of the SLG be proposed when we submit (like a SAB for a P01) or will it be discussed with NIAID after the grant is awarded (like for a CETR center)?

Answer 4: Yes, the Senior Leadership Group (SLG) is the management/leadership team for the Vaccine Center. The SLG should be included in your original proposal submission. Of course, there would be discussions with NIAID during the negotiation phase before any contract award. It’s important to note however, that the External Advisory Group (EAG) is very different. Any external advisors should not be recruited prior to award and they should not be mentioned by name in the proposal.

Question 5: Are we allowed to partner with companies?

Answer 5: Yes, partnerships between academia and industry are allowed.

Question 6: Do we have to have 2 platforms ready to test right away or can we be working on development of one of the platforms?

Answer 6: Offeror(s) must have at least three unique vaccine candidate/platforms in hand at the time of submission.

Question 7: Is there a way to partner with companies that have platforms we could use?

Answer 7: Potential Offerors interested in identifying partners who wish to collaborate in order to address all required components of the solicitation are encouraged to contact Michael

Finn by August 31, 2018. NIAID’s Office of Acquisitions will post a subsequent amendment to the 2018 NIAID Omnibus BAA at FedBizOpps listing all offerors and companies who have expressed such interest. Entities that have shown an interest to date are listed below.

Question 8: Re: A Heterologous Prime-boost approach using an adenoviral vector delivery of the immunogenic influenza antigens. Does NIAID see this approach as being responsive to the product development plan?

Answer 8: There are no restrictions on the type of platforms, however, proposed vaccine approaches should be anticipated to induce robust, durable, broadly protective immunity, and data supporting this should be provided.

Question 9: It is unclear where in the management structure the Statistical, Data

Management and Coordination Center (SDMCC) is supposed to reside. Is it under the purview of the Leadership and Program Management of Component A (the Vaccine

Center)?

Answer 9: The SDMCC will be managed independently of the Vaccine Center (Component

A) but will work closely with all CIVICs Components to provide statistical support, data management and analysis, and preclinical/clinical study coordination services for the entire

CIVICs program as described in HHS-NIH-NIAID-BAA2018.

Pre-solicitation information for the CIVICs SDMCC may be found at the following URLs:

https://www.fbo.gov/index?s=opportunity&mode=form&id=d323b05da57b03acc67fc15e86788f cd&tab=core&_cview=0 https://www.fbo.gov/index.php?s=opportunity&mode=form&id=4cf9714412eef0526709084c9cf e3a8a&tab=core&_cview=0 https://www.fbo.gov/index?s=opportunity&mode=form&id=d323b05da57b03acc67fc15e86788fcd&tab=core&_cview=0 https://www.fbo.gov/index?s=opportunity&mode=form&id=d323b05da57b03acc67fc15e86788fcd&tab=core&_cview=0 https://www.fbo.gov/index.php?s=opportunity&mode=form&id=4cf9714412eef0526709084c9cfe3a8a&tab=core&_cview=0 https://www.fbo.gov/index.php?s=opportunity&mode=form&id=4cf9714412eef0526709084c9cfe3a8a&tab=core&_cview=0

The SDMCC RFP is anticipated to be posted as early as Friday, August 31, 2018.

Question 10: Is the Statistical, Data Management and Coordination Center (SDMCC) an external group with whom the internal CIVIC data team will interact, or will the CIVIC designate the internal data management group as the SDMCC?

Answer 10: The CIVICs SDMCC will serve as an independent, centralized center providing statistical support, data management and analysis, and preclinical/clinical study coordination services for the entire CIVICs program. Data management teams within the CIVICs must coordinate with the SDMCC to ensure data and resource sharing, both within the CIVICs network and publicly, with the broader research community.

cd&tab=core&_cview=0

Question 11: Can we propose clinical studies and human sample acquisition within the

Vaccine Center (Component A) that is distinct from the product development clinical trials of new vaccines or adjuvants that will be conducted by the Clinical Core (Component C)?

Answer 11: Offeror(s) may propose clinical studies and immunological analyses within the

Vaccine Center (Component A) to inform vaccine design and development. However, these studies must be clearly tied to product development of the specific influenza vaccine candidates/platforms proposed by the Vaccine Center. Basic research studies that are not tied to vaccine development are outside of the scope of this BAA.

Question 12: Are foreign components allowed? For example, collaborator sites in foreign countries to obtain human specimens?

Answer 12: Collaborations with foreign entities are permitted. Collection of human samples by foreign collaborators is permitted if sample collection is conducted in accordance with both

NIH policies and policies of the country in which the human specimens will be collected.

Requirements for human subjects research are described in section 4.3.2.3.-HUMAN

SUBJECTS.

Question 13: From the RFP: Conduct primary assays as appropriate for Phase I/II clinical trials and human challenge studies under IND application. Please clarify for budgeting purposes which assays would be done by Clinical Core vs. Vaccine Centers? Can the https://www.fbo.gov/index?s=opportunity&mode=form&id=d323b05da57b03acc67fc15e86788fcd&tab=core&_cview=0 https://www.fbo.gov/index?s=opportunity&mode=form&id=d323b05da57b03acc67fc15e86788fcd&tab=core&_cview=0 https://www.fbo.gov/index.php?s=opportunity&mode=form&id=4cf9714412eef0526709084c9cfe3a8a&tab=core&_cview=0 https://www.fbo.gov/index.php?s=opportunity&mode=form&id=4cf9714412eef0526709084c9cfe3a8a&tab=core&_cview=0

Clinical Core propose to conduct immunologic assays beyond primary endpoints or must those be housed at Vaccine Centers?

Answer 13: The CIVICs Vaccine Center (Component A) is responsible for conducting comprehensive immunological studies of human systemic and mucosal immune responses to influenza vaccine candidates from clinical trials and human challenge studies conducted by the

Clinical Core (Component C) (see 3.2.2.1.3.1, “3. Immunologic Analyses”). The Clinical Core

(Component C) may conduct some immunologic analyses related to defining immunogenicity profiles of the vaccine candidates (see 3.2.2.1.3.3, bullet 2). The Vaccine Center and Clinical

Core are expected to work collaboratively post-award to clinically evaluate influenza vaccine candidates.

Question 14: There does not yet appear to be a solicitation for the SDMCC; what guidance can the Institute give regarding statistics, and data management in the absence of a

SDMCC. It does appear from the Clinical Core RFP that the Core is expected to propose data management and stats related to the trial conduct. Please clarify.

Answer 14: The SDMCC will be managed independently of the Clinical Core (Component C) but will work closely with all CIVICs Components to provide statistical support, data management and analysis, and preclinical/clinical study coordination services for the entire

CIVICs program as described in HHS-NIH-NIAID-BAA2018.

cd&tab=core&_cview=0

Question 15: There is no guidance on cost assumptions for the clinical core (numbers and types of trials) beyond Yr 2; please provide guidance.

Answer 15: The uniform cost assumptions in Section 3.2.3.4 are provided to indicate the general scope of work and for the purposes of estimating costs for a standard Phase I clinical trial, Phase II clinical trial, and human challenge study. The number of trials per year may vary based on the number of vaccine candidates developed by the CIVICs Vaccine Center(s) or brought into the CIVICs program from other sources for evaluation. It is anticipated that any contract(s) awarded from this solicitation will contain option provision(s) and period(s) for each

CIVICs Component to conduct tasks within the scope of that Component.

As mentioned above, Section 3.2.3.4 of the BAA – UNIFORM COST ASSUMPTIONS, paragraph c. Clinical Core will be amended as follows:

Clinical Core: Assume establishment of clinical sample repository in the first year and maintenance of repository in subsequent years. Assume design and planning activities for future https://www.fbo.gov/index?s=opportunity&mode=form&id=d323b05da57b03acc67fc15e86788fcd&tab=core&_cview=0 https://www.fbo.gov/index?s=opportunity&mode=form&id=d323b05da57b03acc67fc15e86788fcd&tab=core&_cview=0 https://www.fbo.gov/index.php?s=opportunity&mode=form&id=4cf9714412eef0526709084c9cfe3a8a&tab=core&_cview=0 https://www.fbo.gov/index.php?s=opportunity&mode=form&id=4cf9714412eef0526709084c9cfe3a8a&tab=core&_cview=0 clinical trials and human challenge studies in the first year. Assume conduct of two (2) Phase I clinical trials in the second year and each year after. Assume conduct of one (1) Phase II clinical trial in the second, fourth and sixth year. Assume conduct of one (1) human challenge study in the second, fourth and sixth year. For the purposes of these cost assumptions, the Phase II clinical trials should include no more than 200 subjects and the human challenge studies should include no more than 200 subjects.

-- End of Amendment 6 --