Amendment_1_RFP_75N93022R00017_0001.pdf

AMENDMENT #1 BAA No. 75N93022R00017 1

Amendment No. 1 RFP No. 75N93022R00017

“RATIONAL SYSTEMIC CHARACTERIZATION AND SELECTION OF ADJUVANTS

FOR HIV VACCINE CANDIDATES (R-CASA)”

Solicitation Number: 75N93022R00017

Amendment Number: One (1)

Amendment Issue Date: April 20, 2023

Proposal Due Date/Time: July 7, 2023, 04:00PM EDT (Changed)

Issued By: Kishan Patel

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

5601 Fishers Lane, Room 3D10, MSC 9821 Bethesda, Maryland 20892-9821

Points of Contact: PRIMARY patelki@niaid.nih.gov Kishan Patel, Contracting Officer Phone: 204-669-5157

Offerors must acknowledge receipt of this Amendment by identifying the amendment number and the date of the amendment on each copy of the submitted proposal. 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 revise the Broad Agency Announcement (BAA).

1. Section A – Solicitation/Contract Form, Box 8., of the solicitation is hereby revised to amend the proposal submission date from 06/21/2023 to 07/07/2023 and shall read as follows:

“Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 4PM EDT on 07/07/2023. Offers will be

AMENDMENT #1 BAA No. 75N93022R00017 2 valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043”.

2. Attachment 7: ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS FORMAT FOR TECHNICAL PROPOSAL, and TABLE OF CONTENTS, Section 4: Technical Discussions, paragraph, B. Immunological Characterization, subparagraphs 2., and 3., are hereby by amended to provide clarity and shall read as follows:

2. The composition of the proposed immunogen-adjuvant formulations to be investigated plus formulation(s) comprising up to two immunogens and two adjuvants, that will be tested for comparison (as semi-controls). Provide a rationale for down-selection (go-no-go criteria) for up to five (5) formulations to further investigation in animal models.

Include preliminary data and/or references indicating that the immunogens and adjuvants, individually (i.e. separately) and/or in combination:

I. can elicit an immune response (e.g. antigen-specific antibodies, for immunogens) and/or enhancement of immune responses (in case of adjuvants);

II. have been already used for in vitro and/or in vivo (i.e. they are not only result of in silico research);

III. for combination adjuvants, data and/or references showing that the combination has been tested in vitro and/or in vivo and can lead to an enhancement of immune responses compared to each component individually (i.e. separately).

3. Provide the rationale for the selection of the immunogens, adjuvants and the formulations that will to be studied, based on the contractor’s experience with the products, previous results, route(s) of administration and/or other pertinent criteria.

Please see revised ATTACHMENT 7 - ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS FORMAT FOR TECHNICAL PROPOSAL, and TABLE OF

CONTENTS

END OF AMENDMENT NO. 1, RFP No. 75N93022R00017