Amendment 2 RFP 75N93023R00012.pdf

AMENDMENT #2 RFP No. 75N93023R00012 1

Amendment No. 2 RFP No. 75N93023R00012

“Humoral Immunology Laboratory for AIDS Vaccine Research and Development”

Solicitation Number: 75N93023R00012

Amendment Number: Two (2)

Amendment Issue Date: January 22, 2024

Proposal Due Date/Time: February 16, 2024 at 3:00 PM, EST (Unchanged)

Issued By: Christopher Ray

Contract Specialist

OA/DEA/NIAID/NIH/DHHS

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

Points of Contact: PRIMARY chris.ray@nih.gov Chris Ray, Contract Specialist Phone: 240.627.3365

SECONDARY

cornorj@niaid.nih.gov Robert Corno, Contracting Officer Phone: 240.669.5151

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 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 provide responses to questions from potential offerors, regarding the solicitation.

RESPONSES TO QUESTIONS FROM POTENTIAL OFFERORS:

mailto:chris.ray@nih.gov mailto:cornorj@niaid.nih.gov

AMENDMENT #2 RFP No. 75N93023R00012 2

Question 1 What does “binding antibody multiplex assay (BAMA)” refer to (below)? Is it the Luminex technology, or is it up to the applicant what technology to use?

Antibody Binding Assays -Perform assays to detect the presence of HIV or SIV antibodies. These may include enzyme-linked immunosorbent assay (ELISA), binding antibody multiplex assay (BAMA), or other appropriate assays.

Response to Question 1 As mentioned in the SOW, BAMA refers to a type of assay. BAMA is a flow cytometric version of an ELISA assay. This is not the same as Luminex. The offeror is to propose a technology that best suits their technical approach.

Question 2 Could you clarify what the following statement under “Good Laboratory Practice (GLP)” means in practice? How can a GLP-compliant assay not be GLP-compliant ?

-New assay development, assay modification, improvement of the level of assay standardization or validation, and evaluation of in vitro/in vivo assay correlations, with the objective of developing a new GLP-compliant assay do not have to be GLP compliant.

Response to Question 2 Only the final assay to be used has to be GLP compliant. The work up until finalizing does not have to be GLP compliant.

Question 3 Given that the SOW states under “Conduct Humoral Immunology Assays” that “The specific assays to be conducted and the samples on which the assays will be conducted will be defined by individual study protocols designed by the vaccine provider, the SVEU staff, and the contracting officer representative, in collaboration with the HICL Contractor. Additional assays or assay-related studies may be included at the request of the Contracting Officer.”

The actual assays are not yet known, so what information should the applicant provide in response to the request below under “Requirements for the Proposal”:

Humoral Immunology Assays

a) For Each Assay Type:

-Describe the step-by-step procedures for conducting the assay.

-Highlight your laboratory's past experience with the assay, specifying the monthly capacity.

-Share non-proprietary assay results through data representation (tables, figures, charts).

-Clarify if the assays are currently implemented in your laboratory.

-Elaborate on past experiences optimizing assays, including steps to enhance sensitivity, reduce background, and ensure reproducibility.

-Present examples of publications resulting from past assay conduct.

AMENDMENT #2 RFP No. 75N93023R00012 3

Response to Question 3 Under Section 3.B. of the Statement of Work, we have outlined the 4 types of assays that we expect an offeror to have the ability to conduct. Please review the Technical Proposal Instructions to respond accordingly.

Question 4 What specific assay methods or procedures are expected to be used to carry out the following under “Technical Cost Assumptions”:

a. approximately 15,000 virus neutralization assays, evaluating the ability of sera or purified antibodies to neutralize SIV, SHIV, or HIV viruses, including Envpseudoviruses containing envelopes of primary isolates of HIV-1.

b. 20 viral stocks (total) of HIV-1, SHIVs, or SIVs will be made and titered for use in the in vitro neutralization assays.

c. 200 HIV-1 Env-Pseudovirus stocks will be made and titered for use in the in vitro neutralization assays.

d. 30,000 Env- or peptide-specific IgG Binding Assays (BAMA).

e. 200 Env-specific antibody avidity assays.

f. 1000 peptide microarray assays.

g. assays for epitope specific (V1/V2/V3) antibody binding assays will be conducted on 400 samples.

h. assays for linear epitope mapping will be conducted on 100 samples.

i. assays for IgA mucosal antibodies will be conducted on 200 samples.

Response to Question 4 We leave this up to the offeror to propose.

Question 5 Can there be more than one Principal Investigator?

Response to Question 5 No. There can only be one Principal Investigator. However, there can be a Co-Investigator.

Question 6 Is a subcontractor allowed to engage another subcontractor to carry out a portion of the work?

Response to Question 6 Yes, a subcontractor is allowed to engage another subcontractor to carry out a portion of the work.

END OF AMENDMENT NO. 2, RFP No. 75N93023R00012