Amendment_1_NIAID-DAIDS-NIHAI2014014.pdf

Amendment No. 1

NIAID-DAIDS-NIHAI2014014

“Staged Vaccine Development”

Solicitation Number:

Amendment Number:

Amendment Issue Date:

NIAID-DAIDS-NIHAI2014014

One (1)

October 14, 2014

Proposal Due Date/Time:

Monday, December 1, 2014, at 3:00 PM, Local Time (UNCHANGED)

Issued By: Michelle L. Scala Contracting Officer

OA/DEA/NIAID/NIH/DHHS

6700-B Rockledge Drive, Room 3214 Bethesda, Maryland 20892-7612

Points of Contact: PRIMARY:

patelki@niaid.nih.gov Kishan Patel, Contract Specialist Phone: 301-594-0983

SECONDARY:

mscala@niaid.nih.gov Michelle L. Scala, Contracting Officer Phone: 301-451-3693

The purpose of this amendment is to provide responses to questions.

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.

Question 1:

We have a DNA vaccine that recently received an IND from the FDA for a Phase I clinical trial.

Our PI is at our company and the CMC section of the IND was based on manufacturing by another company.

Is it appropriate to consider submitting a proposal for this solicitation, as we are in a position to enter Stage II of this contract?

AMENDMENT #1, BAA NIAID-DAIDS-NIHAI2014014

mailto:patelki@niaid.nih.gov mailto:anhughes@niaid.nih.gov

Response:

Yes, it would be acceptable to conduct advanced product development/manufacturing of HIV DNA vaccine that is currently in Phase 1 provided that the requirements for advancement to the next Stage as stated in the Broad Agency Announcement (BAA) are met.

Question 2:

Is this solicitation likely to be posted again next year or is it only envisioned for this year.

Response:

We cannot guarantee whether or not it will be reposted next year, as final FY16 initiatives depend upon availability of funds.

Question 3:

Can the vaccines (e.g. gp120s) be anything we want to propose? Need to be specified by NIH?; or need to be approved by NIH prior to the application?

Response:

The vaccines you propose are not limited to specific design; however they must be in one of the vaccine platforms stated in the BAA. No prior approval is required from the NIH. Only one vaccine platform can be proposed per application.

Question 4:

Do you prefer that the application come from a university (or not for profit) that subcontracts with a company?, comes from a company?, or comes from a consortium involving the university and a company?

Response:

It is the offeror’s choice where the application comes from. There are no restrictions on who the PI is or their affiliation. However, the Offeror must meet the stated criteria described in the BAA either through their own organization or thru a Consortia or collaboration.

Question 5:

Are the vaccines intended to be for the exclusive use of NIH (e.g. HVTN) or can they be used for any studies sponsored by the applicant?

Response:

The vaccines manufactured under this BAA are not intended for the exclusive use of NIH, though it is preferred that the testing of the vaccines be tested in a DAIDS funded clinical trial network. The intention of testing in the DAIDS funded networks is that many of the clinical immunological testing is done in labs that have been qualified, the statistical designs of the clinical trials are appropriately powered, and the clinical testing sites are GCP compliant.

END OF AMENDMENT # 1, BAA No. NIAID-DAIDS-NIHAI2014014

AMENDMENT #1, BAA NIAID-DAIDS-NIHAI2014014