Amendment_1_NIHAI2015040.pdf
PDF 19 KB Posted
- Attached to
- Staged Vaccine Development Federal contract opportunity
- Solicitation number
- NIAID-DAIDS-NIHAI2015040
About this file
The purpose of Amendment 1 is to answer a question from potential offerors regarding the solicitation.
View the file
Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| Amendment_3_NIHAI2015040.pdf | ||
| Amendment_2_NIHAI2015040.pdf | ||
| NIHAI2015040_with_attachments.pdf |
On GovTribe
Work with this file on GovTribe
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
Pre-Sol AMENDMENT #1, BAA NIAID-DAIDS-NIHAI2015040
Amendment No. 1 Pre-Solicitation Notice
BAA-NIAID-DAIDS-NIHAI2015040
“Staged Vaccine Development”
Solicitation Number:
Amendment Number:
Amendment Issue Date:
RFP-NIAID-DAIDS-NIHAI2015040
One (1)
June 11, 2015
Response Date:
Thursday, August 20, 2015 at 3:00 PM, Local Time (Unchanged)
Issued By: Michelle L. Scala Contracting Officer
OA/DEA/NIAID/NIH/DHHS
5601 Fishers Lane, Room 3D10 Bethesda, Maryland 20892-9821
Points of Contact: PRIMARY:
Callie Durand, Contract Specialist durandca@niaid.nih.gov Phone: 240-669-5155
SECONDARY:
Michelle L. Scala, Contracting Officer mscala@niaid.nih.gov Phone: 240-669-5156
The purpose of this amendment is to answer a question from potential offerors regarding the solicitation.
Questions from Potential Offerors:
Question 1:
We have a DNA based HIV vaccine that was produced under cGMP over 10 years ago. This construct has been tested for efficacy in macaques and has been evaluated in three clinical trials for safety and immunogenicity. Unfortunately, the CTM has expired preventing us from executing any further clinical studies. Is the SVD contract an appropriate mechanism to request funds to have a new lot manufactured?
Response to Question 1:
The Staged Vaccine Development contract mechanism is not meant for re-manufacturing clinical lots. It is the mechanism designed to GMP manufacture promising vaccine platforms in early stages of development for testing in Phase I/II clinical trials.
mailto:durandca@niaid.nih.gov mailto:anhughes@niaid.nih.gov
File details come from the government source that posted it. Updated .