HIV/AIDS Vaccine Facility (C06)

Funding Agency:
National Institutes of Health

Development and testing of AIDS vaccines are high priorities for NIH-supported research (NOT-OD-15-137). This Funding Opportunity Announcement (FOA) invites applications from qualified academic institutions to apply for support to upgrade existing functioning space to Current Good Manufacturing Practice (CGMP) standards for production of next generation candidates for HIV/AIDS vaccines, with the goal of creating sufficient quantities of immunogens to conduct Phase I clinical trials. The applicants should: a) demonstrate the highest level of expertise in HIV/AIDS biology and have experience in development and testing of concepts for AIDS vaccines; b) have vaccine candidates that have been produced in pre-clinical lots and tested for immunogenicity in appropriate animal models; c) have vaccine candidates that can be scaled up from pre-clinical lots to CGMP standards for Phase I clinical trials; d) have the capability and analytics expertise to conduct process development, and scale-up production of pharmaceutical quality compounds to clinical trials-levels, and e) have the ability to implement Phase I clinical trials. In parallel, the applicants should demonstrate the highest level of skill and competency in all technical aspect of the design, construction, and commissioning of the facility, to ensure that relevant Federal and Industry standards are met for production of pharmaceutical grade compounds.

Only one application per institution (identified by NIH IPF number) is allowed.

Deadlines:

  • Duke Internal: June 30, 2016
  • Application Due Date(s): August 1, 2016
 
PAR-16-290 Expiration Date August 2, 2016

Agency Website

Eligibility Requirements

Multiple PDs/PIs are not allowed.

It is expected that the PD/PI will be a leader in the field of HIV/AIDS biology and AIDS vaccine development, capable to undertake scientific and managerial challenges associated with planning and executing the project.

Specifically, the PD/PI should have expertise in HIV/AIDS biology and the scientific goals of the project, including designing and formulating a vaccine, producing it, and bringing it to clinical trials. Also, this person should be capable of working with technical personnel who will oversee the technical design of the facility and its subsequent construction.

Amount

$4,900,000

Amount Description

Application budget cannot exceed of $4,900,000.00 for the entire 3 year project period.

Funding Type

Grant

Eligibility

Faculty
Institutional

Category

Medical
Medical - Clinical Science
Medical - Translational

Internal Nomination

Owing to the sponsor's restriction on the number of applications that may be submitted from Duke, anyone wishing to pursue nomination should submit the following materials as one PDF.

* A letter of support from dean or chair - 1 to 1.5 pages
* Project summary - 2 to 4 pages
* NIH Biosketch of project leader

Applicants will need to submit internal materials through My Research Proposal. https://www.grantinterface.com/Common/LogOn.aspx?eqs=ApVvmgXCk2Uj7AzWyDEJKQ2

Instructions for setting up your account and uploading internal applications can be found here: https://ors.duke.edu/sites/default/files/Applicant Instructions_FINAL.pdf

Internal Deadline

June 30, 2016

External Deadline

August 1, 2016