Clinical Trials and Ancillary Assays

Information

  • Research Project
  • 7280623
  • ApplicationId
    7280623
  • Core Project Number
    U19AI074073
  • Full Project Number
    1U19AI074073-01
  • Serial Number
    74073
  • FOA Number
  • Sub Project Id
    3
  • Project Start Date
    3/1/2007 - 17 years ago
  • Project End Date
    8/31/2012 - 12 years ago
  • Program Officer Name
  • Budget Start Date
    -
  • Budget End Date
    8/31/2008 - 16 years ago
  • Fiscal Year
    2007
  • Support Year
    1
  • Suffix
  • Award Notice Date
    -
Organizations

Clinical Trials and Ancillary Assays

The acquired immunodeficiency syndrome (AIDS) caused by HIV-1 is the leading cause of death in Africa and the fourth leading cause of death worldwide. This IPCAVD is developing HIV/AIDS vaccines that use DMA for priming and MVA for boosting (DNA/MVA vaccine) as well as a simpler an ultimately easier to deploy form of these vaccines, the use of MVA for both priming and boosting (MVA/MVA vaccine). Both the DMA and MVA vaccines use single vectors to express virus like particles (VLP). This IPCAVD seeks to build GM-CSF, an adjuvant, into these products for expression in cis. In preclinical studies, co-expression of GMCSF has substantially enhanced protection. A central hypothesis for the IPCAVD is that GM-CSF improves protection by enhancing the mucosal presence of elicited T cell and Ab responses. Clade C HIV-1 which is endemic in southern Africa and parts of Asia accounts for about one half of the infections worldwide and >90% of the cases in India, a country with a rapidly spreading infection that has surpassed South Africa in its total number of cases. The vaccine development effort of this IPCAVD is focused on developing a clade C vaccine for India. This clinical studies project has four specific aims: [unreadable] Provide support for phase 1 b of HVTN-065, an ongoing clinical trial testing clade B DNA/MVA and MVA/MVA regimens for safety and immunogenicity. [unreadable] Conduct ancillary immunogenicity assays for the phase 1 b portion of HVTN 065 [unreadable] Provide specimens from human volunteers for development of mucosal assays [unreadable] Submit the concept sheet and help with protocol development for an HVTN trial assessing the clade C vaccines in the presence and absence of GM-CSF expression in cis [unreadable] Conduct ancillary immunogenicity assays for the HVTN clade C vaccine trial Dr. Mark Mulligan, an experienced clinical trials investigator, will lead the HVTN interface for the project at Emory. Dr. Harriet Robinson will serve as co-P.I. and oversee the conduct of ancillary assays on fresh cells in a dedicated GLP lab at GeoVax.

IC Name
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
  • Activity
    U19
  • Administering IC
    AI
  • Application Type
    1
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
  • Sub Project Total Cost
    437192
  • ARRA Funded
  • CFDA Code
  • Ed Inst. Type
  • Funding ICs
    NIAID:437192\
  • Funding Mechanism
  • Study Section
    ZAI1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    GEOVAX, INC.
  • Organization Department
  • Organization DUNS
  • Organization City
    Smyrna
  • Organization State
    GA
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    30080
  • Organization District
    UNITED STATES