Centralized administration is critical for efficient project management, coordination, and execution. Core A (Administrative Core) will provide all the logistic, scientific, managerial, and financial oversight to facilitate and to coordinate the studies described in this IPCAVD program. The Administrative Core will ensure that the preclinical studies (Project 1), clinical studies (Project 2), manufacturing and regulatory activities (Project 3), and immune monitoring core services (Core B) adhere to the timelines and deliverables described in those sections of this IPCAVD program. The Administrative Core will organize weekly conference calls and regular in-person meetings among the investigators, interface with collaborators and clinical sites, maintain regulatory approvals for all preclinical and clinical studies, provide fiscal and logistic oversight, manage subcontracts, and coordinate meetings with the Scientific Advisory Board and DAIDS Program Officials. This detailed administration and management structure will ensure that all the studies remain focused on the overall objective of advancing the clinical development of our novel Ad26/MVA and Ad26/Protein HI V-1 vaccines. ' To accomplish these goals, we propose the following four Specific Aims: 1. To coordinate communications, interactions, and operations among investigators, projects, and cores to facilitate the overall progress and goals of this IPCAVD program; 2. To ensure and to maintain regulatory compliance for all preclinical and clinical studies; 3. To provide detailed financial oversight and management;and 4. To coordinate meetings with the Scientific Advisory Board and DAIDS Program Officials.

Public Health Relevance

Core A will provide cohesive scientific management, financial oversight, and regulatory support for the proposed studies and will coordinate interactions among the investigators, collaborators, advisors, clinical trials networks, clinical sites, and regulatory agencies. This detailed administration and management structure will ensure that all the studies remain focused on the overall objective of advancing the clinical development of our HIV-1 vaccine candidates.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Program--Cooperative Agreements (U19)
Project #
5U19AI096040-03
Application #
8663687
Study Section
Special Emphasis Panel (ZAI1-EC-A)
Project Start
Project End
Budget Start
2014-06-01
Budget End
2015-05-31
Support Year
3
Fiscal Year
2014
Total Cost
$255,426
Indirect Cost
$47,309
Name
Beth Israel Deaconess Medical Center
Department
Type
DUNS #
071723621
City
Boston
State
MA
Country
United States
Zip Code
02215
Stephenson, Kathryn E; Neubauer, George H; Reimer, Ulf et al. (2015) Quantification of the epitope diversity of HIV-1-specific binding antibodies by peptide microarrays for global HIV-1 vaccine development. J Immunol Methods 416:105-23
Baden, Lindsey R; Liu, Jinyan; Li, Hualin et al. (2015) Induction of HIV-1-specific mucosal immune responses following intramuscular recombinant adenovirus serotype 26 HIV-1 vaccination of humans. J Infect Dis 211:518-28
Barouch, Dan H; Picker, Louis J (2014) Novel vaccine vectors for HIV-1. Nat Rev Microbiol 12:765-71
Dugast, Anne-Sophie; Chan, Ying; Hoffner, Michelle et al. (2014) Lack of protection following passive transfer of polyclonal highly functional low-dose non-neutralizing antibodies. PLoS One 9:e97229
Balandya, Emmanuel; Miller, Andrew D; Beck, Matthew et al. (2014) Adenovirus serotype 26 and 35 vectors induce simian immunodeficiency virus-specific T lymphocyte responses in foreskin in rhesus monkeys. J Virol 88:3756-65
Barouch, Dan H; Michael, Nelson L (2014) Accelerating HIV-1 Vaccine Efficacy Trials. Cell 159:969-72
Penaloza-MacMaster, Pablo; Teigler, Jeffrey E; Obeng, Rebecca C et al. (2014) Augmented replicative capacity of the boosting antigen improves the protective efficacy of heterologous prime-boost vaccine regimens. J Virol 88:6243-54
Nkolola, Joseph P; Bricault, Christine A; Cheung, Ann et al. (2014) Characterization and immunogenicity of a novel mosaic M HIV-1 gp140 trimer. J Virol 88:9538-52
Baden, Lindsey R; Walsh, Stephen R; Seaman, Michael S et al. (2014) First-in-human evaluation of a hexon chimeric adenovirus vector expressing HIV-1 Env (IPCAVD 002). J Infect Dis 210:1052-61
Whitney, James B; Hill, Alison L; Sanisetty, Srisowmya et al. (2014) Rapid seeding of the viral reservoir prior to SIV viraemia in rhesus monkeys. Nature 512:74-7

Showing the most recent 10 out of 26 publications