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Annual and Interim Progress Report Summaries

Principal Investigator: Barton Haynes

Project: Centralized Envelope Phase I Study

Submitted June 15, 2012

There has been significant progress manufacturing the vaccines over the past year which enabled submission of a pre-IND meeting request to the FDA in June 2012.

The three gp160 DNA vaccines were completed, released and are currently on a stability testing program.

Production of the five NYVAC gp120 pre-master virus seed stocks was completed through the combined efforts of Drs Bert Jacobs and Mariano Esteban. These pre-master virus seed stocks were transferred to IDT who first performed manufacturing feasibility studies. IDT has now completed production of the master virus seed (MVS) stocks including sterility and mycoplasma assays. Three NYVAC vaccines have already been produced and the remaining two vaccines are scheduled for production by July 2012.

BIDMC has designed a parallel nonhuman primate (NHP) study to evaluate the immunogenicity of the clinical trial vaccines and regimens. Three cohorts of five monkeys have been immunized IM with plasmid DNA on weeks 0, 4 and are being boosted on weeks 20 and 24 with the corresponding transgenes expressed by rNYVAC. Preliminary data show good DNA priming and a good response with the NYVAC boost.

DAIDS, ABL, Duke/CHAVI, SRI, IPPOX, sanofi Pasteur, FNIH and others have participated on bi-weekly conference calls over the past year to review progress manufacturing the products. Under direction by SRI they have also been writing a pre-IND document to be submitted to the FDA 2Q2012. The HVTN has been working on the clinical trial protocol, and will utilize the infrastructure already in place associated with this network including the established vaccine clinical trial units and DAIDS monitoring plans.

Submitted December 15, 2011 (Interim Report)
Submitted February 1, 2011
Submitted June 30, 2010 (Interim Report)
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