11.28.07
DynPort Vaccine Co. and Baxter International have received a $201.2 million contract modification from the U.S. Department of Health and Human Services (HHS) for the development of Baxter's cell-cultured seasonal and pandemic influenza candidate vaccines.
The contract funds development of the seasonal influenza vaccine through FDA licensure, and the pandemic vaccine candidate through Phase II clinical trials in adults and pediatric Phase I clinical trials. DVC, the prime contractor for this effort, is providing overall management of the clinical trials. Baxter is developing the candidate vaccines, and will manufacture the vaccines and own all clinical data and licenses.
The clinical portion of a Phase I/II clinical trial to test the safety and immunogenicity of Baxter's cell-culture-derived split virus seasonal influenza vaccine candidate in Europe was recently completed. Preliminary data announced in July 2007 indicate that the vaccine induced strong antibody responses and good tolerability in all study populations. DVC and Baxter vaccinated the first volunteers of a Phase III trial in healthy adults using the seasonal vaccine candidate in the U.S. on Nov. 26, and plan to enroll patients in a Phase I clinical trial for a pandemic influenza clade 2 strain vaccine candidate in 2008. This trial will also be conducted in the U.S.
"The progress made on the pandemic and seasonal influenza programs in such a short time reflects the priority and importance of this development program for both companies," said Dr. Robert V. House, president and chief scientific officer of DVC. "By combining Baxter's technology with DVC's biologics life-cycle and contract management expertise, the team has made great progress in advancing these two influenza vaccine candidates."
The contract funds development of the seasonal influenza vaccine through FDA licensure, and the pandemic vaccine candidate through Phase II clinical trials in adults and pediatric Phase I clinical trials. DVC, the prime contractor for this effort, is providing overall management of the clinical trials. Baxter is developing the candidate vaccines, and will manufacture the vaccines and own all clinical data and licenses.
The clinical portion of a Phase I/II clinical trial to test the safety and immunogenicity of Baxter's cell-culture-derived split virus seasonal influenza vaccine candidate in Europe was recently completed. Preliminary data announced in July 2007 indicate that the vaccine induced strong antibody responses and good tolerability in all study populations. DVC and Baxter vaccinated the first volunteers of a Phase III trial in healthy adults using the seasonal vaccine candidate in the U.S. on Nov. 26, and plan to enroll patients in a Phase I clinical trial for a pandemic influenza clade 2 strain vaccine candidate in 2008. This trial will also be conducted in the U.S.
"The progress made on the pandemic and seasonal influenza programs in such a short time reflects the priority and importance of this development program for both companies," said Dr. Robert V. House, president and chief scientific officer of DVC. "By combining Baxter's technology with DVC's biologics life-cycle and contract management expertise, the team has made great progress in advancing these two influenza vaccine candidates."