Baxter avian flu vaccine meets trial endpoints

Baxter International has announced the first scientific peer-reviewed publication of phase I/II study results for Celvapan, its candidate avian influenza (H5N1) vaccine.

Published in the New England Journal of Medicine, the results show the vaccine met the trial endpoints for immunogenicity and safety.

Calvapan is manufactured using Vero cell technology that utilises a well-established cell line derived from African green monkey kidneys in 1962, with a continuous cell line derived from these cells without the need of generating additional cells from animals.

In the study, patients were administered with 3.75 micrograms to 30 micrograms of antigen concentrations, with the development of antibodies observed in those receiving 7.5 micrograms and 15 micrograms of non-adjuvanted formulation.

Hartmut J Ehrlich, vice-president of global research and development for bioscience at Baxter, said: “Celvapan combines innovative science and breakthrough production technology with the aim of protecting people against an H5N1 pandemic flu infection.”

He added that it is an immunogenic vaccine that does not require an adjuvant to enhance the immune response.

In July 2007, Baxter announced positive preliminary phase I/II clinical trial data for its Vero cell-based seasonal influenza vaccine candidate.