Sinovac's avian flu vaccine shows sero-positive rate of 78.3% at 10 ug dose in phase 1 clinical trial

By Lisa Kerner

Charlotte, N.C.., June 19 - Sinovac Biotech Ltd. said preliminary results from a phase 1 clinical trial of its proprietary Inactivated Pandemic Influenza Vaccine (Human-used Avian Flu Vaccine) (Panflu) showed a sero-positive rate of 78.3% for the 10 ug antigen dose, exceeding the criteria for assessment of vaccines in the European Union.

In the double-blind, randomized trial, 120 volunteers were divided into four groups of 30 persons, with 24 persons in each group inoculated with the pandemic influenza vaccine and the other six with a placebo.

Vaccine safety was documented through blood and urine tests, according to a company news release.

No serious adverse events were reported.

A phase 2 clinical trial and submission to appropriate regulatory agencies are planned following completion of the phase 1 study, Sinovac said.

The company's vaccine project is being sponsored by the Ministry of Science and Technology and is co-developed by the Chinese Centers for Disease Control and Prevention.

Officials estimate a flu pandemic could last up to one year or more, putting millions of lives at risk.

Sinovac is a Chinese biopharmaceutical company that researches, develops and commercializes vaccines.

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