H9N2 avian flu vaccine paired with adjuvant provokes strong human immune response at...( aged 18 to 34 in this Phase I clinical...),Health

aged 18 to 34 in this Phase I clinical trial. Phase I vaccine trials assess candidate vaccines' safety and ability to stimulate an immune system response, and are not designed to determine whether the vaccine would prevent infection by naturally occurring virus. The researchers vaccinated 48 volunteers with non-adjuvanted H9N2 vaccine (made from inactivated virus) at one of four dosages--3.75, 7.5, 15 or 30 micrograms. An additional 48 volunteers received MF59-adjuvanted vaccine at one of the same four dosages. Volunteers were vaccinated twice, with inoculations spaced 28 days apart.

An avian flu vaccine, like the seasonal flu vaccine, should stimulate antibodies, which help ward off infection if the vaccinated person later encounters the flu virus. In general, the higher the level of antibodies made in response to a vaccine, the more protective the vaccine is, Dr. Atmar notes.

"In our trial, a single inoculation of adjuvant-containing H9N2 vaccine, even at the lowest dosage, generated a good antibody response," says Dr. Atmar. By comparison, the seasonal flu vaccine contains 15 micrograms each of three different circulating flu strains--much higher than the 3.75 micrograms of H9N2 flu virus contained in the lowest dose vaccine tested in this trial. Furthermore, he adds, a single dose of the adjuvanted H9N2 vaccine was as good as two doses of the vaccine without adjuvant.

Currently, MF59 is licensed for use as a vaccine adjuvant in Europe but not in the United States. The results of this trial, says Dr. Atmar, suggest that MF59 is deserving of further study.

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Contact: Anne A. Oplinger
aoplinger@niaid.nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
25-Sep-2006

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