Dynavax begins universal flu vaccine test earlier than expected

Dynavax Technologies Corporation has begun immunizing volunteers with its universal influenza vaccine candidate in Phase Ib clinical trials half a year earlier than originally planned.

The Berkeley, California, based company was able to begin Phase Ib testing six months earlier than expected because of its dramatic positive safety results from test Phase Ia, which are still being conducted. Phase I testing, according to, is usually geared towards measures of safety and tolerability. They are typically conducted on small numbers of test subjects.

The Phase Ib clinical trials will evaluate a combination vaccine made of Dynavax’s N8295, the novel component of the universal flu vaccine, and an investigational H5N1 avian flu vaccine produced by Novartis.

By looking at the combination of N8295 and the H5N1 vaccine, Dynavax is seeking to broaden its understanding of the immunological properties of the candidate in human subjects without a pre-existing immunity to the H5N1 avian flu strain, reports.

When the data from Phase 1b is examined, which is expected to occur in early 2011, Dynavax will most likely design a proof-of-concept study, generating data that could trigger Novartis’ option on joint development and the commercialization of the combination.

"Our success in moving forward to a Phase 1b study ahead of plan was a result of the positive preliminary data produced in the first safety study. Equally important, however, was close coordination of Novartis with our team and its commitment to supply H5N1 vaccine to meet the accelerated schedule," Tyler Martin, Dynavax president and chief medical officer, told