Acambis says immunogenicity results of phase 2 trial of smallpox vaccine consistent with phase 1 findings

By Lisa Kerner

Charlotte, N.C., July 31 - Acambis plc said preliminary results from the phase 2 trial of its Modified Vaccinia Ankara (MVA) smallpox vaccine, MVA3000, were consistent with the immunogenicity findings from its phase 1 trial, with 75% of vaccine naïve subjects seroconverting (experiencing a four-fold increase or above in neutralizing antibodies) after two doses.

In the 229 previously vaccinated subjects, 88% vaccinated at the highest dose level seroconverted after two doses.

A total of 590 healthy adult subjects, 361 of whom had never received a smallpox vaccine, were enrolled in the randomized, double-blind, study to test multiple dose levels of MVA3000 against a placebo.

The most commonly reported adverse events were injection site reactions (pain, redness, swelling and itching), headache, fatigue, malaise and muscle ache.

MVA3000 is being developed for use in patients with disorders of the immune system or skin conditions, such as eczema.

Acambis is co-developing the attenuated smallpox vaccine with Baxter Healthcare SA.

Phase 1 and phase 2 clinical trials for and manufacture of MVA3000 are funded by multimillion dollar contracts awarded to Acambis by the U.S. National Institute of Allergy and Infectious Disease, part of the U.S. National Institutes of Health.

Acambis, based in Cambridge, England, develops vaccines to prevent and treat infectious diseases.

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