Acambis begins phase II smallpox vaccine trial

MVA vaccines are a weakened form of smallpox vaccine. MVA3000 is being developed for use in people for whom the traditional smallpox vaccine is not recommended, such as patients with disorders of the immune system or skin conditions such as eczema.

The phase II trial is designed to gather further safety and immunogenic data about MVA3000 when administered at three different dose levels. The randomized, double-blind, placebo-controlled study will involve 700 healthy adult subjects, half of whom have been previously vaccinated against smallpox, and is being conducted at up to 10 sites in the US. Each subject will receive two doses of either MVA3000 or placebo, and the MVA3000 inoculations will be given across a broad range of doses.

Data from this study will be used to select a dose of MVA3000 for further clinical testing.

Acambis CEO Gordon Cameron commented, “The MVA3000 trial results to date have been exactly in line with our expectations of the vaccine’s profile and we are confident this will continue in our phase II trial. Under existing contracts with the US government, we are also preparing for additional phase I/II trials in target population subjects with HIV and atopic dermatitis and remain on schedule to commence these later this year.”

Acambis has been awarded two contracts by the US National Institute of Allergy and Infectious Diseases (NIAID) for the manufacture and development of MVA3000. The first contract, awarded in February 2003, was for $9.2 million. The second, awarded in September 2004, is potentially worth up to $131 million, with a $76 million core component requiring clinical testing and manufacture of 500,000 doses of MVA3000, and an optional element worth $55 million for the manufacture of a further 2.5 million doses of MVA3000.