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Lupus Clinical Trials

New Medical Therapies™


May 21, 2007

Acambis issued positive results from two phase III trials of ACAM-2000, a vaccine for the treatment of smallpox. The primary endpoints in both trials were non-inferiority in cutaneous response and the strength of the neutralizing response (GMT) when compared to Dryvax, a licensed smallpox vaccine. The first trial, H-400-009, was a randomized, placebo controlled, double-blind design and enrolled 1,162 treatment-nave subjects aged 18-30 years. Results revealed that 96% of the subjects who received ACAM-2000 and 99% of the subjects receiving Dryvax had a major cutaneous response, establishing non-inferiority. By 30 days after vaccination, neutralizing antibody geometric mean titers (GMT) were 166 in the ACAM-2000 and 255 in the Dryvax group, again this established non-inferiority. The second trial, H-400-012, was a randomized, placebo controlled, double-blind design and enrolled 1,647 treatment experienced subjects aged 31-84 years. Of the subjects receiving ACAM-2000, 84% had a major cutaneous response compared to 98% receiving Dryvax. Non-inferiority was not established. By 30 days after vaccination, neutralizing antibody GMT were 286 in the ACAM-2000 group and 445 in the Dryvax group; this established non-inferiority. A BLA for ACAM-2000 is currently under review by the FDA.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.