Bavarian Nordic closes enrolment for Phase III study of smallpox vaccines


Biopharmaceutical firm Bavarian Nordic has completed enrolment for its Phase III study of smallpox vaccines, IMVAMUNE and ACAM2000.

IMVAMUNE is a non-replicating smallpox vaccine offered in liquid-frozen formulation, indicated to be administered to people for whom replicating smallpox vaccines are contraindicated.

ACAM2000 is a live, vaccinia virus smallpox vaccine developed using advanced cell-culture techniques and has been approved by the US Food and Drug Administration (FDA) for active immunisation against smallpox disease.

The Phase III non-inferiority study will be conducted to establish the non-inferiority of IMVAMUNE to the currently licensed smallpox vaccine ACAM2000.

"Completion of enrolment of this study represents a significant milestone in the collaboration between Bavarian Nordic, and multiple federal agencies."

It has enrolled a total of 440 subjects at a US military garrison in South Korea, headed by the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in collaboration with the US Defense Health Agency.

Bavarian Nordic president and CEO Paul Chaplin said: “Completion of enrolment of this study represents a significant milestone in the collaboration between Bavarian Nordic, and multiple federal agencies.

“IMVAMUNE has served as the cornerstone for our company over the past decade and we will continue to work with the US Government to meet their stated goal of protecting 66 million Americans who are in need of a safer smallpox vaccine.”

The top-line of the study is expected to be released in the second half of next year.

The study has been approved by the FDA and will also support the registration of liquid-frozen IMVAMUNE.