The Danish pharmaceutical firm Bavarian Nordic yesterday reported that its next-generation Imvamune smallpox vaccine is safe to administer to HIV carriers who cannot safely receive the conventional vaccine (see GSN, April 14).
In a Phase 2 clinical study, the company administered the vaccine to 300 HIV-infected subjects and 86 people without the virus. Researchers concluded that HIV carriers suffered no additional side effects, a finding that could potentially support the vaccine’s use to stem a biological weapon attack.
The firm expects to submit its report to the U.S. Food and Drug Administration within several days and receive $25 million under a contract. The company plans to release all data from the report in the second half of next year, including details on the vaccine’s ability to produce immune response and the reactions of additional HIV carriers who previously received another smallpox vaccine (Bavarian Nordic release, Nov. 5).