Smallpox Vaccine Trial To Enroll Individuals With AIDS To Determine Safety and Efficacy in People With Weakened Immune Systems

Researchers are planning to test a new smallpox vaccine in people with AIDS to determine if the inoculation may be given safely to people with compromised immune systems, the AP/Indianapolis Star reports. The existing FDA-approved smallpox vaccine, called Dryvax, is not recommended for people with weakened immune systems because they are more prone to its side effects, which can include skin problems, blindness and brain swelling. Life-threatening side effects occur in 15 out of every million people vaccinated and at least one dies. The study, which will enroll about 88 people, will test the safety and effectiveness of modified vaccinia Ankara, or MVA, a new vaccine that is considered safer than Dryvax. The AP/Star reports that a German study of MVA administered to HIV-positive people found that participants only experienced soreness at the vaccination site. However, scientists do not know if the vaccine alone can prevent a smallpox infection. Dr. Lawrence Fox, medical officer for the HIV research branch of the National Institute for AIDS and Infectious Diseases, said that while it is believed that MVA will create an immune response sufficient to prevent smallpox infection, it will not be known for certain unless there is a smallpox outbreak. The FDA must still approve the study protocol, which could take up to 30 days, the AP/Star reports (AP/Indianapolis Star, 11/21).