On November 17, 2003, the World Health Organization reported 11 cases of Ebola hemorrhagic fever in the Republic of the Congo. Dr. Nabel notes, "The current Ebola outbreak in the Congo provides a stark reminder of the need to rapidly develop vaccines against such perilous infections. A few years ago, we did not imagine that our vaccine would enter human trials so quickly, but the re-emergence of such viruses makes it all the more important to respond quickly. Individuals who volunteer for these vaccine trials can help us understand if our new vaccines ultimately will be effective."
Twenty-seven volunteers between the ages of 18 and 44 will participate in the study. Six people will receive a placebo injection and 21 will receive the investigational vaccine, manufactured by Vical Inc., a San Diego biotechnology company working in collaboration with the VRC. Vical has also secured a nonexclusive license from NIH to proprietary gene sequences used in the DNA Ebola vaccine. In the new trial, volunteers will receive three injections over two months and will be followed for one year. Volunteers will not be exposed to Ebola virus. Individuals interested in enrolling in the trial may visit http://www.clinicaltrials.gov or call the VRC toll-free at 1-866-833-LIFE (5433).
The candidate vaccine is synthesized using modified, inactivated genes from Ebola virus. This gives the immune system information about viral structures so that it can mount a rapid defense should the real virus ever be encountered. There is no infectious material in the vaccine, and the virus was not present during any stage of the manufacturing process, notes Barney Graham, M.D., Ph.D., director of the clinical trials unit of the VRC. "It is impossible for the vaccine to cause infection," he adds, "because it employs new technology known to safely stimulate broad immune responses."
Besides assessing the vaccine's safety, re
Contact: Contact: Anne A. Oplinger
NIH/National Institute of Allergy and Infectious Diseases