First AIDS Vaccine Made At NIAID's Vaccine Research Center Enters Clinical Trial

"To have taken this vaccine from concept to clinical-grade product in such a short time is an extraordinary accomplishment," comments Anthony S. Fauci, M.D., director of the NIAID. "The trial provides a tangible example, along with our outstanding group of scientists and their productive research programs, that the NIAID is moving at an unprecedented speed to try to make an AIDS vaccine a reality."

"The speed with which we reached this milestone demonstrates the VRC staff's dedication to the goal of finding an effective AIDS vaccine," comments VRC Director Gary J. Nabel, M.D., Ph.D. "We are absolutely committed to advancing AIDS vaccines from concept to the clinic, where we can begin the urgent task of evaluating their immune effects in people." Global statistics illustrate why their task is urgent: each day 7,000 people die from AIDS and another 15,000 become infected with the virus.

Dr. Nabel and two of his research fellows, Yue Huang, Ph.D., and Wing-Pui Kong, Ph.D., began developing the HIV DNA vaccine now being clinically tested a little more than a year ago.

Whereas traditional vaccines usually contain a weakened or killed form of a disease-causing agent or its proteins, as their name implies, DNA vaccines instead contain only portions of the genetic material for such.

The new vaccine contains the DNA blueprint for two pieces of HIV called "gag" and "pol." Gag is HIV's core protein. Pol includes three enzymes crucial for HIV replication, all of which have been modified for the vaccine to render them nonfunctional. Gag and pol remain relatively constant across different HIV strains, and together they make up about half of HIV's total protein.

Once inside the body, the DNA in the vaccine instructs certain cells to make small amounts of these HIV proteins. The purpose of this Phase I study is to determine if the vaccine is safe and if the body makes an immune response to these proteins. Because the vaccine does not contain genetic material for the whole virus, it is impossible for someone to become infected with HIV or to develop AIDS from the vaccine. Through a contract with Vical, Inc., of San Diego, the VRC had their laboratory product made into clinical grade DNA used in the vaccine.

The Phase 1 trial is recruiting 21 healthy men and women aged 18 to 60 who are not infected with HIV and who are at low risk for becoming so. Participants will be assigned at random to receive either the experimental vaccine or an inactive salt solution, known as a placebo.

Increasing doses of vaccine will be tested in a stepwise manner in three groups of seven volunteers. At each step, five people will receive vaccine while two other people receive placebo. The lowest study dose of vaccine (0.5 milligrams, or mg) tested in step one will be increased to 1.5 mg in step two, and to 4.0 mg in step three. The dose will be increased only if there are no significant adverse reactions in the previous group.

Participants wil