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One Year After Lab Opens
First VRC AIDS Vaccine Enters Clinical Trial

By Laurie Doepel

NIAID researchers at the Vaccine Research Center have begun a clinical trial testing the first AIDS vaccine invented at the new facility. The vaccine was produced only one year after the building housing the new center opened in September 2000.

Global statistics illustrate why this task is urgent: each day 7,000 people die from AIDS and another 15,000 become infected with the virus.

VRC director Dr. Gary Nabel and two of his research fellows, Dr. Yue Huang and Dr. Wing-Pui Kong, 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.

Dr. Gary Nabel (r), VRC director, and Dr. Barney Graham, chief of the Clinical Trials Core and Viral Pathogenesis Laboratory at the VRC, display the Biojector and the vaccine. VRC scientists produced the vaccine in 1 year.

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 1 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.

A needle-free device called Biojector will be used to administer 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.

There have been several DNA-based vaccines already tested in humans and none has caused serious adverse reactions, notes Dr. Barney Graham, chief of the Clinical Trials Core and Viral Pathogenesis Laboratory at the VRC. Persons interested in the study will be extensively educated and counseled, he adds, prior to signing an informed consent agreement to join the trial.

For more information about the trial, call 1-866-833-5433 or read a description of the trial at http://www.niaid.nih.gov/vrc/clinstudies.htm.

According to Nabel, the HIV DNA vaccine is intended to stimulate cellular immunity to the virus, which is thought to be important to protection against HIV. The vaccine will likely be combined in later studies with other DNA components that stimulate neutralizing antibody responses to the virus. This is the first in a series of studies, he adds, with different vaccine candidates aimed toward identifying those that have the best opportunity to protect against AIDS or HIV infection.

The VRC currently has a roster of about 100 scientists and support staff. Most products evaluated in VRC clinical studies will be products conceived, developed and produced in-house.


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