Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
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Wall Street Journal - July 29, 2004
Marilyn Chase, Staff Reporter of The Wall Street Journal
GenVec Inc. of Gaithersburg, Md., said it is manufacturing the AIDS vaccine for human studies under a $30 million contract with the National Institute of Allergy and Infectious Diseases, a unit of the National Institutes of Health in Bethesda, Md.
Scientists will inject a total of 36 healthy volunteers, most from the Washington, D.C., area, said C. Richter King, the company's vice president of research. Volunteers will receive increasing doses of the vaccine, and then be watched to see what side effects and immune responses they develop in reaction to the vaccine. The vaccine won't contain any infectious AIDS virus particles, but rather only certain genes of the human immune-deficiency virus, or HIV, which causes AIDS.
The GenVec vaccine is an early attempt to outflank HIV globally. The virus is known to have evolved into different geographic subtypes called clades.
The vaccine is designed to work against three main clades designated A, B, and C found in patients around the world.
The vaccine is also designed to induce a very broad protective response by the two main arms of the body's immune system. One kind of immune defense would come from so-called neutralizing antibodies that block HIV from infecting healthy cells. Another kind of immune defense would be provided by special white blood cells known as killer T-cells that seek and destroy human cells already infected by HIV.
The vaccine is constructed like a missile with multiple warheads. The vehicle is another virus, called an adenovirus, armed with genes from the different types of HIV. Adenovirus, best known for causing the common cold, has long been used in vaccine and gene-therapy research and is generally deemed safe. However, questions arose following the 1999 death of an 18-year-old male in a University of Pennsylvania gene-therapy experiment.
That failed experiment was unlike the vaccine test, Dr. King said, because it delivered large amounts of adenovirus directly into the liver of the patient, who suffered from a metabolic disorder. The vaccine study will use much smaller amounts of the adenovirus given as a standard intramuscular shot, he added.
Technology for the multipronged attack on HIV came from the laboratory of Gary Nabel, head of the Vaccine Research Center of the National Institutes of Health, Dr. King said. The $30 million NIH contract covers production of vaccines for both AIDS and SARS, or severe acute respiratory syndrome.
Outside scientists in the vaccine field said it is too soon to judge this vaccine's chances of success, but they generally welcomed another entrant in a field considered underfunded.
About 40 million people world-wide are living with HIV/AIDS, with five million new infections and three million deaths in 2003. More than 14,000 people acquire the infection daily.
The International AIDS Vaccine Initiative, or IAVI, a not-for-profit New York consortium, has called for a doubling of the world's annual AIDS-vaccine investment, which at $650 million is less than 1% of total health-product research and development. So far, 30 vaccines have been put into human clinical trials, but the only one to complete efficacy studies failed to prevent infection.
Anthony S. Fauci, director of NIAID, the sponsoring NIH unit, said monkeys that were inoculated with the experimental vaccine and exposed to the virus weren't shielded against infection, but were protected against developing full-blown disease.
Cheaper and better AIDS drugs "won't make a big difference in 14,000 new infections a day," says Emilio Emini, senior vice president of vaccine development at IAVI. "In the end, the only thing that's going to make a difference in the spread of infectious diseases is a vaccine."
Write to Marilyn Chase at marilyn.chase@wsj.com
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