Initial Clinical Study Shows Safety And Bioactivity Of Vaccine.(Brief Article)

2002 FEB 13 - (NewsRx.com & NewsRx.net) -- A new Phase I clinical trial of a prostate cancer vaccine developed at Duke University Medical Center has shown that the vaccine made from the patient's own dendritic cells causes no adverse side effects. More important, the trials indicate that the vaccine is able to boost the patient's immune system to fight cancer.

The results of this trial in 13 patients are published in the February 2002 issue of the Journal of Clinical Investigations.

"This is the first study that has data on the safety and immunological efficacy of this type of cancer vaccine," said Dr. Johannes Vieweg, an associate professor of urology and assistant professor of immunology at Duke University Medical Center, in Durham, North Carolina, and senior investigator in the study. "And while this work was done in prostate cancer patients, we believe this method may prove to work in most cancers, not just prostate cancer."

Dendritic cells are white blood cells that activate the immune system by capturing antigens - substances that trigger an immune response, such as against a virus, bacteria, or tumor - and presenting them to the body's killer cells, called T cells. The vaccine created in the Duke study introduces genetic information from a prostate cancer patient's own dendritic cells, in the form of RNA from prostate-specific antigen (PSA). This antigen is secreted by the prostate gland and is elevated in some forms of prostate cancer. Once the dendritic cells use the RNA to produce and present the PSA antigen, they are injected back under the patient's skin and activate the T cells to attack tumors.

In the trial, 13 men with metastatic prostate cancer were given three escalating doses of the vaccine. Overall, the vaccine was well tolerated, reported Vieweg and his colleagues. Four subjects had low-grade fevers and flu-like symptoms, and four patients had inflammation at the site of the injection that subsided after 2 to 3 days.

"Patients responded well to the vaccine because we are using materials from their own body to create a vaccine that is designed just for them," said Vieweg.

In the study, the researchers performed immunological tests to ensure that T cells were functioning and able to kill tumor cells, in addition to tests to determine whether ...