Immune-boosting: New clinical trial of a therapeutic vaccine for people living with HIV

A new study of a therapeutic vaccine for people living with HIV is coming to Seattle. The trial, being conducted by the Fred Hutchinson Cancer Research Center and the University of Washington Vaccine Evaluation Unit, is designed to look at the safety of a new HIV-1 gag DNA vaccine (made by Merck Research Laboratories) and its ability to stimulate the immune systems of people living with HIV.

Unlike a vaccine designed to protect people from ever getting a virus, a therapeutic vaccine is intended to help the body fight a virus it already has. It is thought that therapeutic vaccines will play an especially important role in the treatment of HIV-positive people, on highly active antiretroviral therapy (HAART), with undetectable viral loads. While there are many important reasons to keep a person's viral load as low as possible, one of the disadvantages of having only low levels of HIV in the blood is that the immune system stops creating cells specifically targeted at HIV. A therapeutic vaccine acts by introducing pieces of HIV (that are NOT able to cause any infection) into the blood, in an attempt to stimulate the immune system to produce HIV-fighting cells.

The study is 26 months long and there are 19 visits over that two year period. Volunteers are paid $50.00 per visit beginning at study enrollment. Individuals must meet the following criteria for the initial eligibility for this study:

• HIV-positive men or women age 18-55
• Overall good health
• Have a undetectable viral load for the past 24 months
• CD4 cell count of 500 or above, and have never had a CD4 cell count below 200
• On HAART for the past 24 months with no changes in the past 3 months (must remain on HAART for the entire study period)
• Never participated in an HIV vaccine study
• No AIDS-defining illnesses
• No Chronic Hepatitis B
• Never diagnosed with Hepatitis C
• No serious allergic reactions requiring emergency treatment
• No experimental vaccines or medications in the past 30 days
• Not pregnant, breast feeding or plan to become pregnant
• Not taking any medication that thins your blood
• Not on any immunomodulating medications like interferon,IL2, GMCSF, etc.
• No history of chronic liver disease
• No current substance abuse

If you meet the above criteria and would like more information about this study, please contact the trial nurse, David Berger, RN at (206) 667-2344.