LETTERS From CAMP Rehoboth |
CAMPsafe: Getting Involved |
by Dr. Curt Lociejewski |
Well, it is Labor Day weekend once again, drag volleyball is here, (GO FLO!!!) as well as the big SUNDANCE Benefit. Many of us will be buying tickets for the big event, and going out and having a good time. We know that that the money we are spending is going to help a good cause, helping others with HIV and AIDS. I have supported several of these events here at the beach, as well as locally back in Baltimore, but I began to wonder if there was possibly something more I could be doing. Last summer a dear friend of mine was dying because of AIDS and I have been around long enough to see some close, as well as distant friends pass away right before my eyes because of this dreaded disease. Thank God for the newer drugs which have saved my friend but have not necessarily worked for others I have known. If only a cure could be found or a vaccine developed. It was Wednesday, June 24, 1998, I was reading the Baltimore Sun when an article titled "AIDS vaccines final trial begins in PA". Finally, I thought, a vaccine. In reading the article, however, I realized that this was just not the case. The vaccine was still in its trial phase, but 5000 volunteers are needed to test this final phase of the vaccine before the Food and Drug Administration gives its final approval. This, I thought, was how I could make a difference and really become a part of a solution to a major epidemic going on in our country and around the world. I would become a volunteer for this vaccine trial. I found out that trials are going on in Baltimore and DC. In Baltimore they are being held at the Johns Hopkins University, Center for Immunization Research, and in Washington, D.C. at D.C. General Hospital, room 6310 in the main building. I contacted Johns Hopkins and spoke with Brenda Larkin, RN, BSN who explained to me that they are looking for 300 volunteers locally to conduct this study. The individuals that are needed for this study must be HIV negative, but at risk for the virus. The vaccine being tested is the AIDSVAX (TM) made by VaxGen in California. AIDSVAX (TM) is a vaccine directed against HIV, the virus that causes AIDS. It is a preventive vaccine specifically designed to protect HIV-uninfected, healthy individuals from strains of HIV-1 that are typical of the majority of AIDS-causing viruses in North America. It is the very first vaccine against HIV for which the U.S. Food and Drug Administration has given permission to be evaluated in a phase III, meaning large-scale, prevention study in human volunteers. This is a nationwide effort with 30-40 clinics involved over a 3-4 year period. This study is designed to determine to what extent this vaccine will protect against HIV-infection. In the first two phases of studying this vaccine, over 90 individuals were vaccinated. This phase of the study was designed to prove the safety of this vaccine and helped to determine dosing. Now, the goal is to measure how effectively the vaccine can prepare the immune system of its recipients to block HIV, hoping to prevent HIV from infecting an exposed individual. It was made very clear to me that this IS NOT a proven vaccine to prevent HIV infection. That is the point of the trial, to study and hopefully prove the potential protection it may provide. One is encouraged to protect oneself from HIV using all the proven methods. To date there is no HIV-vaccine approved for licensure. As a participant in the trial, you may be helping to develop the first vaccine that could be available for widespread public use. Another main point that was brought to my attention was that I COULD NOT become infected with HIV. The AIDSVAX (TM) is made from man-made genetically engineered proteins which look enough like the outer coat of the virus that the immune system thinks it should create antibodies against it. No forms of live HIV virus are used. I was told that there was a possibility that I may test HIV positive but that other tests could be done to prove that I was not infected with HIV. The first visit for me lasted about 1 hour and a general health and sexual history was taken. Authorizations were signed giving my consent to be a participant, and blood was drawn. Before I could be vaccinated they needed to make sure that I was HIV negative. I was then re-appointed and 2 weeks later I came back to receive the results of my HIV test as well as to be vaccinated. Brenda reported to me that my results were negative and that I was accepted into the trial. At that visit I received my first vaccination and had to wait around for 30 minutes after the injection to make sure I had no immediate side effects. I not only had an absence of side effects, this trial has had only positive effects on my life, and I expect that to be the case as time goes on. I was then asked to make an appointment 2 weeks later for other blood work. After this next visit it would be necessary for me to return in 1 month for my next vaccination, then 2 weeks after that for other blood work, again. The follow up visits after this stage would then be set up at 6 month intervals. I was asked for a 3 year commitment with a total of 15 scheduled visits being needed for the trial. I was also offered $40.00 per visit for my participation in the study. One can either have the check made out to them or to their favorite charity. The experience itself was very self gratifying. I was finally doing something! Something that could help endless numbers of people and actually make a difference. I do know and realize that this is a trial, but what if this is what we have all been waiting for? Volunteers are still needed, so if you too would like to get involved in this trial and really make a difference call Brenda Larkin, RB, BSN or Margaret M. McClusky, RN, MPH. They can be reached in the District of Columbia area at 202-675-7677 or in the Baltimore area at 410-955-7283. |
LETTERS From CAMP Rehoboth, Vol. 8, No. 12, August 28, 1998. |