I have corrected a posting on my site http://www.ihavems.com concerning my having an injection site reaction. There is a quick link at the top of the site to the information. I have read numerous posts about looking forward to seeing an injection site reaction, and this may act as a reverse placebo effect. If a patient does not see an injection site reaction, they may believe they are in the placebo group. I will paste in the correction below. I have never had an injection site reaction and no one in my study has every had an injection site reaction.
From Loobie -- I had absolutely 0 shot site reaction (which I know probably means bupkus), but I just wanna' know!
My family has a personal relationship with the Zhang family. During some of the trips to Houston, we have lunch with them or visit them at their labs. Before I started the study, we had many discussions about the mechanics of the T-cell vaccine and the prior studies that the Zhangs had conducted. One comment was that about 20% of the patients in the 1990's Baylor study had an injection site reaction, so it was something we were looking for as the trial proceeded. You will not find anything in the journal articles about injection site reactions, and if and when they occur in the current trials, they will be noted as an adverse event, even though there really is nothing adverse about the event.
An addition -- Never say never. I did know about Cohen's work. He is on Opexa's scientific advisory board. In all of Zhang's papers, there is no mention of injection site reactions. I should have made that point.
The main reason for that is not that there were none, but rather that Zhang didn't include them in the paper. He was not going for FDA approval and minor adverse events are not worth including in preliminary research.
Thanks to NHE and CureOrBust T Cell Vaccination in Multiple Sclerosis Relapsing-Remitting Nonresponders Patients - http://eng.sheba.co.il/img/upload/6/600_362.pdf
Best regards, Tim
If you are going into the extension study, you should read my post http://www.thisisms.com/ftopict-4868.html There is a buildup period where each successive dose of vaccine stimulates the body to produce more T-cells to eliminate the MRTCs. Each injection also stimulates the immune system to produce memory WBC that continue producing the T-cells that remove the MRTCs as the body mistakenly produces them. You will start building protection with the first injection, but it may take 3 injections to get your immune system up to a level that can handle any large output of MRTCs, an attack.
This is from my website explaining the injection site reaction that I though I had.
March 31, 2005 Three days after Tim received his injection, he removed the little round Band-Aid and discovered that there was redness at the injection site. Dr. Zhang had told Tim that about 20% of the people that he treated in the late 1990s had a reaction at the injection site. The redness was possibly a sign that the army of antibodies were attacking the attenuated myelin reactive T-cells from the vaccine and causing the redness at the point of injection. We were all delighted to see this. It would be 6 months before Tim would receive another injection, and at that time Dr. Loftus realized that the redness was from the Band-Aid and not from any battle between the protective T-cells generated by the vaccine and the injection of attenuated myelin reactive T-cells. Since plenty of time had passed since the original post, it didn't occur to us that we should go back and correct this erroneous observation. Tim has never had any redness at the injection site caused by a reaction to the vaccine. Tim has shown us some websites where people who are getting into the current study are hoping to see redness at the injection site, and he is concerned that if someone in the study does not see redness at the injection site, they will assume that they are in the placebo group. It should be obvious from Tim's experience that people in the study could see redness caused by a reaction to the Band-Aid or see redness caused by a reaction to the vaccine. The vast majority of patients should not see anything. If you know someone who is in the current study, please point this out to him or her.
This is the remainder of the post from 3/31/05 and the picture of the Band-Aid reaction. Notice how it has the outline of a little round Band-Aid. Tim will have his blood checked 4 months from now to see what level of myelin-reactive T-cells is present. A person with MS will continue to produce these bad T-cells, but by evaluating their blood and giving them the appropriate vaccine booster, the amount of myelin-reactive T-cells will approach zero and the destruction of myelin will stop. By analyzing the patient's blood every 6 months, the scientist is also able to look for any epitope (we are not going to try and explain that) shifts in the bad T-cells. The person's vaccine is constantly monitored and adjusted to keep the disease from ever doing damage again. This is personalized medicine. AUTOLOGOUS (the donor and recipient are the same individual) treatments have very little safety concerns, have no rejection problems, and are patient specific. For common short-term diseases, the one size fits all types of treatments are effective, but for autoimmune diseases, various types of cancer, and a host of other diseases, making the treatment using the patient's own cells is a medical missile that is programmed to seek out and destroy the problem.