Vaccine - ExperimentalTreatment

Guest · Postby **Guest** » Tue May 14, 2002 10:23 am

Dr. Kelly called yesterday, and reported he was able to get the vaccine for me. I will be flying to Boston at night on June 3rd, going to Beth Isreal Teusday morning at 9:00 a.m. to have all testing done, stay over night and return to Beth Isreal on Wed. to have the vaccine. My daughter, who is a nurse,is going with me. I feel somewhat apprehensive but know I must do something soon as I am becoming resistant to the vanco. My dosage has been increased to 500 mg's now. I have also ordered VSL3 off the internet. I asked Dr. Kelly if my taking this would interfere with the vaccine and he said, "No". I think the VSL will arrive this Friday. [Guest Posted by: 'Jennie']

Guest · Postby **Guest** » Tue May 14, 2002 1:42 pm

Bobbie, I haven't seen any postings from Friday but I believe in her last posting she said she would be going near the end of June. Dr. Kelly gave me the choice of going to Boston the week of May 26th or the week of June 3rd. After checking the air fares, I discovered the fares were cheaper the week of the 3rd so chose to go then. Friday hasn't posted recently and I wonder if she might be taking exams or something like that. It would have been nice if I could have gone with someone from this site. As far as I know, Friday and I are the only ones going. Lauren- I am now taking 500 mg's 4xdaily. It has been rare that I have been able to escape the getting up in the middle of the night to take meds. Do you know if there is any literature or postings advising how much VSL3 an adult should take? I asked my G.I. doc but he hadn't heard of VSL3 and said he couldn't really advise me without knowing more about it. [Guest Posted by: 'Jennie C']

Guest · Postby **Guest** » Tue May 14, 2002 7:44 pm

Hi, everyone! Looks like I'll be getting my first vaccine injection July 8th. I'll actually be in Botston July 8-16; Dr. Kelly is going to consolidate the first three visits so that I can make fewer coast to coast trips. Jennie, will you be in town any of those days? [Guest Posted by: 'Friday']

Guest · Postby **Guest** » Tue May 14, 2002 8:18 pm

Hi Friday, Sorry - I won't be in Boston on your dates! Dr. Kelly is consolidating my first two visits which are in June. The third injection is in June also. I, too, am scared to death to fly. My daughter offered to drive( but she flies on the road) so I figured I would be just as safe in the sky. [Guest Posted by: 'Jennie C']

Guest · Postby **Guest** » Tue Jun 04, 2002 3:34 pm

To those knowledgable about the vaccine: Do they believe you should see quick results/improvements? Are they relatively confident that it will work? Have they tried it on anyone else and noted improvements? Aren't vaccines usually given as a preventative measure? Do they think those of us that have c-diff can benefit from it? [Guest Posted by: 'Brett']

Guest · Postby **Guest** » Tue Jun 04, 2002 9:27 pm

Here's everything we know about the vaccine, copied from "Dr. Kelly/Vaccine" under "FAQs" on this board: By Bobbie: The vaccine also sounds promising. I've written Dr. Kelly several times, and he's always responded. Here's an excerpt from his last E-mail. Our most appropriate and recent review article is: Kyne L, Farrell R, Kelly CP. Clostridium difficile. Gastroenterol Clin North Am 2001;30:753-77. This covers diagnosis and treatment including treatment of recurrent C. difficile associated diarrhea. I can provide it in electronic format and am happy for you to post it on your site but you would also need the permission of the publisher. The vaccine is not live but based on inactivated C. difficile toxins (a so called toxoid vaccine similar to that used to protect against tetanus) Ciaran P. Kelly, M.D. Associate Physician Director Gastroenterology Fellowship Training Beth Israel Deaconess Medical Center Dana 601 330 Brookline Avenue Boston, MA 02215 Associate Professor of Medicine Harvard Medical School Office (617) 667 1272 Personal (617) 667 1264 Fax (617) 975 5071 email <a href="mailto:ciaran_kelly@caregroup.harvard.edu">ciaran_kelly@caregroup.harvard.edu</A>">ciaran_kelly@caregroup.harvard.edu">ciaran_kelly@caregroup.harvard.edu</A></a> By Bobbie (Bobbie) on Wednesday, May 01, 2002 - 10:26 pm: Kelly (Kyle'smom) submitted the following information about the vaccine. Thanks Kelly. As to the other question about the vaccine being prophylactic...There's a couple of things worth mentioning here---1) Vaccine are usually administered in a diluent or a solution that also contains chemicals called adjuvants. Adjuvants are highly immunogenic molecules that trigger an immune response; this helps the body recognize the "thing" that a person is getting immunized against as "foreign". (In this case, C diff toxins or inactivated, partial toxins) 2)Because the immunizations are probably given intramuscularly, small amounts of the vaccine can be gradually released from the muscle over time and exposed to immune cells --for ultimate antibody production...Because the injections of toxins are "in the body" (as opposed to "in the GI tract"), the body is more likely to react against what it perceives as a foreign invader. Remember, many physicians actually consider the GI tract as external to the body. And the immune responses made in the GI tract--or external to the body--are different than the immune responses that get mounted when the same "invader" is in the body. Think for example about all the trillions of bacteria that are normally in the intestines that our bodies don't react against & that dont make us sick on a daily basis, but if any of these bacteria entered our bloodstream, not only would we get very sick but our bodies would mount a response against it. Even probiotics are this way--they are safe for consumption when they stay in our GI tracts, but if the same bacteria were in the blood stream, we would be septic...3)The way the immune system works is that the first time we are exposed to a bacteria/virus, our bodies have to first recognize it and then begin making antibodies against it - so we usually get sick. BUT with subsequent exposure to the same "bug" the immune system recognizes it right away and already has "memory cells" that already know how to make specific antibodies - so we don't get sick --it just gets eliminated. Thats why we are immunized as kids. If we were exposed to diptheria, measles, mumps, rubella, etc. after being immunized, we are not likely to get sick because of those "memory cells" that react and make appropriate antibodies right away to eliminate the invader before it gets out of control. For people that have C diff and can't get rid of it, the most obvious reason (and shown in some of Dr. Kelly's published data) is that their guts are not recognizing the toxins as foreign and not mounting a response against them. BUT, the study in Boston is introducing the C diff toxins into the body with adjuvants to aid in the likelihood that they will be recognized as foreign. Now the body has been primed and knows that it is supposed to react, so when it sees the same toxins in the gut, those antibodies are already made and ready to go fight! By Bobbie (Bobbie) on Wednesday, May 01, 2002 - 10:39 pm: Here's the information on Dr. Kelly's vaccine (copied from our hyperlink to Beth Israel Deaconess Med. Center in Boston.) For more information, go into the hyperlink. Dr. Ciarán Kelly's laboratory studies the pathophysiology of gastrointestinal infectious diseases. Dr. Kelly has a longstanding interest in the host immune response to Clostridium difficile, the etiologic agent of antibiotic-associated diarrhea and pseudomembranous colitis. Dr. Kelly's research group has shown that a systemic humoral immune response to C. difficile toxin A is associated with natural protective immunity against C. difficile. This important finding has opened the way to clinical studies to develop passive and active immunization regimens to prevent and treat C. difficile diarrhea and colitis. Dr. Kelly's group has also shown that leukocyte activation by C. difficile toxins is an integral component of the pathophysiology of C. difficile enterocolitis. A recent study shows that the pro-inflammatory effects of C. difficile toxins result from the activation of NF-kß and MAP kinase signaling pathways by a mechanism independent of their previously described rho-glucosylation activity. By Bobbie (Bobbie) on Sunday, May 05, 2002 - 01:19 pm: Dave F. also provided the above information plus the hyperlink: <A HREF="http://www.bidmc.harvard.edu/medicine/researchprograms/gastroenterologyrp" TARGET="_top . htm To use this link, cut and paste it. Thanks Dave F. [Guest Posted by: 'Lauren']

Guest · Postby **Guest** » Wed Jun 05, 2002 1:20 pm

Brett, Several posters from this help site are going to try the vaccine. Friday is one, and I think Jennifer is the other. See what they post about it. I'd contact Dr. Kelly directly for more information.

Guest · Postby **Guest** » Wed Jun 05, 2002 11:37 pm

To Brett: I just returned tonight from Boston after receiving the screening yesterday and the vaccine today. It is now ll:40 p.m. Eastern Daylight Time and have been home about an hour. Most of the information about the vaccine has been posted on this site but if you would like a detailed, personal description of what happens when you get to the Beth Isael Deaconess Hospital, and what the doctors told me, you may contact me by email at this address: <a href="mailto:Jenniec101@cs.com">Jenniec101@cs.com</a> [Guest Posted by: 'Jennie']

Guest · Postby **Guest** » Sun Jun 09, 2002 12:00 am

Due to the volume of emails I have received inquiring about the vaccine, I will try to cover all of your questions in this posting. Thus far, there has been only one subject with recurring cdiff who has completed the clinical trial. He has been vanco-free for about 6+ months. He had had cdiff for about one year. I am the second subject with recurrent cdiff to begin the clinical trials. I have had cdiff for nearly two years. I had my first vaccination on June 5th. One week before beginning the "trial" you must begin a diary which they will supply to you. This diary must be kept during the entire clinical trial. If you are participating in the study, but live outside the state of Mass., they will pay your transportation, cab, hotel (as long as you don't try to live to high on the hog". On the first visit, you will be seen by Dr. Kelly first. He will go over the "Informed Consent " with you sentence by sentence. He will then tell you in his very, very kind voice, (but in no uncertain terms) that there is no guarantee that the vaccine will cure you; that his goal and my goal are different. His goal is to see if the vaccine will build antibodies to the toxins and my goal is to be able to come off of the Vanco.. At this point, Dr. Kelly"s associate takes over. He takes your medical history and more particularl y, your cdiff records. ( I would like to add here, that both Dr. Kelly and Dr. Stavros -don't know his last name- are two of the nicest, most cordial doctors I have ever met. This first visit lasts about 2 hours. On the second visit, more blood is drawn. Then the vaccine is given. There is some pain involved, but for me, it only lasted about 5 or 6 minutes. It varies with each patient. There are four vaccinations given that are spread out over approximately 2l/2 months. During these months you stay on the vancomycin and continue on it for 10 days after last vaccination. Before each vaccination, blood is drawn. There are Interim Medical and Targeted Physicals scheduled also during course of clinical trial. Doctor Stavros will call you the following day after each vaccination to see how you are doing. I will be going to Boston for my second vaccination on Wednesday, 12th., one week from date of first vaccination. You must adhere to a very a strict regimen concerning dates of vaccinations. I believe I have covered all of your questions. If you have anymore, please do not hesitate to ask. I am highly optimistic about this study. It may be a coincidence, but yesterday, for the first time in almost two years, my stools were totally formed and mostly brown. They used to be yellowish-orange-tan. I would recommend this clinical study to anyone who has suffered from recurring cdiff.!!!! [Guest Posted by: 'Jennie']

Guest · Postby **Guest** » Mon Jun 10, 2002 11:20 am

Several posters have asked me when the vaccine will be available to the general public. Dr. Kelly told me it would be at least two or more years. [Guest Posted by: 'Jennie']

Guest · Postby **Guest** » Thu Jun 13, 2002 7:15 am

To Jennie, How are you feeling after the vaccine? Has Friday had it yet? [Guest Posted by: 'Jenny S.']

Guest · Postby **Guest** » Fri Jun 14, 2002 9:08 pm

To Jenny S. The week following the first vaccine, I felt good. I had my second vaccine this past Wednesday and am not feeling well at all. I do not attribute this feeling to having the vaccine as I have had diarrhea and pain in the right side so many times. I feel as if cdiff is trying to come back, but then, it may just be IBS.. I believe Friday goes to Boston on July 8th. Thanks so much for asking. [Guest Posted by: 'Jennie C']

Guest · Postby **Guest** » Fri Jun 21, 2002 2:06 pm

I am excited about your upcoming trip to Boston. I would love to visit there just to see all the historical places. Are your classes over for the summer? Please keep us advised about your progress with the vaccine. Hoping for the best for you. [Guest Posted by: 'Bobbie']

Guest · Postby **Guest** » Sun Oct 27, 2002 7:59 pm

It has nearly been three months since I had my last vaccine but it has not been without consequences. The steroids I am now on wreak havoc on my intestines and I questioned at times whether the c.diff was returning. Dr. Kelley says that it probably won't return unless I have to take an antibiotic. My problem lies within the false negatives I received prior to taking the vaccine: The forms explicitly state that you cannot participate in the vaccine study if you have rheumatoid arthritis or any other auto-immune disease. I had complained of arthritis while I had c diff but the G. I. doctors kept telling me it was "reactive arthritis or coming from malabsorption/leaky gut. My family doctor was not convinced of this and had me take a blood test for rheumatoid arthritis. IT CAME BACK NEGATIVE!. So all systems were go for me to take the vaccine. After I completed the vaccine study, I became ill and had severe arthritis. The doctors assumed it was serum sickness and said it would be a temporary thing. However, as days turned into weeks, I became more severely ill and the pain was keeping me awake all night and I could not stand up straight or barely walk and began having severe headaches and blurry vision. I was then sent to a rheumatologist who told me that a very large percentage of RA blood tests come back with a false negative. Undoubtedly, I had RA when I took the vaccines. She ordered a variety of blood tests and I now have been diagnosed with Polymyalgia Rheumatica with Giant Cell Arteritis. She went on to tell me that this form of RA can cause blindness and that there is no cure for this disease. The only treatment is to take steroids every day for at least two years. Already, I am beginning to have symptoms from taking the steroids. I do not regret having taken the vaccine for it has given me a much needed break from the vanco and frustration of having c diff. As for trading off c diff for another very serious disease only makes me angry in that with all the modern technology, labs still have not come up with a way to differentiate between true and false. Oh, and one more thing, one of my blood tests just came back positive for lupus. But the doctor says it may be a false positive because female hormones can affect this test. I think "false negatives" and "false positives" would make a very good TV game show where the contestant had to guess whether the lab work was true or false. (Probably only we c diff sufferers would know the correct answer!) [Guest Posted by: 'JennieC']

Guest · Postby **Guest** » Sun Oct 27, 2002 11:00 pm

Jennie - my mother has been dealing with polymyalgia rheumatica and the steriods as well. I will post again in a couple of days and tell you about her experience. I'd do this now, but today I pounded my left index finger while working on a playhouse for my son (full force blow with a hammer) and I'm having a very tough time typing. The good thing about polymyalgia is that it generally disappears without a trace after it has run its course. However, its course can be lengthy, as you already know. [Guest Posted by: 'Lauren']

Vaccine - ExperimentalTreatment

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