Hi everyone! I just found out about this forum for Tovaxin Lab Rats! I have just finished the Phase IIb protocol so will answer what I can about my experience.
First Dose: May 3 2007; 2nd: May 24, 3rd: July 3rd; 4th: Aug 30th and 5th/last dose was on Sept 21st 2007.
Dose: Phase IIb - double blind so placebo or real? Who knows.
I had an acute exacerbation in August with 3-day 1000 mg IV steroid treatment. The exacerbation was verified by MRI and LP.
I did have another infection induced exacerbation in Dec/Jan that went untreated (due to sinus infection) as it would have put me out of the study had I been rx'd steroids. Only one round of IVSM per study. I got through the exacerbation ok.
I tolerated the vaccines fairly well with running a temperature of between 99-100 for about 24 hours after each injection. No injection site reactions. The worst part for me was the blood draws of 15 tubes of blood for the dosing part of the protocol and then 13 tubes for the observation part. I am not a compliant patient. I clot quickly and it usually takes 2 -3 sticks to get that much blood out of me! I look like i've been beat up when they get done with me! Then I get to have an IV inserted for the MRI/GAD! Oh goody!
The one thing that was noticed is that I lost 22 pounds during the study. Fatigue, spasticity, leg pain, and my feet are usually numb most of the time are my major complaints. The fatigue has not let up at all. In fact, I can say it has gotten worse as has the spasticity. My EDSS has remained unchanged at 1.5.
My last appt was last week and I signed the consent for the OLTerms study and will find out in 2 weeks if I am still making those MRTCs for the vaccine in Phase III. If not, I wait 30 days for retesting. Then I go back for the procurement.
It's been a great year in this study. The study people have been wonderful. I have been travelling 450 miles one way to participate in the trial!