Tovaxin Update
 

Interesting day yesterday. I was supposed to get Tovaxin vaccine #4. But as some of you may have read in another thread, I am having one doozy of an exacerbation.

I meet with the neuro Thursday and by definition, I am having a "protocol defined" exacerbation. So he ordered a 3-day round of IVSM but agreed that I could do them at home and not spend the extra few days in Portland. (like he thinks he can make me stay there LMAO! )

Friday morning I get a phone call from the clinic and my Tovaxin vaccine has been cancelled. :eek: Wha???? The nurse said the company didn't want to give it to me while I was having an exacerbation.

I flew home last night instead of later today. I start the 'roids this afternoon and will be done Monday.

I won't know anything until Monday about why they didn't do the vaccine. I wonder if they will reschedule it for another time or slide the whole schedule or what? :confused:


Missy AMN will be happy to know that I got sherped to the gate for my flight and sherped to baggage claim and to my car when I got home. Nice sherpas! :p

Good doggy, here's a cookie. You must admit, it's rather sherpendipitous to save that agonizing waste of energy!

That's sort of odd, FG, it makes me wonder if the vaccine can't mix with the roids, thus the 1-time rule. Hm. And he didn't say why no vaccine? We need to know!!

Flygirl, you know I'm not a lecturer, per se, but with many years of this under my belt, I believe that you would do well to take the rest and pacing more seriously to shorten this thing and to avoid another one. I sure would hate to see you lose your place in the trial! I do realize that this is your busy season, but please do more managing and less labor!

Mary says that the 'roids interfere with a vaccine response for about a week. So, I guess that's the "official" answer from Dr. Mary.

You know, the sherpa sherped me all the way to my car! Cool, huh? I couldn't have walked that far to the gate if I had wanted to....:( :mad:


I'm not going to have any choice in the matter for the next couple of weeks anyway. 'roids knock the wind out of my sails for about 2 weeks. I get the exact opposite reaction as most people. I don't get that burst of energy...I get lethargic and sleep. In fact, I do them at the hospital out patient clinic now b/c my BP stays so low that the home health nurse started panicking.

Sorry that you have to do the roids :( Here's hoping you are feeling better real soon!

Hi Cheryl,

It takes 30 days for the steroids to wash out of your system. Since steroids not only reduce the inflammation, but also suppress the production of white blood cells, your treatment cannot resume until 30 days after your last steroid treatment.

Thanks Tim. I don't know what's going on right now. The trial doc and study nurse are out of town until next week. I don't even know if they know that the vaccine was cancelled yesterday! So I just flew home last night and got started on the IVSM.

I don't know if the vaccine schedule will be rewritten or anything. Guess I will wait til they all get back from wherever they are!

Right now I just need to get over this flare.

Tim, does this mean that a person could continue with the treatment if they just opted out of steroids to treat the relapse?

Cherie

I can answer that. Yes, b/c I did that already.

Hey Cheryl - how are you doing today? Sorry to hear about the set back!

I'm thinking of ya too, FG!!! Sure do hope you feel better like, right now!!!! Sorry you have to do the roids, but we want you better....:sorry:

take care girlie!!!!

Thanks Char and DM! Day two down, one to go. I am so tired. But I can feel parts of my legs today but my feet still hurt. But I guess these 'roids are working since I can feel parts of my legs again. Off to bed for me. ;)

Sleepy nite babes...Hope you feel so much better tomorrow.....or should I say, FEEL MORE tomorrow.:D

Cheryl,

I got your message. I still don't know how to reply to those things.
Total bummer that you are on the steroids. I hope it wont be too horrible for you.

Yep, what Tim said was told to me also. You do have to have a wash out period on the steroids before your next vaccine. My coordinator told me a number of times that I could not get the shots if I was in a significant flare.
I am not sure about it, Tim would know the technical side, but it has something to do with your T-cells changing during a flare? Maybe I dreamed that. :p

A few weeks ago when I was feeling really crappy I called my coordinator and we talked about if I was in a flare. If I had decided to go on the steroids I would have had to wait some extra time for my final shot. I will never go on steroids again anyway so it wasn't an issue for me.

I didn't have a choice. That's how bad I am this time. I haven't been this bad in over 2 years. I could barely walk into his office on Thursday. I hate this. I guess since it's early in the study, I can deal with it.

I think to reply to me, just hit the comment button?

Tim was a help with his answer.

Hope you are feeling better today Cheryl! I feel so bad that you feel so bad...... :Sick:

take care of yourself and REST!!!! :Zzzz:
:hug:

I guess you wouldn't know if you are on Tovaxin or placebo anyway, but do you have a gut feeling on that based on your history and recent experiences?

I have had MS a LONG time, and had a couple of particularly bad paralysis attacks (where I didn't walk for months). My MS Specialists (two different one's) and doctor, do not normally recommended steriods, but I am comfortable with that as I have problems with so many drugs anyway.

Steroids are a quick fix for many people, however, to take or not take them is always a "choice". It seems they work quickly and well for you, which is good.

Cherie

That's true Cherie, I don't know if I am on placebo or Tovaxin. Gut feeling? You know from my past how med sensitive I am and I react to my B-12 shots so I don't really want to give away anything as we've all been asked not to speculate. It's not fair to anyone else in the study. ;)

Steroids are a quck fix and I have gotten to the point in the past year that I am balking at them now b/c I am getting sick on them. But I had no choice, and I mean no choice. The study doc treats when you have an exacerbation, especially one like this one. My EDSS went up 1.5 since May 24. Protocol to follow and all that. I don't want to get kicked out of the study. Non compliant and all that...who me???? Never! Stubborn maybe, but not non-compliant! LOL!

Now I wait to see what the next step it!

Oh, I didn't realize they don't want you speculating. I suppose that is a good thing, for many reasons. :)

I have high hopes for Tovaxin, but I probably wouldn't be able to be in a trial if they made us take steroids during an attack. I sure hope that won't be the case once Tovaxin goes public . . . but I can't imagine it would be!!

I guess they just want you back to status quo ASAP, so you can resume treatment . . . and the sooner, the better!!

Cherie

Hi Cheryl,

I am not sure what the frequency of treatment is in the IIb study. Whatever it is, your next treatment should be scheduled 30 days after the last steroid treatment. Don't schedule it any earlier than 30 days, and a few extra days after 30 won't matter.

Cherie

If the study neurologist believes that you are having an attack, I would take the steroid treatment. We are all aware that this is a double-blind placebo study. There is a 2/3 chance of getting Tovaxin and a 1/3 chance of getting placebo. At the end of 1 year, everyone in the study will be getting Tovaxin.

I am not completely familiar with the current IIb protocol. I think there is something in the protocol that says you cannot have a treatment while you are having an attack, or it might be that you cannot start the study if you are having an attack. That information should be in Cheryl's study documents that she signed before starting the study, and she can comment on that.

Tim you are right. If I am having a protocol defined exacerbation, no Tovaxin treatment, even if I opt out on the steroids. That is what Opexa said on Friday. The study doc treats with steroids in order to get you back to baseline as quickly as possibly and to not further any damage.

I also could not start the trial while I was having an exacerbation last December. They did a complete MRI = brain, c spine, t spine w and w/o gad to make sure and since nothing showed up, I continued with the entry protocol. By the time I did the testing, I was out of the exacerbation.

My next shot was scheduled for Sept 30. But that was #5, but I just missed #4.

I will keep you posted on the new schedule.

Thanks Tim. You've been a help.

There are 5 vaccines. At visits 4, 6, 8 10, and 12 (Sept 20)

So I guess I just screwed up the schedule! Kay just hates that! :eek:

I am back in the study as of Aug 30th. Did the 3-day IVSM, 30 day washout, and I got the "I am ok" sign off from my neuro here and it was faxed to the study doc.

Now we repeat vaccine visit number 4. I have to resign all the consent forms, etc.

Vaccine #4 on Aug 30th, and the schedule resumes from there. I guess I put quite a fly in the ointment so to speak!

But the LP I had definitely confirmed an exacerbation. It's really taken me almost a month to get back to my baseline. This one was bad, at least from my point of view. Still fighting fatigue, but I think that is due more to the hot hot hot weather we've been having and all the smoke in the air here. Idaho has over a million acres of land currently burning - we've had several red alert air quality days. The states smells like one big campfire. It's just been awful and I am trying to work --- :eek:

I will keep you all updated.

I'm going to pull something positive out of this no matter what. Yes it sucks that you had an exacerbation, but I think it's really cool that it took so long. You're normally on a quarterly schedule even on meds and you stretched out this one and got a lot more time b/w exacerbations. Yea Tovaxin. I can tell you are doing better, believe it too!

Greta's right, FG, that was a long stretch compared to before. You can't be on placebo. Now don't go ticking the study doc off again!:mad:

Greta and AMN are right. You guys can stop choking me now! No, they are right, seriously, you are doing much better!

*stomping away pouting & in a snit*

You're no fun!:mad:

Don't pick on Taffy, she's a nice person! She likes chocolate (did I say that???)

You guys are right, I got a whole 6 months, almost 7 since the last flare. I am not complaining. The less steroids I have to do, the better off I am!
;)
And I WILL NOT TICK OFF THE study doc anymore. Repeating that 100 times!

Where's DM to beat that into me??? :p

I'm proud of Ya, Cheryl and did I ever thank you for your pioneering for the rest of us? Well, Thanks!!

Changing subject, but I was just wondering if you talk to Andrea/spooky anymore? I wonder if that Utah mine cave-in is close to her? How is the little scamp...still doing well on Tysabri?

OK, back to our regularly scheduled Tovaxin stuff.:p

Thanks Sally!

To answer your other question, I hadn't heard from her in months, and then out of the blue about 2 weeks ago I got a short message from her and then no reply. So, I know absolutely nothing. The short message was nothing - just -- I found you, how are you doing -- told her I was ok, not lost, and how was she? Nothing further...so dunno...:confused:

Cheryl,

I'm glad you're feeling better and ready to have your next vaccine soon. I hope it will be smooth sailing for the rest of the trial. :)

:hug:

Thanks Wiz! I hope so too. It's been a tough go since mid-June.

How are you doing on Ty?

So far so good! I have my 4th infusion on 8/22. I sometimes think I have improvements, but I can't say for sure. If they are, they're subtle. I still have a lot of fatigue and haven't been able to cut down on any of my other meds. But I haven't added any new ones either so that's a plus. :)

I'll be finished with my BSBA degree requirements end of November so that should help me with fatigue issues. :)

Good deal on finishing your degree in November. I know when I finally finished mine, it was a huge load off and I remember the fatigue lessening a lot. But it's back now with a vengeance - hmmmm, could be my work load/stress level right now. (Taffy, don't even go there!) :p

Stable is better than going downhill! ;)

Huh? What? (Dang!) FG! Knows me all too well! Fine... :mad: I will bite my tongue this time! Ouch!

Just because someone works way to much.....:wink:

I know, I know. but but....you know the drill. If I don't work, I go crazy. And I can't stand being cooped up in this house. So, it's a double edged sword ... but I do have a plan. Which is good. ;) And I am going to need help sticking to the plan.

Oh, ah, a plan! :Scratch-Head: :Ponder: :Poke: What's the plan?

Right now, it's a secret. But as soon as I start implementing it, I will let you in on it. I promise. :hug:

Egads, Cheryl!:eek: I didn't know you were so sick!

Where have you been????? :hug:

It's a long story, but not too entertaining.;)

We like stories!:D