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Crohn's Disease Forum » Treatment » SSI Vaccine Trial


 
05-20-2016, 12:27 PM   #511
Scared1
Senior Member
 
Join Date: Apr 2016
Oh boy. Not good news...

Crashed and burned about 8 weeks after the end of the trial. Actually pretty spectacularly. No more job, back on Pred and just waiting for the Humira

Sorry, guys.

If you're reading this and about to start or considering starting the SSI, it did some good stuff for me. It sucks it couldn't keep me where I was once I stopped taking it but this is where I was before so it's not that it made me worse.

I'll try and be around more. Been a rough go the last few weeks.
Hi Trevor, I hope all has been well with you! I am sorry to hear what had happened. Did the onset happen gradually or right away and were you on anything for those 8 weeks?
05-25-2016, 10:54 AM   #512
Wendy M
 
Join Date: May 2013
Location: Langley, British Columbia

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Hi all. Haven't checked in recently as everything is still the same. Interesting change in the protocol, again. I am seeing the nurse today for my week 36 check in. When she called she said that they have changed the protocol back to the way it was. Therefore I will be going back to injections every other day rather than once a week.
05-25-2016, 10:57 AM   #513
Scared1
Senior Member
 
Join Date: Apr 2016
Hi all. Haven't checked in recently as everything is still the same. Interesting change in the protocol, again. I am seeing the nurse today for my week 36 check in. When she called she said that they have changed the protocol back to the way it was. Therefore I will be going back to injections every other day rather than once a week.
Hi Wendy,
Thanks for the reply! You are on this trial? Are you doing good on it at all?
05-25-2016, 01:22 PM   #514
David
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Join Date: Feb 2006
Location: Naples, Florida
Hi all. Haven't checked in recently as everything is still the same. Interesting change in the protocol, again. I am seeing the nurse today for my week 36 check in. When she called she said that they have changed the protocol back to the way it was. Therefore I will be going back to injections every other day rather than once a week.
Interesting that they're changing back. Did they say why?

Thanks for the update!
05-25-2016, 01:47 PM   #515
Wendy M
 
Join Date: May 2013
Location: Langley, British Columbia

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Scared1
Yes I have been on the trial since September 15. I have had good success in that my last scopes show no sign of disease. However I am still having some symptoms.
David
They haven't told me why but I will ask my nurse later today at my appointment.
05-25-2016, 02:03 PM   #516
Scared1
Senior Member
 
Join Date: Apr 2016
Scared1
Yes I have been on the trial since September 15. I have had good success in that my last scopes show no sign of disease. However I am still having some symptoms.
David
They haven't told me why but I will ask my nurse later today at my appointment.
Thank you Wendy - please keep us posted, I would love to hear more. This trial is under Bacterial Vaccines and I think the whole opportunistic infection type of premise for Crohn's would be validated even more based on the success of this trial amongst others (i.e. MAP stuff going on).

That's weird that you are having symptoms - did they do any biopsies at your last scope?

Thanks again for the info!
05-25-2016, 02:06 PM   #517
David
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Join Date: Feb 2006
Location: Naples, Florida
Thank you Wendy.

What are your current symptoms?
06-02-2016, 09:46 AM   #518
SauceySciencey
 
Join Date: Nov 2015
Location: New South Wales, Australia

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Thanks Wendy, we need more people like you stepping up for these tests to get through the murkiness! I hope things work out (for us all!)
06-02-2016, 07:43 PM   #519
Scared1
Senior Member
 
Join Date: Apr 2016
There is a clinical trial currently going on which seems to be looking at the use of antibiotics to treat AEIC? Not sure if this would tie in with the vaccine but the estimated completion date is 2020? This seems to be the AMAT version for AEIC....

https://clinicaltrials.gov/ct2/show/...cr=Open&rank=1
06-03-2016, 07:17 PM   #520
SauceySciencey
 
Join Date: Nov 2015
Location: New South Wales, Australia

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I wish they'd hurry up - I went into one of my mini flares at work last night - and I was supervisor with 5 new people, so they were a bit uncomfortable with me walking around their desks checking their work holding an ice pack to my stomach to offset the swelling and since I was supervisor I couldn't go home sick since I was the senior in the entire building and everyone would have to go home haha. Better this morning though. No eating for a day or two. But yeah, they need to hurry up.
06-04-2016, 11:11 AM   #521
Scared1
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Join Date: Apr 2016
I wish they'd hurry up - I went into one of my mini flares at work last night - and I was supervisor with 5 new people, so they were a bit uncomfortable with me walking around their desks checking their work holding an ice pack to my stomach to offset the swelling and since I was supervisor I couldn't go home sick since I was the senior in the entire building and everyone would have to go home haha. Better this morning though. No eating for a day or two. But yeah, they need to hurry up.
I am sorry Saucey, that really sucks. How long have you had Crohn's and what med's are you on? I can't imagine how horrible that must be - just doing your daily tasks and that in of itself is a struggle..:-( This year I think - honestly based on the timelines, we will get good information - either pro MAP (via Redhill studies should be presented end of the year at least interim) or show they failed (at least we will know) and the SSI is supposed to have something presented. I check these everyday - while my husband is asymptomatic. it breaks my heart reading all these struggles everyday:-(
06-04-2016, 11:23 AM   #522
SauceySciencey
 
Join Date: Nov 2015
Location: New South Wales, Australia

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I am sorry Saucey, that really sucks. How long have you had Crohn's and what med's are you on? I can't imagine how horrible that must be - just doing your daily tasks and that in of itself is a struggle..:-( This year I think - honestly based on the timelines, we will get good information - either pro MAP (via Redhill studies should be presented end of the year at least interim) or show they failed (at least we will know) and the SSI is supposed to have something presented. I check these everyday - while my husband is asymptomatic. it breaks my heart reading all these struggles everyday:-(
Thanks, it's all good. The boss is very accepting of it - she knows sometimes I need to disappear and go into the shower (for some reason, cold showers have a nastily positive painkilling effect on me). Well, they could show that MAP has nothing to do with crohn's, but it could still turn out that the redhill clinical trial has positive results treatment wise. I'm leaning towards it being better than placebo - either way, it's another bullet in the arsenal for people

Currently 6 mg budesonide (roughly, it wavers), 100 mg azathioprine. And humira once fortnightly for the ankylosing spondylitis, which it does wonders for. I'm hoping a magic bullet comes along soon, I spent 8 years training to be a medical researcher, I'm supposed to be in a lab curing cancer, according to my mother :P

Hopefully your hubby can stay symptom free a little while longer
06-04-2016, 02:19 PM   #523
Scared1
Senior Member
 
Join Date: Apr 2016
Thanks, it's all good. The boss is very accepting of it - she knows sometimes I need to disappear and go into the shower (for some reason, cold showers have a nastily positive painkilling effect on me). Well, they could show that MAP has nothing to do with crohn's, but it could still turn out that the redhill clinical trial has positive results treatment wise. I'm leaning towards it being better than placebo - either way, it's another bullet in the arsenal for people

Currently 6 mg budesonide (roughly, it wavers), 100 mg azathioprine. And humira once fortnightly for the ankylosing spondylitis, which it does wonders for. I'm hoping a magic bullet comes along soon, I spent 8 years training to be a medical researcher, I'm supposed to be in a lab curing cancer, according to my mother :P

Hopefully your hubby can stay symptom free a little while longer

I really think we are close to a bullet of some sort, I honestly think the biggest hurdle to a cure or anything else is the Crohn's is an autoimmune mindset only. Being someone who I self diagnosed as OCD -and currently since my husband as been diagnosed (who has been asymptomatic always, as of last year before medicine - the basis of his diagnosis is the inflammation but that is another story), I have read soooo many articles, scientific journals and videos discussing the topic and then I read something about it being autoimmune and it annoys me because there is a clear difference between Crohn's and all these other autoimmune diseases, yet people disregard that for some reason. But honestly, I think within the next few years, something big will happen for sure - all thanks to researchers and people who are willing to think outside the box or popular conventions of that time....I hope in the meantime you feel much much better:-) Hang in there!
06-10-2016, 01:41 AM   #524
Wendy M
 
Join Date: May 2013
Location: Langley, British Columbia

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So the SSI nurse says that the reason we get to go back to the original dosing is because patients were relapsing from remission when they were taken from every other day injections to once a week.
My symptoms are:
(Worst)is incomplete evacuation, which effects frequency. And makes for a lot of time spent in the bathroom.
frequency (2-4 times per day.) I know that's not bad for colitis but still not great. Unknown when etc so can't plan things without concern.
Still occasional diarrhea.
So similar symptoms as prior to Ssi. Very frustrating as I always seem to only get to a certain point and then no more improvement.
As I have said before the closest to remission I have come was on low dose naltrexone . I am still taking it but it definitely isn't working like it did for a while.
I had always stayed away from the Biologics but had decided to try entevyo if the ssi didn't work. But the doctor said because my last scope didn't show any signs of disease there was no point in trying it. So I'm not sure what to do now.
They did take biopsies on the scope but I haven't heard anything back.
I am scheduled for a colonoscopy in October.
06-10-2016, 10:41 AM   #525
Scared1
Senior Member
 
Join Date: Apr 2016
Thanks Wendy for the update! I am so sorry you are still having symptoms:-(....Could food or some other reasons perhaps be causing this? That is so strange you have symptoms but no apparent active disease....do you think that the dosage - every day or every other day would affect how the long term impact is after the person stops SSI? Maybe your body just needs extra long to clear out the "infection" or pump your immune system so that it can handle it itself later on?

Sorry for the pain, please keep us posted...I hope it gets better for you soon!
06-10-2016, 02:29 PM   #526
tongtol
 
Join Date: Oct 2015
Location: Ontario
I guess I'll give an update as well.

- Before starting SSI I was going between 15-18 times a day, with blood in my stool probably once a day and lots of painful rectal cramping. not the worst flare i've had, but the longest i've had.

- A month after starting I started to get better. after a month I was down to between 2-5 bowel movements a day that were much more solid than i've had in a long time. much less pain.

- A month after that I was reversing course back to around 10 urgent bowel movements a day. Shortly after I was randomized off of the alt day dose to once a week. Within a month and a half I relapsed and was hitting randomly between 12-18 BMs a day with blood here and there, lots of cramping, and mucus.

Having gone back to alt day dosing seems to have helped some what but its been a rocky road again and I've been told UC seems to be a rockier road than crohns with a lot of back and forth slow improvement. Unlike Wendy I never got rid of my inflammation though. Scopes showed less inflammation than when i started, but nonetheless it was a minor improvement. unfortunately that scope was also timed at a point where i had regressed so its hard to say what i looked like at the peak of my improvement.

In the last month I had gone down to about 5-8 BMs that were starting to look a bit more solid, but then it climbed back up to the 10 more urgent and mucus filled BMs with lots of cramping and gas and what not. One problem is that the SSI induces a type of inflammation to kill off any infection, so as a patient its really hard to know if this inflammatory response is my disease or the ssi doing its job. having lost several months to being on once a week was also a huge set back for me. it's hard to say whether or not that time off means i've essentially started from square one with the treatment again, and now with much less time than I initially thought I would have.
06-10-2016, 03:25 PM   #527
Scared1
Senior Member
 
Join Date: Apr 2016
I guess I'll give an update as well.

- Before starting SSI I was going between 15-18 times a day, with blood in my stool probably once a day and lots of painful rectal cramping. not the worst flare i've had, but the longest i've had.

- A month after starting I started to get better. after a month I was down to between 2-5 bowel movements a day that were much more solid than i've had in a long time. much less pain.

- A month after that I was reversing course back to around 10 urgent bowel movements a day. Shortly after I was randomized off of the alt day dose to once a week. Within a month and a half I relapsed and was hitting randomly between 12-18 BMs a day with blood here and there, lots of cramping, and mucus.

Having gone back to alt day dosing seems to have helped some what but its been a rocky road again and I've been told UC seems to be a rockier road than crohns with a lot of back and forth slow improvement. Unlike Wendy I never got rid of my inflammation though. Scopes showed less inflammation than when i started, but nonetheless it was a minor improvement. unfortunately that scope was also timed at a point where i had regressed so its hard to say what i looked like at the peak of my improvement.

In the last month I had gone down to about 5-8 BMs that were starting to look a bit more solid, but then it climbed back up to the 10 more urgent and mucus filled BMs with lots of cramping and gas and what not. One problem is that the SSI induces a type of inflammation to kill off any infection, so as a patient its really hard to know if this inflammatory response is my disease or the ssi doing its job. having lost several months to being on once a week was also a huge set back for me. it's hard to say whether or not that time off means i've essentially started from square one with the treatment again, and now with much less time than I initially thought I would have.
Thank you for the update! This is very informative and very appreciated...do you feel there is a interim period where the vaccine is helping your body have a "normal" reaction meaning the inflammatory is killing off the bad bacteria if you will and so that is what you are experiencing? And in your opinion, do you think that the length of time you have had UC may also be a factor? Maybe longer = more time to adjust and work?
06-10-2016, 05:41 PM   #528
tongtol
 
Join Date: Oct 2015
Location: Ontario
It's possible that the number of years I've had UC might be a factor. I had UC for 9 years and while it started as pan-colitis, most of my flares are located primarily in the rectum and sigmoid colon gradually tapering off in intensity.

As far as what I think is going on? its really hard to say, I'm not a doctor or researcher. I like to think that the amount of mucus I see is directly related to my body having an inflammatory response that is doing some good, but since we're in effect pioneers of this study there's nothing to compare to.

My guess is that the SSI triggers my body to look for something to kill, and when it finds it, I go into an inflammatory phase. When it finishes killing off that patch of infection, it goes back into a lull. The continued usage of SSI means my body continues to hunt for something, and when it finds another patch of infection it goes back into attack mode.

That's just a wild guess though. I have nothing to base that on really.
06-10-2016, 05:43 PM   #529
Scared1
Senior Member
 
Join Date: Apr 2016
It's possible that the number of years I've had UC might be a factor. I had UC for 9 years and while it started as pan-colitis, most of my flares are located primarily in the rectum and sigmoid colon gradually tapering off in intensity.

As far as what I think is going on? its really hard to say, I'm not a doctor or researcher. I like to think that the amount of mucus I see is directly related to my body having an inflammatory response that is doing some good, but since we're in effect pioneers of this study there's nothing to compare to.

My guess is that the SSI triggers my body to look for something to kill, and when it finds it, I go into an inflammatory phase. When it finishes killing off that patch of infection, it goes back into a lull. The continued usage of SSI means the body continues to hunt for something, and when it finds it again it goes back into attack mode.

That's just a wild guess though. I have nothing to base that on really.
Thank you though - I am really interested in this trial and I really appreciate your first-hand experience. Please keep us posted, and I hope that your symptoms will subside....:-(
06-10-2016, 05:46 PM   #530
tongtol
 
Join Date: Oct 2015
Location: Ontario
Thanks. It's been a 4 year run of constant flares for me, so I'm definitely ready to get my life back and maybe see some more sunshine!

Edit: What's most frustrating about this is that my Colitis never gets beyond "moderate", so it always seems treatable yet its bad enough that the urgency prevents me from going anywhere or concentrating on much of anything. Sadly one day ASAs stopped working, drugs like 6mp had no effect, and anti TNF drugs didnt do a thing for me either, so outside of entyvio, i'm not seeing a lot of options from a pharma perspective.
06-10-2016, 05:50 PM   #531
Scared1
Senior Member
 
Join Date: Apr 2016
Thanks. It's been a 4 year run of constant flares for me, so I'm definitely ready to get my life back and maybe see some more sunshine!

Edit: What's most frustrating about this is that my Colitis never gets beyond moderate, so it always seems treatable, but unfortunately one day ASAs stopped working, drugs like 6mp had no effect, and anti TNF drugs didnt do a thing for me either.
That's the thing with this disease - I just don't believe it can be ONE underlying cause, waaay to much variability and too much differing patient reactions and successes with the drugs that are available. I mean, for diabetes I - you take insulin it works consistently, etc...yet for Crohn's or UC - just so frustrating and different. Have you tried diet changes maybe? 4 years of consistent flares, my heart hurts for you - that is horrible but it seems like you are pushing through - that will make your day in the sunshine when it arrives that much better:-)
06-10-2016, 10:18 PM   #532
tongtol
 
Join Date: Oct 2015
Location: Ontario
My GI told me that Crohn's and Colitis are more likely a spectrum of something like a 100 smaller diseases, with each person having a handful of those, which would explain the variability in effectiveness of treatment.
06-25-2016, 08:48 PM   #533
Scared1
Senior Member
 
Join Date: Apr 2016
So the SSI nurse says that the reason we get to go back to the original dosing is because patients were relapsing from remission when they were taken from every other day injections to once a week.
My symptoms are:
(Worst)is incomplete evacuation, which effects frequency. And makes for a lot of time spent in the bathroom.
frequency (2-4 times per day.) I know that's not bad for colitis but still not great. Unknown when etc so can't plan things without concern.
Still occasional diarrhea.
So similar symptoms as prior to Ssi. Very frustrating as I always seem to only get to a certain point and then no more improvement.
As I have said before the closest to remission I have come was on low dose naltrexone . I am still taking it but it definitely isn't working like it did for a while.
I had always stayed away from the Biologics but had decided to try entevyo if the ssi didn't work. But the doctor said because my last scope didn't show any signs of disease there was no point in trying it. So I'm not sure what to do now.
They did take biopsies on the scope but I haven't heard anything back.
I am scheduled for a colonoscopy in October.
Hi Wendy,
How are you doing? Any updates on your status?
01-13-2017, 10:12 PM   #534
Lady Organic
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So I have read on Qu Biologics website that Phase 1 for UC is closed for recruitment and that a Phase 2 will start...
Anyone with any other updates or any news from people on this trial???
__________________
''UC-like Crohn's'' since 2001:
on: 25mg 6-MP (purinethol)+ B12 shots
minor hands/wrists chronic arthritis since 01/2013

Diet: ''IBD-AID'' : http://www.nutritionj.com/content/13/1/5+ organic food only
suppl Curcuminoid extract, Inulin,psyllium, apple pectin, Vitamin D

past meds:
pred 50mg, 5-ASA, cortifoam, Imuran (failed) Purinethol (success) methotrexate (failed CD and arthritis).
01-14-2017, 03:25 AM   #535
tongtol
 
Join Date: Oct 2015
Location: Ontario
I'll give my take on the trial. I think the treatment helped, but unfortunately due to the design of the study, I ended up being taken off the effective dose for several months and regressed close to pre-trial conditions. I was put back on the original dose because of this but had a much smaller window of opportunity to recover fully. That being said, I went from 18 bowel movements + cramping and blood per day to about 2-4 now, with the occasional 5. I'm definitely not in remission, but theres no blood, and the pain is basically not there anymore. just mild discomfort during the first few hours of the day typically.

So, I think there's promise, though it sounds like the treatment probably works better for crohn's than colitis considering how much faster the drug becomes effective for people. Also I think the reason for the trial closing and coming back with a phase 2 is to redesign a much more rigorous trial. I think perhaps its the kind of thing that might also be combined with another treatment, like say FMT, for a more guaranteed result, and perhaps a faster result.

Anyway, it was a long and rough journey. I went through repeated weeks long cycles of 2 steps forward, 1 step back, which got pretty discouraging since it makes positive progress seem so much less significant. It's hard to see the forest for the trees when you're parked on the porcelain throne for a year, but at least I no longer have to go to the washroom 18 times a day!
01-14-2017, 10:15 AM   #536
Lady Organic
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Thanks for sharing Tongtol. I am sorry you didnt get the full package treatment, seems like it helped in part though. 2/2 UC acheived continuing remission under SSI compassionate initial trial, so I am hoping it can work as much for CD and UC.
01-14-2017, 06:45 PM   #537
Scared1
Senior Member
 
Join Date: Apr 2016
I'll give my take on the trial. I think the treatment helped, but unfortunately due to the design of the study, I ended up being taken off the effective dose for several months and regressed close to pre-trial conditions. I was put back on the original dose because of this but had a much smaller window of opportunity to recover fully. That being said, I went from 18 bowel movements + cramping and blood per day to about 2-4 now, with the occasional 5. I'm definitely not in remission, but theres no blood, and the pain is basically not there anymore. just mild discomfort during the first few hours of the day typically.

So, I think there's promise, though it sounds like the treatment probably works better for crohn's than colitis considering how much faster the drug becomes effective for people. Also I think the reason for the trial closing and coming back with a phase 2 is to redesign a much more rigorous trial. I think perhaps its the kind of thing that might also be combined with another treatment, like say FMT, for a more guaranteed result, and perhaps a faster result.

Anyway, it was a long and rough journey. I went through repeated weeks long cycles of 2 steps forward, 1 step back, which got pretty discouraging since it makes positive progress seem so much less significant. It's hard to see the forest for the trees when you're parked on the porcelain throne for a year, but at least I no longer have to go to the washroom 18 times a day!
Thank you for sharing, I really appreciate getting any information about this treatment - I am eagerly waiting for it for my husband to give it a try, hopefully within the next 5 years it will have passed all the phases.

If you don't mind me asking - are you still at 5 times a day even after you are done with the treatment? Are you taking any other medication?
01-15-2017, 03:12 AM   #538
tongtol
 
Join Date: Oct 2015
Location: Ontario
I started entyvio about two months ago, about a month and a half after I stopped the trial. I feel roughly the same since I stopped the trial, and considering entyvio takes a minimum of 4 months to kick in for most people I'd say the trial must have had a lasting effect on me. Usually by this point I'm starting to flare pretty significantly. It's possible the entyvio is already doing something but it's quite rare for it to kick in so quickly (sometimes it takes up to 9 months for people), and like I said, it's not like I feel any different from when I exited the trial.

Hopefully the next trial gives them enough useful data that it can be the last trial, assuming its very effective at the dose and duration they administer it for. But yeah its probably at least 5 years away from coming to market, so I hope your husband is able to find something that works for him in the mean time!
02-07-2017, 04:15 PM   #539
Lady Organic
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Article on two Crohn's patients who received the compassionate SSI trial:
http://www.ourperth.ca/community-sto...linical-trial/
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