Phase II trials for c diff vaccine

[beth22]

I wondered if any of you that are from the UK (Roy and others) have heard any more regarding the Phase II trials for the C diff vaccine that are being conducted in England. The article said there is more information at the UK Health Protection Agency c. difficile information page - don't know how to access that, but the link to the article is

http://www.newswire.ca/en/releases/arch ... c8937.html

Does anyone know how long a phase II trial lasts?

[Bobbie]

Years ago, Dr. Ciaren Kelly, currently at the Beth Israel Deaconess Medical Group in Boston, MA conducted a trial for a vaccine for C. diff. There were a limited number of participants --maybe 10? (I don't remember.) Two posters from this site particpated. I am not sure what the total result was, but one person had severe side effects I believe the second person had no side effects but am not sure. The first participant tried to sue Dr. Kelly and wanted to use this site to help her do so.

Google Dr. Kelly for more info. He has helped several posters on this site, including Christina, & evidently is an excellent, caring doctor.

Remember, a "trial" is just that -- a trial. Docs. don't know what can happen with established meds./ vaccines. "Buyer beware."

[cindym]

Before entering into a clinical trial for a vaccine I would mandate having the results from the previous trials to review. I know one person that participated and she definitely had horrible problems afterwards to the point that she stopped corresponding altogether and I have not heard from her since. The last I heard she was having massive problems which she was told by a doctor outside of the trial was a direct result of the ingredients of the vaccine. Just proceed with caution- of course if not for clinical trials we would never have new medicines!

[beth22]

I wasn't interested in participating in the trials - they are in England anyway, but my understanding is that if the second phase is successful the drug company will be producing the vaccine to be used in nursing homes, hospitals, etc. That's why I wondered how long the second phase trial might go - it is for 600 people apparently. It would be great if it were soon.

[cindym]

Beth - I hope that is true and it does get approved however usually there are IV trials before approval. I guess the FDA could fast track them if they wanted to..........God only knows we need it!