HER2 Support Group Forums - View Single Post - Encouragement needed to decide whether to join a vaccine trial

Debbie L. · 01-11-2011, 11:26 AM

Hi Marcia,

I think that only you can make this decision. It sounds like you have not yet done the full consenting process? They will go over possible side effects in detail (perhaps more detail than you care to know, smile). This is a small phase I study -- the earliest kind of study, where the least is known both about efficacy and safety. I'm curious why you chose this study over others -- can you tell us about that?

I think that so far, there have been no concerning issues with the vaccine trial side effects. There are some theoretical concerns, and lack of longterm safety data which is of course the case with almost all clinical trials. I have not heard any concerns about cancer vaccines increasing cancer growth, as you mention. Regarding effects on the cancer, the issue so far has been the lack of clinical success from all these trials -- so it's a lot of time and effort on everyone's part (including patients), with a return of more information but not the clinical benefit we'd hope for. But maybe now is the time to be doing this -- maybe the vaccine tide is ready to turn (I sure hope so). There have been several small cancer vaccine studies reporting positive results recently. I keep meaning to go back and find the poster I saw at SABCS that had a positive report. But no time today.

Keep us posted. I hope others who know more will chime in here. And I'll throw out a concern, not about vaccine trials but about trials in general: what do you all think about the fact that access to trials, and to expanded access (such as TDM-1) is limited by a person's ability to afford the travel and other expenses? Unless of course you happen to live in a city and that city happens to be a trial location. I can see for a wee trial (20 people) like Marcia is considering, that it's impractical to expect it to be available more broadly. But for the larger ones, with locations all over the country yet still not not available locally for most -- I see a big access disparity issue here and have not heard much talk about it. Your thoughts? We can take it to its own thread if anyone want to talk about this.

Debbie Laxague

01-11-2011, 11:26 AM	#3
Debbie L. Senior Member Join Date: Jul 2006 Posts: 463	Re: Encouragement needed to decide whether to join a vaccine trial Hi Marcia, I think that only you can make this decision. It sounds like you have not yet done the full consenting process? They will go over possible side effects in detail (perhaps more detail than you care to know, smile). This is a small phase I study -- the earliest kind of study, where the least is known both about efficacy and safety. I'm curious why you chose this study over others -- can you tell us about that? I think that so far, there have been no concerning issues with the vaccine trial side effects. There are some theoretical concerns, and lack of longterm safety data which is of course the case with almost all clinical trials. I have not heard any concerns about cancer vaccines increasing cancer growth, as you mention. Regarding effects on the cancer, the issue so far has been the lack of clinical success from all these trials -- so it's a lot of time and effort on everyone's part (including patients), with a return of more information but not the clinical benefit we'd hope for. But maybe now is the time to be doing this -- maybe the vaccine tide is ready to turn (I sure hope so). There have been several small cancer vaccine studies reporting positive results recently. I keep meaning to go back and find the poster I saw at SABCS that had a positive report. But no time today. Keep us posted. I hope others who know more will chime in here. And I'll throw out a concern, not about vaccine trials but about trials in general: what do you all think about the fact that access to trials, and to expanded access (such as TDM-1) is limited by a person's ability to afford the travel and other expenses? Unless of course you happen to live in a city and that city happens to be a trial location. I can see for a wee trial (20 people) like Marcia is considering, that it's impractical to expect it to be available more broadly. But for the larger ones, with locations all over the country yet still not not available locally for most -- I see a big access disparity issue here and have not heard much talk about it. Your thoughts? We can take it to its own thread if anyone want to talk about this. Debbie Laxague