So, let’s see where we’ve been and where we are going. Please note, I have no idea if I’m getting the Nexvax drug or not. Because it is double-blind, placebo controlled, the people at the testing facility don’t know and I don’t know. A few levels up the chain of the study, they know, but us low level folks don’t.
I am one of the early trial participants. I started in November with the gluten trial, testing, and endoscopy. Through Thanksgiving, Christmas, and early January I went through 6 weeks of up dosing. Up dosing is required because your body can’t take the therapeutic dose of the medicine without significant side effects. The up dosing period allows the body to adjust to the medicine.
In mid-January, I was given 20 auto-injectors to bring home and taught how to inject myself. I’ve been giving myself injections twice weekly for about six weeks. I will take my 12th at home injection at the therapeutic dose on Wednesday in preparation for a food challenge on Thursday.
The past couple of weeks I’ve been great. Home injections have been easy peasy. Injection process takes 32 minutes – 30 minutes of letting the refrigerated injection come to room temperature, 20 seconds for injection procedure, and 1 minute to write down the time, note injection location, and confirm all medicine was injected. No problem.
Now the work begins.
For the next six weeks, every other Thursday I will be in Nashville for the food challenges. I have three food challenges. Each week I will be given either placebo or gluten. One will be guaranteed to be gluten and one will be guaranteed to be placebo. The remaining challenge will be either gluten or placebo. I will not know. Theoretically, I should be able to tell if I’ve been getting medicine or placebo at the end of the food challenges. If I get really, really sick once or twice, I will know and if I don’t get sick, I will know.
So, my first food challenge is Thursday. Luckily, my friends are going with me on this trip. We will drive to Nashville on Wednesday and go out on the town. Then Thursday, my friends will go sightseeing and I will be in the facility participating in the food challenge.
I will be at the facility for 6 hours. They will give me a drink of some sort to drink. Last time, I had to drink the drink in less than 5 minutes. I’m assuming it will be the same. I drink the drink and we wait. We wait to see my reactions. Hopefully, there won’t be any reactions. If there are reactions, Nurse Ratchet will write it down and let the study people know.
During the food challenges there is repeated blood work. They are testing the blood to see how your immune system is reacting to the gluten/placebo invasion. I don’t mind blood draws. I’ve given gallons of blood over the years, so their little needles don’t scare me.
I’ll let you all know how it goes. Wish me luck!!
Finally, I’m feeling lucky and grateful that there is a trial to do and that I can be a part of it. I want a cure for this disease and am willing to put my body on the line to ensure we all have a brighter future. I think this is the cure for Celiac because it gets to the root cause of the problem – the T-Cell response to gluten. I also hope that it will be to market sooner rather than later.
I’m also a bit selfish because I’ve been sick and getting sicker over the seven years since diagnosis. This trial has helped me refocus my diet and really concentrate on my health. I’m healthier now because I’ve been extra careful since the trial started. I’m not sure if its the medicine or cleaning up my diet that has made the difference. Either way, the trial has helped me.