Notes from my Participation in a Research Study
at the National Institutes of Health (NIH)
STUDY TITLE: A Phase I/II Study of Adjuvant PRGN-2012 in Adult Patient with Recurrent Respiratory Papillomatosis
STUDY SITE: NIH Clinical Center, Bethesda, MD
NIH PRINCIPAL INVESTIGATOR’S: Scott Norberg, DO and Clint Allen, M.D.
My journey with RRP began 30 years and countless surgeries ago. I have been through every adjunct therapy; none ever stopped the disease. Whenever I think about reviewing the RRPF website there is always a battle that goes on inside me. I want to see if there is a new treatment posted – hope! Yet usually there is not, so why bother – despair. Do I look or not? On this day, I looked.
As I reluctantly gazed through the website, I had no idea what was to come. There was a link to an RRPF Facebook page. I was not aware of this page, and I sat there in my chair staring at my computer, wondering if I should click on the link.
I clicked on it, and it took me to the page. Scrolling through, I noticed a posting that identified Dr. Clint Allen, an Otolaryngologist at the NIH that was working on a research study for a new drug to treat RRP. It was late in the evening, and I decided to send him an email outlining my RRP history and asking for some details about the study. He emailed me back very early the next morning, asking if I was available for a phone call. We spoke later that morning and Dr. Allen gave me pertinent information about the study. I answered his questions about my disease process/history and then he invited me to travel to the NIH to go through testing to confirm that I was eligible to participate. It was an exciting phone call!
I took the information and relayed it to my Otolaryngologist, as well as to other doctors that I know. I wanted their opinions about the study and if I should participate. All were supportive of me joining the study. I then spoke with family and friends to get their input. I informed Dr. Allen that I would travel to the NIH and go through the testing necessary to see if I qualify.
A member of the NIH study team contacted me, and I began the process of signing up for the study. Registration and consent forms had to be reviewed and signed, schedules had to be determined and travel had to be planned. The NIH staff was great! They helped with all the details; the registration process was effective and efficient.
We (my spouse and me) arrived at the NIH on Sunday, May 1, 2022. Monday, Tuesday and Wednesday were about having medical tests and meeting with the research team. One of the major purposes of these tests was to determine if I was indeed eligible to participate in the study. On Wednesday, the research team informed us that I qualified! I was then scheduled to have surgery to remove papilloma on Friday morning. After the surgery, I would receive an injection of PRGN-2012 which is the drug on which this study is based.
During the time-period of Monday to Thursday there was some free time. We took advantage of this by taking the Metro into DC and exploring Capitol sites. This was a nice bonus to our trip to the NIH!
On Friday, with the surgery complete and having awoken from the anesthesia, I was taken to the clinic where I would receive the injection. I got the shot in my left arm and had to remain there in that clinic for two hours for observation. All went well – no issues or side-effects at this point. We were told though, by the NIH medical team that side effects from the drug would be likely. They were described to us as flu-like symptoms and would likely happen within a day or two of the shot. We then returned to our hotel for the night.
After our first week at the NIH, we want to communicate how positively impressed we were with the facility, the staff, the care and the service. It was a great experience at a marvelous place! We left the NIH feeling very grateful for the opportunity to be a part of this research study.
The next morning (Saturday), as we headed to the airport to catch our flight back home, I began to experience a headache. I took some Tylenol which kept it in check. Later that evening and back at home, the headache got worse. During the night I experienced a fever (101 degrees F), chills and some body aches. I continued to take Tylenol to help manage these side-effects. At about 3:00 am my fever broke and soon after I fell asleep. The next day (Sunday) these side-effects were gone and all I experienced was some fatigue. By Monday I felt well and normal. We feel that the NIH team described these possible drug side-effects well and that I was prepared for them.
On May 17th I flew back down to the NIH. It was not necessary for my spouse to accompany me, as there was no surgery scheduled. The next day (12 days after the first shot) I had lab work in the early morning and then met with the NIH team for an interview and exam. Soon after, I received the second shot of PRGN-2012 in my left thigh, was monitored for 30 minutes and released. I flew home the afternoon of May 18th. The only side-effects that I experienced after the second shot were minor fatigue and soreness at the injection site.
Regarding monetary costs, the following has been my experience. For our first trip (one week long, starting on a Sunday), the NIH paid for my flight to and from my home airport to Baltimore/Washington International airport. They did not pay for my spouse’s flight. They provided a free shuttle from the airport to our hotel. The first three nights in the hotel were our responsibility. Once I was approved for the study, which for me was on Wednesday of that first week, the NIH reimbursed us $120.00 per night for our hotel room for the remainder of our stay. Meals were on our own. The free shuttle returned us to the airport at the end of the week. If the free shuttle does not correspond with flights, the NIH may order and pay for a taxi. Transportation from the hotel to the NIH is via a free hotel shuttle. You can also take the DC Metro at your own cost. For early morning appointments, the NIH may order and pay for a taxi from your hotel.
On my second trip (two days in duration), the cost of my flights and hotel were fully covered by the NIH. My spouse did not accompany me on this trip as there was no surgery involved, so we incurred no costs there. Again, food was on my own. Ground Transportation costs were as described in the previous paragraph.
We are very grateful that the majority of costs associated with participating in this research study are covered by the NIH!
My next trip to the NIH is June 15th, where I will receive my 3rd shot. I will write more after that trip.