Craig’s Final NIH Trial Update

September 13, 2022, Blog Entry – fifth PRGN-2012 research study visit to the NIH.
On September 6, 2022, I travelled to the NIH/Bethesda, MD. This was my fifth of seven visits for this research study. This visit was different in that I would not be receiving a dose of the PRGN-2012 vaccine. I had received my fourth and final dose of the vaccine at my last (fourth) visit to the NIH, which was six weeks ago. This visit was strictly for follow-up and to have the apheresis procedure (voluntary, to be described later). My spouse did not travel with me on this trip as I was not going to have surgery, no matter the outcome. At this point in the research study, if surgery was needed, I would go back to my home Otolaryngologist for the surgery. To save some travel money expenses, we made the decision for my spouse to stay at home for this visit. I checked-in to the Residence Inn in Bethesda and once again had a nice evening of dinner and walking around downtown Bethesda.
On September 7, 2022, I caught the DC Metro subway (Bethesda Station) and arrived for my first scheduled appointment at the NIH at 10:45 am. After a verbal Covid screening at the entrance, I proceeded to Phlebotomy where 12 vials of blood were drawn from my left arm. My next appointment, at 11:45 was with my research team. This meeting consisted of a verbal interview to see how I was doing and then a scope to see what was going on in my larynx. The scope revealed that there was no discernable papilloma in my larynx! This was welcome and wonderful news. I then completed the written voice quality survey. This is a survey given at each visit to assess the quality of my speaking voice.
The next appointment, scheduled at 1:00 pm was for the apheresis procedure. Apheresis is defined as – the removal of blood plasma from the body by the withdrawal of blood, its separation into plasma and cells, and the reintroduction of the cells, used especially to remove antibodies in treating autoimmune diseases. This was requested by the research steam as this test provides valuable information for the ongoing study of RRP. The test is voluntary. Realizing how valuable the results would be, I consented to the test. I laid down in a hospital bed, had one IV inserted into my left arm and a second IV inserted into my right arm. Blood flowed out of my left arm and into a centrifuge where it was processed and analyzed. Most of the blood then flowed from the centrifuge back into me through the IV in my right arm. I had to keep my left arm very still and squeeze a ball with my left hand to keep the blood flowing. This entire procedure took about 2 hours. About 1/3 of a pint of blood was permanently removed from my body and I did not experience any side-effects from this test. I was instructed by the apheresis team to rest for the remainder of the day, eat well and drink plenty of fluids (no alcohol or caffeine).
I will return to the NIH on October 19, 2022 (six weeks after my last visit) for another exam and follow-up. There will be no apheresis at this visit, as that was a one-time test. After that, there will be a final exam and follow-up in 12 weeks.
I want to communicate how we continue to be positively impressed with the facility, the staff, the care and the service that we receive at the NIH. It continues to be a great experience at a marvelous place! Each time, I leave the NIH feeling very grateful for the opportunity to be a part of this research study.
Regarding monetary costs for this fourth trip to the NIH, the following was our experience. The NIH paid for my flight to and from my home airport to Reagan/National airport in DC. They offered a free taxi from the airport to my hotel; however, I took the metro (subway). The two nights in the hotel were covered by the NIH. Meals were on my own. Transportation from the hotel to the NIH is via a hotel shuttle or a taxi – both paid for by the NIH. You can also take the DC Metro at your own cost. A taxi returned me to the airport at the end of the stay with no charge to me.
I am very grateful that most costs associated with participating in this research study are covered by the NIH!
I would like to let the RRP community know that this research team is actively seeking additional candidates for this PRGN-2012 vaccine trial. If it seems right for you, I highly recommend it. Contact Dr. Clint Allen at clint.allen@nih.gov and/or Dr. Scott Norberg at scott.norberg@nih.gov