Covid Vaccine Trial

[missyrand]

Since my husband benefitted from participation in a melanoma trial for TIL, and from those who went before him with Keytruda and Optivo, I have sought opportunities to participate in clinical trials.

I been acepted into the Novavax Covid trial described below. I got my first injection yesterday (did not hurt, no redness, no swelling, no side effects). I"ll be in the cohort for 2 years. Second vaccine in 21 days. I have a 2/3 chance of getting the actual vaccine vs placebo (control group). I have a daily log of temperature, general and vaccination site updates to complete on a phone app in addition to in-person visits.

I also have the option to become "unblinded" when my age group/ circumstance allows for me to have access to one of the other ones. This means the study group will let me know whether I received the placebo (then head out to get one of the others available in my state/ area) or theNovaVax (receive a document stating vaccination status and date, which then allows me to travel in Sept to my delayed trip to Hawaii

Apparently 45,000 is the magic participant number to establish a statisticallly relevent cohort group upon which effectiveness for a vaccine is required. This is an international cohort. This vaccine is different from the 2 currently available emergency released Covid ones in the US from Pfizer and Moderna in that this one contains an "immune booster". Theory is that it will allow the proliferation of the cells to move with more intensity, and perhaps with more longevity over time. Also means the immune response could potentially mean more side effect (gosh, now we are totally in our melanoma immunotherapy space!). Data from phase 1 and 2 did not result in more side effects than what you expect from other vaccines (flu, childhood vaccines, pneumonia or shingles). I've never had an unexpected vaccine response, so makes me feel 100% comfortable volunteering. Also, this is not a "live" vaccine, so there is ZERO chance of developing Covid from the vaccine (or the Pfizer,, Moderna, or Johnson and Johnson (not released yet) ones).

I'll post again is anything exciting occurs, and after the second injetion. I expect I'll have to ask to be unblinded this summer because as of now, Hawaii is requiring documentation of status before they'll let me on the islands in September.

NVX-CoV2373

Overview

Subunit vaccine

Dose: 2 injections, 21 days apart

NVX-CoV2373 (Novavax) is engineered using recombinant nanoparticle technology from SARS-CoV-2 genetic sequence to generate an antigen derived from the coronavirus spike protein. This is combined with an adjuvant (Matrix-M). Results of preclinical studies showed that it binds efficiently with human receptors targeted by the virus.

Phase 1/2 trials were initiated in May 2020. Phase 1 data in healthy adults showed that the adjuvanted vaccine induced neutralization titers that exceeded responses in convalescent serum from mostly symptomatic patients with COVID-19. [14]

The phase 3 trial in the United Kingdom has completed enrollment of 15,000 participants, including more than 25% who were older than 65 years. Researchers conducting the US and Mexico phase 3 trial, which started in December 2020, plan to enroll up to 30,000 participants.

Peace,

Missy

[missyrand Ambassador]

Had my second injection for the Novavax trial 2 days ago. I had zero injection site pain, redness, or swelling. No fever, discomfort, nausea. So I may be in the 1/3 placebo group? But you can't tell.My much younger niece had a banging immune response and has had fever, headache, malaise, lack of interest in food, and generally feeling crummy for past 48 hours. Onset was about 11 hours post injection, but study docs said younger folks were having a more likely initial injection response due to their younger age/ immune system kicking in stronger, although this was a small trend group rather than all in that age group

So that's my update! Refraining from any inflammatory diminishing meds (no NSAIDS or cortisone) for several days before and after injection seems newest medical guidance so that when you get one of the Covid vaccines you don't dampen down the immune response/ uptake. Acetomeniphen (Tylenol) only recommended for discomfort.