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  • Terry Clayton

My AZD1222 SARS-CoV-2 Vaccine Trial

Updated: Jan 9

1/8/21

Its the new year of 2022 and I was looking at a Christmas ornament from 2020. Its strange how not much has changed in the last 2 years. Alpha, beta, delta, omicron. Its like Jason in a Friday the 13th movie. It just won't die.....


I have been told the AstraZeneca vaccine may offer protection from beta as well as delta, but probably not omicron. I have read that omicron is the most contagious but the least pathogenic. Here is a Yale summary (subject to change) of the variants. There are now calls for kids to be vaccinated and Israel is now offering a 4th booster.


According to the Coronavirus Aid, Relief, and Economic Security Act, (CARES/ H.R. 748) house bill hospitals receive additional funding when coding patients into the system as covid positive. Around 20%. There are concerns this may be an incentive to an unscrupulous hospital administrators For example.


$3000 for a positive covid case

$30,000 for putting a person with covid on a ventilator


There is a growing resistance regarding vaccine mandates, as well as concerns regarding potential side affects to children. Unkown longer term safety studies related to fertility, myocarditis risk, etc. due to the Emergency Use Authoriation. Some voices have been cancelled in news and social media for promoting "vaccine hesitancy".


This all has me uncomfortable. At this time, I have chosen to continue with my participation in the Astra Zeneca clinical trial but I will pause on going in for boosters. My wife and I have decided our children are healthy and we don't feel comfortable with vaccinating children until the longer studies are completed. After the Emergency Use Authorization ends I would like to see Pharma follow thorough with all the true rigor for FDA approval.


I would recommend those with health issues talk seriously about getting vaccinated as it may be the safest path. But its looking like the vaccines are not as effective as originally reported and the evolving variants may be resistant as well. That's all for now. I hope everyone is healthy as we kick off 2022!


 



12/5/21


FREE AT-HOME COVID 19 KITS


Yesterday, an Amazon shipment arrived with 4 boxes of at-home Covid-19 tests (for a total of 8 tests).

I asked my wife how much these cost and was a bit concerned about how we have been spending money on Christmas so far. I actually didn't believe her when she said they free. It came from Amazon so I kept pushing. I looked at the receipt and sure enough. Free.


Want to see if you can order some? Your can click here. However, if you are located in New Hampshire (03249 zip code) it looks their supply is at least temporarily exhausted.





You may think its some government program spending tax payer dollars....I did. But it in digging into this a little deeper, I found an interesting research project behind it: Say Yes! COVID Test


"....What does Say Yes! COVID Test hope to achieve?

The program hopes to better understand how communities can use at-home tests to reduce viral spread, not just during the COVID-19 pandemic, but also during any future pandemics. To achieve this, NIH-supported researchers at the University of North Carolina at Chapel Hill and Duke University, Durham, North Carolina, will work with the Centers for Disease Control and Prevention (CDC) and the NIH to use publicly available COVID-19 case surveillance data in Say Yes! COVID Test communities. They will study factors like test positivity rate, COVID-19-related illness and hospitalizations, and measurements of viral particles in sewage wastewater. At the same time, publicly available data will be reviewed from other communities of similar size that have not received widespread at-home tests to evaluate the impact of frequent at-home testing....."


Okay, so it is funded by tax payer dollars but it looks pretty interesting.....


11/30/21

Today I received my CDC card. With potential mandatory vaccination being pushed by governments I am glad to see the Center for Disease Control recognizes AZD1222 (now called Vaxzevria) in the US even though AstraZeneca chose to pursue full approval rather than an Emergency Use Authorization.

Although I am confident in the science behind vaccines, I do not support mandatory vaccination, especially vaccines fast tracked via Emergency Use Authorizations. Had I been required to take another vaccination for any reason I would decline on principal and because I want to follow through on my commitment to the clinical trial I volunteered for.

I am glad to see that my vaccine is highly effective against the Delta variant and will continue to watch efficacy against future variants.





 


11/23/21

Last week I had my 1 year blood draw. That means I am 50% done with the safety study. I have not had Covid or so much as a cold in over a year. Pretty crazy but I also have not been traveling nearly as much as I used to. I was informed that there is the possibility of a booster but it is not available yet.

This is becoming a hotter topic as there are a growing number of reported cases of vaccinated individuals contracting the virus. An interesting article was published in Nature, discussing discussing Covid-super immunity. Essentially individuals who have had a real Covid infection have a stronger immune response to vaccination as compared to those who have never been infected. Although this seems obvious on the surface, there is a growing number of people who are concerned "natural immunity" offers better protection against reinfection. A team in Israel has just released a study evaluating SARS-CoV-2-naive individuals with those who received Pfizer vaccine. All of this is very controversial and we will learn more in the months to come.


Although the safety study will continue for another year, Astra Zeneca has published early data and can be found here in the New England Journal of Medicine.


Many companies with more than 100 employees are implementing a vaccination mandate. Currently, the vaccines approved in the US are Moderna, Pfizer, and J&J. I have inquired as to whether I can obtain a CDC card regarding my vaccination. I will update as I learn more.



 


4/8/21

Just got my "papers" so to speak. Not sure where I need to present this but I'll keep it with me.





 

3/31/21

This week I scheduled my NH appointment for vaccination in order to help the drive "herd immunity". With an appointment in hand, I was able have AstraZeneca open my records and disclose if I was in the control group or if I was indeed vaccinated. I had an antibody test run in December and concluded I received the placebo. But I just wanted to confirm. To my surprise, the nurse revealed I was vaccinated in December of 2020! Wait....what?? I called an immunologist questioning how I tested negative for antibodies if I was vaccinated.


 

...the nurse revealed I was vaccinated...


 

I was originally told by a state representative that I should not try to confirm vaccination efficacy by conducting my own antibody test, but they did not explain why...So naturally, that is exactly what I did.... My immunologist explained that many of the antibody tests are designed to look for nucleocapsid antibodies. See below for an illustration. So what, right? Well, these types of antibodies will only be present if I had been truly infected with the virus in the last 3 months. After that antibodies, in general, disappear from your blood and the information to fight the virus is stored in your T cells and memory B cells. The Astrazeneca vaccine, like other vaccines (Pfizer, Moderna and Johnson & Johnson’s Janssen, etc..), was developed against the spike protein, not nucleocapsids. Whoops! I guess I knew enough to be dangerous!



Go figure.. right? Well I'm still confused by the lack of clarity on antibody testing. I also wish there would be a bit more education on the fact that antibodies don't need to be present in the blood in order for the immune system to know how to battle the virus. Anyway, I am excited that I will continue in the clinical trial knowing I have received the real vaccine. Crazy times....



 


3/30/21

Today Astrazeneca published results of its primary analysis of the Phase III trial data evaluating its COVID-19 vaccine, AZD1222. In brief, efficacy is 76% when two doses are administered. Efficacy was 85% in those 65 years of age or older. The vaccine was found to 100% effective in the prevention of severe or critical disease and hospitalization and was found without safety concerns. AstraZeneca has yet to file the regulatory submission for Emergency Use Authorization in the US.




However in Canada, the rollout has been paused with the National Advisory Committee on Immunization citing a blood clot risk in 1 out of every 100,000 people. Dr. Shelley Deeks, vice chair of the National Advisory Committee on Immunization communicated concerns over these potential risks.



 


12/26/20


And so 2020 ends in proper fashion. With one more dollop of disappointment. Not because of Christmas.... And my health is very good. In fact, I'm probably in better shape than I have been in a few years. My disappointment is due to the result of my antibody test:


Since the clinic wouldn't share any info with me, I had my own blood test run. With a negative test result for specific Ig G (Immunoglobulin G) against Covid-19, I have to believe that I was administered the placebo....I did call the clinic to verify. The nurse said they have not been given guidance by the CDC if the antibody test could be used to verify a vaccine was working, however staff working the NH Covid hotline stated the antibody test was a legitimate test. According to Astrazeneca, 91% of those vaccinated #covid19vaccine would have had a strong antibody response 1 month after vaccine injection.


I must admit, I was feeling as though I was not capable of catching the bug, especially as I heard of many in the community and schools getting sick. I guess my confidence was misplaced. I did just receive the second injection and I will of course complete the trial requirements, but with a little less enthusiasm. If I find the test was not accurate or that a spike antibody test is different I will communicate those after my next clinic visit in January.


Merry Christmas and Happy New Year everyone!


 


12/21/20

This morning I received my second shot (booster) of the AZD1222 vaccine. I was hoping they might give me a rapid Covid-19 test or even tell me if I have elevated antibodies. Unfortunately this really is a double blind and the staff simply takes the blood, administers the injections, and sends out the samples. I spoke with a nurse researcher there who said she has not been vaccinated yet, but she felt it will likely be required soon. I asked my network on Facebook if any nurses were required to be vaccinated for Covid-19. I was glad to hear about 10 people across the country say the vaccine was available but not required.


So after I gave blood at the clinical lab in Portsmouth, I drove over to ConvenientMD fin Belmont for testing. The clinics are crazy right now. People are getting tested, before traveling, as a result of 'contact tracing' or even just looking for peace of mind before family get togethers. They were booked solid and said I could only get tested after interviewing with a physician. Across the street was a ClearChoiceMD with 24 people waiting but I could register and get tested with a 2.5 hour wait.



One of my kids was in quarantine because her teacher tested positive. Its been 5 days so we both got tested. We tested Negative. I also asked to had blood drawn for an antibody test (I gotta know.......) As some have been frowning on the antibody test I asked the nurse her thoughts. She said the antibody test is 99%+ accurate, they just don't want people using an antibody test as an excuse for not following social distancing practices. My samples are out for testing and I should receive the results in 2-10 days.


My next lab visit for bloodwork is in January. I am happy to report I feel great and excited our family is heading into Christmas in good health!


 

12/9/20


Antibody tests and a vaccine booster shot in 1 week. My household is currently Covid-free, I am feeling fine and excited for next steps. In parallel, new data continues to emerge reporting that many of the mRNA and vector virus vaccines are showing potent efficacy. Canada has just announced:

We could be just days from the anticipated greenlight from the FDA and markets are treating the producers favorably. If you purchased Moderna stock on November 9th it is now worth double what you paid for it.


I have been asked by a few people on how the SARS-Cov-2 virus potentially can re-infect people and if vaccines may be “ineffective”. Reinfection is not to be confused with secondary infection. I have spent some time studying media accounts of reinfection and what the scientific community has determined about this virus as compared to influenza and other SARS viruses. My conclusion are that it appears this virus is similar to influenza and the SARS outbreak in 2003. Reinfection is rare but a reality. However its more likely in someone with a compromised immune system. In general, those who develop antibodies from natural infection or vaccination will be protected for about a year. I would hope as more data comes available, the majority of us will be protected longer as our B cells "remember" how to fight it. There have been outlier cases, (VERY few) where it appears a person may have been reinfected within a year. Many experts feel its likely that in these cases, its likely an immune response was minor and not enough to develop high level antibody levels.


Regarding masks, I would predict mask-wearing will be advised until the world reaches herd immunity.


To reiterate, the vaccine in the phase III I am enrolled in is for a recombinant vector vaccine. This drug has not received FDA approval yet. In the next 2 weeks its likely FDA will be giving its position on Pfizer and Moderna vaccines. Both are based on messenger RNA.

 

12/1/20

Its been 2 weeks from first injection. I spoke with the lab and reported no side effects or symptoms. I have setup my appointment for second injection (booster) and bloodwork in 2 weeks. They will test for antibodies (as well as SARS-Cov-2). Thirty days after second booster I can get my flu shot.


With respect to Covid-19 in my area, my family is currently clear. Our local school is remote this week with several cases popping up last week. The number for positive infection are rising across NH:


Antibody tests are also trending upward with a bit more noise in the data, but still positive:


In order to reach herd immunity we need to hit 65% immunity via vaccination or natural immunity. I have been reviewing the literature on the success of using attenuated or "weakly" transmissive vaccines. Its been used to control disease in wildlife but not in humans. It could cut the time and resources needed to immunize significantly, ultimately saving lives. At present, some of the relevant vaccines use an adenovirus which have been rendered "replication-incompetent" by gene removal making them non transmissible. There is more on this fascinating potential strategy. What if.....?



 

11/22/20

I was reading the daily update from the State of NH today which can be found here.

Although we all know daily case counts are rising, there is another trend I see which has not been given much press: Antibody test positive rates are increasing.


Many are critical of this data as well as antibody testing, in general. And for good reason! One could assume that if they test positive for Covid-19 antibodies......well then, they have already been exposed and had an immune response. Further, it could build confidence that they are immune and need not wear masks or take other social distancing best practices. It's too early to know for sure if a person's immune response protects them from future infection and even if so, for how long.

Regardless, of these very real concerns, I am excited. No, I am VERY excited by the potential of what the data could mean in terms of moving towards herd immunity by natural infection as well as vaccination. We will have to watch both rates of infection as well as antibody positive trends.

With respect to me, I am at 100% as we head into the holiday week!

 

11/20/20


I feel pretty good today. My shoulder is still a bit sore but that's it. I did go to bed early last night and slept 11 hours (7pm - 6am). On average I shoot for 7-8 hours. I ran 6.5 miles at lunch, no problem.

The interest that has come from me sharing this clinical trial experience has been fun. There are two questions that seem to be popular so I thought I'd include them in my post today:

  1. Are you getting paid?

Yes, I am getting compensation. Here is how it works: The study is two years long and without incentive many participants will drop out as it can become an inconvenience. At the beginning of the study participants are give a debit card with zero value. Each time you show up for an appointment $100.00 dollars will be added to the debit card. So my debit card should ring up $100 for Wednesday's appointment. From schedule I shared yesterday, if you total up all the appointments/blood tests I have over the course of the next 2 years, I could make $700. Is that a motivator for me? Not really. I live in Gilford, NH and the clinic is in Portsmouth. That's 2.5 hours of driving round trip, >100 miles driving. Money is not a driver here. If your going to volunteer, I encourage you to stick with it. The most valuable data is the safety data that can be learned over the next 2 years.

  1. Why are you doing this?

I am really excited. I have never been in a clinical trial and I have never followed a drug/vaccine development effort this closely. I was actually following Pfizer and Moderna more closely than Astrazeneca because their approach is based on the novel mRNA strategy. I think one of the major reasons I sought out to be a part of this is that I am excited about it. Not the virus, but the global effort to beat it. In some very small way, I feel like I am contributing. Imagining that we are weaponizing our body to fight a global virus has a Cyberpunk romanticism to it. Even if my data is just 1/40,000 of the data set. When I heard AstraZeneca was running a clinical trial near me, it wasn't even a question. I understand the science, I believe it will work, and I would happily participate if it could help bring a vaccine forward.

Which brings me the second reason. There are a couple buzz phrases I have heard critics using in the last year: " dangerous shortcuts" and "liability exemption". These two statements taken out of context have eroded public trust. There is more to the story and I encourage anyone concerned to research vaccine liability issues through out history. I also believe we are seeing a "condensed timeline" as opposed to "dangerous shortcuts". I had my own concerns and I tried to find posts, articles, or blogs from those involved in the Pfizer clinical trial.


I could not find anyone who participated in a vaccine trial and shared their experience.......So I will....


I will share the activities involved in the clinical trial. I will share how I feel. If I learn the vaccine is or is not working for me I will post it. If I get sick with Covid-19 I will share it as well as how sick I get.


Its my hope the vaccines work and that by sharing my story, it will help people to make data driven decision rather than decisions based on fear.


Just read the tweet that Pfizer is submitting today an Emergency Use Authorization with the FDA. I was particularly excited to see that 45% of participants were between 56 and 85 years old. I have not reviewed the data but Pfizer has provided more information here.



 



11/19/20


After 24 hours I have only noticed mild pain in my left deltoid and very slight nasal drip. I am trying to pay close attention to any potential side effects without acting like a hypochondriac. Should I develop any serious side effects, I carry a card in my wallet with clinic phone number and patient ID so they can look at my charts and advise. Unless I have concerns or encounter any strange side effects I have no scheduled activities until day 8 which is a simple phone call to see how I'm doing. The interesting work will begin in 4 weeks when my blood is evaluated for immune response and I receive the 2nd (and final booster), provided of course I am not getting placebo. I thought I would post the schedule of activities for those interested:


As I'm writing this update the governor is issuing at statement regarding covid. Looking at heat maps of the globe it appears its more of effort to slow down the virus as opposed to stopping it. Its found its way to every corner of the planet already!


Will post anything interesting but all in well at the moment!


 

11/18/20


At the clinic there were 4 others scheduled in my group. One did not show up and two left as they were not comfortable. The two of us remaining were walked through the details of the clinical trial. After a lot of paperwork I was taken to an examination room. My health history and vitals were taken:


Blood pressure 126/84 (I had not taken my lipitor/losartan yet)

Pulse: 54


After receiving the greenlight from the doctor, I had blood drawn and was given a Covid-19 test via nasal swab.





At 11:20am, I was then given my first vaccination. The syringe was opaque so I could not see the fluid. They outsmarted me.... (I had read that adenovirus excipient is often yellow in color......) This is a double blind study and I have a 2 out of 3 chance of receiving the vaccine versus a placebo. I was monitored for 15 minutes following vaccination and released.


I do not typically get symptoms following a flu shot so its possible I would not feel side effects with the vaccine either. However, general reactions, besides sore arm, include

chills, fever, headache, tiredness, nausea, and body aches. Those who had side-effects stated they were mild, appearing in 24-48 hours and going away within 1-7 days.


As stated previously, the vaccine is based on a weakened version of a common cold (adenovirus) virus that causes infections in chimpanzees. The adenovirus has been modified so it cannot replicate inside a human. However, it will present a part of the Covid-19 virus (Spike glycoprotein) to the body so an immune response can be made to it.


I am scheduled to receive a booster shot in 29 days and have blood drawn for study.


As of 5:02pm, I feel great.....


 

11/17/20

I have been accepted into the clinical trials of a new vaccine for Covid-19. My first appointment is tomorrow November 18, 2020. I will keep a diary here of my experience in the trial and what I learn. The trial I will be a part of focuses on the vaccine candidate developed by AstraZeneca. Unlike mRNA vaccines being developed by Pfizer and Moderna, this vaccine is a non-replicating ChAdOx1 vector. Details on this trial can be found here.





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