Vaccine Trials

[kyzymurgist]

I'm currently sitting in exam room #1 waiting the requisite 30 minutes after receiving my first Covid-19 vaccine injection. Of course I could be in the control group and received a saline injection. But the odds favor the real thing.

DW and I volunteered and are participating in the Novavax phase 2 trial. There are 5 study groups with one control and 4 active groups. 5ug and 25ug doses with and without 50ug Matrix-M adjuvant.

The formal study name is SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine with Matrix-M adjuvant

If my reaction to this adjuvant is anything like my reaction to Shingrix, I will know I got the real thing.

This research group is currently administering 5 different vaccine trials. DW asked why we both were assigned to the Novavax trial and was told that trial needs more of our demographic.

The trial will last at least 13 months and require at least 7 clinic visits and many Nasal swab and blood tests.

If a Covid-19 vaccine is approved and available before the end of this trial, we will be notified if in the control group so we can opt to withdraw from the study.

Any other forum members involved in a vaccine trial or considering volunteering?

Mike

 

[braumeister]

Thank you both for doing this.

 

[Mark1]

That's neat.

...
If my reaction to this adjuvant is anything like my reaction to Shingrix, I will know I got the real thing.
...
Mike

Maybe they will put something in the control groups injection to make you feel like crap in order to make it a truly blind study.

 

[JoeWras]

I'm not in a trial, but our friend is. She had bad arm pain for two days so she's convinced she's not in the placebo group.

 

[easysurfer]

I can think of a lot of wise cracks to say.

But I'll just say I hope everything goes well and "Thank you" .

 

[Brat]

First, thank you for your participation.

Did they ask your vaccine history? If you are in the placebo group they could give you another vaccine like phenomena. You have already had the shingles shot so maybe that as it wouldn't distort your antibodies. If there were last year's flue vaccine handy and you received it last year that would be another possibility. This year's influenza vaccine might muddle their analysis.

I have read that in Roseburg or Medford Oregon they are recruiting people who work in food processing plants as that environment is classic for the spread of Covid19.

Kaiser has a trial going in Oakland.

 

[Amethyst]

Thank you for volunteering. Takes guts.

 

[boog]

I added myself to the NIH registry for volunteers but haven’t yet been contacted. Here’s the link for those interested.

https://www.coronaviruspreventionnetwork.org/clinical-study-volunteer/

 

[SecondCor521]

I added myself to the NIH registry for volunteers but haven’t yet been contacted. Here’s the link for those interested.

https://www.coronaviruspreventionnetwork.org/clinical-study-volunteer/

Me too.

Although I am 51, I don't consider the risks of a trial vaccine to be high compared to the risks of contracting the virus in the wild. Also, my Mom set an example by participating in a clinical trial for her disease and helping in a very small way advance medical knowledge for those who went after her. So I'm happy to do it.

The one thing I'd want to make sure of though, is if I were in a trial for vaccine A for medical knowledge advancement purposes and decided for personal protective reasons that I wanted to get vaccine B, could I do that? Or would the trial for A preclude getting B? Anyone know?

 

[aaronc879]

Is this a completely out-patient study or do you have to spend time in-house at a clinic?

I am currently under contract for a phase 1 study that lasts until December 6th so I can't do any other study. Otherwise I may be interested in doing a Covid study even though I assume the pay is very little(or maybe nothing) since it's phase 2. I do phase 1 studies for a living so phase 2 would be no worries at all for me, well except that it wouldn't pay my bills. Hopefully the vaccine keeps you from getting Covid and you have no bad AE's(adverse events).

 

[aaronc879]

Me too.

Although I am 51, I don't consider the risks of a trial vaccine to be high compared to the risks of contracting the virus in the wild. Also, my Mom set an example by participating in a clinical trial for her disease and helping in a very small way advance medical knowledge for those who went after her. So I'm happy to do it.

The one thing I'd want to make sure of though, is if I were in a trial for vaccine A for medical knowledge advancement purposes and decided for personal protective reasons that I wanted to get vaccine B, could I do that? Or would the trial for A preclude getting B? Anyone know?

I do phase 1 trials and I have to sign a contract. In that contract I agree not to take any other medications(I assume a vaccine would count) for the duration of the study. Phase 2 studies could be different but I would assume taking a seperate vaccine would invalidate the data from the first vaccine and the study would be a waste. That said, studies are voluntary and you can withdraw any time you want. Your data will be thrown away at great cost but it is your right to withdraw at any time. You could then take any other vaccine you want.

 

[kyzymurgist]

They did ask about any previous vaccinations within the past 45 days but I'm not sure a positive response would have any effect in our participation. I think just for information.

I'm fairly confident that the control group is just saline solution. No additional substance to provide a reaction. I got the sense that the administrator is not overly concerned with participants having a positive reaction to the active vaccine.

They were looking for a wide range of participants with few outright exclusions. No BMI over 35. No chemotherapy. No one taking biologic RA drugs since the immune response is supressed.

The Novavax trial was particularly in need of age 60 - 84 participants.

We need to carry a card in our wallet with trial info contact info in case of accident. And no blood donation for the foreseeable future.

 

[Gumby]

I'm not in a trial, but our friend is. She had bad arm pain for two days so she's convinced she's not in the placebo group.

Maybe someone with better medical knowledge will chime in, but I'm not sure the pain at the injection site is a function of the immune response. I think it is just mechanical damage to the tissue cause by the injection of fluid. I had the flu shot and the shingles shot two days ago, one in each arm. The shingles shot was about twice as much fluid as the flue shot, and I would say that the shingles arm hurt about twice as much as the flu arm.

 

[kyzymurgist]

We cannot participate in any other vaccine studies and if another Covid-19 vaccine becomes available, it is not recommended for us if we were in one of the active groups. They will notify us at that time if we were control so we can opt out and get a real vaccine.

The compensation is reasonable at $1250 each for less than 20 hours of clinic time, maybe 5 hours of homework and phone calls and some unpleasant nasal swab tests.

 

[Go-NoGo]

We cannot participate in any other vaccine studies and if another Covid-19 vaccine becomes available, it is not recommended for us if we were in one of the active groups. They will notify us at that time if we were control so we can opt out and get a real vaccine.

The compensation is reasonable at $1250 each for less than 20 hours of clinic time, maybe 5 hours of homework and phone calls and some unpleasant nasal swab tests.

Typically all clinical trials have inclusion and exclusion criteria, they will not accept you if have any of the conditions in exclusion list and conversely you have to meet the inclusion criteria to be included.

For the OP's trial the exclusion criteria are : (it's for the Phase-1 trial, but the conditions would be the same.

Exclusion Criteria (Phase 1):

1. Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care, inclusive of changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the investigator). This includes any current workup of undiagnosed illness that could lead to a new condition.
2. Chronic disease inclusive of: a) hypertension uncontrolled for age according to JNC 8 guidelines; b) congestive heart failure by NYHA functional classification of greater or equal to II; c) chronic obstructive pulmonary disease by GOLD classification of greater or equal to 2; d) recent (within 6 months prior to first study vaccination) exacerbation of coronary artery disease as manifested by cardiac intervention, addition of new cardiac medications for control of symptoms, or unstable angina; e) asthma (diagnosed by spirometry showing reversibility of disease and must meet at least the Step 1 classification with current prescription/use of medications to control symptoms); f) diabetes requiring use of medicine (insulin or oral) or not controlled with diet.
3. Participation in research involving an investigational product (drug/biologic/device) within 45 days prior to first study vaccination.
4. History of a confirmed diagnosis of SARS or COVID-19 disease (confirmed by a specific test for each disease) or known exposure to a SARS-CoV-2 positive confirmed close contact (eg, family member, housemate, daycare provider, aged parent requiring care), at the discretion of the investigator.
5. Currently working in an occupation with a high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel).
6. Currently taking any product (investigational or off-label) for prevention of COVID-19 disease.
7. Positive rapid test for SARS-CoV-2 (ELISA or PCR) at screening or prior to first vaccination (if available).
8. Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 4 weeks prior to first study vaccination.
9. Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital).
10. Chronic administration (defined as more than 14 continuous days) of immunosuppressant, systemic glucocorticosteroids, or other immune-modifying drugs within 4 months prior to first study vaccination or anticipation of the need for immunosuppressive treatment within 6 months after last vaccination.
11. Received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination.
12. Any acute illness concurrent or within 14 days prior to first study vaccination (medical history and/or physical examination) or documented temperature of >38°C during this period. This includes respiratory or constitutional symptoms consistent with SARS-CoV-2 (COVID-19) exposure (ie, cough, sore throat, difficulty breathing)
13. Known disturbance of coagulation (iatrogenic or congenital). NOTE: The use of ≤325 mg of aspirin per day as prophylaxis is permitted, but the use of other platelet aggregation inhibitors, thrombin inhibitors, Factor Xa inhibitors, or warfarin derivatives is exclusionary, regardless of bleeding history, because these imply treatment or prophylaxis of known cardiac or vascular disease.
14. Evidence of Hepatitis B or C or HIV by laboratory testing.
15. A positive test result for drugs of abuse (except a positive test result associated with prescription medication that has been reviewed and approved by the investigator) or alcohol at screening.
16. Any neurological disease or history of significant neurological disorder (eg, meningitis, seizures, multiple sclerosis, vasculitis, migraines, Guillain-Barré syndrome [genetic/congenital or acquired]).
17. Active cancer (malignancy) within 5 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma, at the discretion of the investigator)
18. Vital sign (blood pressure, pulse, temperature) abnormalities of toxicity grade >1
19. Clinical laboratory abnormalities of toxicity grade >1 for selected serum chemistry and hematology parameters
20. Any known allergies to products contained in the investigational product or latex allergy.
21. Women who are pregnant, breastfeeding or who plan to become pregnant during the study.
22. History of alcohol abuse or drug addiction within one year prior to the first study vaccination.
23. Any condition that, in the opinion of the investigator, would pose a health risk to the subject if enrolled or could interfere with evaluation of the study vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
24. Study team member or first-degree relative of any study team member (inclusive of sponsor, PPD, and site personnel involved in the study).

https://clinicaltrials.gov/ct2/show...nant+Spike+Protein+Nanoparticle&draw=2&rank=1

 

[aaronc879]

We cannot participate in any other vaccine studies and if another Covid-19 vaccine becomes available, it is not recommended for us if we were in one of the active groups. They will notify us at that time if we were control so we can opt out and get a real vaccine.

The compensation is reasonable at $1250 each for less than 20 hours of clinic time, maybe 5 hours of homework and phone calls and some unpleasant nasal swab tests.

You have to make 7 clinic visits? If you live a ways away that could be a lot of miles. When you file taxes for this income you could file under "other income"
or you could file it under self employment. If it's self employment then you can deduct expenses including 57.5 cents per mile. However if you file SE then you have to pay SE tax which is 15.2% on every dollar after expenses. I do studies for a living so I have to file SE tax which is expensive even after all the expense deductions. Hope everything works out well for you.

 

[aaronc879]

Exclusion criteria vary from study to study. The sponsor(drug company) determines the criteria. For example, the post above shows one exclusion criteria being you must not have been in another study for 45 days. I have don't over 30 studies and non of them have had that restriction. It is usually 30 days from dose to dose but has been 60 days a couple times, never 45 days.

 

[Go-NoGo]

Exclusion criteria vary from study to study. The sponsor(drug company) determines the criteria. For example, the post above shows one exclusion criteria being you must not have been in another study for 45 days. I have don't over 30 studies and non of them have had that restriction. It is usually 30 days from dose to dose but has been 60 days a couple times, never 45 days.

Those are the exclusion criteria for the Novavax P1/2 study: "Evaluation of the Safety and Immunogenicity of a SARS-CoV-2 rS (COVID-19) Nanoparticle Vaccine With/Without Matrix-M Adjuvant:

 

[sengsational]

kyz...did the rules specify that you were not to talk about / attempt to guess whether you got the placebo vs treatment? I understand that it's usually a question they ask you (along with many others), but wondering if they ask you avoid "comparing notes" to try to uncover which group you are in.

 

[aaronc879]

kyz...did the rules specify that you were not to talk about / attempt to guess whether you got the placebo vs treatment? I understand that it's usually a question they ask you (along with many others), but wondering if they ask you avoid "comparing notes" to try to uncover which group you are in.

You are never supposed to tell other subjects about any AEs(side effetcs). It happens, but it's not supposed to

 

[SecondCor521]

I do phase 1 trials and I have to sign a contract. In that contract I agree not to take any other medications(I assume a vaccine would count) for the duration of the study. Phase 2 studies could be different but I would assume taking a seperate vaccine would invalidate the data from the first vaccine and the study would be a waste. That said, studies are voluntary and you can withdraw any time you want. Your data will be thrown away at great cost but it is your right to withdraw at any time. You could then take any other vaccine you want.

Thanks. I'd be willing to wait a while so that my trial data would be usable, but probably only on the order of months, not years.

I'm also a regular Red Cross platelet donor, so I'd have to consider what to do about that - usually there's no deferral if the vaccination is normal and has no AEs (like a flu shot in the fall), but I don't know if trial vaccines are different.

 

[aaronc879]

Thanks. I'd be willing to wait a while so that my trial data would be usable, but probably only on the order of months, not years.

I'm also a regular Red Cross platelet donor, so I'd have to consider what to do about that - usually there's no deferral if the vaccination is normal and has no AEs (like a flu shot in the fall), but I don't know if trial vaccines are different.

When I used to donate plasma they asked if I had been in a clinical trial in the past 30 days and if you say yes then you are excluded. Probably better not to give blood if you are taking a non FDA approved medication/vaccine.

 

[kyzymurgist]

No they did not discuss this issue. And when I stated that I have an extreme reaction to adjuvant vaccines and will know if I had one, the nurse just smiled and nodded. And if course DW and I will discuss any side effects.

kyz...did the rules specify that you were not to talk about / attempt to guess whether you got the placebo vs treatment? I understand that it's usually a question they ask you (along with many others), but wondering if they ask you avoid "comparing notes" to try to uncover which group you are in.

 

[REWahoo]

Speaking of vaccine trials, I came across this a few minutes ago:

Moderna and Pfizer’s COVID-19 vaccine candidates require ultra-low temperatures, raising questions about storage, distribution

... mRNA-1273, which is Moderna’s coronavirus vaccine candidate, requires a storage temperature of negative 4 degrees Fahrenheit. BioNTech and Pfizer’s candidates, BN1162b2 and BNT162b2, need to be stored in negative 94 degrees Fahrenheit.

“These storage conditions would make traditional office or pharmacy administration very difficult,” SVB Leerink analysts wrote in a note to investors on Thursday. “These conditions could be met at tertiary hospitals and laboratories and could be accommodated in intensive one-day vaccination events at such sites, but this would still only cover a fraction of the healthy population.”

 

[JoeWras]

Maybe someone with better medical knowledge will chime in, but I'm not sure the pain at the injection site is a function of the immune response. I think it is just mechanical damage to the tissue cause by the injection of fluid. I had the flu shot and the shingles shot two days ago, one in each arm. The shingles shot was about twice as much fluid as the flue shot, and I would say that the shingles arm hurt about twice as much as the flu arm.

I think you are right! I didn't argue with her. It is best she has a firm the placebo illusion, if she has the placebo. Makes for a solid study, right? Truly blind.

As for ME... I'd consider it, but right now my gift to humanity is biweekly platelet donations. Vaccinations are part of the deferral criteria, and for now, I just don't want to go there.