Novavax vaccine Trial

[ert]

I just received the call. I'm having the health screen check on Saturday followed by the injection if I pass. Is anyone else on the trial? I feel like I've won the lottery. 300,000 have signed up for the original 5,000 places.

 

[JaneC]

I signed up and was accepted but decided not to go ahead last week as there are quite a few long hospital visits involved over a year and with only a 50% chance of getting the vaccine rather than the placebo it didn’t seem worthwhile on top of all the other diabetic appointments we have. I really don’t know if it was the right decision though.

 

[DCUKMod]

I just received the call. I'm having the health screen check on Saturday followed by the injection if I pass. Is anyone else on the trial? I feel like I've won the lottery. 300,000 have signed up for the original 5,000 places.

All the best with that Ert.

 

[becca59]

Am in awe of your bravery. Thank you!

 

[mariefrance]

Hi ert
Kate Bingham, Head of the UK Taskforce has just been on TV (BBC) and she was saying she has just had here first injection as part of the Novavax trial. So you're in good company!

 

[ert]

They called me in a day early so had the injection yesterday. I've had a strong reaction to it - pain in my arm at the injection site, terrible headache, fever, horrible muscle aches and pains, nausea - I hardly slept at all last night. My symptoms aren't easing with paracetamol. My blood sugars are high so I'm following sick day rules. I've never been more excited about feeling unwell.
I'm starting to feel better, but my blood sugars haven't responded to my four-hourly corrections yet.

 

[Mr_Pot]

They called me in a day early so had the injection yesterday. I've had a strong reaction to it - pain in my arm at the injection site, terrible headache, fever, horrible muscle aches and pains, nausea - I hardly slept at all last night. My symptoms aren't easing with paracetamol. My blood sugars are high so I'm following sick day rules. I've never been more excited about feeling unwell.
I'm starting to feel better, but my blood sugars haven't responded to my four-hourly corrections yet.

I think you can be pretty confident that you didn't get the placebo! I hope you are back to normal soon.

 

[hyponilla]

I've never been more excited about feeling unwell.

This sentence made me giggle. You're a hero at the frontier of science. I also hope you feel better soon. It will be interesting to see how long the symptoms last.

 

[bulkbiker]

I think you can be pretty confident that you didn't get the placebo! I hope you are back to normal soon.

Depends what the placebo is.. in the US trials I believe they used a meningitis vaccine so hardly saline.

 

[Dr Snoddy]

Also, the placebo should contain everything except the 'active ingredient'. So suspension fluid, preservatives etc some of which could also cause reactions.

 

[Mr_Pot]

Depends what the placebo is.. in the US trials I believe they used a meningitis vaccine so hardly saline.

Actually the placebo is saline....
Sodium chloride injection (BP, sterile), 0.9%

 

[Fawbs89]

What is novovax

 

[KK123]

They called me in a day early so had the injection yesterday. I've had a strong reaction to it - pain in my arm at the injection site, terrible headache, fever, horrible muscle aches and pains, nausea - I hardly slept at all last night. My symptoms aren't easing with paracetamol. My blood sugars are high so I'm following sick day rules. I've never been more excited about feeling unwell.
I'm starting to feel better, but my blood sugars haven't responded to my four-hourly corrections yet.

Wow, our very own blow by blow account and hot off the Press. Keep on posting if you can Ert! x

 

[ert]

I had my first antibody test. It was negative, day 5. I'm starting to wonder if I imagined all of my symptoms. Or I have to keep the faith that on average it takes 14 days for most people to develop antibodies. And some people not until the second injection.

 

[NicoleC1971]

Depends what the placebo is.. in the US trials I believe they used a meningitis vaccine so hardly saline.

Agreed. Bizarrely they use a different vaccine as a placebo and apparently vaccines for 1 virus tend to make you more susceptible to other viruses. Doesn't that skew the results in favour of the vaccine you are testing because the placebo group are more likely to get sick?

 

[ert]

Agreed. Bizarrely they use a different vaccine as a placebo and apparently vaccines for 1 virus tend to make you more susceptible to other viruses. Doesn't that skew the results in favour of the vaccine you are testing because the placebo group are more likely to get sick?

They need 100 people to get Covid-19 for the vaccine to be considered a success, hopefully from the placebo group. They're not recording symptoms, just testing to see if the vaccine gives you immunity. The placebo is just saline (unlike the Oxford), but some people supposedly react to it (in their imagination?)

 

[Mr_Pot]

Agreed. Bizarrely they use a different vaccine as a placebo and apparently vaccines for 1 virus tend to make you more susceptible to other viruses. Doesn't that skew the results in favour of the vaccine you are testing because the placebo group are more likely to get sick?

They are using saline as the placebo - see page 52 of the the Novavax trial protocol.
They are however testing a subset of participants with flu vaccine in their other arm "to evaluate the safety and immunogenicity of SARSCoV-2 rS with Matrix-M1 adjuvant when co-administered with a licensed seasonal influenza vaccine."

https://www.novavax.com/resources#protocols

 

[ert]

They are using saline as the placebo - see page 52 of the the Novavax trial protocol.
They are however testing a subset of participants with flu vaccine in their other arm "to evaluate the safety and immunogenicity of SARSCoV-2 rS with Matrix-M1 adjuvant when co-administered with a licensed seasonal influenza vaccine."

https://www.novavax.com/resources#protocols

Wow. You're more informed than I am, and I'm on the trial.

 

[NicoleC1971]

https://theconversation.com/coronav...important-to-know-whats-in-the-placebo-146365

This explains why sometimes researchers (Oxford vaccine) use an actual vaccine rather than saline. As BulkBiker said that is meningitis and pneumonia given so that participants who get the placebo feel that they've been given the real thing and hence get a true 'placebo' effect alongside those who get the actual thing.
Still if the minks have mutated the thing, that seems to make the vaccine even more ineffective. As Boris has just said not the bugle from the cavalry yet...

 

[Mr_Pot]

Wow. You're more informed than I am, and I'm on the trial.

How are the side effects now? Do you get to find out, at some point in the trial, if you had the vaccine or placebo ?