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Interview with Oxford vaccine trial participant

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 freeflyer 27 Jul 2020
 elsewhere 27 Jul 2020
In reply to freeflyer:

There's the placebo effect of special treatment such as study participation, hence studies are difficult to design.

However as a patient the placebo effect is a logical incentive to participate.

Even if you get the sugar pill placebo or the real drug is no better than the placebo you still get the benefit of the placebo effect.

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In reply to elsewhere:

> Even if you get the sugar pill placebo or the real drug is no better than the placebo you still get the benefit of the placebo effect.

I think in this case you get the real benefit of a comprehensive meningitis vaccine in the control group.

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 Andy Johnson 27 Jul 2020
In reply to elsewhere:

> you still get the benefit of the placebo effect.

Unlikely. A placebo can affect a subject's subjective assessment of how they feel, but it doesn't actually affect the underlying condition or disease. If it did then it would be useless as a placebo.

If the psychological effect of receiving a placebo makes people feel temporarily less stressed then that might have some temporary effect on their medical condition, but that's all.

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In reply to Dave Garnett:

> I think in this case you get the real benefit of a comprehensive meningitis vaccine in the control group.

I think the idea is that participants have some mild symptoms of an illness, which means they have less chance of knowing if they've had or haven't had the actual trial drug. They don't want people who are convinced they've had a placebo deliberately avoiding all social contact etc. 

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 elsewhere 27 Jul 2020
In reply to Andy Johnson:

Blind studies exist because placebos measurably work so you compare the benefit of the treatment with the benefit of the fake/placebo. 

The study participants get the benefit of the placebo effect without knowing if they got the real thing or the fake.

If placebos did not measurably work the control would be no treatment rather than fake/placebo control.

Post edited at 21:02
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In reply to summo:

> I think the idea is that participants have some mild symptoms of an illness, which means they have less chance of knowing if they've had or haven't had the actual trial drug. They don't want people who are convinced they've had a placebo deliberately avoiding all social contact etc. 

Yes, that’s right, plus there’s the ethical issue of the injections and the regular sampling. There’s real benefit from the control vaccination, which more than balances out the tiny risk.

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 LeeWood 28 Jul 2020
In reply to freeflyer:

Exactly which vaccine variant is being trialled here - and from which mfr ?

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In reply to LeeWood:

It’s the Oxford/Vaccitech/AZ chimpanzee non-replicating adenovirus one (AZD1222).

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 mcdougal 28 Jul 2020
In reply to freeflyer:

I can understand the placebo effect on someone with an ailment who believes they have received a remedy but I'm having trouble getting my head around a placebo vaccine. Can anyone help? 

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 elsewhere 28 Jul 2020
In reply to mcdougal:

Maybe if you feel better psychologically due to placebo your immune system is better and you are less likely to catch the disease. Or being in the study means your are more Covid aware than average and less likely to catch it so control is not the average for the general public.

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In reply to LeeWood:

Here are the preliminary results in the Lancet preprint: 

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext

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 Andy Johnson 28 Jul 2020
In reply to elsewhere:

I didn't say a placebo has no measurable effect, I said it has no actual effect on the disease process. The "placebo effect" isn't some magical disease fighting ability of the body that is activated by the placebo. It's about the patient's perception and expectation.

> If placebos did not measurably work the control would be no treatment rather than fake/placebo control.

And how could you do a blind study if the entire control group doesn't even receive a placebo? That would reveal who was in the treatment and control groups.

Post edited at 12:34
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 Andy Johnson 28 Jul 2020
In reply to mcdougal:

> I can understand the placebo effect on someone with an ailment who believes they have received a remedy but I'm having trouble getting my head around a placebo vaccine. Can anyone help? 

It's to do with the double-blind nature of the trial. The trial vaccine is injected and is expected to cause noticeable (but minor) side-effects, so the placebo has to have similar characteristics.

From https://www.ox.ac.uk/news/2020-04-23-oxford-covid-19-vaccine-begins-human-trial-stage :

"The MenACWY vaccine is a licensed vaccine against group A, C, W and Y meningococcus which has been given routinely to teenagers in the UK since 2015 and protects against one of the most common causes of meningitis and sepsis. This vaccine is also given as a travel vaccine for high risk countries.

The MenACWY vaccine is being used as an ‘active control’ vaccine in this study, to help us understand participants’ response to ChAdOx1 nCoV-19. The reason for using this vaccine, rather than a saline control, is because we expect to see some minor side effects from the ChAdOx1 nCOV-19 vaccine such as a sore arm, headache and fever. Saline does not cause any of these side effects. If participants were to receive only this vaccine or a saline control, and went on to develop side effects, they would be aware that they had received the new vaccine. It is critical for this study that participants remain blinded to whether or not they have received the vaccine, as, if they knew, this could affect their health behaviour in the community following vaccination, and may lead to a bias in the results of the study."

[my emphasis]

Post edited at 12:44
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 elsewhere 28 Jul 2020
In reply to Andy Johnson:

> I didn't say a placebo has no measurable effect, I said it has no actual effect on the disease process. The "placebo effect" isn't some magical disease fighting ability of the body that is activated by the placebo. It's about the patient's perception and expectation.

Exactly. If you perceive you feel better that is a real benefit. It's measured by questionnaires and interviews asking patient about how they feel and report to their symptoms.

> And how could you do a blind study if the entire control group doesn't even receive a placebo? That would reveal who was in the treatment and control groups.

Exactly. The placebo for the control group is required to control for the placebo effect of the real treatment under study.

Real or fake you get the same placebo effect as in a blind study they are indistinguishable to the patient/participant. 

Post edited at 12:51
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 Andy Johnson 28 Jul 2020
In reply to elsewhere:

> Exactly. If you perceive you feel better that is a real benefit.

The important word here is "feel".

In a blind study of patients with a known medical condition then the placebo effect may produce a perceived benefit in that they feel better. But if their underlying disease process is progressing unaffected because they received the placebo then I'd argue its not a real benefit for them.

In a vaccine trial of healthy subjects, the effect is different. They are unlikely to "feel better" because they're not ill, but participation in the trial may change their future behaviour w/r/t risk because they know they have a 50% chance of having some unknown degree of protection.

> Real or fake you get the same placebo effect as in a blind study they are indistinguishable to the patient/participant.

Yes.

Post edited at 13:08
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 abr1966 28 Jul 2020
In reply to Dave Garnett:

Sorry to be a bit lazy Dave...but for the non science folk.....is it any good and looking promising?

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In reply to abr1966:

Yes, and yes, although it would frankly be a bit surprising (and rather worrying) if it had been otherwise at this stage.

There's a (reasonably straight and factual) summary on AZ's website

https://www.astrazeneca.com/media-centre/press-releases/2020/covid-19-vaccine-azd1222-showed-robust-immune-responses-in-all-participants-in-phase-i-ii-trial.html#!

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 elsewhere 28 Jul 2020
In reply to Andy Johnson:

> The important word here is "feel". It may be a perceived benefit in that you feel better. But if your underlying disease process is progressing unaffected because you received the placebo then I'd argue its not a real benefit for you or the study.

That's where we disagree. For me subjectively feeling better is a real benefit. Hence an anticipated placebo effect was part of my motivation for being in a study for the treatment I required anyway.

It's even better if you are cured.

Post edited at 13:15
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 abr1966 28 Jul 2020
In reply to Dave Garnett:

Thanks! I was never any good at science....I have quite a few mates working at Alderley and Macc, good to see what they've been up to!

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 Iamgregp 28 Jul 2020
In reply to elsewhere:

Funny story about feeling better - my mum had salvage chemotherapy for Lymphoma last year.  All went well but her white and red blood cell count rose much more slowly than they'd hoped after the treatment. 

She got a bit depressed as she felt like she would never get better and be left with shortness of breath (she went from going to the gym 3 times a week to barely being able to walk up the stairs) but then she started to feel a bit better and more herself and started to feel less down.   Then when she went to have her cell counts tested again they told her they hadn't gone up any more and that they may not ever.  She got more depressed than ever. 

Then she saw a Macmillan nurse and told her all about how down she was about her cell count not going up and the nurse asked "but do you not feel better in yourself thought" she replied "oh yes, I feel much better" so the nurse told her to not worry about the cell counts, if she feels better what has she got to worry about?  Just concentrate on how you feel, and forget about cell counts. 

She did just that, her depression lifted she went about her normal daily things, started back at the gym etc.  Then she went to have her cell count looked at and bingo, they were even better than they had hoped.  She's right as rain.

I'm not saying that it was any kind of mind over matter or some mumbo jumbo like that, but how a person feels is really important to recovery.

I make a monthly donation to Macmillan now - the chemo saved her life, but the nurse got her to start living again.

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 LeeWood 28 Jul 2020
In reply to Dave Garnett:

> Here are the preliminary results in the Lancet preprint: 

I note that this vaccine is produced using GMO techniques. And apparently this vaccine usage is authorised -

Q: Vaccine use was authorised by Genetically Modified Organisms Safety Committees at each participating site.

Many of us reject GMO foodstuffs - which are at least filtered by the gut wall. A vaccine however will bypass the digestive system - being injected straight into the bloodstream

If this becomes the world's choice I may as well quit eating organic ?! NB. several other candidates are also GMO 

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In reply to LeeWood:

> If this becomes the world's choice I may as well quit eating organic ?!

That depends on why you eat organic.  If it’s because you believe in high standards of animal welfare and object to indiscriminate use of pesticides, then carry on.

Objecting to all GMO on principle makes as much sense as rejecting chemistry.

Post edited at 00:37
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In reply to freeflyer:

The interviewer should have opened with the line

" has your body always been that size "

😂😂😂

Experimental vaccine and all.  

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 El Greyo 29 Jul 2020
In reply to Andy Johnson:

Another reason why this is a blind trial is that, as they want to monitor how many in each group contract Covid 19, it is important that both groups behave similarly (on average). The researchers want to the average risk of exposure to be the same for each group: if you knew you had had the Covid 19 vaccine, you may behave differently (perhaps be more blase about risk of infection) than if you knew you had been given the control.

I volunteered for the trial and went to a screening session. Sadly, I was rejected due to allergic reactions I've had in the past which were nothing to do with vaccines and I thought were minor - but they couldn't take any chances. Having got all psyched up about actually doing something that might help, I was absolutely gutted to have to walk away. Thankfully they have had lots of volunteers and hopefully the trial will be successful.

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 Andy Johnson 29 Jul 2020
In reply to El Greyo:

Yes. As I said upthread (at https://www.ukhillwalking.com/forums/off_belay/interview_with_oxford_vaccine_trial_participant-722661?v=1#x9259390) the meningitis vaccine is used as a placebo in this trial because it has similar side effects to those anticipated for the sars-cov-2 virus. This nsures that the participants don't know if they're in the treatment group or the control group.

Post edited at 13:29
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