Can someone help me understand the Oxford University vaccine - it doesn't make any sense to me!

[thebellsofsaintclements]

So from what I gather, half the participants will be given the vaccine against coronavirus, and half will be given a vaccine against meningitis. They they will let people mingle in the community and will test them when they start developing symptoms. They hope that the people who subsequently test positive to Covid19 will be the ones who have received the meningitis vaccine.

So my questions are:

a) why a meningitis vaccine rather than a placebo?
b) How will the participants 'mingle' in the community when we're still in lockdown?
c) Isn't it better to expose them to the virus in a more 'controlled' way (so that all participants get exposed to the same viral load etc)
d) If they're only testing participants who are exhibiting symptoms, what about the asymptomatic ones?

It all sounds very strange, however, it's Oxford University so I'm sure they know what they're doing (even if I don't!) But I'm really curious as to the rationale!

Since the problems at the Parexel unit at Northwick Park Hospital a few years ago all "first in human" studies start off with two sentinel subjects, one on the new drug, one in the comparitor to make sure there are no immediately obvious problems. I presume the same applies to vaccines. There would be an outcry if they vaccinated 100 people & 50 of them died within a couple of days.

This one is puzzling me too and so far I have not seen/heard anyone officially state exactly what happens to the volunteers once they are injected. If I have missed that info then I will no doubt be told. A trial drug seems to have been developed very quickly and I read that it is one of several so is this a sign of desperation to slow this pandemic down and grind it to a halt and the human guinea pigs are at a greater risk than they are told? I know an effective and proven vaccine may be a long way off but all these sudden trial drugs mean many volunteers taking huge risks.

My thoughts were:

Do they give the trial vaccine drug to eg. a volunteer - isolate them in a hospital and wait to see if any adverse reactions etc. - if not then expose them for however long to a covid patient so they have the best chance (oh dear) of catching the virus. If they do catch it then at least they are in the best place to be quickly treated.

If they don't catch it then what? Assume the vaccine is effective? The volunteers would be under close scrutiny and careful monitoring for several weeks while still isolated in hospital to see if warnings signs begin to show. Or just give them the trial drug and let them loose outdoors and do regular and frequent testing on them? Surely not!

I obviously know far too little but wanted to give my own thoughts and hope we are informed honestly about these trials.

Lots of information here:
clinicaltrials.gov/ct2/show/NCT04324606

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

What about after the vaccination?

Participants will be given an E-diary to record any symptoms experienced for 7 days after receiving the vaccine. They will also record if they feel unwell for the following three weeks.

Following vaccination, participants will attend a series of follow-up visits. During these visits, the team will check participants’ observations, take a blood sample and review the competed E-diary. These blood samples will be used to assess the immune response to the vaccine.

If participants develop COVID-19 symptoms during the study, they can contact a member of the clinical team, and we will assess them to check whether they have become infected with the virus. If a participant was very unwell, we would call our colleagues in the hospital and ask them to review the volunteer if appropriate.

They are in absolute unknown territory and going way faster than usual. I suppose they want to go slowly and observe what happens. They can hardly infect directly people, realise the vaccine isn't working (or even making it worse) and lose half of the participants.

I suppose infecting people directly will be another phase of the testing process?

Only once there is an antiviral drug that works.

I'm pretty sure that the point of only giving ONE person the vaccine to begin with is in case he dies horribly from the vaccine itself.

There was a similar test once where they started off with a few dozen subjects and unfortunately it seriously damaged them.

So give it to one and wait a bit. If he doesn't die then give it to a larger test group

Thanks all, some really good points

There was a similar test once where they started off with a few dozen subjects and unfortunately it seriously damaged them.
See above, Parexel. It wasn't a similar test in that it wasn't a vaccine, but yes, it was a first in human study. As I said, that is why you have the initial group of two now.

Mustbetimeforachange Ah yes! that's the one I was trying to remember. "Parexel unit at Northwick Park Hospital" I couldn't even remember if they died or not, but I remember it went very badly.

@NotEverythingIsBlackandWhite Science requires certain skill sets that someone who has studied literature for example is unlikely to posses and most certainly will not practice in the course of their studies. Additionally they have specialist knowledge so in addition to knowing how to think they have the relevant facts and base level understanding.

A lay person isn’t capable of correctly interpreting statute for example (as evidenced by the endless mn threads where people can’t get their heads around what the coronavirus act does and doesn’t allow). Science is no different.

I don't think anyone died but it was a close run thing & I think some were permanently damaged. I know nurses who were working there & they were traumatised for a long time after. The first person started getting sick & then the next. They knew it was going to happen to them all one after another.

c) Isn't it better to expose them to the virus in a more 'controlled' way (so that all participants get exposed to the same viral load etc)

This would be best but there were explaining on news last night until there was a treatment for it it wouldn't be ethical to deliberately infect people with a virus that could kill them.

I'm not sure if its a really small group to start with to test for safety but another news report I saw suggested they were hoping HCP and others more likely to come into contact with virus would be part of the people volunteering in early more widespread trials.

I saw a scientist on bbc news yesterday saying that they use several rounds of testing to check a vaccine is 'safe' and 'effective'.

So first round of testing (the 'safe' test) involves a small number of people. They look for side effects and make sure it doesn't make anyone ill.

The second part is testing the 'effectiveness' of several different vaccines so would involve a larger sample and would focus on community transmission etc.

The final part would be scaling up manufacture of the chosen vaccine (which I read will be difficult in the UK as we don't currently have a large number of available labs).

She said there would usually be a delay between each round of testing but that it was to do with securing funding rather than waiting for results. So as time is of the essence in this situation, they would go ahead with the next trials and risk financial loss.

Sounds like it is a problem they don’t really have a solution to!

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