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!

Place marking as I'm also confused by this too..

I too am confused by the just sending them out to see if they catch it. If we’re still on lockdown and socially distancing surely the chances in general of them catching it are low, vaccine or not.

I said this to dh last night though and he reminded me that they are world class scientists and I am not......

The meningitis jab is because it gives similar side effects to the corona one I think, so the participants don’t get a clue from that.

The early testers are just checking for additional side effects, and maybe testing for antibodies (disclaimer. I’m no dr, it’s just what I read somewhere) etc, later on the trial they’ll consider deliberately infecting, or trialling in an area with less restrictions on movements.

Good I'm glad I'm not the only one who doesn't get it ! I forgot to add one more thing - if the participants catch it in the community and keep mingling without realising they've already been infected, surely they can pass it on to lots more people (potentially vulnerable ones) - how is this ethical!

I think the meningitis was given because it has similar side effects to the ones anticipated by the covid one.
The mingling is difficult because its such a dangerous virus so I believe that frontline nhs/carers are among the cohort as they are more likely to be exposed. .
Can't answer the other two but this brief explanation is what I gleaned from the news yesterday.

I am wondering if they could test whether people have mounted an immune response by testing to see if they have made antibodies (having checked that they didn't have them before they started of course). This wouldn't test whether it prevented them getting the illness but would test whether they are capable of fighting it?

The other jab being administered usually gives people similar side effects to the covid one, if they used saline or something it would probably be quite evident to the control group which jab they had recieved as there would be no side effects. It has also only been routinely offered to teens since 2015, so it's likely that the volunteers wouldn't have already had it. The other side, maybe if they were to give a controlled dose in the lab it wouldn't be representative of the chance of catching it out and about or to the same levels? It seems like they are almost trying to create a microcosym of society and how the vaccine might protect people 'in the wild'. That's just a guess though, there are several stages to trials and this is just one of them, so I am sure it has been carefully thought out and planned. They will hopefully release more on why it's being done this way, for no other real reason then it's very interesting!

"I said this to dh last night though and he reminded me that they are world class scientists and I am not...."
They are just people who have studied different topics to you. I'm so glad my DH is capable of thinking for himself.

I agree that by just sending them out among people is a but random and I can't see how that is a controlled experiment.

There should be ethical problems with deliberately exposing participants to the virus, half of whom won't have had a relevant vaccine.

Also would give more natural real world data. A range of time points and routes of exposure etc

@NotEverythingIsBlackandWhite

The meningitis group is the control. Other than that real world conditions are usually good for clinical trials.

They are just people who have studied different topics to you. I'm so glad my DH is capable of thinking for himself

Er yes, they presumably studied science which is directly relevent to this. Her DP wasn't saying she didn't understand as she was stupid or whatever, cripes.

There was a piece on the news that explained that as CV can be quite dangerous, it would be irresponsible and unethical at this stage to deliberately infect people. Even in lockdown, unless you are shielding or isolating, you are exposed to the virus e.g. key workers, going to the supermarket. I assume the two groups are broadly similar so they should be able to at least get an indication of whether the vaccine is reducing transmission rates by comparing the two groups.

They've only vaccinated 1 person with the CV vaccine, and 1 with meningitis. Total of 2 people involved in this first trial.

It’s not real world conditions though is it. We have measures in place to actively stop people trying to get the virus and the number of people who actually have it is still very small in relation to the total population. So surely there is still a very good chance that the volunteers will simply just not come into contact with the virus? Very confusing.

@NotEverythingIsBlackandWhite
he just meant that obviously they will have considered this as they know what they’re doing!

Without an effective antiviral drug it would be unethical to deliberately infect someone with this virus (but they can go so with flu for example). One of their concerns is that with an effective lockdown people in the study may take ages to be exposed naturally. I believe they are planning a similar study in ?Africa.

Harriet the first trials are just over 1000 people across different regions. 500 alone at Southampton. So it's not just 2 people.

There are a lot of follow up appointments but looking at the different groups you may be able to work out which vaccine you’d been given by the number of follow up appointments.

I can’t take part in the trial due to a blood clotting disorder unfortunately but there is more info on the stages of the trial if you read the application forms.

@DaisylovesDonald

Well if they scale up with more people enough will get infected. It will take a bit of time though you're right. Community transmission will continue or increase as lockdown is lifted.

@Mustbetimeforachange ah that's a very good point, seen as though there isn't a 'cure'. It all very interesting.

It is unbelievable that the vaccine is not being tested against a placebo with no active ingredients including no adjuvants and no preservatives. I have never understood the rationale behind this method of testing vaccine safety.

It reminds me of the study that showed that sugar did not make children wild at parties when the control substance was aspartame. Though obviously the testing of vaccines had much more serious consequences.

There have been questions over whether the vaccine process of injecting an adjuvant into our bloodstream can make us sensitive to other pathogens, what if the MenC patients become more susceptible to Coronavirus and other respiratory illnesses like pneumonia as has been suggested about the flu vaccine, evidenced in the fact that the flu vaccine has not resulted in a decrease in the number of hospitalisations due to respiratory illnesses.

People need the vaccine to protect them from the virus out in the community so community infection is the best way to assess the efficacy of the virus as I understand it.

As mentioned above it is generally considered unethical to deliberately expose people to an illness.

The developers are purposely chasing this epidemic wave to try and get some community results whilst there are still sufficient cases in the community for people to be exposed. NHS staff are being used as much as possible as they are most likely to have exposure in the course of their everyday lives.

As I understand it, one of the reasons it takes so long to develop vaccines generally is that it can be difficult to get sufficient exposure to the illness you’re looking to protect against to establish whether the vaccine works. That side of things is much easier in an epidemic.

The other challenge is not having a reliable antibody test...

It's in the news - only 2 people have been vaccinated so far as a start.

Wow I had no idea it was only two people so far.

What would happen if the CV vaccine recipient(s) had already had CV without realising? And maybe hadn’t had enough time to build up their own antibodies so it wouldn’t show up yet? (I read it takes quite a while)

I'm guessing they start with 1 person just to make sure no sudden adverse affects from the vaccine itself (rather than be too concerned about whether it works IYSWIM) - before then vaccinating larger numbers with it.