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Medicine United Kingdom

First Human Trial In Europe of a Coronavirus Vaccine Has Begun In Oxford (bbc.com) 183

An anonymous reader quotes a report from the BBC: The first human trial in Europe of a coronavirus vaccine has begun in Oxford. Two volunteers were injected, the first of more than 800 people recruited for the study. Half will receive the Covid-19 vaccine, and half a control vaccine which protects against meningitis but not coronavirus. The design of the trial means volunteers will not know which vaccine they are getting, though doctors will. The vaccine was developed in under three months by a team at Oxford University. Sarah Gilbert, professor of vaccinology at the Jenner Institute, led the pre-clinical research.

The vaccine is made from a weakened version of a common cold virus (known as an adenovirus) from chimpanzees that has been modified so it cannot grow in humans. The Oxford team has already developed a vaccine against Mers, another type of coronavirus, using the same approach -- and that had promising results in clinical trials. The only way the team will know if the Covid-19 vaccine works is by comparing the number of people who get infected with coronavirus in the months ahead from the two arms of the trial. That could be a problem if cases fall rapidly in the UK, because there may not be enough data.
Researchers say they hope to have one million doses ready by September, and to dramatically scale up manufacturing after that, should the vaccine prove effective.

"A larger trial, of about 5,000 volunteers, will start in the coming months and will have no age limit," the report adds. There's also another team at Imperial College London that hopes to begin human trials of its coronavirus vaccine in June.
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First Human Trial In Europe of a Coronavirus Vaccine Has Begun In Oxford

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  • The VA 'study' gave every patient the identical dosage, and all got the drug as they were, to borrow a phrase, already 'knocking on heavens door.'

    The dosage has to be appropriate for each subject (a 100 pound woman got the same dosage as a 300 pound man, and the subjects need to get the treatments earlier (not after you roll them into hospice care).

    • by gweihir ( 88907 )

      No, this is not a drug trial. This is a vaccine trial.

  • by spitzak ( 4019 )

    If they actually could confirm that their MERS vaccine worked, it should be possible to confirm this works, as even with a drop off there are going to be vastly more people infected with COVID-19 than MERS.

  • There is already a huge control group who have not had to this vaccine/serum. So why is this sample being split.

    • by fintux ( 798480 )
      For a double-blind study you need to have the control group that is being monitored as well so that any symptoms can be observed fairly. Otherwise the people doing the study can be inclined for a bias, even if they want to be as neutral as possible. This is true for any drug trial: one group gets the medicine, the other one gets placebo. The same people monitor people in both groups, not knowing who was given the drug and who was given the placebo. This way, the people doing the observations (or receiving t
      • And as many of us have already read, Las Vegas Mayor Carolyn Goodman doesn't understand what a double-blind study is either...

        "We offered to be a control group," she said. "I offered to be a control group and I was told by our statistician you can't do that because people from all parts of southern Nevada come in to work in the city and I said, Oh, that's too bad because I know when you have a disease, you have a placebo that gets the water and the sugar and then you get those that actually get the shot...W

        • by Luckyo ( 1726890 )

          And as many of us have already read, Las Vegas Mayor Carolyn Goodman doesn't understand what a double-blind study is either...

          "We offered to be a control group," she said. "I offered to be a control group and I was told by our statistician you can't do that because people from all parts of southern Nevada come in to work in the city and I said, Oh, that's too bad because I know when you have a disease, you have a placebo that gets the water and the sugar and then you get those that actually get the shot...We would love to be that placebo side so you have something to measure against."

          How nice of her to make sure her citizens aren't the ones taking an untested drug.

          Most people don't understand specialist concepts, because you need to actually understand a fairly large body of specialist information to get it.

          I can guarantee that most people on slashdot will not understand specific metallurgy references for example, that are however easily understood if you ever did any hobby welding. This doesn't make people on slashdot somehow deficient, nor does it mean that them genuinely wanting to help with something and making offers that don't really make sense in context of we

          • by cusco ( 717999 )

            No, you have to see more of the interview to really understand how unhinged this woman is. Think a combination of Rump and Reagan's last years, with a little meth-head tossed in. I know Las Vegas is full of weirdos, but they actually elected someone who can barely string two thoughts together, three times.

            • by Luckyo ( 1726890 )

              Possible, but my understanding (I will admit I googled the interview, but didn't see the entirety of it) is that her offer for help was genuine.

              Consider the fact that there are countless people in this very thread talking about "double blind study" when talking about this specific study that is NOT double-blind but single-blind. Doctors know who gets the actual vaccine being tested.

              Literally everyone talking about double-blind study referencing this one is just as ignorant on this specific topic as the woma

      • Thank you for trying to teach me to such eggs, come back when you understand when and why a cohort studies are more appropriate.

        My point is that there is already a huge control group of people getting infected, being monitored, so a cohort study would seem to be better.

        They did not choose that approach and I want to know the specific reason why, not vague generalities about stuff I already know.

      • by dgatwood ( 11270 )

        For a double-blind study you need to have the control group that is being monitored as well so that any symptoms can be observed fairly.

        <pedantic>For it to even be a double-blind study, you have to have a control group. :-)</pedantic>

        Otherwise the people doing the study can be inclined for a bias, even if they want to be as neutral as possible.

        On the flip side, to play devil's advocate, if you plug the numbers into a sample size calculator, a study with the rest of the population as a control requires something like one-third the study size of a placebo-controlled study to achieve the same level of statistical significance, because with a placebo-controlled study you have the odds of your experiment group not being a representative sample

    • by amorsen ( 7485 )

      You have a 5 digit userID yet you do not know why double-blind studies are the gold standard for medical evidence?

      Did you buy the account?

  • by tronicum ( 617382 ) * on Friday April 24, 2020 @03:15AM (#59983260)
    Not the first in Germany, Source: https://www.dw.com/en/coronavi... [dw.com]
    • by Luckyo ( 1726890 )

      Straight from the headline:

      >Germany's federal institute for vaccines has said it has given the go-ahead for clinical testing of a potential COVID-19 vaccine. Two phases of testing are envisaged.

      This is a political decision to ok the starting of trials, not actual starting of trials. It takes quite some time from decision being made to actual trials.

  • The design of the trial means volunteers will not know which vaccine they are getting, though doctors will.

    That means it is a single-blind study and not a double-blind one.

    • >"That means it is a single-blind study and not a double-blind one."

      Bingo! I thought the exact same thing and was surprised it was called a "double blind." If the researchers KNOW who is a control, it is NOT a double blind study. The whole purpose of a double blind study is to prevent any bias not only in those being studied, but by those who are doing the study.

      I am not saying it can't be a useful study. But calling it "double blind" is not only incorrect, it gives it a higher standard/value than it

      • by Luckyo ( 1726890 )

        Indeed, and a large portion of people here and elsewhere talking about "double blind" and mocking people for "not knowing what it is" shows just how deeply ignorant pretty much everyone is about these kinds of complex concepts.

        But in this case, from my reading of it single-blind study is more than justified. They need to have much more rapid results, and increased error margin is far more acceptable in scenario where pandemic is ongoing and every extra day matters. Double-blind confirmation run can be done

  • by AndyKron ( 937105 ) on Friday April 24, 2020 @05:45AM (#59983512)
    Here come the "corona virus trial begins..." posts. I'll just add them to all the "new super battery found..." file, which is circular.
  • First in Europe? (Score:2, Informative)

    by Syberz ( 1170343 )
    Oxford isn't in Europe, it's in the UK.
    • by Luckyo ( 1726890 )

      UK is in Europe. Are you confusing geography with politics?

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