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Covid vaccine passes phase 1 human trial

thelancet.com

47 points by rntz 6 years ago · 23 comments

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gok 6 years ago

...which, to reiterate, just means it's not extremely dangerous to healthy people.

ineedasername 6 years ago

This does not say that the vaccine is actually effective in preventing infection. That is not the point of phase 1 trials, and there was no statement to that effect.

What they have demonstrated is preliminary safety of a possible vaccine through no severe adverse effects, and also that it did produce some type of immune system response.

Phase 2 trials will begin to determine the actual effectiveness of the vaccine.

lbeltrame 6 years ago

Compared to the other vaccines in study, this one has a significant limitation: a lot of the population has antibodies against the Ad5 vector used to deliver the antigen, which significantly lowers the efficacy. High doses to contrast this effect were met with adverse events, so this means that Phase 2 and 3 protocols will need to be adjusted.

  • toufka 6 years ago

    Would the use of the Adenovirus vector used here foreclose future gene therapies delivered with a similar vector? If so, that could devastate in one go a lot of people’s ability to get specific therapies as they start to come online in the next decade.

    • lbeltrame 6 years ago

      It is actually a very known problem for gene therapies. IIRC, similar vectors were used in the past, with the same problem, of course.

  • nknealk 6 years ago

    Here’s the critical paragraph from results. I think another path forward would be to keep the low/medium dosing but titer for lack of Ad5 antibodies before qualifying a patient for the vaccine.

    > Before vaccination, 20 (56%) participants in the low dose group, 19 (53%) participants in the middle dose group, and 16 (44%) participants in the high dose group had a high pre-existing Ad5 neutralising antibody titre (>1:200). Only five (25%) participants of 20 in the low dose group, seven (37%) participants of 19 in the middle dose group, and ten (63%) participants of 16 in the high dose group, who had high pre-existing Ad5 immunity, had at least a four-fold increase in neutralising antibody titre at day 28 post-vaccination (appendix pp 8–10). Multivariable analysis showed that high pre-existing Ad5 neutralising antibody titres compromised the seroconversion of neutralising antibody post-vaccination, regardless of the vaccine doses, and recipients aged 45–60 years seemed to have lower seroconversion of neutralising antibody compared with the younger recipients (appendix p 11). The Ad5 neutralising antibodies were significantly boosted post-vaccination (appendix p 12).

LockAndLol 6 years ago

> Our findings suggest that the Ad5 vectored COVID-19 vaccine warrants further investigation.

It's good that they aren't expressing this like a "Eureka, we did it". At least we have one candidate. Let's see what else comes our way.

tqi 6 years ago

Is The Lancet considered a good/unbiased journal? As someone who is not a medical researcher, my awareness of it comes mainly from their various controversies (link between vaccines and autism, Iraq war deaths, letter for Gaza, etc).

  • Veen 6 years ago

    It is generally well-regarded. Its editors have a political position that is occasionally exhibited in the publication of agenda-based content, but for the most part and with all the usual caveats it is trustworthy where scientific papers are concerned.

  • boruto 6 years ago

    Yes it is highly rated journal, I have not read the article yet but the headline seems like a fact than an opinion.

  • erentz 6 years ago

    See also the PACE trial.

Awtem 6 years ago

At n=109, and the multitude of reported observed side effects, I would still much prefer the virus over this supposed vaccine...

schoolornot 6 years ago

Zero chance the American public are going to tolerate wide distribution of a vaccine from a Chinese company. And with the side effects, I can't imagine how it will be presented. Plus the study is only 18-60 which excludes the high risk population.

  • nate_meurer 6 years ago

    Nope. It sucks that China has a such a stranglehold on pharmaceuticals, but I guarantee you 100% that almost nobody will give a shit where a vaccine is made if it's perceived to be safe and effective. The vaxxers don't care where it's made, and the rest of us will only need to be convinced that it's safe enough given our individual conditions.

    I think it's a safe bet that there will be multiple different vaccines. What you get will be determined by availability firstly, and safety profile if necessary. It's really no different from any of the medicines we already use. For example, the vast majority of antibiotics are manufactured in China; have you ever heard of someone turning down antibiotics because they were made in the wrong country?

    • djsumdog 6 years ago

      > if it's perceived to be safe and effective

      Safe vaccines take years or decades. I personally get all my shots, but I'm not about to take a vaccine developed in two years! Especially if I'm not in the high risk group. I don't think it would be unreasonable for people to wait 5~10 years and see the effects of early adopters first.

      • sterwill 6 years ago

        Vaccines for seasonal influenza are prepared each year, about six months ahead of flu season to leave time for manufacturing. Do you avoid those when you get all your shots? We've been making these for decades and they seem as safe when they hit the general population all at once as any other vaccine.

        I'm sure a SARS vaccine is a completely different animal, and I don't know enough about viruses to know how hard it is to make a safe coronavirus vaccine, but your objection seems to be entirely about the timeline.

        • djsumdog 6 years ago

          I should have gone into more detail, but it's because of many of the things you mentioned. Flu vaccines are not "new" .. the procedure for making them is well known and many strains are made and kept ahead of them. (I believe they're all inactivated virus, typically bread in chicken eggs). They aren't made in six months; they took decades to develop the process where strains can be isolated, inactivated and combined in a shot.

          SARS1 vaccines had some very troubling imunopathic responses and feline SARS1 vaccines made reinfections worse. This will be a totally new vaccine, for a virus family we've never developed vaccines for before, and some of the techniques they're using (the DNA/RNA technique pushed by Gavi/Gates) has never had a vaccine make it through a clinical trial before.

          Those are the troubling things. I wrote more about it here:

          https://battlepenguin.com/politics/this-is-not-a-time-of-hon...

  • doopy1 6 years ago

    Phase 1 is intended to exclude the high risk population, and most of today's medications are made in china.

  • blackrock 6 years ago

    The thought experiment is fascinating.

    Say, the United States votes Trump in for a 2nd term. And he goes on a media blitz to convince people to not take the China vaccine.

    Meanwhile, the rest of the world takes it. The vaccine is ultimately successful, and Covid-19 is effectively eliminated.

    What will happen to the United States? Will the virus continue to ravage the country and the economy? Meanwhile, the rest of the world begins their economic recovery.

    Never could I imagine that this idea would even be a probability. But yet, here we are.

    • djsumdog 6 years ago

      > Trump in for a 2nd term. And he goes on a media blitz to convince people to not take the China vaccine.

      Why would he do that? He's in the pockets of big pharma. The president is pretty much a puppet. Both Biden and Trump will push any vaccine presented to them by the big pharma giants (Gavi/Gates/GSK/Bayer/etc.) because that's the base that supports them. Biden and Trump may promote different vaccines from different companies, but it's just depends on which one gets elected and which particular giants are backing that candidate.

    • Proven 6 years ago

      > Say, the United States votes Trump in for a 2nd term

      Does that need to be hypothesized about? Of course he will win.

      If you like your Chinese vaccine you can take your Chinese vaccine.

      The more people want it, the less value it has for people not eager to take it.

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