6 ms·

Covid vaccine passes phase 1 human trial

47 points by rntz 6y ago

lbeltrame 6y 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.
- nknealk 6y 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).
- toufka 6y 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 6y 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.
tqi 6y 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).
- boruto 6y ago
  Yes it is highly rated journal, I have not read the article yet but the headline seems like a fact than an opinion.
- Veen 6y 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.
- erentz 6y ago
  See also the PACE trial.
gok 6y ago
...which, to reiterate, just means it's not extremely dangerous to healthy people.
Awtem 6y ago
At n=109, and the multitude of reported observed side effects, I would still much prefer the virus over this supposed vaccine...
- stonogo 6y ago
  Make sure you get this information to the researchers as quickly as possible. Pandemic response hinges on whether Awtem personally wants to participate.
  - deleted 6y ago
    [deleted]
schoolornot 6y 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 6y 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 6y 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 6y 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.
LockAndLol 6y 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.
ineedasername 6y 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.

47 points by rntz 6y 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.

nknealk 6y 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).
toufka 6y 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 6y 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.

tqi 6y 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).

boruto 6y ago
Yes it is highly rated journal, I have not read the article yet but the headline seems like a fact than an opinion.
Veen 6y 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.
erentz 6y ago
See also the PACE trial.

gok 6y ago

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

Awtem 6y ago

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

stonogo 6y ago
Make sure you get this information to the researchers as quickly as possible. Pandemic response hinges on whether Awtem personally wants to participate.
- deleted 6y ago
  [deleted]

schoolornot 6y 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 6y 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 6y 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 6y 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.

LockAndLol 6y 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.

ineedasername 6y 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.