3 ms·

Thirteen adults? It‘s actually incredibly unlikely to get HIV, how does this study have any worth? Wouldn‘t it need thousands of participants?

tootie 5y ago
Safety test. They can also test for antibody response.
markus92 5y ago
Phase 1 trial, just to see if they are fine and if there’s any major safety signals or not.
- anitil 5y ago
  I can imagine the ethical approval for this would be difficult, because I think people would be more likely to engage in unsafe sex if they're in the trial. So participating could expose them to more risk than they would otherwise be exposed to. Do you know how they work around this?
  - Ballas 5y ago
    I don't know the answer to your question, but the trials would still be double blind, right? Knowing that I might have been vaccinated would certainly not affect my decision process.
  - e7dyxhwhe 5y ago
    Participating wouldn't be what exposed them to higher risk in the situation you've outlined. This is the sort of strategic wordplay I'd expect from the social sciences.
    - anitil 5y ago
      I think it's a legitimate, if small, concern. There's a possibility that people participating would be more likely to take a roll of the dice. Yes it's stupid, but people do stupid things all the time, particularly when it comes to sex. Obviously I'm all for the research, I'm just interested to hear if/how they handle it.
verelo 5y ago
I initially downvoted this, but now i'm upvoting it as the comments it exposed probably educated a lot of people on how the phases of testing work. Thanks for not being afraid to ask the question!
Gibbon1 5y ago
I remember a Phase 1 Trial for a drug (TGN1412), all six volunteers suffered serious reactions within an hour of being dosed. Four suffered multiple organ failure. https://en.wikipedia.org/wiki/Theralizumab https://en.wikipedia.org/wiki/Theralizumab
- sterlind 5y ago
  the trial design for that was extremely negligent. Phase 1 dosages - which should be low for first-in-man - far exceeded what was tested in animals by mg/kg, resulting in the drug completely saturating its target receptor. Derek Lowe covered the story years back when it happened, my knowledge comes from him and wikipedia. edit: not to mentioned they dosed six people at once! what the hell?

tootie 5y ago

Safety test. They can also test for antibody response.

markus92 5y ago

Phase 1 trial, just to see if they are fine and if there’s any major safety signals or not.

anitil 5y ago
I can imagine the ethical approval for this would be difficult, because I think people would be more likely to engage in unsafe sex if they're in the trial. So participating could expose them to more risk than they would otherwise be exposed to. Do you know how they work around this?
- Ballas 5y ago
  I don't know the answer to your question, but the trials would still be double blind, right? Knowing that I might have been vaccinated would certainly not affect my decision process.
- e7dyxhwhe 5y ago
  Participating wouldn't be what exposed them to higher risk in the situation you've outlined. This is the sort of strategic wordplay I'd expect from the social sciences.
  - anitil 5y ago
    I think it's a legitimate, if small, concern. There's a possibility that people participating would be more likely to take a roll of the dice. Yes it's stupid, but people do stupid things all the time, particularly when it comes to sex. Obviously I'm all for the research, I'm just interested to hear if/how they handle it.

verelo 5y ago

I initially downvoted this, but now i'm upvoting it as the comments it exposed probably educated a lot of people on how the phases of testing work. Thanks for not being afraid to ask the question!

Gibbon1 5y ago

I remember a Phase 1 Trial for a drug (TGN1412), all six volunteers suffered serious reactions within an hour of being dosed. Four suffered multiple organ failure. https://en.wikipedia.org/wiki/Theralizumab https://en.wikipedia.org/wiki/Theralizumab

sterlind 5y ago
the trial design for that was extremely negligent. Phase 1 dosages - which should be low for first-in-man - far exceeded what was tested in animals by mg/kg, resulting in the drug completely saturating its target receptor. Derek Lowe covered the story years back when it happened, my knowledge comes from him and wikipedia. edit: not to mentioned they dosed six people at once! what the hell?