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Comment by Traubenfuchs | Hacker News Reader

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

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

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?

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.

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.

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.

Safety test. They can also test for antibody response.

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

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?

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!

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