Perhaps publishing negative or non-novel results ought to be an equally important goal of publication. Only publishing novel results is a primary cause of publication bias: https://en.wikipedia.org/wiki/Publication_bias
I guess this applies but I keep seeing reference to the "novel coronavirus". It is new and interesting?! But i mean...feels like the point the parent is making is more correct than the virus is novel, biologists just love this word as it doesn't seem necessary here.
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.
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.
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.
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!
Not really. HIV vaccine candidates as well as trials for them have existed for decades. One of the earlier ones: https://en.wikipedia.org/wiki/AIDSVAX
The issue is just that the trials have all failed. Since the earliest vaccines, a lot has been learned about HIV and its interactions with humans, which allows advanced approaches like this one, targeting parts of the virus that we know are highly conserved.
I've been hearing about upcoming cures to horrible diseases two or three times a month for several decades and the number that pan out is a rounding error. The only noteworthy development I can think of over the past decade is a 'cure' for peanut allergies (and when I looked into it closer, it turns out it's not even a complete cure). There's apparently neither any incentive nor stomach for humanity to be realistic about how much progress we really make, which, though considerable, is not breathtaking.
Hoe it works out! But I’m not sure I understand how it works, so 13 hiv negative people not considered at risk of HIV are getting injected, how will they know if the vaccine works ? Wouldn’t you rather take two groups of people exposed to HIV, vaccinate one and compare the rate of infection of both ?
And also, I had no idea male circumcision contributed to reducing the infection rate during unprotected sex, how is that, is it because there’s less friction somehow and therefore less chances of blood exchanging between partners ?
This is most likely a Phase I human trial which only establishes the safety of the drug (or vaccine), which is why it is such a small group. Phases II and III establish the efficacy.
>"While the biological mechanism of action is not known".
Keep this in mind, and anyone reading HN should know that circumcision is quite possibly the least effective way to reduce HIV transmission. Circumcision has always been peddled as some disease reducing measure. Don't accept that on face value and research the subject. Especially Non-American sources.
You're supposed to clean under the foreskin and regularly wash male genitalia, unlike vaginas - which are self-cleaning and should never be soaped or washed. Many men in less-developed places such as poorer countries in Africa aren't taught that.
The studies that show STD rates being lowered with circumcision almost all take place in places like those, where along with poor genital hygiene, contraception (such as condoms) are used much less frequently and proper sex ed is almost never taught.
The reality is that the rates of STD transmission aren't higher for uncircumcised penises as long as proper genital hygiene is maintained.
But why would human male genitalia be so different from other male animals in the regard? I'm pretty sure soapy water isn't part of the cleaning regime other animals have...
Proper care for animals increases their life expectancy a lot as well. The difference in life expectancy between (domestic) cats being cared for by humans and living in the wild is huge: 15-20 years vs. 1.5-4.2 years.
Yet cats are self cleaning in both cases, with the SPCA saying that cats should not usually be bathed [1]. This longevity is most likely related to diet, and not being eaten by predators.
This was not meant to be a direct reply to the cleaning method.
I meant to give an example that showed that the life span of animals can easily be extended to multiple times of it just by not doing things as nature does them.
And wild animals die of small infections and deal with parasites all the time. Success is just being able to live long enough to reproduce. Being able to clean ourselves improved our health a lot.
The number of things that will reduce STD rates "as long as" you do them is very very high. I'm sure I don't need to provide you with a list.
The reality is that people don't do all of them.
Despite the claims of some activists, circumcision has no negative consequences, so if it helps, then it helps.
There's this weird messaging I see sometimes, where people are against something that can help because "you could do this other thing (but no one is)".
>"Despite the claims of some activists, circumcision has no negative consequences, so if it helps, then it helps."
It's really telling that studies in non-circumcising cultures show that the foreskin has a purpose and that removing it has an actual effect on the body. They do not recommend it as a routine practice, despite the claimed benefits. And, those benefits themselves are also questioned from an efficacy standpoint.
But studies done in circumcising cultures confidently declare that such a densely innervated piece of tissue made to protect a mucous membrane does nothing of value, removing it has no negative consequences, and that its removal has no negative impact whatsoever on sexual function.
These two schools of thought are mutually exclusive.
From what I've read, and heard from friends in Kenya (where circumcision is a prevalent tradition and the area has a high infection rate), is that circumcision reduces the infection rate because it hardens the skin of the penis - meaning less abrasions and cuts, meaning less blood mixing/contamination.
That and some studies have made the error of including recently circumcised men in their circumcised group, which drops their rate of infection drastically because they don't engage in sexual activity during the recovery period of their operation.
