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Comment by humanfromearth | Hacker News Reader

So have they developed a vaccine, but they need money for trials, delivery..? How exactly would they go about and test if it works on humans? Are there people who volunteer to get infected with HIV?

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I'm Ian Cinnamon, one of the members of the Immunity Project YC team. We have in fact developed the vaccine. We've completed 2 years of animal testing, and we have one final experiment to run before we start our Phase I Clinical Trials in humans. In order to test the efficacy of the vaccine in human trials, we go to Durban, South Africa, where HIV has a prevalence rate of ~15%. We dose a wide range of healthy volunteers, and we check back again at regular intervals to make sure they have no contracted HIV. We're also able to perform a wide range of laboratory tests to show the dosed human blood is now immune to HIV.

Ian- YOU developed the vaccine for HIV? Were you part of some team from a university? Or did some other company develop the real science and you are partnering with them? How can you offer everyone in the world a free vaccine for your crowdfunding target of only $500K? where does the money you raise go?

If you look at the fundraising page they have a budget but it looks like the $500k just pays for the next experiment it wont even get them to Phase 1. Microsoft Research gave them $1M to get this far.

I did some more research and would really like a clarifcation of this project.

First of all - Flow Pharma is the inventor of the vsaccine - they are a FOR PROFIT angel backed company. Why do they need crowdfunding?

Second - How does Immunity project work? It seems that the real non-profit is "Until there is a cure". So you are donating money to them, which then give the money to the immunity project which pays for a trial of an unproven drug for a FOR prfit company.

This is a fantastic project and I promise I will donate if you have full disclosure. thank you for doing this.

More then happy to give you the full details on how we've set this up: the vaccine is being developed by Flow Pharma Inc. Instead of setting up our own 501(c)3, we setup a fiscal sponsorship agreement with Until There's A Cure, a leading HIV/AIDS focused 501(c)3. We are operating the project as a non profit even though our entity type is technically a corp. In other words we are obligated to follow 501(c)3 rules and regulations, and we are obligated to give our vaccine away for free regardless of our entity type. The primary reason we did this is because its much better to work with a well established 501(c)3 that has team members who can help provide validation and support then to start from scratch on your own. It is also much faster to do this then setup your own 501(c)3.

Thank you very much for your response! Unfortunately, I do not think you actually answered my questions!

* Why does Flow Pharma need crowdfunding when they are FOR PROFIT? * How can you guarantee FREE vaccines for everyone for only $500k? * What will the crowd founding be spent on and will there be follow on investing needed? * What is the future of Immunity Project? Have you begun your application to be your own official non-profit?

EDIT: I seem that someone else answered a part "Dr. Reid Rubsamen, developed the vaccine is part of the Immunity Project", but does not explain the exact relationship with Flow Pharma?

Our Immunity Project Science team, led by Dr. Reid Rubsamen, developed the vaccine. The $500K pays for our final experiment before we begin our Phase I Clinical Trials. We've already conducted over a decade of research and two years of pre-clinical trials with overwhelming success.

> How exactly would they go about and test if it works on humans?

Presumably, the same as the other HIV vaccines that are in trials.

> Are there people who volunteer to get infected with HIV?

There are people who volunteer for vaccine trials. They don't need to volunteer to get infected with HIV -- basically, you get a large enough experimental and control group, study risk factors in the groups, and track infection rates, and evaluate whether, based on that, the vaccine reduces infection rates.

For human trials of this nature, typically at-risk populations can be used, and it's seen if there's a reduction in infection rates.

Exactly. In this case, we're lucky enough to use an amazing clinic set up in Durban, South Africa, which has a ~15% prevalence rate of HIV.

This sounds great. I'm genuinely interested, how is the potential vaccine going to be presented to volunteers in Phase I? And do you also deliver a placebo vaccine for blinding?

It seems like believing you are vaccinated would increase risky behaviour. This is bad in itself. It is also bad if the vaccine is only partially effective, since the risk effect might balance the vaccine effect.

With a placebo, knowing you only have a 50/50 chance of getting the actual trial vaccine might also help mitigate the risk effect.

Anyway, just wondering how all this works. Finding an effective vaccine would be fantastic; keep up the good work!

Thank you for your support! Yes it will be presented as a double blind, placebo controlled study. Regarding the risky behavior point, this is a well known challenge with all vaccine studies. And yes telling people that they don't know whether or not they have the actual vaccine helps in mitigating the risk effect.

> It seems like believing you are vaccinated would increase risky behaviour. This is bad in itself. It is also bad if the vaccine is only partially effective, since the risk effect might balance the vaccine effect.

But this will also be true of the vaccine as employed in reality, and thus a useful piece of information to capture.

Yes we've developed a vaccine prototype and we are raising funds for the final experiment before we start working with the FDA to file our IND and start working on our phase I clinical trial. In terms of testing on humans, the first thing you do is dose healthy volunteers and withdraw a blood sample to test for an immune response. Then assuming success in phase I, in a phase II trial we will dose high risk healthy volunteers and see if they get HIV over a time interval.

Monkeys. After all, the HI virus originates from apes and they are similar enough to humans for clinical tests. And as for "ethical research", once you know the vaccine will not harm you, give it to a big enough group of "risk people" in Africa or another HIV hotspot and look if they, compared with a placebo group, are immune from HIV.

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