We are creating the HIV/AIDS vaccine to give away to the world for free. Dr. Rubsamen, Co-Founder of Immunity Project here. AMA.

Why have you provided no sources or scientific background on your website?

We have submitted our manuscript with our animal data for publication in a PRJ - we will link to the article as soon as it is released!

If I may ask, what journal? When did you submit? It seems a bit fast to move on to human trials before the animal trials are published. (Speaking from personal experience in extremely cautious publishing/funding schedules)

We have submitted to Vaccine. Our funding is not dependent on the publication. We aim to start FDA Phase I clinical trials this year.

Just wondering why, if this is a potentially revolutionary vaccine, it's not in one of the holy trinity journals? Why not aim high?

Great question! Nature, Science at al cover science broadly and need articles of general interest to scientists across disciplines as well as non-scientists. Our work to date is more relevant to speciality journals interested in the vaccine and drug-delivery domains.

If you don't mind. Who are the first and last authors on the manuscript?

No problem! I am the first and Dr. David Heckerman is the last!

What about previous research that informed this project? It would be nice to see what you are basing it on. Would you consider adding a more sciency FAQ for researchers who want more background?

You can take a look at this -

Jain, S., D. O'Hagan, and M. Singh The long-term potential of biodegradable poly(lactideco‑glycolide) microparticles as the next-generation vaccine adjuvant. Expert Rev. Vaccines, 2011. 10, 11 DOI: 10.1586/ERV.11.126.

Thanks for the suggestion! For sure we need a more science-oriented FAQ! We will get to work on that.

If this was compelling enough, wouldn't it be easy to get the Gates Foundation behind this? Seems like small money compared to the problem and if the case was strong enough, I'm sure he'd put up the cash.

I have spoken with them and they are really great people! Like the NIH, with some positive human clinical data we can get them interested in our approach. We need crowd funding to get us to that point. Hence, pledge.immunityproject.org. Thanks for your support!

Great news. Thanks for the reply!

[deleted]

There is also no good science on their site. This is a big red flag for me. Their reason seems plausible, but I'll probably wait until they have something to show to donate.

Hi Soulbandaid! We actually just released our white paper- check it out: http://bit.ly/1ebKRTP

You're welcome! :)

Will it always be free?

Our primary mission is to end HIV/AIDS. In order to accomplish this goal the vaccine has to be free. There are far too many people who are living with HIV who could never afford a commercial drug. Therefore the answer is yes!

I've got no question, but I just wanted to thank you for what you're doing. Here's wishing you all the very best!

We really appreciate your support! Please remember to donate at http://pledge.immunityproject.org

Why are you forgoing NIH funding and focusing on crowdsourced funds? You realize this looks a little sketchy to the medical community?

Also, are you publishing anything soon in a peer-reviewed journal?

Edit: your website has some great design; I would just like a little more science.

HIV vaccine research, including that funded by NIH, has largely been based on neutralizing antibodies. We are taking a different approach – we need to generate some human data to get funders like the NIH interested in our approach.

Couldn't you just pay a university laboratory, with hands on experience with murine infection with HIV, experienced personal, and already in possession of likely superior lab equipment (60k seems rather low for a FACS machine).

What you're describing seems like it could be accomplished in a couple of weeks by a lab that already had the equipment and expertise necessary.

We have spot-on expertise to do these experiments. We actually found a $60K FACS machine on Bio Surplus! University overhead makes working in University labs very expensive. Also, University teams would have to task us in - I've had great experiences working with University labs in the past but speed was always an issue.

Thank you very much for answering my question. I'll have to look into Bio Surplus!

If you don't mind me asking are you planning or renting lab space from a facility that provides space for independent researchers like your team, or will you be setting up your own laboratory from scratch.

If your starting your own laboratory from scratch, are finding the process relatively easy or have you found the regulation and certification etc to be burdensome?

I ask because I am finishing my PhD in the next few months and am in the process of founding my own Biotechnology company, and so will be faced with the same decision that your company has, is, or has already made.

Thank you very much for your time!

We got really lucky and found a (really old!) lab that looks pretty good to expand into for low rent. We are doing most of the work ourselves. Right now we outsource animal handling to a specialty lab and we have our elisopt plates read by an outside vendor. HPLC, tissue culture, sample prep, sphere sizing (except SEM imaging) and formulation development we all do in house. We also have access to a machine shop to make the sphere manufacturing equipment. If I can give you any tips, please email [email protected]. Thanks for your thoughtful questions!

I'd like to see some more published research before getting excited about this. Good luck!

Thank you for your support! We've submitted our manuscript and data to Vaccine and we will link to the article as soon as its published.

Four questions:

1) How is your approach different from other HIV T cell-inducing vaccines (http://www.plospathogens.org/article/info%3Adoi%2F10.1371%2Fjournal.ppat.0030157, http://www.ncbi.nlm.nih.gov/pubmed/24166483, http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0086254 among others) that likely include the same conserved regions that you intend to target?

2) If your immutable region of the virus proteome is small, what is the likelihood that the majority of the population will have HLA class I molecules that can bind peptides derived from this region?

3) What do you mean when you say the vaccine will be free? That there will be no royalties or patents? That it can be manufactured by any group free of charge without licensing? That all components of the vaccine will be gifted from the supplier?

4) From 2000-2010, there are hundreds of articles describing HIV-specific T cell responses in general and immune responses mounted by HIV controllers in particular. How is your approach distinct from and superior to these studies?

Thanks!

1) We are targeting a single, specific epitope.

2) The epitopes in the vaccine will be HLA restricted - we will need a master vaccine "cocktail" with enough epitopes (maybe two dozen) to cover relevant multiple HLA types.

3) We want the vaccine to be free to the end-user.

4) We are developing a vaccine that will be able to make essentially anyone a controller by creating killer T cell clones that will attach HIV at the same points favored by the controllers. Thanks for your questions!

Thanks for the answers - can I ask a few followups?

1) Is there any evidence from any system (HIV/other viruses where T cell responses are important for control but are not as variable as HIV) that a single T cell epitope can confer protection?

2) Fair enough, but wouldn't this mean that you would need different formulations for different parts of the world where HLA types are different? Are the different clades of HIV found in different parts of the world completely sequence identical in any part of the viral genome?

3) Couldn't the same claim be made for anything whose delivery to end-users is completely subsidized by someone else (e.g., I want to build a "free cell phone", but it is only free if someone else pays for it)? Can you also comment on licensing? Are all the components of the vaccine free-to-use and manufacture by anyone, including generics manufacturers?

Thanks again!

1) As far as I know, we are the first.

2) We plan to make an all-clade master vaccine.

3) Yes. We hold the IP and will make sure all licenses are provided for free all the way for the end consumer.

You're welcome!! :)

Wow, first AMA where I saw the author reply to the follow up questions. Wow.

I try! :)

Realistically, how close do you think you are to developing a working HIV vaccine that can be mass-produced on a workable scale, meaning cost and resources don't limit quantity?

We are raising money currently for the final experiment before we approach the FDA. This experiment will help us see how close we are now to having a working vaccine. We are designing the vaccine for manufacturability from the get-go. We plan to use the same manufacturing process for large scale manufacturing by building more of the same spray-drying modules we use today.

Flow Pharma is the inventor of the vaccine - they are a FOR PROFIT angel backed company. Why do they need crowdfunding? What is your exact relationship with them?

Hi opendomain, thanks for your question! I am CEO of Flow Pharma, Inc and Immunity Project. Immunity Project is a non profit initiative in partnership with Flow Pharma, Inc.

Yes, Flow Pharma is a for-profit company and we have developed all of the delivery technology for the Immunity Project HIV vaccine prototype. While Flow Pharma is a for profit entity, our HIV vaccine is a 100% non profit project. To facilitate this we setup a fiscal sponsorship arrangement with HIV/AIDS focused 501(c)3 Until There's A Cure. What this means is that any funds that are donated to Until There's A Cure via our crowd funding campaign for the Immunity Project are then given to us to use solely on our HIV vaccine project. And we must operate our project in a 100% non profit manner. The reason we did this is because we wanted to partner with an existing, well regarded 501(c)3 vs. setting up our own, and we wanted to expedite our work (setting up a 501(c)3 takes a long time). To be clear I am required to operate Immunity Project as a non profit in every way, and to distribute our vaccine worldwide for free.

We need crowd funding and donations because our project doesn't have a profit motive so we cannot finance it with venture or angel capital. Our mission is to end HIV/AIDS and in order to do that we need to give our vaccine away to the world for free. Please let us know if you have any other questions!

Thank you for the reply! I may be able to generate a large donation for the project. I am the founder of OpenDomain - a non-profit that gives domains (some worth millions) to open source groups for the past 15 years. I recently created a new non-profit: CharityCoin - we mint silver and gold coins with Celebrities for charities like the immunity project. Please see http://cplace.beepweb.co.uk/ for our demo site and contact me at reddit @ charitycoin dot org

Hi opendomain, thank you very much for your kind offer! We will email you right away. We would love to learn more about what you are doing and work with you to fund our project!

Do you take bitcoin donations?

We certainly do! http://www.immunityproject.org/bitcoin

Loved the idea so much I donated on the first day and shared on every possible social media available.

If everything else fails, you are at least revolutionizing medical research funding: you are the second non profit on YCombinator, and you're using crowdfunding. What do you think the future of medical research funding will be? Will these new methods (or other innovations) be the main source of funding, in your opinion?

Hi rjtavares, thank you for your support! We in the medical research community need to focus on solving problems. There are millions of people living with HIV who could never afford any commercial medication. Therefore why even both trying to charge? Our hope is that Immunity Project serves as a model for other researchers with the same mission driven focus. If there are any researchers who want to pursue a similar approach, we would be more then happy to help them in anyway we can!

Thanks for the answer!

Follow-up question: I'm a big fan of Paul Graham and YCombinator, but their experience is far from this particular field. What do you think they can add to the project?

Paul Graham, Paul Buchheit, Sam Altman and the entire team at Y Combinator have been absolutely incredible. They have by far the best experience on how to build great organizations, and focus on whats important whether the goal for profit, or non profit, biotech or not. Without their help we wouldn't have setup pledge.immunityproject.org! We are honored to be a part of the Y Combinator W14 batch!

But your "vaccine" wouldn't heal people with HIV. It's not a vaccine for those of us already ill, is that correct?

This would only prevent future infections. Those of us struggling with the illnesses and the virus...we wouldn't benefit from what you're discovering. Is that correct?

I'm so sick of waiting for a fucking vaccine so that everybody can breathe a sigh of relief and wait for those of us already infected to just die off.

I hear you! The approach we are taking MAY help people living with HIV with normal CD4 counts (e.g. people taking HAART meds). We have to study this carefully before we will know! We would love to be able to help you! Shoot us an email at [email protected] and we can discuss further.

Is this something that can be used on current HIV infections or is it solely a preventive measure?

Thank you for your question! We need to test this but our vaccine may have the potential to be therapeutic. The approach lends itself to that possibility but testing is required to confirm our hypothesis.

As a microbiologist with infectious disease background: You guys are awesome. Take my money!

Question: What's a best- and (semi-, we don't want it just plain not ever working)worst-case estimate of when this will be available 1) In the western world and 2) In sub-sahara Africa?

We can begin testing in Sub Sahran Africa about 6 months after the US FDA clears our IND (due to the African regulatory authority review process). Phase I, II testing should be done by 2016 or early 2017 - may be possible to start Phase III in late 2016 or early-mid 2017. Phase III could be completed in a high-infection rate place like Durban in two years. Best case scenario for approval in the US would be probably 2019-2020.

Sounds pretty fast-ish for a new drug. Then again, for something charitably crowd-funded, it's hella fast. Those billions of research cash Bayer et al burn through tend to speed things up a lot I imagine.

Expect a 10³ shoved your way when(if) my massive bonus actually shows up. I'll also be spreading the word around the lab, if you don't mind.

We would love to speed things up further with billions in the bank account! But for now, crowd funding it is. We really appreciate your support. And when that big bonus does show up... you know where to go... http://pledge.immunityproject.org

Assume everything goes as planned and you are able to start distributing the vaccine worldwide. Are you concerned you'll meet the same resistance that the Polio Vaccine is meeting in the Middle East and Africa? And if so, what do you think can be done to avoid this?

Controllers have been followed for many years now and their "immune system strategy" keeps on working. If we can successfully copy their approach, hopefully resistance will not be an issue!

I think you may have misunderstood my question. By "resistance" I don't mean resistance in the medical sense- I'm referring to people in these regions refusing to take the vaccine, spreading anti-vaccine propaganda, and in some cases attacking and killing workers who are there to give out the vaccine.

These problems seem to stem from a general distrust of western culture and I'm curious if you think it will be a problem for you when you get to the stage where you're ready to distribute it in those regions, and if so what you plan to do about it. It's more of a public relations question than a medical question I suppose.

Thanks for your time! Sorry for the confusion.

Sorry I miss understood! The environment in Durban looks pretty receptive based on my conversations with investigators there although I am not an expert on the subject

Seeing as the cold chain poses a considerable obstacle to vaccine dispersal, is this vaccine stable at room temperature? I'd imagine distributing the vaccine in warmer climates (Africa, parts of Asia, etc.) where continuous refrigeration may not be available would prove difficult otherwise.

Our vaccine is being designed in a nasal dosage formulation (as opposed to a needle injection) This means it will be in powder format, inert at room temperature, and will require NO refrigeration at any time. Pretty cool, huh?

I appreciate all you guys are doing! I've been HIV+ for about a year now and just got my viral load to an undetectable level, a vaccine would be life changing.

Thanks so much for your kind thoughts and encouragement!!

I am REALLY glad you are getting a good response from therapy!!!

Have any companies tried to stop you guys yet?

With all of your guys help and support, no one can stop us! Thank you for helping us make Immunity Project happen!

Why did you choose HIV/AIDS to cure. Do you know anyone with AIDS personally?

I was an intern in medicine in San Francisco in 1986. I had unusually good training in immunology for the time at Stanford where I actually got to use one of the first FACS machines (cell sorters) in Dr. Leonard Herzenberg's lab - now commonly used in immunology research. Despite all this, we could do nothing to help any of the inpatients with a diagnosis of AIDS. Although we don't routinely see young people among us dying of AIDS, the problem is extremely severe in places like Durban. Immunity Project represents what I think is the best IT/Biotech collaboration in history. This is a great opportunity for me to leverage my medical and computer science background to make a safe and effective HIV vaccine.

I'm curious, what are the estimated monetary and time costs to develop the vaccine? I understand these would be very loose numbers. Just generally curious.

Round numbers:

We need less than $500K to finish this experiment, $25MM to complete Phase I (if we really squeeze the buffalo off of the nickel!) and another $20MM to complete Phase II. Phase III will require an order of magnitude more funding to complete.

But if you get to phase III, won't the Gates Foundation back you up to a certain degree, making the funding a non-issue?

Absolutely. Once we get to Phase I, foundations such as the Gates Foundation will come into play. They've already expressed interest, but want to see initial Phase I Human trial data first.

Your project is called the "immunity project" but it's a misleading name: according to your website you don't give people immunity, you just make them into carriers:

Controllers have detectable levels of HIV virus in their blood. Therefore, we don’t know if we can prevent transmission.

I don't want to sound callous when I say this, because I really want to see a cure for HIV. But if controllers can infect others with HIV and never get AIDS themselves, aren't they the most "dangerous" of infected individuals? By creating a treatment that creates more of them, is there the risk that HIV might spread even more: even though you might relieve suffering of some, not everyone might be able to afford or get access to your treatment?

It's a really good question! Controllers are born with some (small) number of T-Cells pre-programmed to hit an epitope critical to preventing the evolution to AIDS. I want to see if our vaccine can set up a more "potent" immune response resulting in more T-Cells going after targets. We now know that an HAART blood level in an HIV negative person can prevent HIV transmission (to them). Maybe a fast, robust T-Cell response to an acute infection would do the same thing. We won't know without clinical data.

Do you think this approach can be used for developing other drugs useful for mankind in the future ?

Absolutely!! We are solely focused on HIV at the moment, but are very excited to explore this in the future.

Has this been tested on any humans yet?

Hey riveroaken! We have performed an ex-vivo test with human blood. The experiment we are crowd funding right now will test the vaccine in human blood in an external environment (humanized mice). We aim to test in live humans this year during our Phase I Human Clinical Trials.

Thanks for the response. Do you see any big pharmaceuticals jumping on board to fund?

Not at this time. It may be difficult for Big Pharma to get their arms around a non-profit effort like this - but maybe not!

When/if this reaches FDA approval who will this be targeted to?

Our goal is the end of HIV/AIDS so we want to reach everyone starting with those at highest risk for HIV infection worldwide!

Good afternoon, Doctor! Thank you so much for coming to reddit.

I just one simple question. Do you have any thoughts on string cheese as a snack food? Do you enjoy it?

My kids love the stuff and send me to the fridge hourly to gat it (we buy the really large packs from Costco) - I often grab one for myself!!

How close are you to a cure?

Our vaccine is being designed to upgrade your immune system to give you the same power as HIV Controllers. There is a possibility the vaccine will also function similarly to a "cure", acting therapeutic for those already infected with HIV. Thank you for your support!

This may sound like a stupid question, but how do you even know this will work?

Not a stupid question! We think it will work because we are trying to copy the immune system behavior of HIV controllers - individuals who get the HIV virus infection but who do not progress to AIDS.

Fair enough. Will it cure the virus completely and make people immune or put it into a state of remission for those who have it already?

We are hoping that people living with HIV who also have a healthy immune system (e.g. people on HAART meds with normal CD4 counts) will benefit from a vaccination with our vaccine - ideally be able to stop taking HAARTs. No way to know this without careful clinical testing.

My big brother died due to HIV/AIDs complications. Thank you for what you're doing and know you're appreciated deeply.

I'm so sorry for your loss. I have seen many of my patients die from this horrible disease and they all became my friends.

Are you gonna get to work on herpes and other viruses after HIV/AIDS is taken care of?

Great question! Sure, if there are controllers for herpes or other diseases we may be able to help there as well.

So aside from the crowd funding, how can we help both promote what you are doing and keeping the distributors (when it us in production) honest?

We need help keeping the black helicopters at bay! Kidding! Please tell anyone who you think might be interested or benefit from our work or approach! We hope what we are doing gives other mission driven research teams a path forward with their projects. With regards to the distributors, we will be reaching out if we run into any trouble. We hold the keys to the castle so we are confident we can keep them honest.

Quite possibly the greatest thing i've read all year if true. How close are you to "creating" it?

If we achieve our funding goals for the Phase I clinical trial (separate from the experiment we are raising money for now) we can be testing in humans this year!

Reid, how many mice are you planning on infected? Are you planning on doing a series of infections or just one?

Hi Surf_Science, thank you for your question! Our plan is less then 50. We are vaccinating the mice, taking the blood out and then infecting the CD4 cells.

Do other scientists/researchers believe you will succeed? How will it be decided who gets it, if it's free how will it be paid for (I'm assuming the crowd funding is for the research?) Last one isn't a question but a good luck, I hope it works out message instead

We are getting tons of great support from the scientific research community. We are targeting anyone and everyone for the vaccine, but may start in regions with the highest infection rates. It will be paid for by everyone who wants to see the end of HIV/AIDS

What's you favorite color?

Green, obviously! The color of my scrubs!

Do you fear that the whole idea of it being free could go wrong, like some big pharmaceutical company making a huge con and try to make profit from your vaccine?

Hi blocodents, thank you for your question! We are fearless! We are firmly committed to making our vaccine free no matter what curve balls are thrown our way.

What happens if the vaccine is unsuccessful?

We are designing the vaccine to be as safe as possible. We are tuning the formulation using animal models to have the best shot at getting an immune response in Phase I. I have a lot of confidence in the target selection - hence a lot of confidence in success as we go forward!

Not quite relevant to your vaccine, but are there any tests still out there to determine whether an individual has the Delta32 gene? I read that 23andMe was doing it but with the recent FDA crackdown on 23andMe I doubt they still do as they pulled all their health testing.

Was that the one that made you basically immune to HIV due to receptor stuff going on (Yeah, HIV is so NOT my field), or was it the one that, ELI5, gives the carrier a built-in antiretroviral?

I seem to remember quite well that a guy in Berlin (HIV+) Got his leukemia cured via bone marrow transplant, and later had a routine viral load test (any many after that one) which showed no detectable HIV.

My original question had a slight inaccuracy- the gene is CCR5, the mutation in question is called delta32.

That mutation makes you immune to HIV by altering one of the receptors that HIV uses to get inside white blood cells. And yes, Timothy Ray Brown received a bone marrow transplant from a donor that was homozygous for that mutation and afterward showed no evidence of HIV infection. The delta32 mutation doesn't appear to be very uncommon in caucasians but it must be homozygous to confer immunity so only about 1% of caucasians are technically immune.

Interestingly, I just read that there there is a hypothesis that this mutation also protected against smallpox and thus was selected for in those of European ancestry. (source)

Interesting! Of course, the CCR5 mutation basically provides cells with a "cellular force field" preventing entry of HIV - different from something you could do with a vaccine.

Isn't this what you're essentially trying to accomplish? I read your FAQ- needs more science btw- and I am not familiar with the term "HIV controllers" but I assumed that this mutation was what you were referencing.

Gotcha! Our vaccine is being designed to guide Human CD8 killer T-Cells to attack HIV at the same targets favored by the controllers. We are not providing a physical blockade to HIV entry as seen with CCR5.

Who or what is your biggest influence in regards to your career path?

My father, who said "the greatest opportunity occurs at the interface between two disciplines" which is why he became a doctor and lawyer focused on patient safety.

Strong T cell responses to HIV have been demonstrated hundreds of times in the HIV field already, and an HIV T cell vaccine that targeted conserved viral proteins has already been evaluated by a Merck phase II clinical trial. It was shown to demonstrate no effect on viral loads and actually increased the rate of viral acquisition in certain populations. Why do you believe your vaccine would have any different results?

We believe the difference is our choice of target selection. We are specifically trying to immunize against the same targets favored by the killer T-Cells of HIV controllers, individuals who have contracted HIV but don't progress to AIDS. We are also not using a live virus vector as part of our dosage form.

Thank you for the reply, but don't these elite controllers typically control infection so well because they possess MHC allelles that bind peptides in areas of proteins (in particular gag I believe) that can't be mutated away without severe loss of viral fitness? Are you able to get enough coverage from the peptides you're immunizing with to cover these exact areas and still be confident they'll bind an array of MHC types?

Also, what are you're feelings on the RV144 Thai trial that showed low but positive efficacy against HIV acquisition most likely mediated by antibodies?

Good luck with your work

Thanks for the follow up question!

We believe that the key element of the controller attack approach is in fact the specific epitopes that Dave Heckerman has discovered with his machine learning-based analysis. We need to have a specific epitope for each HLA type - we plan to make a master vaccine "cocktail" with multiple epitopes to cover a wide range of HLA types in the target population. We believe that this single epitope site (in a given person) is indeed all we will need to get a controller-like response to infection.

The RV144 Thai trial data is really interesting. I was hoping we could draw some kind of analogy from success they had to our approach but I have been unable to see a connection as of yet - more folks have been looking at that data and writing papers about it. Maybe that will change?

How are you intending to keep this vaccine 100% free even though there will be costs such as producing it? Donations?

Through donations including crowd funding and large legacy donor entities who may become interested as we get more data. And http://pledge.immunityproject.org!

No questions, just thank you.

We really appreciate your support! At the end of the day, we just want to do everything we can to end HIV/AIDS.

You all are brilliant... Serious question... Can I get your autographs?

!!!! This is the first time someone has asked for our autographs. Crossing this off the bucket list! Yes absolutely, please email us @ [email protected]!

No question, just want to thank you for doing something to help those in need. You truly will and are making a difference.

The support for our campaign is awe inspiring! Thank you for helping us make it happen!

I was speaking with my infectious disease doctor at her office yesterday as I went in for my booster. I remarked that I'm stunned that no one throughout my 24 years as an elite controller that no one not a doctor, not even Dr. Levy [Berlin patient] have ever taken the interest to study my blood. Female, 52 pos for 24 years, no medications ever, no OI's ever 300 t-cell and still an undetectable viral load. You would think someone would think my blood would be worthy of a study, who knows I may be that missing link to a cure.

Very interesting! Thanks for the note! If you would like us to get in touch with you please email us at [email protected]

How are you today?

Doing pretty well... really excited about the $150,000 we raised yesterday on pledge.immunityproject.org! How are you doing?

No too bad! How do you think the world will react when they hear this?

They'll probably ask for a Reddit AMA ;)

Where is your financial backing coming from? ($1 Million dollars sadly is not a great deal of money in regards to research and development...)

Have you experienced any backlash for what you are doing (ie. someone speaking out against you and what your team is doing?)

Any chance of a brief youtube video/hand drawn sketch showing your process?

Cheers, and the best of luck!

We have been really careful with our resources! Microsoft Research has funded our studies to date with the $1MM you mentioned.

I haven't heard any backlash so far. We are just trying to do some good science with alternative forms of funding. We need to work on more visual explanations of what we are doing - thanks for the suggestion!

How close are you to completing this vaccine? Are they already in human trials?

We having a working prototype and plan on being in Phase I clinical trials in the US this year pending FDA approval.

So how do you test the efficacy of your vaccine? Do you infect the subject somehow? My question is what happens if ones vaccine doesn't work and ends up with a lifelong disease?

I saw a vaccine a few months ago for HIV and had the same thought.

All vaccine studies (including our planned Phase III human clinical trial) basically rely on natural study designs where half the subjects receive the vaccine and the other half placebo. The study volunteers are followed over time and the infection and complication rates compared between the two groups. All participants are told that they may be in the control group (and that, if they are in the vaccine group that the vaccine may not work), and that they should take all precautions to prevent infection during the trial just as they were before.

Hi Dr Rubsamen - what strategy are you using for vaccine dev, live attenuated virus, or subunit, which adjuvant etc? And why do you think your strat has the best chance to succeed? What level of immunity in your trials do you need to achieve to consider releasing to the gen pop? Oh, and break a leg, awesome idea, didn't know y combinator would sponsor a nfp!

Please call me Reid!

We are using a purely synthetic vector made from PLGA microspheres (containing the target epitopes) and adjuvants (MPLA and CpG). We have gotten good immune responses in our BL/6 mouse model after a single inoculation. If we get a similar reliable immune response with memory in our Phase I clinical trial we should be good to go!

We really happy to be in the YC W14 batch!!

Great cause. One question: I keep seeing "need more human data" ... does this mean the test would be to give someone your vaccine, then inject them with HIV to see if it accepts the virus?

No!! We need to do natural studies by vaccinating large numbers of at-risk individuals and see over time if protection from the vaccine is better than control.

Thanks for being human :)

You too! :D

What exactly is HIV and what is the difference between HIV and AIDS?

HIV (Human Immunodeficiency Virus) is the virus that causes AIDS (Acquired Immunodeficiency Syndrome).

I think it's a very noble cause you have taken up. I'm just wondering though, what will be the consequences to the planet with overpopulation if the HIV/AIDS virus is eradicated? Would it not create a situation far worse then that which virus has created?

I believe that history has taught us that we will have more social stability world wide if families have confidence that their kids will live a normal life span.

Why is there a 29 day limit? Why not make it without a day limit?

I thought the month-long campaign would add a sense of urgency. We also want to complete this experiment by mid-March so we can move faster with our FDA approval process. Of course we'll always be accepting donations to fund our research further.

Hey everyone! We've received a lot of questions about how our vaccine prototype works. To best answer these questions, we are excited to release our formal scientific white paper that shows our research and approach to date. It is now available here: https://bitly.com/1ebKRTP

What is the biggest misconception about HIV/AIDS do you feel people absolutely need to know.

It's really awesome what you're doing by the way.

The biggest misconception is that a vaccine is impossible!

How can I work with you guys

Thanks for the note!!

Please send us an email to [email protected]

Im currently doing a medical trial in the UK for a HIV vaccine :D so this is pretty cool :)

Thanks so much for the kind comment! Good luck with your research as well!

Also wanted to just chime in and say thanks for everything you're doing! Love it! I'm happy to contribute and support such a great project!

Thanks so much for your support! We really appreciate it :). You can contribute here: http://pledge.immunityproject.org

Is this a routine vaccination that everyone should recieve, or only given to those infected?

Yes, we are designing this to be a routine vaccination. It MAY be useful to those who are infected - only carefully designed clinical trials will tell us the answer.

Can you assure us this wont end in a Zombie Apocalypse?

Unfortunately, no. I'm just as scared of zombies as you are!

Doesn't it worry you that giving out the vaccine for free will help the virus evolve?

If we can make everyone a controller, the virus should do a lot less evolving because it will be held in check!

keep up the good work!

Thank you for your support!

Thanks for the AMA! In all honesty, when do you believe HIV+ will be cured, if it will be?

Assuming success in our trials, we are optimistic that we can start vaccinating humans in 2014 and hopefully begin widespread vaccination in 2015/16

Is there a age limit similar to the HPV vaccine?

We don't think so.

Do you think, drug manufacturers/governments will give you a hassle or make your product harder to obtain in any part of the world for releasing an HIV immunity vaccine? and if they do, what could be a few good reasons why?

If you had the funding of one of the top US drug manufacturers, how would you change the way they run and what they do? (you don't have to answer this one to protect the innocent)

No one has given us a hard time so far. Maybe I'm eternally optimistic but I think we are in a big tent with a great technology and I would personally welcome anybody in who wants to help us!

Making an safe and effective HIV vaccine is the Mount Everest of pharma development projects. When we make some forward progress with human clinical testing maybe we'll get some interest from Big Pharma for the world's biggest Pharma give-away!

With HIV being able to evolve so fast and being able to live for up to 20 years in cells, how are you able to end HIV?

3rd year microbiologist here! So while I'm most defiantly not an expert, I know some things.

Thanks for the question! We are trying to copy what controllers do. They target specific (HLA restricted) epitopes such that, when HIV is attacked at those points, it is forced to mutate into what I would describe as a dormant state resulting in the host not progressing to AIDS. Other approaches have presented the immune system with multiple targets (e.g. with whole dead virus) which have resulted in decoy targeting: hitting sites that the virus can easily mutate away from. Our approach is only possible because of the work of David Heckerman who reverse engineered the controllers' biological processes, identifying the epitope targets they favor.

What's the delivery technique for the epitopes, and how is it that you're able to synthesise this HLA-specific sites?

We are using biodegradable PLGA microspheres (containing the epitopes) and adjuvants (MPLA and CpG). We are getting are epitopes from an analysis of the HIV targets favored by HIV controllers. By knowing the HLA types of the controllers we studied, we can understand the HLA restrictions on the epitopes.

Thank you for your work, I'm excited to follow Immunity Project! I've heard that HIV evolves rapidly, will a vaccine need to be updated at the same rate in order to be effective?

Good question! Controllers continue to effectively defend against the virus for many years. This is at least indirect evidence that the epitopes they target are static and that the vaccine may need not to be routinely modified and re-administered.

Have you talked to bill gates about your project? I'm sure he'd be glad to offer his support

Hi beatsdropheavy, thank you for your question! We have spoken with the foundation folks a bit about our project. And we actually did meet with Bill very briefly at a conference. We think they will be more interested when we have phase I clinical data to present. If you know Bill however we would absolutely love to discuss our approach with him in more detail!

How does your vaccine work?

CD4? CCR5? CXCR4?

We are copying the behavior of controllers by getting CD8 killer T Cells to attack at specific targets which force the virus to mutate into a state where it doesn't cause a progression to AIDS. This is not related to CCR5 and is related to CD4 in the sense that we are trying to protect the immune system from attack by HIV.

Hi there! High school student here. Our class has been reading about HeLa cells, and I just wanted to know what type of cells do you use for testing! Is it a type of cell line, or do you use regular blood you get in blood drives?

Also, sorry in advance if this is a dumb question.

Not a dumb question at all! We use peripheral blood white cells from volunteers through a regular blood draw.

This is awesome! With all the craziness in this world today, people like you and your team give me hope for humanity :)

Thanks so much for your support! We really appreciate the kind words :)

When will it be mass produced

We're hoping to begin widespread vaccination during our Phase III and IV clinical trials, projected for late 2016, early 2017.

How close are you? Your personal opinion.

I am personally very confident that we have something here that will work. I believe that the targeting is correct and that our current dosage form will produce an immune response with memory in humans.

This isn't going to bring back Freddie Mercury

We're huge fans of Queen! But unfortunately, no :(