HIV vaccine produces no adverse affetcs in trials...

[Guest ff-whole]

Phase I Clinical Trial (SAV CT 01) of the first and only preventative HIV vaccine based on a genetically modified killed whole virus (SAV001-H) has been successfully completed

OKAY.... lets get this out there.. so that we can really pig out ! ! !

http://communications.uwo.ca/western_news/stories/2013/September/hiv_vaccine_produces_no_adverse_effects_in_trials.html

[wood]

Phase I Clinical Trial (SAV CT 01) of the first and only preventative HIV vaccine based on a genetically modified killed whole virus (SAV001-H) has been successfully completed

OKAY.... lets get this out there.. so that we can really pig out ! ! !

http://communications.uwo.ca/western_news/stories/2013/September/hiv_vaccine_produces_no_adverse_effects_in_trials.html

Unfortunatly its a lot more complicated than that. HIV is a complicated virus, and many people have been working on it for a lomng time, and thus far it has eluded almost all success. I have faith that as computing power, and genetic engineering improves we will one day get a vaccine, but in the mean time, we can just wait.

[bearbandit]

It's a long way from phase one trials to the market place.

If, like me you have a tendency to leave your destop machine on all the time why not consider putting Fight Aids at Home on it (available from http://www.worldcommunitygrid.org/home.do ). After a user defined period of inactivity it starts number crunching and sending its results back to the lab, whereever that is. Basically it's distributed computer with thousands of machines giving up their spare processor cycles to crunch numbers that need crunching.

[rawTOP]

There are certain strains of HIV which they know are pretty harmless - people who have them are long-term non-progressors. They've known about these strains from the very early days of HIV research. I don't understand why they don't offer people to be infected with those strains since they can protect them from more serious strains of HIV. In other words whole, LIVE, viruses. Mind you I think it's only a decent idea for high-risk groups (like the guys on this site).

[wood]

There are certain strains of HIV which they know are pretty harmless - people who have them are long-term non-progressors. They've known about these strains from the very early days of HIV research. I don't understand why they don't offer people to be infected with those strains since they can protect them from more serious strains of HIV. In other words whole, LIVE, viruses. Mind you I think it's only a decent idea for high-risk groups (like the guys on this site).

Because it goes directly against the hippocratic oath. A doctor who did anything close to that would be stripped of his license almost instantly. Also while con-infection is considered to be pretty rare, being infected with a mild strain is little protection against some other more virulent strains.

A friend of mine is currently getting his MD/PHD, and is directly involved with HIV vaccine trials. Its kind of morbid, but he said he cant even count the number of monkeys he has killed over the years during his research. The reason this article is even being published is because so many vaccine trials never even come close to making it to the human stage. This occurs simply because what works in theory often kills the subject (monkey, human) almost outright. Based on how often HIV mutates I think a once and done HIV vaccine is pretty far off. What I do think may occur in a shorter time period is something more like the flu vaccine. Its never 100% effective, but you yearly updates and it then further protects you from newer strains of the virus.

Remember, we still dont have vaccine's for many virus's, herpes, epstein-barr, coronavirus, rhinovirus, etc, etc. While some of those just cause discomfort, just like HIV many of them stay dormat in the bosy for years, and all of their effects are not known either. The field of virology is still fairly new, and it may be a long time before we know how to control these different pathogens.

[rawTOP]

Because it goes directly against the hippocratic oath.

Are researchers bound by the Hippocratic oath? Either way, what they failed to realize in the height of the AIDS crisis and even now, is that there are people who would be willing to volunteer for dangerous clinical trials. Back then it was poz guys who only had a couple years to live anyway. Now it's people like bug chasers. I'm a firm believer in "first do no harm" - it's why I was so against PrEP for so long. But if the person is making an informed decision to participate, I don't see the problem.

[wood]

Are researchers bound by the Hippocratic oath? Either way, what they failed to realize in the height of the AIDS crisis and even now, is that there are people who would be willing to volunteer for dangerous clinical trials. Back then it was poz guys who only had a couple years to live anyway. Now it's people like bug chasers. I'm a firm believer in "first do no harm" - it's why I was so against PrEP for so long. But if the person is making an informed decision to participate, I don't see the problem.

yes, and no, a majority of researchers are also MD's, so yes they are, but even the ones who are not need to have human testing signed off on by MD's. Things are much different in a crisis, and in the height of the AIDS crisis, in some cases more drastic measures should have been taken. That being said, the crisis is in a much different stage right now. The end argument you are trying to make is something like the argument for assisted suicide, if there is informed consent, and the patient makes the end decision, its okay. The problem with that is the law says differently. Also in the case of random infection with a specific strain, there are way too many variables with such a study, it would never be taken seriously. And lets remember to be taken seriously and to contribute to medicine is the end goal of all researchers MD's or not. They have to follow the scientific method exactly, so the research can be proven. Without that they are laughed out of town, and will likely never publish again.

[pisstopper]

The Hippocratic Oath is neither binding nor related to any MD's licensure or ability to practice. Things docs lose their license over have nothing to do with the oath which is more if a PR thing than anything else

As for informed consent - this is a very complicated subject on many levels. Who is able to give consent and under what circumstances is wrought with ethical issues. People that are disparate enough for something may agree to anything regardless of how sound the logic behind the intervention in question is. Furthermore there are issues of sampling bias. If everyone who enrolls in your vaccine study is a chaser, it may run the risk of biasing the results of your study if "chasers" as a group share other characteristics that predispose them to respond differently to a vaccine than a much broader population that you hope will benefit from the same intervention. (Not to mention, if you're a chaser why would you want a vaccine anyway)

As for infecting people with "non-progressing strains" as a way to prevent more severe infections - the problem is that by doing so we might find out that those strains aren't as "non-progressing" as we thought or that there are certain people they are far more virulent for than what we thought. Not to mention the issues of mutation and development of strains in populations. Infect enough people over enough time and your non-progressing strain may not stay that way as it gets passed around in real life. Hence why we vaccinate people for Chickenpox as opposed to your and my mother's old "expose all the siblings so they all get it at once" methodology of getting it through a family

[rawTOP]

As for infecting people with "non-progressing strains" as a way to prevent more severe infections - the problem is that by doing so we might find out that those strains aren't as "non-progressing" as we thought or that there are certain people they are far more virulent for than what we thought. Not to mention the issues of mutation and development of strains in populations. Infect enough people over enough time and your non-progressing strain may not stay that way as it gets passed around in real life. Hence why we vaccinate people for Chickenpox as opposed to your and my mother's old "expose all the siblings so they all get it at once" methodology of getting it through a family

But I can't see how infecting a bug chaser with a strain that's thought to be extremely mild makes their situation any worse. Chances are it will make it better. And if they're followed over the years the data can be helpful.

[pisstopper]

But I can't see how infecting a bug chaser with a strain that's thought to be extremely mild makes their situation any worse. Chances are it will make it better. And if they're followed over the years the data can be helpful.

The issue is the "thought to be" part. If the docs giving the shot are wrong about that and the chaser in question ends up having regrets about the real outcome of the decision he made despite all the fair warning - it is, in fact, very different than the same chaser getting an everyday infection in the way millions of other have.

Also the entire scenario begs the question - if the chaser in question really WANTS an infection, why would they want a non-progressing strain or for that matter a vaccine? Doesn't that defeat the purpose of being a chaser?

[HungLatinDom]

RawTOP: That's not the only case when patients would be willing to take extra risks, but the current status quo won't let them make that choice. I have a few friends working in immune-system approaches for cancer. There's actually a lot of people willing to try anything for having a chance, yet, according to current regulations, patients HAVE to have access to the best available treatment at the same time. But chemo/radio wrecks your immune system completely. So, the proposed treatment can't be tried.

We need a less paternalistic approach to these issues. I am a scientist, and I believe that people have the right to be informed and make choices.

[GermanFucker]

AFAIK the problem with "mild strains" is that it's never the strain allone that decides the progression rate, but rather the specific interaction of that strain with the patients immune system, whose response is largely determined by his genes.

So IMHO there is an ethical difference between experimental treatment for cancer patients, be it immune or even gene therapy and infecting a hitherto healthy patient with something that might be harmless to many, but still has the potential to do harm in specific cases.

[4poztops]

Research in North America and Europe is governed by very specific regulations and guidelines. In the US, there are two parts of the Code of Federal Regulations that govern what researchers may do in clinical trials. Each part of the CFR mandates that an independent Ethics Board review the research and if the Ethics Board believes it to be sound and believes the risks to the people volunteering for the research are appropriate, all the risks have been disclosed to the volunteer, and the volunteer is willing, there is nothing to stop the research from moving forward. So in terms of the Hippocratic Oath, pisstopper hit it right on the head - it's not about that - and Informed Consent is a very complicated process, not just a document. In short, if the volunteer understands the risks and is willing to take them, that's what counts.

And remember, this article deals with a Phase 1 trial, which is generally very small and very dangerous. The entire purpose of a Phase 1 trial is to determine what kinds of side effects the experimental drug causes (the technical term used in a Phase 1 Trial is "maximum tolerated dose" which in lay terms means "how much can the human body take of this experimental treatment before it's poisoned".) Nothing else. Lots of drugs and vaccines that show promise in Phase 1 trials don't always move to Phase 2, 3 or 4 trials because of the costs involved - which run into the millions of dollars. It will be interesting to see if this vaccine moves into a Phase 2 trial and if it does, where it will be conducted. The article says, “We are now prepared to take the next steps towards Phase II and Phase III clinical trials. We are opening the gate to pharmaceutical companies, government, and charity organization for collaboration to be one step closer to the first commercialized HIV vaccine.” Translation: we don't have the resources to mount a large-scale trial.

I guess we'll all stay tuned!

[totalasspig]

Yes one day we all hope for an HIV Vaccine or a few shots a few that takes care of all your HIV meds instead of taking them each everyday.

What people fail to realize is that HIV is different in every person - I have seen four different HIV doctors and when they see I am on Intelence, Reyataz, Norvir and Viread they scratch their head and order a resistance test - then they figure out why.

Unfortunately from one person to another HIV is not the same. If it was there would have already been a vaccine and possibly a cure.

We all dream of the day for a vaccine for all, and maybe a shot every quarter for those that still have HIV for their meds.