HIV Vaccine Approval For Human Trials 365
An anonymous reader writes with news that researchers from the University of Western Ontario have been given approval from the U.S. Food and Drug Administration to begin testing an HIV vaccine in humans. From the article:
"The vaccine is the first based on a genetically modified killed whole virus, [researchers said.] ... a clinical trial on 40 HIV-positive volunteers will begin next month. That phase will last a year, after which 600 HIV-negative volunteers will see how the vaccine impacts their immune systems. A final phase, which will take about three years, will involve about 6,000 HIV-negative volunteers."
I for one, hope they get this right (Score:5, Insightful)
I hope this vaccine is as effective as the smallpox and polio vaccines have been. The world would do well to be rid of this particularly crafty and deadly virus. It is also a whole lot easier to introduce vaccination programs into third world countries (which counts as medicinal treatment) which would otherwise have severe religious problems with contraceptives like condoms (which counts as interfering with "God's work").
- Toast
Re:I for one, hope they get this right (Score:4, Funny)
But it might cause autism in Jenny McCarthy's future kid!
Re:I for one, hope they get this right (Score:5, Informative)
That whole boondoggle is the perfect example of why you shouldn't take your kids to a doctor with an ax to grind. It turns out that after they took her kid to a real doctor, they found out he had Landau-Kleffner syndrome [wikipedia.org]. Even she doesn't claim that vaccines cause autism anymore, now it is just a general "we need to study vaccines for safety" and "we need to study causes and treatments of autism." Of course, that news didn't get anywhere near the attention the idea that it did cause autism got because it doesn't fit the loons message.
Re:I for one, hope they get this right (Score:4, Insightful)
If you are offered a drug that has a 90% chance of saving your life and a 1% chance of giving you a life threatening side affect, would you take it? I do think that with these things we should be given the choice. If I am in a strong loving relationship, would I want to take the 1% risk with an AIDS vaccine? My choice, do I really trust my partner? If I am playing around, would I want to risk not taking the vaccine...
All drugs have a risk as does all surgery. If you get taken into hospital next month for a life saving operation, there is a very small chance that the surgery will kill you. If the chance that not having the surgery will kill you is greater then you have the surgery.
The MMR vaccine has risks associated with it but the benefits far outweigh those risks and in my opinion those parents who do not vaccinate their children are not responsible parents.
Re:I for one, hope they get this right (Score:5, Funny)
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Only if it cures her congenital stupidity first.
Re:I for one, hope they get this right (Score:5, Interesting)
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Don't worry, once HIV goes the was of Smallpox and Polio, there will be an even more deadly infectious disease to fill the void. People keep forgetting that mother nature isn't just sitting on her ass while our scientists are working hard coming up with vaccines. SARS and Swine Flu where probably some of her clinical trials for her new disease. =P
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I hope this vaccine is as effective as the smallpox and polio vaccines have been.
It's a technically sophisticated piece of work. But as someone who has previously worked on an HIV vaccine, I don't see any indications they've solved the fundamental problems that have dogged all previous attempts. With the exception of a very small number of "elite controller" individuals, the adaptive immune system just simply does not seem to be capable of handling this particular virus.
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I for one am looking forward to that.
Re:I for one, hope they get this right (Score:5, Informative)
As a matter of fact, there is one. It's called Flu-V [telegraph.co.uk], and was apparently developed using the same methodology used to create the AIDS vaccine.
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Meanwhile... reports of dangerous side effects have been linked to the vaccine, severe illness, deaths, permanent disability.
I don't claim to have any expertise in this area, but I'd be more inclined to trust public health officials in dozens of countries than this. For a start it would appear you have an edit on Wikipedia [wikipedia.org] to make (or you'd imagine someone would if this were true at least)...
Both Gardasil and Cervarix have been tested in tens of thousands of people in the United States and many other countries. Thus far, no serious side effects have been shown to be caused by the vaccines. The most common problems have been brie
Maybe link to a more reputable source? (Score:4, Informative)
You can even have another Toronto paper [thestar.com] if you like.
A brighter future? (Score:3, Insightful)
Good to hear that this is going forward. Hopefully, this will lead to a brighter future for Africa.
I worry about the health of the participants, but, HIV isn't a death sentence anymore. I would volunteer for the trial, assuming that, in the worst case, they cover my medical expenses and anti-retrovirals to control it.
It would be worth it.
Re:A brighter future? (Score:5, Informative)
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Good to hear that this is going forward. Hopefully, this will lead to a brighter future for Africa.
I worry about the health of the participants, but, HIV isn't a death sentence anymore. I would volunteer for the trial, assuming that, in the worst case, they cover my medical expenses and anti-retrovirals to control it.
It would be worth it.
Ah, if you think covering your medical expenses while toying with an unproven vaccine is your "worst case" here, then perhaps you should really sit back and re-think this, no matter where your ethics lie.
Trust me, I commend you for stepping forward for the betterment of all mankind, but realistically your life is on the line here, not your bills. In theory you could end up better...or worse, and any "controls" put in place would likely be questionable at best.
Positive news (Score:4, Funny)
This isn't just positive news, its HIV positive.
Just curious (Score:5, Insightful)
Why does a Canadian University need approval from the U.S. FDA?
Re:Just curious (Score:5, Insightful)
I assume it's because they want to run the trials in the United States. I imagine there's practical reasons for that - the US is a pretty significant pharma market, and anything denied there is quite likely to be blocked in other countries, whereas Canada is a smaller country (11% the size of the US by population) that's not as critical for a pharmaceutical company to sell in.
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That makes sense too, given that there's really no distinction between University research and corporate R&D. The ethics of that situation is another topic altogether.
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I assume it's because they want to run the trials in the United States. ... and anything denied there is quite likely to be blocked in other countries
Say what now?
There are plenty of trials that are run in Europe or Asia (India) to test out drugs that make their way to the US market.
More relevant to the discussion are the large number of drugs that are approved in Europe and banned in the USA.
The FDA has historically been criticized for not approving many drugs and it's only this year that the FDA has sped things up.
The medical device industry has been especially critical of the FDA & has been focusing more on Europe where regulatory approval is fast
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A Korean pharmaceutical company developing a vaccine in its Canadian subsidiary and then conducting clinical trial in the US.
Re:Just curious (Score:5, Funny)
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Hmm. I suppose then the FDA regulates the export of the vaccine for use in trials, rather than regulating the research of scientists in another country. That makes sense.
Once again, Science (Score:5, Insightful)
delivers the goods.
Seeing aids go from you are going to die, to testing a vaccine in 25 years is freaknig awesome.
Re:Once again, Science (Score:5, Informative)
To (mis)quote "Evolution"... (Score:2)
Oops, you've got... (Score:2)
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Re:FP (Score:4, Informative)
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I guess the joke was "too soon".
Re:FP (Score:5, Funny)
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No, it's been more than 22.3 years. AIDS is finally funny.
Are you positive its finally funny? Are you HIV positive its funny?
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Or they're just making dumb jokes and you have chosen to project wholly invented motivations onto people you know nothing about. One of the two.
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Oh, you been to El Taco Loco on Augusta Blvd, too? IMHO, their goat's brain tacos are the best in town.
OK then. (Score:3)
Now we can go back to eating raw monkey meat like god intended. Just don't forget that dipping sauce!
Re:FP (Score:5, Informative)
Attitudes like yours are the reason it took so long for us to get around to curing this disease in the first place.
Are you sure that it doesn't have more to do with the fact that it is incredibly difficult?
Re:FP (Score:5, Insightful)
I know about the trials and tribulations of the communities when HIV was found out and pointed out as being "god's punishment" by those whom are uncaring and hateful.
But such hate and ignorance doesnt mean I cant joke about the hate or ignorance.
If anything, it points out our history... much like blackface, hooded cloaks, and hitler of which you see many jokes making fun of these topics.
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I would.
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No, it is NOT technically possible.
Stop spreading your ignorance.
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circumcision reduces the risk of all STD, not just AIDS.
Plenty of studies on pubmed. of course you have no interest in actually learning the science or the facts.
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Re:Numbers game. (Score:5, Insightful)
Could more people be saved overall by considering testing volunteers semi-expendable in order to hasten medical advance?
Ask the volunteers.
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"this ahs better be good."
don't be a dumbass. It is what it is. If it doesn't work, then that's data as well. Learn why we have this process before showing everyone how stupid you are.
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Could more people be saved overall by considering testing volunteers semi-expendable in order to hasten medical advance?
The ends never justify the means. Never. Note that if they could, any action, no matter how heinous, could be justified. So they don't. Which is why such experiments ought to never be considered ethical.
Re:Numbers game. (Score:5, Insightful)
Re:Numbers game. (Score:5, Insightful)
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You can take that statement literally in that manner. But that isn't what it means nor what has ever been meant by it. What it means is that you can never do an action which is evil in and of itself, even for a good end. So the deliberate killing of an innocent is never justified. However, killing in self-defense can be (because the action is self-defense, not the killing itself. But that is a rather complex argument). In any case, my point was you can never perform reckless trials on humans no matter how g
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(note I'm not saying all means are justified by the ends, or even that all means to a good end are justified. But saying the ends never justify the means seems to me to be just as inaccurate as saying they always do.)
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An action (means), to be justified, would seem to need to be beneficial... but what makes it beneficia
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Or 3 years, if you bypass the FDA.
If human trials look good. Field test in Africa. Some regions have a 1 in 3 infection rate. Almost any reduction, even with side affects, would probably be beneficial in that region.
In fact, I think if approved. I'd like to see a President/Congress with the balls to purchase and donate a few million doses for Africa.
Re:I'm still sore about Herpes! (Score:5, Informative)
There's some progress on that [scienceblogs.com], though still probably some years out from having something available.
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Pretty sure this means that they know it works but want to see if it fucks anything else up?
Well..., only if it fucks it up really bad. When "...common side effects may include: itching, rash, diarrhea, constipation, shortness of breath, nausea, inability to urinate, hair falling out, unusual hair growth, erections lasting longer than four hours, seizure, coma, or death...", it's a pretty safe bet that something that might keep you from getting AIDS will get even more slack that most of the miracle-cure-of-the-month medications whose manufacturers buy so much time on NASCAR broadcasts and Oprah. W
Re:Wow (Score:5, Funny)
When "...common side effects may include: itching, rash, diarrhea, constipation, shortness of breath, nausea, inability to urinate, hair falling out, unusual hair growth, erections lasting longer than four hours, seizure, coma, or death..."
WHERE DO I SIGN UP?
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When "...common side effects may include: itching, rash, diarrhea, constipation, shortness of breath, nausea, inability to urinate, hair falling out, unusual hair growth, erections lasting longer than four hours, seizure, coma, or death..."
WHERE DO I SIGN UP?
GET IN LINE.
Re:Wow (Score:4, Informative)
Re:Wow (Score:5, Funny)
WHERE DO I SIGN UP?
When you walk into the ER, the sign up desk is usually the first thing you see in front of you.
/Well, if you've had an erection for 4 hours, maybe the second thing you see.
Re:Wow (Score:5, Funny)
What are you going to do with it when you simultaneously have diarrhoea and constipation?
Try not to sneeze?
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How do vaccines manage to have so many side effects if they are made from killed viruses? And what does it mean to kill a virus?
Re:Wow (Score:5, Informative)
Anything that happens to you during a trial gets noted as a possible side-effect.
Note that diarrhea and constipation are noted right next to each other, for instance. Ditto for hair loss and increased hairiness.
It is highly likely most of those are completely unrelated to the vaccine, and that you’ll experience no such effects, but at this point, it’s really hard to tell. It pays to be cautious, or even paranoid, when conducting trials.
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IMO it pays the lawyers, who put everything but curing you as a bad side effect. "Hey we warned ya it would fall off, see, turn the page over."
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You're correct, however, there are two charts, the side effects experienced by the group receiving the medication, and the side effects of those receiving a placebo. What's relevant are the ones that differ significantly (positive or negative) in frequency between the groups. That's where you see both the benefits, and the potential side effects.
Re:so many side effects (Score:3)
Basically any decently powerful medication goes all batty on side effects because of the body's irritating habit of requiring some 5-70 interactions to get anything done. So it's only 3rd generation medicines etc that get the job done right because of 20 years of practice. My own minor hobby is studying stomach acid preventers. (Not cheap calcium rolaids etc, the other pills that are supposed to prevent your stomach from overproducing the acid in the first place.)
The first gen ones did work, but over-target
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If so, that would be a pretty strong case for proving God, so I'm sur
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So do you think Big Condom is behind the lie?
Re:So how much does it cost ... (Score:5, Informative)
My guess, the second batch of volunteers will be those in marriages/committed relationships with HIV+ positive spouses (eg: married to a nurse who got pricked, a spouse who had a bad blood transfusion, victim of rape, etc, etc).
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Right, but where would the other 99% come from?
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Among other things. You could also get it from you yourself sleeping around, a trusted partner that has never slept around or get it from your parents, a dentist, other forms of blood transfer (such as during fights) or even during "safe" sex (there is really no such thing as safe sex).
Some STD's are so common they don't even routinely test for them anymore (HSV) and many don't know they have a form of it until someone else gets an outbreak.
Also with current medicine most are curable, can be depressed or tr
Re:So how much does it cost ... (Score:5, Insightful)
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Who the hell dies in four yeas after getting aids? wait, that would be no one.
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Quit your whining. Four years isn't a long time for phase 2 and 3 testing. Do you really want to mass inoculate people before you know it's safe?
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You know not all cancers are the same? and saying 'cure for cancer' is ignorant, right?
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You know not all cancers are the same? and saying 'cure for cancer' is ignorant, right?
Then why is there a "Cure for Cancer" wonder in Civilization, eh? Answer that smart guy.
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1. If it's proven safe for 2 year olds and prevents them from acquiring HIV infection, why the hell not?
2. There are a whole lot of other ways to get infected besides sex.
3. Personal freedom without consequence to other people is a lie that unscrupulous politicians and for-profit demagogues tell to get what they want from the credulous.
(3b. Social engineering without consequence to personal freedom is also a lie that a different set of unscrupulous politicians and for-profit demagogues tell to get w
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1. Define proven safe for 2 year olds. Cough medicine was proven safe for 2 year olds. It wasn't until one mother refused to accept a diagnosis of SIDS that it was discovered that some children had not developed the ability to metabolise certain compounds.
In other words, we often know what is safe for most 2 year olds, but not all.
2. Yes, blood transfusions, and toddler drug parties. Just to name a few.
3. We're not asking for personal freedom without consequence. We're just asking that our toddlers be allow
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1. Define proven safe for 2 year olds. Cough medicine was proven safe for 2 year olds. It wasn't until one mother refused to accept a diagnosis of SIDS that it was discovered that some children had not developed the ability to metabolise certain compounds.
In other words, we often know what is safe for most 2 year olds, but not all.
Point taken, but sometimes we have to go with what we know and change it when we learn more. Actually, that applies pretty much all the time. With that said, I'm not opposed to a prudent level of caution. Just opposed to failing to take action because somebody is afraid without evidence to back it up - which happens a lot. A compromise between acting on imperfect knowledge and analysis paralysis has to happen.
2. Yes, blood transfusions, and toddler drug parties. Just to name a few.
Just making sure - the "kids can't get HIV, they don't have sex" argument is common among people wh
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Fine, give the vaccinations. Maybe at 10 years of age. But requiring toddlers to have STD vaccines is kind of pushing it.
Currently, Hep B and now in some regions the HPV vaccines are mandated.
My argument is taking away the opportunity to educate your child is not a fair or morally justified policy. Not for non-infectious diseases.
***
"But just imagine the disadvantage of completely unknown long-term vaccine affect applied to the entire human race."
Imagine if 15 years later we discover every adult who receive
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Fine, give the vaccinations. Maybe at 10 years of age. But requiring toddlers to have STD vaccines is kind of pushing it.
It all depends on how long it takes the vaccine to produce the best immune response.
The whole stupid issue with the "Mandating HPV vaccine for 11 year olds" is because it takes years for the immune system to fully gear up against HPV after the vaccine, just in time for 15 or 16 year olds who are become sexually active.
And I encourage you to tell some poor 8 year old who was infected via blood transfusion that it was better that he didn't get the vaccine as a 2 year old...
Re:Just curious? (Score:5, Insightful)
Imagine if 15 years later we discover every adult who receives the vaccine is fine. But every child has become sterile. Sucks to be the human race.
Imagine if 15 years later we discover every adult who receives the vaccine is fine. But every child has gained super-human intelligence. Awesome to be the human race.
I can play the "let's make shit up" game, too!
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There is always an element of risk with any vaccine. Needle contamination, bad nurse sticking the wrong spot, bad manufacturing batch, etc. (Thought there may or may not be some potential issues with HepB.)
The point is, where there is a legitimate risk of concern, it makes sense to me to give my daughter a vaccine.
When there is essentially zero risk cases for a toddler age 2-10 to contract the disease. It doesn't make sense to me to subject her to the procedure.
I am actually a skeptic of vaccine dangers. M
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Right, and that's why I accept mandatory vaccines for highly communicable diseases. If my child didn't have her measles vaccines she could pass it on to other children.
The same is not true for diseases that are not highly communicable such as STDs.
"Plus, noone is being held down at needle point, just being denied privileges that they can be replaced with private sources."
No Sir, this is where I get f***** g*d d**n annoyed. Everyone retorts this....but it gets applied to private schools. Which are pressured
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The good news....You didn't contract HIV.
The bad news....you did contract syphillis and gonorrhea.
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You don't need a placebo for this sort of trial, you have the rest of humanity acting as the control group.
We aren't concerned with "does it feel better" placebo effects here, we're talking about do you or do you not have HIV virii in you, which is measurable.
Comment removed (Score:4, Informative)
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Vaccination is not only for prevention. There are a few diseases where the body can develop immunity from the vaccine significantly faster than it can from the natural disease, so even after infection there may be time for the vaccine to be helpful.
Re:Why are they testing on HIV positive people? (Score:5, Informative)
I've worked with an organization providing care to the homeless a few years ago, and while being HIV+ is not a short-term death sentence anymore, it is nowhere near as easy to treat as you make it. Most patients can expect to spend about 3 to 7 years using drugs with only moderate side-effects, but after that, most start needing to use some stronger drugs. These can have very serious side effects, including vomiting several times a day, constant headaches, extreme dizziness, lack of appetite so bad that they have to force themselves to eat every meal, sexual dysfunction, etc.
I'm not a medical professional but from what I understand there are also strains of HIV that need the "strong" treatment right away, and people can even get multiple strains (I saw a few of those). Even with the medication being free in Canada, where I live, I spoke with people in their late 30s who stopped taking the meds because they'd rather have a few more years of relatively good life than living with the drugs' side effects.
We've made a lot of progress, but HIV is still a death sentence, just longer term. And you'll feel miserable for the better part of your remaining life. Not something to take lightly.
Re:AIDS is a Hoax (Score:5, Informative)
I'm a scientist in mind, if not in profession, but really... come on and put some effort into it.
I click the link.
I see the hyperbole in the first few paragraphs. Start to ignore the rhetoric and go for the linked "facts". Hit a site, linked to prominently under the heading "Informative Websites" (alongside other prominent links such as "Mind Control 101", "State Use of Schizophrenia", "Human Race Being Nonconsensually Brain-Linked", "US Army Intelligence Officer: Gang Stalking Phenomenon is Precursor to Coming Holocaust", etc.).
Whoop, whoop, amber alert, plough on.
Anyway, the link I click is centre-page, top of the fold, with the name "AIDS Controversy" (and they don't capitalise AIDS properly half the time) on the domain biblebelievers.org.au
Whoop, whoop, red alert, plough on anyway.
Read the first name on the list. Apparently a Nobel prize-winning biochemist is top of the list. Look him up on Wikipedia. Read the first two paragraphs about him which contain the following:
"Since winning the Nobel Prize, Mullis has been criticized in The New York Times for promoting ideas in areas in which he has no expertise. He has promoted AIDS denialism, climate change denial and his belief in astrology."
Right up until the last line I was prepared to give the guy a chance, at least, but I don't believe he's been misquoted at all based on the links there.
I tried to get further down the list but either the people listed were non-notable, outside their field of expertise (a mathematician... really?), misquoted, not discoverable via some quick searches or just plain loopy. There probably are a couple of sensible people in there but even being ASSOCIATED with those organisations, websites, etc. and not clearly stating their personal position somewhere I can find it is pretty damning evidence that they just don't care who quotes them or what they are associated with.
I terminated my investigation there. Please note that I've seen people claim man didn't walk on the Moon and their "evidence" got several stages further than this just by the presentation (but obviously fall down on facts later on).
If you want to quote random crap at me, at least make sure it's *feasible* random crap, not linked to complete timewasters, attention-seekers and tinfoil-hat-nutters. Any form of argument, whether religious, scientific or otherwise, needs to be able to stand alongside who it cites and quotes with pride, and to be taken seriously when doing so. Otherwise, we will just file it in the bit-bucket within literally SECONDS of checking facts.
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Because it's a US trial. The vaccine was developed in Canada, but they're doing the trial in the US, presumably as people meeting the trial criteria (HIV negative people at high risk of infection) are easier to come by, if only due to having 10x as many people.