HIV Vaccine Trial Starts at Oxford (ox.ac.uk) 124
The University of Oxford this week started vaccinations of a novel HIV vaccine candidate as part of a Phase I clinical trial in the UK. From a report: The goal of the trial, known as HIV-CORE 0052, is to evaluate the safety, tolerability, and immunogenicity of the HIVconsvX vaccine -- a mosaic vaccine targeting a broad range of HIV-1 variants, making it potentially applicable for HIV strains in any geographical region. Thirteen healthy, HIV-negative adults, aged 18-65 and who are considered not to be at high risk of infection, will initially receive one dose of the vaccine followed by a further booster dose at four weeks. The trial is part of the European Aids Vaccine Initiative (EAVI2020), an internationally collaborative research project funded by the European Commission under Horizon 2020 health programme for research and innovation.
Professor Tomas Hanke, Professor of Vaccine Immunology at the Jenner Institute, University of Oxford, and lead researcher on the trial, said: 'An effective HIV vaccine has been elusive for 40 years. This trial is the first in a series of evaluations of this novel vaccine strategy in both HIV-negative individuals for prevention and in people living with HIV for cure.' While most HIV vaccine candidates work by inducing antibodies generated by B-cells, HIVconsvX induces the immune system's potent, pathogen obliterating T cells, targeting them to highly conserved and therefore vulnerable regions of HIV -- an "Achilles heel" common to most HIV variants.
Professor Tomas Hanke, Professor of Vaccine Immunology at the Jenner Institute, University of Oxford, and lead researcher on the trial, said: 'An effective HIV vaccine has been elusive for 40 years. This trial is the first in a series of evaluations of this novel vaccine strategy in both HIV-negative individuals for prevention and in people living with HIV for cure.' While most HIV vaccine candidates work by inducing antibodies generated by B-cells, HIVconsvX induces the immune system's potent, pathogen obliterating T cells, targeting them to highly conserved and therefore vulnerable regions of HIV -- an "Achilles heel" common to most HIV variants.
Vaccinated people will test positive? (Score:2)
Might be a drawback in some backwards countries.
Not necessarily (Score:5, Informative)
This was part of the confusion for how long you remain immune to Covid. It's true that after some time you'll no longer have the antibodies to fight it and will become susceptible to reinfection. Only this time your body is ready and will create antibodies before it gains any traction. In the middle of the pandemic it was found out the people who survived MERS were not getting Covid. The MERS antibodies were effective at fighting SARS-COV-2 (the virus) so they didnt get Covid (the disease). This was true even though MERS had been extinct for 17 years.
A friend of mine used to work in a lab where they test dead animals, livestock mostly, for diseases. It was routine to test every year for exposure to certain diseases. He said a couple people would test positive for Rabies every year, but since they were all required to be vaccinated no one ever knew until the test came around.
As a side note, I think its very likely this is how Covid happened. In labs where they are testing on animal diseases there arent a lot of precautions taken because its assumed humans cant get it. And for the most part theyre right. I figure they werent being cautious with a non-human coronavirus and one managed to do the correct mutations to jump to people. You wouldnt really know until it got out.
Re: Not necessarily (Score:2)
Anyhow, your lab story doesn't make sense, those animals were handled by humans before getting there, so the infection could just as easily have taken place earlier, and afaict there's no need to fabricate some origin with the word lab in it.
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Not necessarily, it strongly depends on the type of test.
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There always is. Best to ignore those people.
I'm still baffled by the opposition to the HPV vaccine from busybody religious conservatives who oppose it because it would somehow promote sex before marriage.
Like, screw that, sex before marriage is great, there should be more of it. Get it out your system before you settle down. More to the point, who's business is it but your own. The reality is the vast majority of people will sleep with a few people before marrying (I think the average is around 7 partners
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Only for the older gen rapid tests, and even then it's only possible. It depends how those rapid tests are designed (the antibodies may not match up. A COVID vaccine likely won't trigger a positive antibody test for example).
Because of the false positive rate with the rapid tests, they often do later gen PCR tests for HIV that look for the virus directly. So this wouldn't be an issue at all.
The last couple of years (Score:2)
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Right, I dont have my hopes up too high. HIV vaccines tend to get announced every few years and then get defeated by that wily litle bastard of a virus.
However, even when it fails, we get to work out why, and thus the science generated still gets us further in that direction. And thats still progress. To be honest, like cancer, we might never crack HIV. Its a notoriously complicated disease with an astonishing capacity for mutation. But despite the failures, we've learned to get really good at treating it,
They were going to call it the "4H disease" (Score:1)
I remember reading somewhere that when looking for a name for HIV they considered calling it "4H". Not because of any association with the youth organization but because of who was most likely to get it. Those were heroin users, homosexuals, hemophiliacs, and Haitians. The reason heroin users were getting the disease was because of needle sharing. Homosexuals because of their tendency to have many sexual partners. Hemophiliacs because of a lack of testing for the disease in donated blood at the time.
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Evidently you aren't aware of the AIDs crisis in Africa, given your singular obsessions with Haitians.
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I didn't come up withe the early name for HIV. This was in the early 1980s and so maybe at the time there were few cases of AIDS in Africa, or at leas not identified. Again, it was called the "4H disease" because of who they found most common as victims. Was there an epidemic of HIV/AIDS at the time? Or is that a more recent development? Maybe it spread from Haiti to Africa, and if Haiti had better law enforcement then there we would not see this problem in Africa now.
Does Africa have a problem with ra
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No tears and no hearts breakin', no remorse
Oh - congratulations, this is your Haitian Divorce
(leaving out the part about lotion and kinky hair. for now.)
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Dude, talking about Haiti and 9mm pistols right now is at the very least in very bad taste.
Why? I'm talking about women being left defenseless by their government in the middle of an AIDS epidemic, which happened in the 1980s.
Because the Haitian president was assassinated today.
Admittedly he was the head of an illegal regime for a year and a half, but he had finally gotten around to organizing the next elections so he wasn't trying to hang on forever. Anyway, he was shot to death by a squad of mercenaries. They also shot his wife, though didn't kill her.
Re:Why "not at high risk" (Score:5, Informative)
Probably so that they can first test the safety of the vaccine first. This is probably a Stage 1 trial.
But, yes, in a Stage 3 trial they will need people to actively participate in high risk behaviors, which makes the ethics of this whole thing complicated.
Re: Why "not at high risk" (Score:3)
How are the ethics of it complicated? They donâ(TM)t ask people to engage in high risk behavior in fact they provide a ton of information about avoiding the high risk behavior. However human nature being what it is, it doesnâ(TM)t work. And no, they donâ(TM)t wish for it. They wish that providing the information would be the cure. If that works, they wouldnâ(TM)t need to look for a vaccine. The vaccine would be the literature and presentation that enabled them to avoid HIV. Education doe
Re: Why "not at high risk" (Score:4, Interesting)
How are the ethics of it complicated?
Because someone may engage in riskier behavior after they think they've received a vaccine.
And then it turns out they got the placebo.
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Which is why they are clearly told not to take risk
And the fact that people will ignore you, and you need them to ignore you to actually measure the effectiveness of the vaccine, is why it's an ethical minefield.
Re: Why "not at high risk" (Score:2)
It only needs the risk reduction (if there is any; could be zero if advice ignored) to be the statistically similar for both placebo subjects and vaccine subjects.
Randomised double-blinding should ensure this.
Re: Why "not at high risk" (Score:2)
No, if the education piece works they could get rich and a Nobel prize just off that. A method to educate people to not engage in sex, that would be worth more than a vaccine.
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Some people will assume they're safe because they got a cootie shot in elementary school.
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I don't think phase 3 trials always have to be placebo controlled, though. For something where if you get a placebo, you may end up with a terminal illness, it may be justified in not having placebos.
Sometimes when they have results from a trial that are very very positive, they actually halt the trial early and give all the people receiving placebos the actual medicine, as it would be unethical to continue to withhold treatment already shown to be effective.
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Because a lot of people at high risk for HIV take PrEP to prevent infection. To be a participant in this trial you'd have to stop taking it.
Re: Why "not at high risk" (Score:2)
Why would they allow anyone on PrEP into the trial?
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Be nice to go back to the days when you didn't have to worry about wrapping yourself in a tire before having sex. Just have fun, get a shot....go to the next in line.
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There's nothing unethical about that.
Only for people with a low level of ethics.
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Yeah, try to get that past an ethics board. Good luck with that. There is a reason such trials are not done with a placebo-group.
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Probably so that they can first test the safety of the vaccine first. This is probably a Stage 1 trial.
But, yes, in a Stage 3 trial they will need people to actively participate in high risk behaviors, which makes the ethics of this whole thing complicated.
One wouldn't (officially) say "take (or risk) one for the team", but some might feel they want to do exactly that.
But scientifically, one could ethically inject a large population, which Phase III does, to gain statistical certitude for exactly this reason, and just look at the differences between infection rates of placebo injection vs. the real deal, as sufficiently large populations will have new infections from time to time.
Two groups of 10,000, one has 49 infections over some period, the other, 3, well
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In parts [ourworldindata.org] of southern Africa, it might be more like: Two groups of 10,000, one has 490 infections over some period, the other, 30, well, you're probably on to something.
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But scientifically, one could ethically inject a large population, which Phase III does, to gain statistical certitude for exactly this reason, and just look at the differences between infection rates of placebo injection vs. the real deal, as sufficiently large populations will have new infections from time to time.
Only a small amount of people participate in a Phase III trial. There is no placebo needed. The rest of the population who gets nothing, is already the reference group.
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Probably so that they can first test the safety of the vaccine first. This is probably a Stage 1 trial.
The very first sentence of the summary says it's Phase I.
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Yes it seems unethical to test to actually encourage high risk behaviors and just by contacting the researchers unfortunately doctors probably have some ethical responsibility to discourage high risk behaviors. So its going to be hard to test this one .
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Seems like testing both at once would be best (Score:1)
They're more interested in the side effects from the vaccine on healthy people.
By definition, the people who do not yet have HIV, even if they are more at risk, are also healthy people you can use to understand the effects of the vaccine on healthy people.
Although I would normally say it's better to test one thing at a time, the aspect of testing the effects of vaccines on healthy people, and the aspect of testing if the vaccine is effective stopping HIV infection are distinct enough you could be testing bo
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I think it would be a good way to judge what side effects could it have. Also if they are already HIV positive (or could be before the Vaccine kicks in) you could get some false outcomes.
13 people even at high risk, wouldn't be enough to determine the effectiveness of preventing HIV. And it would be highly unethical to give people a shot and ask them to try to get HIV.
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At this stage they are looking at safety and for an immune response. Not if it is actually effective at preventing HIV.
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I think the general order of things is:
1. make sure you aren't injecting poison into people
2. make sure the injection serves a medical purpose.
They're on step 1.
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Close. It's actually:
1. Use a little to make sure you aren't injecting super strong poison into people
2. Since everything is poison, figure out how much you'd actually like to inject and then make sure that much is also not poison
3. Find out if that dose is effective.
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Wouldn't you want to give the vaccine to people who *were* at high risk of contracting HIV, so you would haver a better idea of the vaccine worked?
A Phase I trial is not designed to judge whether a vaccine works. It's designed to judge whether it will kill someone if it progresses to Phase II.
For Phase II you would want people at higher risk since there you would judge efficacy.
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And you continue to be utterly clueless. As co much has been written about COVID vaccine trials, I can only conclude that you are either a complete moron or exceptionally intellectually lazy.
This is a fucking _PHASE 1_ trial! Read up on what that means.
Re:The Ethics of this seems weird (Score:4, Insightful)
Yeah, because "just say no" works great when it comes to the most powerful drive humans have. After all, abstinence-only also worked wonders in combating teen pregnancies.
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(psst) Teen pregnancy has been falling in America for decades including in "abstinence-only" States. But... Facts and all. I know.
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You sure about that? https://www.independent.co.uk/... [independent.co.uk]
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Yes. I'm actually quite sure. Yes, southern and more conservative states remain higher than their liberal counterparts, but they are still declining. Which is what I said.
https://www.cdc.gov/nchs/press... [cdc.gov]
Arkansas, the state with the highest teen birth rate today, has about the same teen birth rate as California had 20 years ago. California remains lower, but both have dropped about 50% respectively in that time.
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That indicates that abstinence-only has no effect either way.
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That is correct.
It also indicates that providing contraceptives and sex education to teens also had no effect. Rates have dropped about the same regardless of tactic.
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It also indicates that providing contraceptives and sex education to teens also had no effect.
One word: Bullshit [9cache.com].
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No, I'm saying that neither tactic can claim to be the cause of the national decline in teen birth rates.
Teen birthrates probably would have declined if States did nothing at all.
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It has been falling less in abstinence-only states .. so there's that. Maybe it has nothing to do with abstinence education? Maybe other factors are at play? Also, unintended pregnancy is from lack of education in general. You know there are ways people can have sex and not get pregnant, right?
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There are almost certainly other factors at play that have had a larger net effect then either abstinence or more direct sex education. Case in point is that birth rates have similarly declined in adults and families as well. Even traditional heterosexual married adults are having fewer babies.
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Actually no it doesn't. Ever heard of rape? Date rape?
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Are you recommending that the vaccine be tested on people that are at high risk of getting raped?
How about we just remove them from being at high risk of getting raped.
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Let me know your 100% effective way of educating people not to have sex and also to avoid rape. It'll be worth far more than a vaccine.
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I do have a 100% proven method of preventing rapes:
Step 1) Don't rape people.
That's it. I'll take my consulting fee now.
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Very funny, except it can't be used to inoculate anyone. You have no way of making that command stick, unlike a vaccine.
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So... to avoid burglaries, just don't break in somewhere?
Yeah, doesn't work so far. I never broke into some other house, but I've had an unwelcome visit before, so I guess I must be doing it wrong somehow.
Re: The Ethics of this seems weird (Score:2)
Education does not work on everyone. Not everyone gets a 4.0 in school, do they? Heck not everyone even graduates.
Re:The Ethics of this seems weird (Score:5, Insightful)
It would be much more ethical just to encourage them to stop doing their high risk behaviors. Yet, I truly hope the vaccine tests are successful and prove to be highly effective.
So I am assuming you have never had a condom break, or had a one slip off, or just had one too many drinks and just went for it?
Because I have had all three of those things happen to me. (Fortunately no consequences.)
If encouraging people to engage in less risky activities worked, HIV would be extinct by now, also there would be no unwanted pregnancy.
Re:The Ethics of this seems weird (Score:4, Interesting)
We see this same basic argument play out in many policy areas. A common one these days are safe injection clinics (just stop doing drugs and you won't overdose or get arrested!). Boils down to a factually correct solution to a problem that doesn't work in reality vs. an approach which seems counterintuitive yet yields better results in reality. Some may call that pragmatism but I think it's actually the science-based approach of using empirical results. There's tons that is counterintuitive when talking human behaviour.
Interestingly enough, this is what we learned about mask policies during the pandemic. This got pretty lost in the raging political argument that dominated discussion, but there are many studies showing general mask-wearing policies have minimal effect (initially) on transmission rates, and ultimately do not alter the course of total infections. This isn't because masks don't work, it's because compliance never achieves a level for it's intended efficacy (note: further study may show improper mask application by untrained people limits their overall effectiveness as well). On the flip side, data shows lockdowns work exceeding well in the same regard. Thus those arguing for general mask policies are factually correct... if everyone just wore a mask correctly it would prevent many infections. Those arguing against general mask policies are also correct that it's an approach that doesn't work well in reality. Further, I bet many people find themselves on opposite sides of the argument in that situation vs the HIV one on hand: in one, push for the factually correct solution, in the other, push for the pragmatic solution that yields real results.
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Indeed, promoting abstinence is a policy only the Catholic church could love.
As a recovering Catholic, I would point out that the abstinence campaigns are widely loved by almost all religions who claim to be Christian.
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Difficult to get laid living in moms basement.
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Thanks for sharing your experience.
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condom breaking or slipping off is rape? Two drunk people having consentual sex and forgetting condom is rape? Nope, nope and nope, You're clueless.
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Yes. It's rape. If you and a significant other agree to have sex with condoms and the condom somehow "slips off", then the intercourse becomes rape.
Don't rape women.
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And who exactly is raping whom when a condom slips off?
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The person wearing the condom that allowed for the condom to slip off. If the condom is "slipping off" sex should stop. If sex doesn't stop, it's rape.
Don't rape people.
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Do you feel when the condom slips off the guy?
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So you've never had sex. It isn't always obvious when a condom slips off and no one may notice. Get real world experience before making up stupid rules.
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You're wrong. Use a legal dictionary.
You're going to have a lot of trouble interacting in the human world if you make up nonsense between your ears and believe it. Let me guess, you're an incel living in your mom's basement.
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All three of those events are called rape. I don't rape.
I suspect judging from your knowledge of sex, STD transmission, and definitions of rape that you don't anything. Have you even seen a naked woman? I mean in 3D... Without a VR headset.
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All three of those events are called rape.
Maybe in your head, but not in any law book.
Re:The Ethics of this seems weird (Score:5, Informative)
nearly 100% entirely avoidable
Not in the countries where HIV runs rampant, mainly third world african nations.
These would be the ideal places to run stage 3 trials, both medically and ethically, since whatever you do, or don't do, HIV will spread in these populations.
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Yes its obvious you would pick the highest risk populations to run the test. Thats probably crossed their minds.
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We've been doing that for 40 years and yet the disease hasn't been eradicated because people are dumb, unlucky, or too trusting. If HIV were contracted only dumb people, fine. The problems are that sometimes condoms break, people lie about their status, and sometimes people trust them. People who take all the known precautions (except from abstaining which is never going to happen because sex is both such a base s
Re: The Ethics of this seems weird (Score:2)
Rape is 100% avoidable? Being cheated on by your spouse is 100% avoidable?
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You exist here today, because you parents had sex, your parents exist because your grandparents had sex. (Unless you or your parents were artificially inseminated)
We are hard wired for sex with someone we feel romantically close with. While we can resist our urges, it takes constant effort.
It is like someone who smokes, and decided to quit. They just don't have to buy a pack of cigarettes and no problem right? Well, because of the addiction they will often break down and get a pack.
Of if you want to loos
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and condoms have existed at least 2000 years. You can have sex and dramatically lower your risk for disease (and unwanted pregnancies for het couplings) with a very cheap appendage wrap. Do you have a point?
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If they're only testing on 13 adults, that's not enough to see if the vaccine actually prevents illness or not. It's a first step which measures whether the vaccine is safe, and perhaps whether it creates a measurable immune response.
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I know. I meant to say when they start Stage III trials with many more people.
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OK. In that case, you can give a shot (vaccine or placebo) to people, and encourage them (all of them) not to engage in risky behaviors.
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That would be fine. But then if you don't get a sizeable enough sample of people getting infected in the group, then 1) good for the people involved and 2) the study fails.
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It would be much more ethical just to encourage them to stop doing their high risk behaviors.
Is being stupid something that comes naturally to you, or is it something you need to practice?
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You seem confused on who the stupid people are. Do you fuck men in the ass without a condom? or whores?
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taking majority credit for being capable of making responsible decisions is one of the hallmarks of a self involved shithead - the flipside being that people who make irresponsible decisions are not automatically shitheads who deserve everything that befalls them (to say nothing of those in the blast radius of the consequences of their actions)
maybe one day you'll manage the emotional growth to see it, although I ain't holding my breath you'll ever get off the island you think you're on
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Making responsible decisions is part of being a true adult. You are the one making proclamations like a hedonist manlette living in mom's basement. Grow up, little manlette.
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No it is not more ethical to just "educate" them. It doesn't work. If that worked, we'd be using that as a vaccine. We know it doesn't work, it's unethical to rely solely on that. All HIV vaccine trials attempt the education angle too. If they found a way to make education work 100%, they'll be selling that instead.
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All infectious diseases are 100% avoidable. What you said is equally applicable to a cold or the flu.
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AIDS is a Syndrome, not a disease. Acquired Immune Deficiency Syndrome. See that, right there in the very name itself. Yes, HIV infection can *eventually* cause AIDS in some people, but not all. There are also other things which cause AIDS.
This is a vaccine against HIV. AIDS has nothing whatsoever to do with it.
Just like the current vaccines against SARS-CoV-2. They are not vaccines against ARDS, which is also a Syndrome, not a disease, although some persons infected with SARS-CoV-2 will get ARDS, mo
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The mainstream view is that HIV almost always causes AIDS, so there is a connection between them of course.
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Right, noticed later I wasn't clear in my comment. I meant when/if they move to Stage III trials.