HIV vaccine safe for Phase II human trials
Canadian university claim no adverse effects from first tests
Researchers from the Schulich School of Medicine & Dentistry at Canada's University of Western Ontario have issued a statement saying the first phase of clinical trials of an HIV vaccine have produced “no adverse effects observed including local reactions, signs/symptoms and laboratory toxicities”.
The Reg understands the trial of the vaccine, dubbed'SAV001-H' involved only 40 patients, all of which were HIV-positive. Some of those participating in the trial received a placebo.
The researchers say data from the trial is still being analysed, but say the results they have been able to gather show “significant increase in the HIV-1 antibody formations after SAV001-H administration compared to the base line in some patients.”
That result, along with the lack of adverse effects, sees the researchers declare “we are now prepared to take the next steps towards Phase II and Phase III clinical trials” among a wider population.
The vaccine is described as a a “killed whole virus”, a type of vaccine that uses a genetically-engineered version of the HIV virus that is subjected to chemicals and radiation in ways that allow it to fight HIV without hurting the patient. Such vaccines are already used to treat polio, rabies, influenza and other diseases.
There's still a long way to go before SAV001-H becomes widely available. As the USA's national Institutes of Health explains, Phase II trials use a larger sample to test whether a drug “is effective and to further evaluate its safety” while Phase III trials work with more people again to test “effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.” ®
COMMENTS
Yes - probably the next step is trials on groups of HIV- people who are at risk of catching the virus.
Not sure what the "ethical" position is regarding those who get the placebo.
Also, bets on how soon it is before an American or African evangelical complains this vaccine is a "sodomy license" or similar and campaigns against it being made available to young people (or anyone)?
I suspect
it's because these are only phase 1 trials.
Trying to convince your ethics board to allow you to inject HIV (although it's like totally dead we swear) into people, possibly wouldn't go down too well.
If all you want to do is check there's an anti-body response, then those already infected are less at a risk of adverse side-effects (not as if there's a chance you'll "give them HIV").
Plus there's the HIV/AIDS things - you contract the virus HIV and you're fine at first. There's then the ongoing battle in your body between the virus trying to replicate and ultimately 'win' giving you AIDS (OK, it's not a win, it's a slightly stupid virus that kills its host) and your body trying to resist. it. Current treatment for HIV sufferers isn't a cure, it's an bundle of 'stuff' designed to assist your body/slow the HIV to help your immune system on the winning side of the fight. Having additional antibodies, may help with this.
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