Original URL: http://www.theregister.co.uk/2012/11/07/hiv_vaccine_ready_for_phase_ii_trials/

HIV vaccine safe for Phase II human trials

Canadian university claim no adverse effects from first tests

By Simon Sharwood

Posted in Science, 7th November 2012 04:32 GMT

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.” ®