Canada researchers to move to phase 2 clinical trials with new HIV vaccine
Researchers at the Western University in Ontario, Canada recently announced that they are ready to begin Phase II clinical trials of an HIV vaccine, taking a big step in moving forward with the fight against the disease.
The results of the Phase I trial showed that the vaccine is both safe for use and effective in triggering an anti-HIV immune response in HIV-positive patients.
According to the researchers, Phase II could begin as early as September 2017 and will allow them to determine the vaccine’s ability to produce anti-HIV antibodies in 600 patients across North America who are not infected.
“The trial demonstrated that our vaccine stimulates broadly neutralizing antibodies that will neutralize not only single sub-types of HIV, but other sub-types, which means that you can have the vaccine cover many different strains of the virus,” said team leader Chil-Yong Kang, who developed the vaccine.
The vaccine is known as SAV001-H, and it’s made in an entirely different way to previous HIV vaccine attempts – by using particles of “killed whole” HIV-1 that’s been genetically modified not to infect human cells. It is the world’s first preventative HIV vaccine to be approved by the US Food and Drug Administration (FDA) to make it to human clinical trials.
Killed whole virus vaccines, also known as inactivated vaccines, are one of the most common types of vaccines out there. The vaccine works by exposing the immune system to a safe, dead version of a virus, so it can prepare antibodies against it and be ready to launch an attack as soon as a live version enters the body.
Researchers around the world have been concerned that it’s not possible to actually deactivate HIV, seeing as it’s so quick to evolve and avoid our defenses, so a vaccine like this has never been developed before.
The Western University team swapped out some of HIV’s genes with genetic material taken from honeybees, rendering it harmless to humans.
In the Phase I clinical trials, the team took a group of HIV-positive patients and gave half a placebo and half the vaccine, to test how their bodies responded.
The results showed that the vaccine was safely tolerated by the immune system, with no adverse reactions reported, and no signs that the inactivated virus had turned virulent.The group given the vaccine also had a “significant increase” in the pre-existing antibodies against HIV – a sign that it could do the same in people without HIV to help protect them against the virus.
In the Phase II trials, around 300 volunteers will be selected from the general population, and 300 will be from groups considered high-risk for HIV infection, including men who have sex with other men; intravenous drug users; sex workers; and those living with an HIV-positive partner.
The team will look at how well these people develop antibodies against HIV, and also whether or not it reduces their risk of contracting the virus.
“If we can show that this vaccine is effective in preventing people from contracting HIV, we can stop the AIDS epidemic and that would be tremendous,” said Kang. “It would be a tremendous contribution to humankind, and it would make all of our efforts worthwhile.”
Once Phase II has been successfully completed, Phase III will be conducted worldwide with 6,000 subjects and will be the true test to show if the vaccine is effective in protecting people against HIV infection.
The vaccine is being tested in partnership with Sumagen Canada, the Canadian branch of a Korean pharmaceutical venture company. Sumagen Co. Ltd. has been producing the vaccine for trials and holds the patent for mass production and distribution.
HIV/AIDS has killed more than 41 million people worldwide, and more than 35 million people currently live with the infection.
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