A research team in Canada has announced that the first round of human trials into the safety and effectiveness of a new HIV vaccine have exceeded their expectations.
Researchers at the University of Western Ontario, with Dr. Chil-Yong Kang heading the team, are in the process of testing the SAVoo1-H vaccine. It is unique among current attempts at an HIV vaccine because it uses a genetically modified version of the entire HIV-1 virus, making it roughly analogous to the polio vaccine.
Mr. Jung-Gee Cho, the CEO of Sumagen Co. Ltd, which is the group supporting the development of the vaccine, is quoted as saying the process has been a long one but the results are very encouraging:
Even though Sumagen has struggled and spent a much longer time to overcome manufacturing difficulties and to meet the U.S. FDA’s requirements, we have accomplished successfully Phase I Clinical Trial of SA001-H and proven that there is no safety concern of SAV001-H in human administration. We are now prepared to take the next steps towards Phase II and Phase III clinical trials. We are opening the gate to pharmaceutical companies, government, and charity organization for collaboration to be one step closer to the first commercialized HIV vaccine.
The vaccine works by taking the modified HIV-1 strain and introducing it into normal cells which are then collected, purified and made inactive so that they will not infect the vaccine recipient but rather trigger an immune response.
The Phase 1 trial, which was used to evaluate safety, tolerability and immune response, began in March 2012 and was completed in August 2013. Trial participants included a group of HIV-infected asymptomatic men and women, all between 18 to 50 years of age, and a placebo group in the same age range.
After receiving the vaccination, volunteers were tested at four, six, 12, 18, 26 and 52 weeks to asses general physical responses and also to closely analyze specific medical indicators like hematology, urinalysis and chemical chemistry.
The researchers were pleased to find that there were no serious adverse responses to the trial. Moreover, they noted that tests revealed an unexpected rise in antibody production. This will be followed up in Phase 2 trials which will measure immune response. For those wanting more detailed medical information on these results, please click here.
It is hoped that because this process is relatively straightforward, it will be cheap to produce — a key feature if we are wanting to create a preventive HIV vaccine that could have an impact in, say, Sub-Saharan Africa.
Sumagen Canada has secured test patients for the SAV001 vaccine across more than 70 countries. These include patients from the United States, the EU, China, India and South Korea. Researchers, as noted above, have gone to pains to comply with the highest safety ratings possible. The fact that this is a genetically modified virus raises its safety profile due in part to the stringent analysis and modification process that has gone into producing the vaccine.
There are currently a number of HIV vaccines in the market but few have shown such promise has SAV001.
Given that the vaccine has only just completed Phase 1 trials, there are still many steps left before a HIV-1 vaccine is on the market and helping to stop the HIV/AIDS crisis. However, the announcement of success in Phase 1, and the fact the vaccine has exceeded initial expectations, point to the possibility of the vaccine being available in the not too distant future, providing real hope that putting a stop to HIV’s 35 million death toll and rising could be in sight.
Image credit: Thinkstock.
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