Canadian HIV vaccine approved for human testing
Based on a genetically modified killed whole virus
Developed by Dr Chil-Yong Kang and his research team from The University of Western Ontario, the SAV001 vaccine has been shown to stimulate a strong immune response in preliminary toxicology tests in lab animals with no adverse effects or safety risks. It is the only HIV vaccine currently under development in Canada, and one of only a few in the world.
‘FDA approval for human clinical trials is an extremely significant milestone for our vaccine,’ said Kang, a researcher and professor at Western’s Schulich School of Medicine & Dentistry.
HIV/AIDS has killed more than 28 million people worldwide, and more than 35 million people currently live with the virus infection. Since the virus was characterised in 1983, there have been numerous trials through pharmaceutical companies and academic institutions around the world to develop vaccines; however, no commercialised vaccine has been developed to date. Other HIV vaccines evaluated through human clinical trials have focused on either one specific component of HIV as an antigen, genetic vaccine using recombinant DNA, or recombinant viruses carrying the HIV genes. Kang’s vaccine uses a killed whole HIV-1, much like the killed whole virus vaccines for polio, influenza, rabies and hepatitis A. The HIV-1 is genetically engineered so it is non-pathogenic and can be produced in large quantities.
Before it can be commercialised, the SAV001 vaccine must go through three phases of human clinical trials.
Phase I, set to begin this month with 40 HIV-positive volunteers, will check the safety of the vaccine.
Phase II will involve approximately 600 HIV-negative volunteers who are in the high-risk category for HIV infection and measure their immune responses.
Phase III will measure the efficacy of the vaccine in a larger group of approximately 6,000 HIV-negative volunteers who are also in the high-risk category for HIV infection.
The vaccine has been developed with support from Sumagen Canada, a biotech company established in 2008 specifically to support clinical development of Kang’s vaccine. Sumagen Canada is a subsidiary of Sumagen Co Ltd, a Korean pharmaceutical venture company.
Through WORLDiscoveries, Western’s technology transfer office, Sumagen Canada has secured patents for the SAV001 vaccine in more than 70 countries, including the US, the European Union, China, India and South Korea.
The vaccine has been manufactured at a bio-safety level 3 (BSL3) GMP plant in the US.
You may also like
Trending Articles
You may also like
Research & Development
From lab to launch: transforming pharmaceutical formulation development with GEA’s CFC Lab Coater
A new generation of continuous film coating technology is giving R&D teams the speed, precision and scalability they need to take products from the laboratory to commercial production without the traditional bottlenecks
Manufacturing
Bristol Myers Squibb licenses Lonza ADC linker-payload technology for undisclosed target
BMS has secured exclusive access to Lonza’s SYNtecan linker-payload platform, alongside GlycoConnect and HydraSpace technologies, to advance development of an antibody-drug conjugate against an undisclosed target
Pharmaceutical
Ardena strengthens executive team to drive its next phase of growth
Ghent, Belgium, 4 May 2026 – Ardena, a specialist pharmaceutical CDMO and bioanalytical CRO enabling precision medicines and other complex therapies, announces the appointments of Ben Ash as Chief Financial Officer and Henny Zijlstra as Chief Commercial Officer. These additions further strengthen Ardena’s executive leadership team as the company continues to scale its operations and commercial reach globally
Pharmaceutical
Backed by investments exceeding $1 billion, PCI Pharma Services announces major expansion of US sterile fill-finish and drug-device delivery combination capabilities
As pharma manufacturers prioritise US supply chain resilience, highlights include high-speed isolator filling lines for prefilled syringes, cartridges and vials, and drug-device combination assembly and packaging