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AIDS Vaccine Passes Safety Test
Seattle biotech startup Targeted Genetics passes important hurdle, but faces challenges.
August 31, 2006
Targeted Genetics, a small biotech firm based in Seattle, has taken on what has been called the toughest adversary ever for vaccine development—HIV/AIDS.
This week, positive interim results from a Phase I trail of Targeted Genetics’ investigational vaccine, called tgAAC09, were presented at the AIDS Vaccine 2006 Conference in Amsterdam.
Dr. Nathan Clumeck, head of the department of infectious diseases at St. Pierre University Hospital in Brussels, and principal investigator for the study, noted that no safety concerns were identified and that the vaccine was well tolerated. In a subset of trial participants receiving the highest dose of the vaccine, modest immune responses were observed.
The study, the first ever to test a recombinant AAV-based vaccine, was designed to assess the safety and tolerability of the vaccine at escalating dose levels and gauge immune responses following vaccination. Trials conducted in Belgium and Germany involved 50 healthy volunteers not infected with HIV. Another portion of the study, conducted in India, enrolled 30 HIV-negative participants.
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Targeted Genetics is also conducting a Phase II trial for the vaccine in South Africa, Uganda, and Zambia. Investigators are evaluating the potential impact of a higher dose of the vaccine in volunteers at high risk. They also are observing the results of a boost vaccination on the strength and duration of immune responses.
Global Effort Under Way
An estimated 40 million people worldwide are infected with HIV, according to the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS). More than 4 million people die of the virus every year and, to date, there is no vaccine for prevention.
But there is hope. The International AIDS Vaccine Initiative (IAVI) is tracking the progress of 32 clinical trials on its website, www.iavi.org. Dr. Seth Berkley, who heads the global nonprofit, said at a recent news conference, “An AIDS vaccine is the only tool that can end the pandemic and all evidence suggests that a vaccine is possible.”
The candidates furthest down the path to approval are a combination live recombinant vaccine prime from Aventis Pasteur with a boost of VaxGen’s AIDSVAX vaccine and an adenovirus vaccine from Merck. Dr. Berkley expects the results of Merck’s vaccine trial in 2008.
Meanwhile, China is fast advancing its AIDS vaccine. On August 22, the Chinese government announced its first human trial showed efficacy in protecting the 49 trial participants against the HIV-1 virus and did not produce any serious side effects.
The next phases of testing are expected to involve 800 volunteers and involve the participation of high-risk groups.
Although research into a vaccine for AIDS has been under way in China for more than 15 years, the country does not have the intellectual property rights over its AIDS vaccines in trial, according to a report released by the government in August. Ongoing vaccine trails in China include 29 in Phase I, four in Phase I/II, three in Phase II, and one in Phase III.
The official estimate from the Chinese government is that more than 650,000 people in the country are living with HIV, including approximately 75,000 AIDS patients.
The hurdles to approval that remain are significant. Clinical trials are expensive and volunteers difficult to recruit. There are technical difficulties too. The virus infects the immune system cells that are stimulated by conventional vaccines. An effective AIDS vaccine needs to stimulate both antibodies and so-called cellular immunity—a job regulated to dendritic and T-cells.
Steven Lewis, the United Nations delegate to Africa for AIDS, sees even a partially effective vaccine as a huge step forward: “Even a modestly effective vaccine could cut the number of new infections by one-third over a decade, saving tens of millions of lives.”
Contact the writer: [email protected]
