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news.International collaboration the HIV Vaccine Trials Network and pharmaceuticals giant Merck & Co have begun a collaborative phase II study using one of Merck's investigational HIV/AIDS vaccine candidates.
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The trial will be conducted at both Merck and the HIV Vaccine Trials Network (HVTN) clinical trial sites in North and South America, the Caribbean, and Australia.
The vaccine candidate has generated strong and durable cellular immune responses against HIV in early human trials; this collaboration could accelerate HIV vaccine development work by guiding scientific decisions for future HIV vaccine trials.
The trial is known as a ‘proof-of-concept’ study because it enables researchers to test the concept that the vaccine candidate prevents HIV infection, or results in lower HIV levels in the blood of those who become infected with HIV.
If the concept is proven – that is, if data generated by the study show that the vaccine candidate provides some protection against HIV, or delays or diminishes the course of HIV infection – this information will guide future research.
The collaborative trial is the first study specifically designed to test the ability of a Merck-developed adenoviral vector-based trivalent vaccine candidate to affect the clinical course of HIV infection. This vaccine candidate is designed to generate a cellular immune response, as opposed to the antibody response typical of most vaccines in use today.
The trial is expected to provide vital data about the ability of this vaccine approach to either prevent infection with HIV, and/or to maintain a lower average viral load compared with placebo in individuals who may become infected with HIV during the course of the study.
Information from several different sources, including HIV drug studies and studies of HIV-infected individuals, suggests that maintaining a lower viral load may be associated with clinical benefits to patients. The study will also evaluate whether the investigational vaccine is generally well tolerated by study participants.
This is the second collaboration between Merck, whose scientists have been conducting research to develop an HIV/AIDS vaccine for nearly 20 years, and the HVTN, a global clinical trial network funded and supported by NIAID, one of the National Institutes of Health.
Merck and the HVTN are already collaborating on a global clinical trial that is testing the tolerability and immunogenicity of an earlier version of Merck’s vaccine candidate. That study is ongoing in 18 cities around the world.