Release date: 2017-07-26
Today (July 25), Johnson & Johnson announced that its Janssen Pharmaceutical Companies has received the first clinical (APPROACH study) data for its HIV-1 vaccine.
Humans have made significant progress in the global fight against HIV/AIDS, including the development of key antiretroviral therapies and HIV prevention tools, but the disease remains one of the most serious global health threats of our time. There are currently 37 million people worldwide suffering from HIV infection, with nearly 2 million new infections per year. Due to the unique nature of the HIV virus, including its genetic diversity and ability to rapidly mutate, effective HIV vaccines are still not available.
Since 2005, Janssen's Vaccine Prevention Department has been involved in a comprehensive preclinical/clinical AIDS Vaccine Development Program (IPCAVD) supported by NIH. The above APPROACH clinical study uses a class of vaccines based on "mosaic" chimeric technology containing immunogens from different HIV subtypes that cause HIV-1 infection worldwide. These immunogens were delivered by a viral vector using Janssen's AdVac technology based on adenovirus serotype 26 (Ad26). Thus, viral vectors combine with components such as soluble proteins to form a chimeric initial booster vaccine regimen: they first elicit an immune system response and then boost the immune system, with the ultimate goal of producing stronger and more durable immunity.
In preclinical clinical studies, protocols containing "mosaic" chimeric vaccines have been shown to prevent HIV-like infection. The most effective initial enhancement program in these studies reduced the exposure risk of infection by 94% and resulted in 66% complete protection after six exposures.
APPROACH (HIV-V-A004 / NCT02315703) is a multicenter, randomized, parallel, placebo-controlled, double-blind clinical trial involving 393 healthy, uninfected HIV adults in the United States, Rwanda, Uganda, South Africa and Thailand. /2a study. It is evaluating the safety, tolerability and immunogenicity of various "mosaic" chimeric initial enhanced HIV-1 vaccines. All vaccine programs appear to be well tolerated. The main analysis after the third vaccination showed that most active vaccine regimens elicited antibody responses in 100% of the study participants.
The lead HIV-1 vaccine regimen combining Janssen Ad26 chimeric candidate and Clade C gp140 soluble protein was selected as a further Phase 2b proof of concept based on the immune response observed in APPROACH and the protective effects observed in preclinical studies. The basis of research on proof-of-concept efficacy. If the study moves forward, Janssen and its global partners are expected to conduct the survey in southern African countries by the end of 2017 or early 2018.
Dr. Paul Stoffels, Chief Scientific Officer of Johnson & Johnson (Source: Johnson & Johnson)
Dr. Paul Stoffels, Chief Scientific Officer of Johnson & Johnson, said: "In recent years, new optimistic prospects have surfaced: we will be able to find effective HIV vaccines to prevent AIDS in our lifetime. The findings announced today enhance this belief, we look forward to As soon as possible to enter the next stage of clinical development."
Source: WuXi PharmaTech
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