Today (July 25th), Johnson Corporation (Johnson & Johnson) announced that its Janssen Pharmaceutical Companies vaccine in the field of HIV-1 has achieved its first clinical (APPROACH study) data.

Humans have been in contact with HIV / AIDS global battle has made significant progress, including the development of a key role of antiretroviral therapy and HIV prevention tools, but the disease is still one of the most serious threat to global health of our times. At present, a total of 37 million people worldwide suffer from HIV infection, nearly 2 million new infections each year. Because of the unique nature of the HIV virus, including its genetic diversity and the ability to mutate rapidly, an effective HIV vaccine has not yet been obtained.

Since 2005, Janssen's vaccine prevention division has been involved in the integrated preclinical / clinical AIDS vaccine development program (IPCAVD) supported by the NIH. The APPROACH clinical study uses a class of vaccines based on mosaic mosaic technology that contains immunogens from various HIV virus subtypes that cause HIV-1 infection worldwide. These immunogens were based on Janssen, a adenovirus based serotype 26 (Ad26) AdVac technique, delivered via viral vectors. Then, virus vector and soluble protein composition, the formation of chimeric vaccines: they strengthen the initial scheme first by the immune system response, and enhance the immune system, the ultimate aim is to produce a more powerful and more lasting immunity.

In preclinical clinical studies, the inclusion of mosaic type chimeric vaccines proved to prevent infection with HIV like viruses. The most effective initial strengthening programme in these studies reduced exposure to infection by 94% and resulted in 66% complete protection after six exposures.

APPROACH (HIV-V-A004 / NCT02315703) in the United States, Rwanda, Uganda, South Africa and Thailand, is a multi center, involving 393 cases of healthy *****s were not infected with HIV virus, randomized, placebo-controlled, double-blind clinical study 1/2a. It is assessing the safety, tolerability, and immunogenicity of various mosaic type initial enhanced HIV-1 vaccines. All vaccine regimens appear to be well tolerated. The primary analysis after the third vaccination showed that most active vaccine protocols triggered antibody responses in 100% of the study participants.

The immune response observed in APPROACH based, and observed in preclinical studies of the protective effect, combined with the pilot scheme of gp140 HIV-1 vaccine candidate Ad26 chimeric soluble protein Janssen and Clade C are selected as further proof of concept phase 2B efficacy (proof-of-concept efficacy) on the basis of. If the study goes ahead, Janssen and its global partners are expected to carry out the survey in southern Africa at the end of 2017 or early 2018.

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Dr. Paul Stoffels, chief scientific officer at Johnson Inc. (photo source: Johnson Corporation)

"In recent years, new optimism has surfaced: we will probably find an effective HIV vaccine against AIDS in our lifetime," said Paul Stoffels, chief scientific officer at Johnson. The findings of today's announcement reinforce this belief and we look forward to moving forward to the next phase of clinical development."