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JJ announces the first efficacy study for the preventive vaccine against HIV-1

  Ed Miseta

By Ed Miseta Editor-in-Chief, Clinical Leader
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On the eve of World AIDS Day 2017, the project by law The Melinda Gates Foundation and the National Institutes of Health (NIH) have joined forces with Johnson & Johnson (J & J) to promote a possible "global vaccine" that could prevent a wide range of viral strains responsible for the HIV pandemic Worldwide.

Janssen Pharmaceutical Companies (J & J's research arm), together with its partners, have initiated the first efficacy study for a preventive mosaic HIV-1 mosaic vaccine. Paul Stoffels, scientific director of J & J, said in a written statement that developing a vaccine against HIV is a priority for Janssen and the best hope for a world without AIDS. Stoffels added that finding an effective HIV vaccine to protect people at risk has been a major scientific challenge. Still, he believes there is a new optimism that the goal is now within reach. For that reason, J & J has joined forces with leading HIV researchers and global health advocates to help advance an experimental vaccine. "Working together, our ultimate goal is to support efforts to make HIV history," says Stoffels.

The new large-scale study, also known as "Imbokodo", will assess whether Janssen's investigational vaccine regimen is safe and effective to reduce the incidence of HIV infection among 2,600 women in sub-Saharan Africa. A statement from J & J points out that, although in recent years there have been great advances in the treatment and prevention of HIV, almost 2 million people are still infected with HIV each year. According to UNAIDS, the Joint United Nations Program on HIV / AIDS, women and girls represent almost 60 percent of people living with the HIV virus in eastern and southern Africa.

The two main partners in the study are Bill and Melinda Gates Foundation and the National Institute of Allergy and Infectious Diseases (NIAID). Additional partners include the US Military HIV Research Program. UU At the Walter Reed Army Research Institute, the US Army Medical Equipment Development Activity. UU., The General Hospital of the Ragon Institute of Massachusetts (MGH), the Massachusetts Institute of Technology (MIT) and Harvard. The coordination of clinical sites is provided by the HIV Vaccine Trials Network funded by the NIAID (HVTN), while the South African Medical Research Council (SAMRC) is helping to implement the study in South Africa.

Completing a Global Health Challenge

The Imbokodo study is the result of a public-private partnership committed to the response to HIV. The start of Imbokodo means that, for the first time in more than a decade, two studies of the effectiveness of the HIV vaccine are being carried out at the same time. Another study is currently being conducted in South Africa to evaluate a different vaccine candidate. The search for an effective vaccine against HIV has been a challenge due in part to the unique properties of the virus. These properties include its ability to rapidly mutate and its global genetic diversity with multiple strains and subtypes prevalent in different parts of the world.

Having a preventive vaccine would play an instrumental role in a comprehensive global strategy to end the HIV pandemic. The Janssen research phase vaccine is based on mosaic antigens that have been designed using genes from a wide range of different HIV subtypes. According to Janssen, the ultimate goal is to deliver a "global vaccine" that can be deployed in any geographic region of the world to help protect vulnerable populations at risk of infection.

In 2016, an estimated 37 million people were living with HIV-1 worldwide, and 1.8 million people were newly infected with the virus. An estimated 790,000 new HIV infections occurred in eastern and southern Africa in 2016, where the new efficacy study is underway. In the USA UU., An estimated 1.1 million people were living with HIV at the end of 2014, and nearly 40,000 people were diagnosed with HIV in 2015. This makes HIV / AIDS one of the most pressing global health challenges.

The test The concept efficacy study will evaluate the safety and efficacy of the mosaic-based vaccine, as compared to placebo, to prevent HIV-1 infection. The study aims to enroll 2,600 sexually active women between 18 and 35 years old in five countries in southern Africa. The first participants have already started receiving vaccines at clinical research sites in South Africa. At the same time, regulatory approvals are being sought to conduct the study in additional sites in Malawi, Mozambique, Zambia and Zimbabwe. Janssen also hopes to have studies underway in those countries too.

Since women represent 60% of people living with HIV in eastern and southern Africa, it was considered that they would be the best patients to treat treatment. Younger, sexually active women are also a segment of the population most at risk of HIV infection. If additional efficacy studies are initiated, they are likely to involve men, as was the case with early-stage studies for this vaccine.

Overcoming test challenges

Vaccination to the right patients are critical. Since it is a vaccine to prevent HIV, women and girls who participated in the study had to undergo tests and are known not to have HIV. This is necessary to evaluate the ability of the vaccine to prevent HIV infection. Still, Maria Pau, senior director of composite development and leader of the HIV vaccine team at Janssen, says it was not a significant barrier to trial recruitment.

She notes that a patient challenge that had to be overcome was the lack of communication in local communities of new health technologies. "We have consulted extensively with local stakeholders, including HIV experts, clinical researchers and community leaders, to overcome the problem," says Pau. "To help with the recruiting effort, we chose the name & # 39; Imbokodo & # 39; for the studio." Imbokodo is the Zulu word for & # 39; rock & # 39; that is part of a well-known proverb in South Africa that refers to the strength of women and their importance in the community, the name was chosen as a result of consultations with our stakeholders and represents our commitment to engage with local communities in a positive and meaningful way. "

At the time, logistics was a challenge for HIV researchers. Vaccines must travel long distances to places in Africa and stay at the right temperatures. The vaccine itself requires standard refrigeration: storage at 2 to 8 degrees Celsius in the pharmacies of the clinical sites. But Pau points out that many of these challenges have been overcome and today there is a sophisticated supply chain to bring vaccine supplies to the test sites. The sites themselves are affiliated with HVTN. Pau says they are incredibly well managed, and that South Africa has become home to some of the world's leading HIV researchers and clinical researchers.

Although vaccines should be administered in clinics, all sites have experience in the conduct of HIV clinical trials of vaccines. In addition, the site staff has received guidance and training to ensure that they are familiar with the protocol specific to Imbokodo.

Finally, the learnings from previous trials have been incorporated into Imbokodo to increase their chances of success. "Janssen and our partners have worked hard to ensure that this study embodies all current best practices for conducting an HIV vaccine trial and conducting a clinical trial in a developing country," adds Pau. "Our main priority is to ensure that we communicate clearly and transparently with all study volunteers about every aspect of the test from beginning to end." The well-being and active commitment of our study volunteers is paramount. participate in the study, we will not find a vaccine to prevent the spread of HIV. "

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