Johnson & Johnson (J&J) have announced that its Janssen Pharmaceutical Companies together with a consortium of global partners have initiated the first efficacy study for an investigational mosaic HIV-1 preventive vaccine.

The Bill & Melinda Gates Foundation and National Institutes of Health (NIH) have joined forces with J&J to advance the potential prevention option, which is designed to be a ‘global vaccine’ that could prevent a wide range of viral strains responsible for the HIV pandemic.

“Developing a vaccine against HIV is a top priority and our best hope for a world without AIDS. Finding an effective HIV vaccine to protect people at risk has been a major scientific challenge, but today there is new optimism that we can get there,” said Chief Scientific Officer at J&J, Dr Paul Stoffels.

“That’s why we’re joining forces with the world’s leading HIV researchers and global health advocates to help advance our experimental vaccine. Working together, our ultimate goal is to support efforts to make HIV history,” continued Dr Stoffels.

The new, large-scale study (HVTN 705/HPX2008), also known as “Imbokodo” – the Zulu word for “rock”, will evaluate whether the investigational Janssen vaccine regimen is safe and able to reduce the incidence of HIV infection among 2,600 women in sub-Saharan Africa.

Although there have been great advances in HIV treatment and prevention in recent years, nearly two million people still become infected with HIV every year. According to UNAIDS, women and girls account for nearly 60% of people living with HIV in eastern and southern Africa.

“The Imbokodo study is a result of an undeterred public-private partnership committed to responding to our formidable foe HIV,” said CEO and President of the South African Medical Research Council (SAMRC) and chair of the Imbokodo study, Professor Glenda Gray.

“Africa’s leadership role in bringing an end to the epidemic is documented in its ground breaking scientific research and evident in the dedicated contribution of its people,” continued Prof Gray.

The initiation of Imbokodo means that, for the first time in over a decade, two vaccine efficacy studies are taking place at the same time. Another study, HVTN 702, is currently underway in South Africa to evaluate a different vaccine candidate.

Historically, the search for an HIV vaccine has been challenging due in part to the unique properties of the virus – including its ability to mutate rapidly and its global genetic diversity with multiple strains and subtypes prevalent in different parts of the world.

“Having a preventive vaccine would be a vital tool in a comprehensive global strategy to end the HIV pandemic,” said Janssen Vaccines & Prevention B.V. and Therapeutic Area Head, R&D, Infectious Diseases & Vaccines, Dr Johan Van Hoof.

“Our investigational vaccine is based on mosaic antigens that have been engineered using genes from a wide range of different HIV subtypes. The ultimate goal is to deliver a ‘global vaccine’ that could be deployed in any geographic region to help protect vulnerable populations at risk of infection,” concluded Dr Van Hoof.

HVTN 705/HPX2008 is being sponsored by Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of J&J, with co-funding from two primary partners, the Bill & Melinda Gates Foundation and National Institute of Allergy and Infectious Diseases (NIAID). Additional partners providing support include the US Military HIV Research Program at the Walter Reed Army Institute of Research, US Army Medical Materiel Development Activity, and the Ragon Institute of Massachusetts General Hospital (MGH), Massachusetts Institute of Technology (MIT) and Harvard.

The study will be conducted at clinical sites coordinated by the NIAID-funded HIV Vaccine Trials Network (HVTN). The SAMRC is helping to implement HVTN 705/HPX2008 in South Africa.

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