HIV Vaccine Enters Large Clinical Trial

Mosaic HIV-1 vaccine candidate enters phase 2 clinical trial in Africa

Janssen Pharmaceutical and several partners have initiated the first efficacy clinical study for an investigational mosaic HIV-1 preventive vaccine.

This large-scale clinical study, also known as “Imbokodo”, 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.

“Imbokodo” is the Zulu word for “rock” which is part of a well-known proverb in South Africa that refers to the strength of women and their importance in the community.

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.

Johan Van Hoof, M.D., Janssen Vaccines & Prevention B.V. and Therapeutic Area Head, R&D, Infectious Diseases & Vaccines, said, “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,” said Dr. Hoof.

HIV/AIDS continues to be one of the world’s most pressing global health challenges. In 2016, an estimated 37 million people were living with HIV-1 globally, and 1.8 million people became newly infected with the virus.

The proof-of-concept efficacy study will evaluate the mosaic-based vaccine’s safety and efficacy, compared to placebo, in preventing HIV-1 infection. The study aims to enroll 2,600 sexually-active women aged 18-35 in five southern African countries.

Paul Stoffels, M.D., Chief Scientific Officer, Johnson & Johnson said, “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.”

HVTN 705/HPX2008 is being sponsored by Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, 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 U.S. Military HIV Research Program at the Walter Reed Army Institute of Research, U.S. 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 South African Medical Research Council (SAMRC) is helping to implement HVTN 705/HPX2008 in South Africa.

More information about the study is available at www.Imbokodo.org.za or NCT03060629.