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Investigating a Mosaic-Based Preventive HIV Vaccine

Active Since: 2017

Contributing to SDGs…

Collaboration to advance an investigational HIV vaccine which has the potential to prevent a wide range of viral strains responsible for the HIV pandemic.

MEMBER COMPANIES

PARTNER ORGANISATIONS

  • Academia or research institute

    HIV Vaccine Trial Network

  • Government

    US National Institutes of Health (NIH)

  • Private foundation or development organization

    Bill and Melinda Gates Foundation

Objectives

  • 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

What are the health needs and challenges?

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. An estimated 790,000 new HIV infections occurred in eastern and southern Africa in 2016, where the new efficacy study is being conducted. In the United States, 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.

Partnership activities and how they address needs and challenges

Janssen Pharmaceutical Companies together with a consortium of global partners initiated the first efficacy study for an investigational mosaic HIV-1 preventive vaccine. The Bill & Melinda Gates Foundation and National Institutes of Health joined forces with Johnson & Johnson 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.

The large-scale study (HVTN 705/HPX2008), 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. 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 percent of people living with HIV in eastern and southern Africa.

About Imbokodo (HVTN 705/HPX2008)

The proof-of-concept efficacy study is evaluating the mosaic-based vaccine’s safety and efficacy, compared to placebo, in preventing HIV-1 infection. The study has enrolled 2,600 sexually-active women aged 18-35 in five southern African countries, including South Africa, Malawi, Mozambique, Zambia and Zimbabwe. “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.

Two early-stage, Phase 1/2a clinical trials (APPROACH and TRAVERSE) have evaluated mosaic-based HIV vaccines.  The ongoing TRAVERSE study compares two regimens containing adenovirus 26 (Ad26) vectored vaccines delivering either three (trivalent) or four (quadrivalent) mosaic antigens. Preliminary data suggest that both types of mosaic-based vaccine appear to be well-tolerated and able to elicit anti-HIV immune responses. Based on these studies, a lead vaccine regimen comprising the 4-component Ad26 mosaic candidate and a Clade C gp140 soluble protein will be evaluated in HVTN 705/HPX2008 to see if it actually reduces HIV infections.

HVTN 705/HPX2008 is 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.

About Janssen’s HIV Preventive Vaccine

The investigational HIV-1 preventive vaccine regimen utilizes Janssen’s AdVac® adenovirus vector platform and PER.C6® production cell line technology. The regimen is comprised of a 4-component (quadrivalent) mosaic-based adenovirus serotype 26 vector (Ad26.Mos4.HIV) and a soluble protein (Clade C gp140, adjuvanted with aluminum phosphate).

Since 2005, Janssen Vaccines & Prevention B.V. has been participating in the NIH-supported Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program under grants AI066305, AI078526 and AI096040, in collaboration with Professor Dan Barouch at Beth Israel Deaconess Medical Center (BIDMC).

Janssen’s HIV vaccine program has also received funding or support from the United States Military HIV Research Program (MHRP) at the Walter Reed Army Institute of Research (WRAIR), with the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF); the Ragon Institute; and the International AIDS Vaccine Initiative (IAVI).

Quote
“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. 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.”
Paul Stoffels, M.D.
Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson
“Having a preventive vaccine would be a vital tool in a comprehensive global strategy to end the HIV pandemic. 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.”
Johan Van Hoof, M.D.
Janssen Vaccines & Prevention B.V. and Therapeutic Area Head, R&D, Infectious Diseases & Vaccines

SDGs THE PARTNERSHIP CONTRIBUTES TO

SDG 3: Good Health and Wellbeing

  1. 3.3: Communicable Diseases & NTDs

SDG 9: Industry Innovation and Infrastructure

SDG 17: Partnerships for the Goals