Johnson & Johnson Announces New Public-Private Partnership to Support First Phase 3 Efficacy Study of Janssen’s Investigational Prophylactic HIV Vaccine
National Institutes of Health (NIH), HIV Vaccine Trials Network (HVTN) and U.S. Army Medical Research and Development Command (USAMRDC) join forces with Johnson & Johnson to advance global investigational vaccine to prevent HIV-1 infection
NEW BRUNSWICK, NJ, July 15, 2019 – Johnson & Johnson today announced that Janssen Vaccines & Prevention B.V., one of its Janssen Pharmaceutical Companies, together with a consortium of global partners are preparing to launch Mosaico, the first large-scale Phase 3 efficacy study of Janssen’s investigational mosaic-based HIV-1 preventive vaccine. Janssen’s mosaic vaccine is designed as a global vaccine with the goal of preventing infections from the wide range of viral strains responsible for the HIV pandemic.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), the HIV Vaccine Trials Network (HVTN) based at the Fred Hutchinson Cancer Research Center, and the U.S. Army Medical Research and Development Command (USAMRDC) are joining forces with Janssen to advance the potential global vaccine. The public-private partnership’s plans for Mosaico will be described in more detail at the 10th IAS Conference on HIV Science (IAS 2019) in Mexico City, along with new late-breaking data regarding the mosaic-based vaccine regimen to be studied in Mosaico.
“Our vision at Johnson & Johnson is to develop a preventive vaccine that can be deployed anywhere, worldwide, to halt the HIV epidemic,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “No single organization can tackle this historic challenge alone. By working with our global partners and leveraging cutting-edge technologies, we are optimistic that we can achieve an HIV vaccine in our lifetime.”
Mosaico (HPX3002/HVTN 706) will have a target enrollment of 3,800 individuals in eight countries across North America, South America and Europe. It is expected to commence later in 2019. Conducted at approximately 55 clinical sites worldwide, the study will evaluate Janssen’s mosaic-based HIV vaccine in men who have sex with men (MSM) and transgender people.
“We are determined to develop a globally effective HIV vaccine to reduce the trajectory of the estimated 1.5 million new HIV infections that are occurring,” said Larry Corey M.D., Principal Investigator of the HVTN, virologist, and president and director emeritus at the Fred Hutchinson Cancer Research Center in Seattle.
“The search for a vaccine began the moment HIV was first identified over 35 years ago, but there have been many challenges along the way due to the unique properties of this virus, including its global genetic diversity,” said Johan Van Hoof, M.D., Global Therapeutic Area Head, Vaccines, and Managing Director, Janssen Vaccines & Prevention B.V., Janssen Pharmaceutica NV. “Janssen is committed to advancing clinical trials to help build an HIV-free future. With each new study we are working to optimize the mosaic-based vaccine regimen.”
Mosaico will be the second, and largest, efficacy study for Janssen’s investigational HIV vaccine. The first efficacy study, the proof-of-concept Phase 2b clinical trial known as Imbokodo (HPX2008/HVTN 705), is currently evaluating a mosaic-based vaccine regimen in 2,600 young women (aged 18-35) across five southern African countries.
Initial findings from Imbokodo and Mosaico are expected in late 2021, and 2023, respectively.
About Mosaico (HPX3002/HVTN 706)
The Phase 3 Mosaico study plans to enroll 3,800 individuals in Argentina, Brazil, Italy, Mexico, Peru, Poland, Spain, and the United States. The HIV-1 preventive vaccine regimen being evaluated in Mosaico will utilize Janssen’s AdVac® adenovirus vector platform and is administered through four vaccinations over one year. It is comprised of a mixture of four adenovirus serotype 26 vectors delivering mosaic HIV antigens, Ad26.Mos4.HIV (in vaccinations 1-4), and a combination of two soluble proteins, Mosaic and Clade C trimeric gp140 adjuvanted with aluminum phosphate (in vaccinations 3 and 4).
Mosaico is sponsored by Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, with funding support from the National Institute of Allergy and Infectious Diseases (NIAID) and the U.S. Army Medical Research and Development Command (USAMRDC). The HIV Vaccine Trials Network (HVTN), headquartered at the Fred Hutchinson Cancer Research Center in Seattle, is facilitating the implementation of the study.
Since 2005, Janssen Vaccines & Prevention B.V. has participated as a sub-grantee in the NIH-supported Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program under grants AI066305, AI078526, AI096040 and AI128751 (Principal Investigator, Professor Dan Barouch).
Visit www.jnj.com/HIV for further details on the breadth of HIV science and collaboration being undertaken by the Johnson & Johnson Family of Companies and its partners.
About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at www.jnj.com. Follow us at www.twitter.com/JNJNews.
About the Janssen Pharmaceutical Companies
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995, regarding development of a potential preventive vaccine for HIV. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Vaccines & Prevention B.V., any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 30, 2018, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” in the company’s most recently filed Quarterly Report on Form 10-Q and in the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.