Johnson & Johnson Announces Full Enrollment in Proof-of-Concept Efficacy Study of Janssen’s Investigational HIV Preventive Vaccine

Phase 2b efficacy study of mosaic-based vaccine successfully enrolls 2,600 women aged 18-35 across five southern African countries

NEW BRUNSWICK, NJ, May 29, 2019 – Johnson & Johnson today announced that full enrollment has been achieved in a Phase 2b proof-of-concept efficacy study evaluating an investigational preventive vaccine against HIV-1 infection. Sponsored by Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, in collaboration with a consortium of global partners, the Imbokodo study is evaluating a mosaic-based vaccine regimen in 2,600 young women across five southern African countries where women and girls experience high rates of HIV infection.

Imbokodo (also known as HVTN 705/HPX2008) is the first efficacy study conducted in relation to Janssen’s mosaic-based preventive vaccine and is testing whether it can safely and effectively reduce the rate of new HIV infections. The mosaic-based concept is designed as a global vaccine with the goal of preventing infection by a wide range of viral strains responsible for the HIV pandemic. Initial results from Imbokodo are anticipated by 2021.

“Achieving full enrollment in Imbokodo is an important step forward in our work to advance a universal vaccine that could ultimately help turn the tide on HIV,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “Finding a safe and effective vaccine has proven to be one of the greatest public health challenges of our time. Johnson & Johnson stands with other stakeholders in ensuring that this scientific effort remains a top global priority.”

Although significant progress has been made in the fight against HIV, more than 35 million people are living with the virus globally. In 2017, 1.8 million people were newly infected with HIV and nearly 1 million people died of AIDS.[i] According to UNAIDS, in sub-Saharan Africa young women aged 15–24 years are twice as likely to be living with HIV than men.[ii]

“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.

“The rapid progress we have seen with women enrolling in Imbokodo is impressive, and a sign that the world’s quest to find an HIV vaccine is accelerating,” said Professor Glenda Gray, CEO and President, South African Medical Research Council (SAMRC), and chair of the Imbokodo study. “I’d like to pay tribute to the 2,600 women who have volunteered to participate in Imbokodo. They are the true heroes in this effort.”

Imbokodo is supported by a public-private partnership led by Janssen Vaccines & Prevention B.V., the Bill & Melinda Gates Foundation, the National Institutes of Health and the HIV Vaccine Trials Network (HVTN). Additional partners providing support include the U.S. Army Medical Materiel Development Activity (USAMMDA), and the Ragon Institute of Massachusetts General Hospital (MGH), Massachusetts Institute of Technology (MIT) and Harvard. The study is being conducted at clinical sites coordinated by HVTN, and SAMRC is helping to implement Imbokodo in South Africa.

“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 IDV, Vaccines, and Managing Director, Janssen Vaccines & Prevention B.V., Janssen Pharmaceutica NV. “Today, there is new momentum in this field. By leveraging cutting-edge technologies and working in partnership, we are optimistic that we can find a preventive vaccine in our lifetimes.”

Additional Phase 3 studies will be needed for licensure of the mosaic-based vaccine regimen against HIV-1. Janssen will disclose further details regarding these studies as plans are finalized.

About the Investigational Mosaic-based HIV Vaccine
Janssen’s investigational HIV-1 preventive vaccine regimen contains mosaic immunogens (molecules capable of inducing an immune response) that have been created using genes from a wide variety of viral subtypes responsible for the HIV pandemic. The regimen is delivered through a heterologous vaccination schedule, involving four immunizations given over one year. By using different vaccine components for vaccinations one and two, as compared to vaccinations three and four, the goal is to produce strong and long-lasting immunity to HIV. Early-stage clinical data from Phase 1/2a studies conducted to date (APPROACH, TRAVERSE) suggest that mosaic-based vaccine regimens are well tolerated and induce robust immune responses to different HIV-1 strains.

The Phase 2b Imbokodo (HVTN 705/HPX2008) proof-of-concept efficacy study has enrolled 2,600 sexually active HIV-negative women between the ages of 18 and 35 years at more than 20 trial sites across Malawi, Mozambique, the Republic of South Africa, Zambia, and Zimbabwe. Components of the regimen being evaluated in Imbokodo are an adenovirus vector using adenovirus serotype 26 (Ad26.Mos4.HIV) that carries transgenes of mosaic HIV genes (gag, pol, env) and an aluminum phosphate-adjuvanted soluble protein (Clade C gp140). More information about the Phase 2b Imbokodo study is available at Imbokodo.org.za and ClinicalTrials.gov using identifier NCT03060629.

Since 2005, Janssen Vaccines & Prevention B.V. has been participating 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, Prof. Dan Barouch).

Visit www.jnj.com/HIV to learn more about the breadth of HIV science being pursued by the Janssen Pharmaceutical Companies of Johnson & Johnson and its partners across prevention, treatment and cure research.

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 @jnjglobalhealth.

About the Janssen Pharmaceutical Companies of Johnson & Johnson
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.

Learn more at www.janssen.com. Follow us at @janssenglobal. Janssen Vaccines & Prevention B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development. 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., Johnson & Johnson and/or their affiliates. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product development, including the uncertainty of clinical success and of obtaining regulatory approvals; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; and trends toward health care cost containment. A further list and description 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. The Janssen Pharmaceutical Companies, Johnson & Johnson and their affiliates do not undertake to update any forward-looking statement as a result of new information or future events or developments.

[i] UNAIDS (2018) Fact Sheet, World AIDS Day 2018. Available at http://www.unaids.org/en/resources/fact-sheet. Last accessed May 2019.
[ii] Ibid.