HIV Preventive Vaccine Launches Large Phase 2b Efficacy Study
J&J Janssen Vaccines announced the full enrollment for a Phase 2b efficacy study evaluating a preventive vaccine candidate against Human Immunodeficiency Virus (HIV-1) infections.
This is important news since this is 1 of only 5 experimental HIV-1 vaccine concepts that have progressed to human efficacy trials in 35 years.
The Imbokodo study is evaluating an Ad26.Mos4.HIV regimen in 2,600 women in Malawi, Mozambique, the Republic of South Africa, Zambia and Zimbabwe.
Women in these African countries experience very high rates of HIV infection.
Imbokodo, also known as HVTN 705/HPX2008, is the first efficacy study conducted in relation to Janssen’s investigational HIV-1 preventive vaccine Ad26.Mos4.HIV, which contains molecules capable of inducing an immune response that has been created using genes from a wide variety of viral subtypes responsible for the HIV pandemic.
Early-stage clinical data from Phase 1/2a studies conducted to date, Approach and Traverse, suggest that mosaic-based vaccine regimens are well tolerated and induce robust immune responses to different HIV-1 strains.
“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.
Although significant progress has been made in the fight against HIV, more than 35 million people are living with the virus globally.
HIV weakens a person’s immune system by destroying important cells that fight disease and infection. No effective cure exists for HIV. But with proper medical care, HIV can be controlled.
In 2017, 1.8 million people were newly infected with HIV and nearly 1 million people died of AIDS, according to the Joint United Nations Programme on HIV/AIDS.
The Imbokodo study 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).
Initial results from the Imbokodo study are anticipated by 2021.
Additional Phase 3 studies will be needed for licensure of the mosaic-based vaccine regimen against Human Immuno Virus-1.
Janssen will disclose further details regarding these studies as plans are finalized.
Visit Johnson&Johnson/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.
- Johnson & Johnson Announces Full Enrollment in Proof-of-Concept Efficacy Study of Janssen’s Investigational HIV Preventive
- A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted
- A Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Modified Vaccinia Ankara (MVA)-Mosaic
- Global HIV & AIDS statistics — 2018 fact sheet
- HIV Basics