Johnson & Johnson (J&J) has completed enrolment procedures for the Phase IIb Imbokodo clinical trial of an investigational, mosaic-based vaccine regimen to prevent HIV-1 infection.
The proof-of-concept efficacy study has recruited 2,600 women aged between 18 and 35 years that are living in five African countries that have high rates of HIV infection prevalence.
Sponsored by J&J’s unit Janssen Vaccines & Prevention, the study is evaluating the vaccine’s ability to safely and effectively decrease the rate of new HIV infections.
Janssen’s vaccine comprises mosaic immunogens that are created using genes from multiple viral subtypes responsible for the HIV pandemic. It has been designed as a global vaccine in an effort to target a wide range of viral strains. The regimen is delivered via a heterologous vaccination schedule, where four immunisations are given over one year.
The Imbokodo study is being conducted at more than 20 sites in Malawi, Mozambique, the Republic of South Africa, Zambia and Zimbabwe. Initial data from the Phase IIb trial are expected to be available by 2021.
The study is supported by a public-private partnership between Janssen Vaccines & Prevention, the Bill & Melinda Gates Foundation, the National Institutes of Health (NIH) and the HIV Vaccine Trials Network (HVTN).
Janssen Vaccines & Prevention managing director Johan Van Hoof said: “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.
“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.”
More than 35 million people are infected with HIV globally. In 2017, 1.8 million people were newly infected with the virus and approximately one million people died of AIDS.
Data from the Joint United Nations Programme on HIV/AIDS (UNAIDS) showed that women aged 15-24 years in sub-Saharan Africa are twice at risk of infection than men.