WASHINGTON – The US National Institutes of Health (NIH) and Janssen Pharmaceutical Companies of Johnson & Johnson announced Monday a plan to carry out an HIV vaccine efficacy trial in North America, South America and Europe.
This Phase 3 efficacy study will enroll 3,800 HIV-negative men and transgender people aged 18 to 60 years who have sex with men and/or transgender people.
The study will evaluate an investigational vaccine called Mosaico based on “mosaic” immunogens, vaccine components comprising elements from multiple HIV subtypes, aiming to induce immune responses against a wide variety of global HIV strains.
“We are committed to developing a safe and effective preventive HIV vaccine suitable for the global populations most vulnerable to HIV acquisition,” said Anthony S. Fauci, director of NIH’s National Institute of Allergy and Infectious Diseases.
It is anticipated to open for enrollment in the United States later this year and the clinical research will also be done in Argentina, Brazil, Italy, Mexico, Peru, Poland and Spain, according to NIH.
“We are in the process of submitting regulatory applications to the respective Health Authorities/Ethics Committees,” Corina Ramers-Verhoeven, a spokesperson with Janssen Pharmaceutical Companies, told Xinhua.
The vaccine candidate may work against multiple strains of the rapidly changing virus. Currently, there is no vaccine that could bring forth broadly neutralizing antibodies, the body’s most effective protection against viruses.
Initial findings from Mosaico are expected in 2023, according to Janssen.
Mosaico will be the third HIV vaccine efficacy trial in progress worldwide. The other two are Imbokodo and HVTN 702, both being tested in African countries, according to NIH.
The World Health Organization has set a goal of ending the AIDS epidemic by 2030, and a vaccine is seen as a critical tool to achieve that goal.