RIO DE JANEIRO, BRAZIL – Along with research centers from several countries, the Federal University of Minas Gerais (UFMG) has joined the study to test the efficacy of a vaccine against the HIV virus, which impairs the body’s ability to fight infections. The mosaic trial will test two immunizers designed to provide protection against different strains of the virus worldwide.
Professor Jorge Andrade Pinto of the Medical School, coordinator of the Research Group on HIV/AIDS in Children, Adolescents and Pregnant Women and responsible for the trials in Minas Gerais, explained on video to UFMG the features of the vaccine and the research stages.
“The Mosaico study is a phase three efficacy trial, which seeks to answer the following questions: is the vaccine in this population safe? Is there any discomfort or adverse reaction? Is the vaccine capable of producing an immune, effective, and protective response to HIV? And finally, is it able to prevent infection in the vaccinated population?”
The coordinator also specified the type of immunizer. “There are two vaccines, one is a viral vector vaccine containing a vector that is the adenovirus, in which the immunogenic components of HIV are inserted, and a protein vaccine – of HIV protein sequences”.
According to Pinto, the Phase 3 trial is a double blind study: “Neither the recipient nor the person administering the vaccine will know which one is being administered. One group will be vaccinated and another will be given a placebo, which is an inert substance that serves as a comparison group.”
In Brazil, the research will recruit subjects in five capitals. In addition to Belo Horizonte, through UFMG’s Medical School, the clinical trial will be conducted in São Paulo (USP Clínicas Hospital), Rio de Janeiro (Fiocruz and Nova Iguaçu General Hospital), Manaus (Tropical Medicine Foundation) and Curitiba (São Francisco Medical Center).
The trial is part of an initiative developed by the HIV Vaccine Trials Network (HVTN) – funded by Janssen Pharmaceutical – and by the U.S. National Institutes of Health (NIH). A total of 3,800 gay or bisexual men and transgender individuals aged between 18 and 60, HIV-negative, who do not use pre-exposure prophylaxis (PrEP) and with no comorbidities against the use of the substance to be tested will be recruited.
“This is a long-term trial, with approximately three years of monitoring, so interested volunteers must also be willing to remain in this segment for that period. The mosaic trial will be conducted in Brazil and also in the United States, Latin America, Europe and seeks to reflect the HIV virus’ geographical diversity,” said the study coordinator in Brazil.
Anyone interested in taking part in the trial and seeking further information may e-mail [email protected] or call/whatsApp (31) 99216-0407 and (31) 99331-3658.