The international clinical study to evaluate the effectiveness of a vaccine against the different strains of HIV, in which six hospitals in Madrid, Barcelona, Valencia and Córdoba participate, will have 250 Spanish participants out of a total of 3,800 people.
In an interview with EFE, the researcher María Jesús Barberá, from the Infectious Diseases Service of Hospital Vall d’Hebron in Barcelona, who participates in the project, explained where is this international vaccine study at? to prevent HIV infection, which has already started phase III.
In this phase, the safety and efficacy of the drug are verified and tested in a large number of participants, as is the case in this international study, which had to be interrupted in March of this year due to the COVID-19 pandemic.
Now, back on track, the multicenter study, known as ‘Mosaico’ and also as HVTN 706, has divided the participants into those receiving the vaccine and those receiving placebo, and it is double blind, that is, neither the patient nor the doctor know if they are receiving or providing medication or not.
Barberá has indicated that the research is aimed at cisgender men who like men and transgender people who have sex with men, between 18 and 60 years of age and who are at risk of contracting HIV.
The cisgender neologism, introduced by the German psychiatrist Volkmar Sigusch in 1991, defines people who identify with gender and gender assignment at birth, regardless of their sexual preferences, while transgender people do not identify with it. gender they were born with.
The doctors and scientists involved in this vaccine trial want to know if the vaccine can protect against HIV infection, since the aim is to get a preventive drug and prevent HIV-negative people from acquiring the virus.
Also known as Ad26.Mos4.HIV, the vaccine is based on a genetically modified adenovirus vector to carry a ‘mosaic’ of optimized HIV immunogens or antigens that stimulate the body’s immune responses.
The study includes a selection period of 45 days, another twelve-month vaccination and a follow-up of at least 18 months after the fourth vaccination.
The Spanish hospitals participating in the trial are the Catalan Vall d’Hebron (Barcelona) and Germans Trias i Pujol (Badalona, Barcelona); the San Carlos hospital complex and the Jiménez Díaz Foundation Hospital, both in Madrid; the General Hospital of Valencia and the Reina Sofía Hospital, of Córdoba.
In addition, there are other participating centers in the United States and Latin America and European hospitals.
“The expectations with this trial are great, although we must be cautious, because we will have to wait two and a half years to have results” of the research, has considered Barberá.
Despite significant advances in HIV treatment and care, such as pre-exposure prophylaxis (PrEP), There is still a need for a vaccine, which could be very useful for those who still do not use an HIV prevention method, the researcher has argued.