Posted: Dec 1, 2021 15:59 GMT
It will be administered in four doses and its purpose is preventive. 3,800 people who do not have the virus participate in the trial.
Janssen, a pharmaceutical division of Johnson & Johnson, is conducting Mosaic, a phase III clinical trial (the first to reach that point in a decade), in which it tests a vaccine to prevent infections from different strains of HIV.
Its about “largest study ever conducted”said Maria Grazia Pau, compound development team leader for HIV vaccine programs at Janssen, quoted in a firm’s press release.
Who participates in the study?
The clinical study, also known as HPX3002 / HVTN 706, is carried out in 3,800 people in about 55 sites in eight countries in Europe and America, which are: Spain, Italy, Poland, USA, Mexico, Brazil, Peru and Argentina.
The participants chosen for this trial are men who have sex with men and transgender people, between 18 and 60 years old; and, since it is a vaccine that has a preventive purpose, these people do not have the virus.
“The objective is to know if the administration of the four planned doses of the investigational vaccine prevents the acquisition of HIV infection in people at risk of acquiring it. There is a group that is going to receive the doses of the vaccine and another group receives placebo “, commented, in an interview with Gaceta Médica, Miguel Górgolas, head of the Department of Infectious Diseases of the Hospital Universitario Fundación Jiménez Díaz in Madrid (FJD), one of the health centers where the study is carried out.
What is administered?
The trial is called Mosaic because it has a composition of different vaccines previously tested and that, together, they have a presumed prevalence of prevention in HIV infection.
“A mosaic vaccine contains mosaic immunogens (molecules capable of inducing an immune response) that have been created using genes from a wide variety of HIV-1 subtypes. The goal is to unleash a strong and long-lasting immune response“said Sabrina Spinosa Guzmán, director of Clinical Development and physician responsible for the study.
The vaccines in this clinical trial are called Ad26.Mos4.HIV, composed of a virus known as adenovirus type 26; and bivalent gp140, composed of two proteins known as clade C gp140 and mosaic gp140.
Spinosa explained, like Górgolas, that the test consists of the application of four doses within a year and the specific components of the vaccine vary for the last two.
That formulation for the last doses, detailed Górgolas, “is made up of the specific protein of the virus and incorporates aluminum as an immunity promoter.”
After the application of the doses, there is a follow-up period of at least 18 months to the vaccinated.
Imbokodo, a suspended trial
In late August, Johnson & Johnson and its global partners announced the suspension of the clinical trial of the phase 2b HIV vaccine, known as the Imbokodo study (HVTN 705 / HPX2008).
Approximately 2,600 women at high risk of contracting HIV participated in this trial, from five sub-Saharan African countries: Malawi, Mozambique, South Africa, Zambia and Zimbabwe.
According to the company, the study was suspended because data showed that the vaccination regimen “did not provide sufficient protection against HIV infection” in the population that participated in the trial.
The firm clarified that, on the other hand, “the investigational vaccine was found to have a favorable safety profile without serious adverse events.”
“We are extremely grateful to the women who volunteered for the Imbokodo study and to our partners, including the people on the front lines, who contribute every day to this enduring quest to make HIV history,” said Paul. Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson.