The aim of the institute is to prepare the country to face potential pandemics
THE Butantan Institute received this Tuesday 1, the approval of the National Health Surveillance Agency (Anvisa) For a new phase of research with your candidate for avian influence (H5N8): Human tests. In the coming months, the Institute intends to recruit 700 adults and elderly volunteers for phases 1 and 2 of clinical studies in five research centers.
The institution presented the order to the agency for about 10 monthsAfter tests on preclinical animals, which showed favorable results for safety and effectiveness. Now the study will evaluate the safety and ability of two formulations of products to generate immune response in humans.
The immunner will be tested in two doses intramuscularly, with a 21 -day interval between applications. The first doses will be applied to adults from 18 to 59 years and 11 months and then in the elderly. All the results will be compared with those of a placebo.
What will the research be like?
The study will be conducted in different stages. In the first, 70 adults will be recruited, who will receive the doses in a research center in Recife.
The first dose of the two formulations of the VaccineThe security data will be evaluated. If the evaluation is positive, a new recruitment phase will be opened to include 280 people, who will receive applications in the research centers of San Paolo, Belo Horizonte, Sao Jose Do Rio Preto (SP) and Ribeirão Preto (SP).
After another favorable evaluation of the safety profile in adults, the second phase of the study will begin, in which 70 people from age or over 60 years will begin. Then another 350 volunteers. It should be integrated into research.
The goal is to put an end to the monitoring of the participants in 2026 and have a regulatory package that includes a vast age group to be presented in Anvisa.
Concern for the future
THE avian influence In man it is considered sporadic. Usually, cases occur after close contact with a contaminated bird or their feces. Therefore, the infected are often people who work directly with these animals. So far there is no proof of the transmission of this human virus to human.
However, the possible diffusion between people worries scientists due to the high mortality rate (close to 50%) and the severity of the symptoms. In addition, a survey published last year in the magazine Science He underlines that the occurrence of a single mutation could be a pandemic risk indicator – and the mutations are concerned, since the virus before reaching only the birds and now infected cows and humans in contact with contaminated cattle.
“The influence virus A (H5N1) is transmitted by poultry, poultry to mammals, mammals to mammals, birds to humans and mammals to humans. We have not yet seen the transmission of people per person, but it is potential for the virus, the virus of acquiring this ability, which is very dangerous because it increases the risk of a Pandemic” I have, in a note.
Therefore, although there are no cases in recorded humans, buttan’s goal is to prepare the country to face potential pandemics.
“The institute can produce a contingent of 30 million doses after the initial results,” says the Director Butandan, expert Kalllas. This volume, according to the director, could be used in a scenario of spreading the virus.
Source: Terra
Ben Stock is a lifestyle journalist and author at Gossipify. He writes about topics such as health, wellness, travel, food and home decor. He provides practical advice and inspiration to improve well-being, keeps readers up to date with latest lifestyle news and trends, known for his engaging writing style, in-depth analysis and unique perspectives.
