A “hyper-accelerated” process. This will be the production of a vaccine in Chile against the coronavirus that is being developed by scientists from the Catholic University and the Millennium Institute of Immunology and Immunotherapy (IMII). The tests will be possible thanks to the agreement signed by the UC with the Chinese laboratory Sinovac Biotech, which will allow the injection they are developing to be used in the local population.
Preparations began in May and human testing will begin in September, which will require between 3,000 and 5,000 volunteers. The researchers are working on the ethical protocol for the trials, which must be approved by the Institute of Public Health.
Miguel O’Ryan, an infectologist and researcher at the ICBM Institute of Biomedical Sciences of the Faculty of Medicine of the University of Chile, is part of the team that will carry out the trial. He says that normally the whole process takes a year, but that the population can be inoculated earlier. “For the study of an emergency pandemic vaccine, interim evaluations will be made and, for example, if at six months it is found that the vaccine makes a difference between vaccinated and unvaccinated in terms of protection, the study is continued, but it can already be used to advance to a registry of the vaccine for its use, ”he explains.
Behind the development of the test protocol is Marcela Potin, an infectious pediatrician at the Catholic University, who points out that the Chinese injection will be tested in health workers, since they are the most likely to carry the infection, and that there will be age and age criteria. sex, but will not consider genetic conditions.
The trial will be carried out in the Metropolitan Region, although they are evaluating the inclusion of another region. The call for volunteers would begin in the next two weeks and by regulation people will not be paid.
“The clinical studies in Chile are reviewed by an ethics committee, which includes health personnel, people from the community, lawyers and researchers. They analyze the protocol, the informed consent document, and seek that the rights of the volunteers are respected, make suggestions and approve or reject the trial, “says Potin.
Alexis Kalergis, an academic at the Catholic University and director of the Millennium Institute of Immunology and Immunotherapy (IMII), explains that the trial in people is Phase 3 of testing a vaccine, where its efficacy is tested, not its safety, which It must have been checked before, so the volunteers are not at risk.
“These are studies that are intended for vaccines that have prior safety demonstration. We are trying to do this in a consortium way, that is, with the participation of various universities and research centers, not only in Santiago, but also in regions, ”he says.
This consortium of clinical trials has already been formed and brings together eight universities in the country. Private funds are already committed to the clinical trial, and the government will also have public resources.
In addition, the Ministry of Science heads a committee made up of the Ministries of Health and Foreign Affairs, which is overseeing the trials.
The Minister of Science, Andrés Couve, states that “since these are multi-center studies and involve more than one university, it is essential to have a network of institutions that allows these capabilities to be used to develop the clinical trial.”
He adds that “having a wide network can have a better design of parallel clinical studies and our strategy considers the realization of three clinical trials. The consortium, which is being formed at the initiative of the universities, will define which subset of institutions will carry out each test. Whoever directs the clinical study will be responsible for recruiting volunteers and following up. ”
Chile has accumulated experience in clinical trials of vaccines, in its three phases. For example, vaccines and treatments against respiratory syncytial virus (RSV), vaccines for polio, rotavirus, influenza, meningococcal serogroup B, hepatitis A, acellular pertussis vaccine, Haemophilus influenza type B, human papilloma virus (HPV), and vaccine have been evaluated. conjugated against 10-valent pneumococcus (PCV-10), among others.
Miguel O’Ryan led the rotavirus vaccine test (2006), which was tested on 2,000 Chilean infants, and the serogroup B meningococcal vaccine (2010-2012), which was tested on 1,200 adolescents in the Region. Metropolitan. Both trials were successful.
The infectologist explains that, in the trial, a group of people is vaccinated with the dose and another group is injected with a placebo, based on a saline solution, which the volunteer does not know.
“Before and after blood samples are taken over the extended period of several months to see what the immediate immune response looks like and then persists over time,” he says.
The volunteers are followed up for two weeks, with records of possible adverse effects, such as pain, swelling, fever and decline.
“There is a follow-up to see how severe the disease is or not, and periodic telephone checks are carried out, even if the person is well, to ask how he is”, he details. The entire process lasts about a year, experts say.