Unicamp's Hospital de Clínicas will take part in a multicenter study to test 500 health professionals, volunteers for the third phase of the Chinese vaccine against coronavirus (Sars-CoV-2). The announcement was confirmed this Monday (13) by governor João Doria and yesterday (15) by the project coordinator at HC, professor Francisco Aoki. The tests will begin within 30 days as soon as the site structure is ready and inspected by the Butantan Institute team.
The accreditation of Unicamp HC, as one of the selected research centers, along with 11 other research centers for clinical trials, is double-blind, randomized, placebo-controlled phase III for evaluating efficacy and safety in healthcare professionals of the SarsCov2 adsorbed vaccine (inactivated) produced by the pharmaceutical company Sinovac Research & Development Co., Ltd (Sinovac Biotech Co., Ltd), from China.
Approval was approved by the National Health Surveillance Agency – ANVISA, by CONEP – National Ethics and Research Committee of the Ministry of Health and FCM. Volunteer registration at HC begins soon and will be detailed on the hospital website. Through the portal https://www.saopaulo.sp.gov.br/coronavirus/vacina/?nocache, it will be possible to access the screening platform to find out if the candidate matches the recruitment criteria.
According to Professor Francisco Aoki, candidates must be between 18 years old and 59 years old and work in hospital or outpatient areas that have some routine related to coronavirus (SarsCov2). Aoki explained that half of the volunteers will receive two doses of the vaccine, while the remainder will receive the placebo quota. Volunteers will not know who received the vaccine and who received the placebo. Applications will take place every two weeks.
“The individual will have eight visits over 12 months. The last two months, the 13th and 14th, will be dedicated to the final reviews of all data collected from the research, laboratory data, exam results, clinical data and, for the purpose of future work, producing a publication that supports the study,” he says.
For this authorization, Anvisa analyzed data from previous stages of product development, in Phases 1, 2 and now culminating in Phase III with a much larger number of volunteers that allows statistical analyzes that prove, among other factors such as immunogenicity, effectiveness of vaccine, immunization capacity, side effects, among all possible detectable variables. Non-clinical studies were carried out on animals, the results of which demonstrated that the vaccine presents adequate and acceptable safety.
Phase I and II studies have also been carried out in healthy adult humans. These studies demonstrated favorable safety and immunogenicity with the two-dose vaccine regimen.
This is the second test of the vaccine against the new coronavirus authorized by Anvisa in Brazil. On June 2, ANVISA had already authorized the clinical trial of the vaccine developed by the University of Oxford, in the United Kingdom, to prevent Covid-19, with a different technical method to the one being tested in this study.
Analysis priority
To approve the clinical trials, Anvisa held a series of meetings with the laboratory team at the Butantan Institute and the Chinese laboratory Sinovac, in order to align all the technical requirements necessary for the tests.
Since the recognition of a public calamity in Brazil due to the new coronavirus pandemic, Anvisa has adopted strategies to speed up analyzes and decisions on any demand aimed at combating Covid-19.
One of these strategies was the creation of a committee to evaluate clinical studies, registrations and post-registration changes to medicines for prevention or treatment of the disease. The group also takes actions to reduce the risk of drug shortages with an impact on public health due to the pandemic.
What are clinical trials
Clinical trials are studies of a new medicine carried out in humans. The clinical phase serves to validate the efficacy and safety relationship of the medicine and also to validate new therapeutic indications.
Within this trial, there are three phases (I, II, III), where information about activity, functioning and safety is collected so that the product can be released to the market and used in patients along with the standard research treatment.
To carry out any clinical research involving human beings, approval from the Research Ethics Committees (CEPs) and the National Research Ethics Commission (Conep) is mandatory.
Clinical research consent by Anvisa only applies to clinical research that has the purpose of registration and post-registration of medicines, at the request of sponsoring companies or their representatives.
Phases of clinical vaccine research
During phase I, small groups of individuals, usually healthy adults, are evaluated to verify safety and determine the type of immune response provoked by the vaccine. Challenge studies can also be carried out at this stage in order to select the best vaccine projects to proceed to the next phase.
In phase II, a greater number of individuals are included and the vaccine is already administered to individuals representing the vaccine's target population (babies, children, adolescents, adults, elderly or immunocompromised). In this phase, the safety of the vaccine, immunogenicity, dosage and method of administration are evaluated.
In phase III, the vaccine is administered to a large number of individuals, normally thousands of people, to demonstrate its efficacy and safety, that is, that the vaccine is capable of protecting individuals with as few adverse reactions as possible.
Criteria to be a volunteer:
- Need to be a healthcare professional working to combat Covid-19
- May not already be participating in other clinical studies
- You cannot have contracted Covid-19
- Women cannot be pregnant or intend to become pregnant within the next three months
- You cannot have unstable diseases or need medications that alter the immune response
- Live close to the testing center
Published article originally on the HC Unicamp website
