Generales

By: Julián David Ospina Sánchez - Journalist

The Immunovirology group and the Program for the Study and Control of Tropical Diseases (PECET), which are part of Universidad de Antioquia’s Faculty of Medicine, were chosen in Colombia to evaluate the results of the Sinovac vaccine against SARS-CoV-2 in children between 3 and 11 years of age in Medellín and the Aburrá Valley.

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In the next 12 months, the Immunogenicity Study of the Sinovac Vaccine in the Infant Population will be conducted in Medellin and its metropolitan area. The Immunovirology Group and the Program for the Study and Control of Tropical Diseases (PECET), which belong to Universidad de Antioquia’s Faculty of Medicine, were chosen to perform the study. "We were chosen because the institution has invested all its responsibility and interest in research activities to try to understand and control the pandemic", noted the director of PECET, Iván Darío Vélez Bernal.
   
The multinational Sinovac Life Sciences Co. Ltd. chose the university researchers to find out how its biologic against COVID-19 is working in children between 3 and 11 years of age in this area of Antioquia. "We have just signed the contract and are starting to recruit volunteers", said the coordinator of the Immunovirology Group, María Teresa Rugeles López.

According to the parameters of the study, 100 children from Medellin and its metropolitan area between 3 and 11 years of age who have received the two doses of the vaccine or are about to receive the second dose, will be selected. According to Professor Rugeles López, those who have the full schedule must have their second dose administered in the last month, and those who are waiting for it must have it scheduled for June or July. In addition, half of those selected cannot have been infected with COVID-19 or been close to someone infected.

"Being chosen for this work is a result of the research capacity of our groups, which undoubtedly transcends borders", John Jairo Arboleda Céspedes, president of Universidad de Antioquia.

The selected children must have parental consent and be willing to do the necessary follow-up for the biological evaluations. "It is a great opportunity to evaluate the immune response in their children", said Velez Bernal.

Contributions in the Pandemic

The international recognition of the Program for the Study and Control of Tropical Diseases (PECET), which belongs to UdeA’s Faculty of Medicine, has prompted the company Janssen to entrust it with the clinical studies of the Johnson & Johnson intramuscular vaccine since August 2020. In addition, the Chinese pharmaceutical company Wantai BioPharm trusted PECET to conduct phase three clinical trials of an intranasal vaccine against SARS-CoV-2.

In the case of the Immunovirology Group, also of UdeA’s Faculty of Medicine, the isolation and culture of the virus have enabled the characterization of the immune response and the viral load of patients, the evaluation of hundreds of products to know whether they inhibit SARS-Cov-2, the formulation of new research projects and collaboration with other institutions.

Follow-Up of Selected Subjects

"The effectiveness of the Sinovac vaccine in preventing SARS-CoV-2 infection in children is between 40% and 60%, and 70% against the possibility of hospitalization, according to international data that have been published so far", said the coordinator of UdeA’s Immunovirology Group, who noted that the new study will contribute what happens in Medellin and the Aburrá Valley.

For this purpose, children who are duly authorized and meet the selection criteria mentioned above must provide two blood samples: the first one, two months after completing the vaccination schedule, and the second one, four months later, that is, six months after receiving the second dose.

In addition, during the four months between the first and second blood samples, children will have to provide a saliva sample every 15 days to evaluate whether they have been infected during that period. "To facilitate the process, Universidad de Antioquia will provide two alternatives to families: take blood and saliva samples at home or pay for refreshment and travel expenses of those who come to the University Research Headquarters (SIU).", clarified Professor Vélez Bernal.

"These types of studies have been so important that they have shown the need to reinforce different age groups", concluded Professor Rugeles López.

For further information about participation in the studies, you may write to WhatsApp number 302 357 51 73 or e-mail ensayosclinicos@udea.edu.co. Candidate registration can be done here.