Health workers from Sancti Spiritus, central Cuba, will be participating in the intervention trial to be started on April with Abdala vaccine candidate
An intervention trial to evaluate how much safe and effective is Abdala (CIGB-66), one of the Cuban vaccines candidates against COVID-19 currently undergoing phase III of the clinical trial, will be carried out April in Sancti Spiritus.
Last Saturday, the Center for State Control of Medicines, Equipments and Medical Devices (CECMED) authorized the intervention trial with this vaccine candidate, the first stage of which will be started on Monday in Havana.
The general objective of the trial is to evaluate both direct and indirect effects of the vaccine candidate in population cohorts at high risk of contracting the infection, the disease or spreading the disease, said sources from the institution.
The study will also evaluate specific objectives related with direct and indirect effects on the prevention of symptomatic COVID-19 disease, the effect on preventing severe COVID-19 disease in the selected cohorts and the effect on SARS-CoV-2 mortality in the selected cohorts.
Also to identify and characterize adverse events attributable to
immunization with Abdala vaccine candidate, supported by the
surveillance system of the National Immunization Program, and to determine changes in hospitalization rates in the immunized population. Inclusion criteria: Subjects of both sexes, between 19 and 80 years of age who give their consent to participate.
Exclusion criteria in the controlled intervention study population with
Vaccine Candidate #Abdala are individuals previously vaccinated with a vaccine candidate or anti-SARS-CoV-2 vaccine, documented history of previous COVID-19 infection by medical questioning, and allergy to any of the vaccine components.
These also include administration of immunomodulators in the 30 days prior to vaccination, decompensated chronic diseases that limit vaccination, pregnancy, puerperium and lactation, acute illness that contraindicates vaccination and HIV-positive subject with detectable viral load.