Soberana Centro clinical trial begins today in Cienfuegos

More than 1,160 inhabitants of the municipalities of Palmira and Cruces, in the province of Cienfuegos, are participating from this Monday in the Soberana Centro clinical trial with vaccine candidates produced by the Finlay Vaccine Institute.

The objective is to evaluate the non-inferiority of the immune response in adults, of the prophylactic vaccine candidate Soberana 01 with respect to Soberana 02, according to Dagmar Garcia Rivero, Ph.D., head of research at the Finlay Vaccine Institute.

This study approved by the CECMED, has a scheme with two doses of these prospects and a last booster of Soberana Plus, at an interval of 28 days, to better measure the performance of the immunogen.

She said that the research will be carried out randomly in 1,166 people, between 19 and 80 years of age, half of them residents of Palmira and the other half of them residents of Cruces.

In this selection, she said, there are ethical principles, of gender equity, and they will be able to include people with associated diseases as long as they are under control, such as hypertensives and diabetics and asthmatics, the latter without steroid treatment.

Pregnant women and women breastfeeding their babies are excluded from the study.

She clarified that none of the candidates contain thimerosal.

She added that the trial is required to be "double-blind", because the products are coded and neither doctors, nurses nor individuals know which candidate they are inoculating or receiving.