According to a publication by the scientific entity on its social network X, “it is necessary to protect adults over 50 years of age, who, due to immunosenescence, among other risk factors, present an increase in the burden of this disease.”
The clinical trial was approved by the Ministry of Public Health and authorized by the Center for State Control of Medicines, Equipment and Medical Devices (Cecmed) of the Caribbean nation, and its objective is to evaluate the safety, immunogenicity and efficacy of the 11-valent anti-pneumococcal conjugate vaccine candidate.
Four clinical sites in the Cuban capital were selected for this study, and stage II began yesterday at the Institute of Hematology and Immunology.
Next week it will begin in three health areas of the Plaza de la Revolución municipality: April 19, Abelardo Ramírez Polyclinic and Cosme Ordoñez Polyclinic, also in Havana.
Once the results of the study are obtained, the Institution intends to request authorization for medical registration from Cecmed and be able to have a vaccine for adults in order to contribute to healthy aging. The IFV recently registered the 7-valent pneumococcal conjugate vaccine Quimi-Vio® for children from one to five years of age.
Data from the Institute indicate that from September 2024 to date, more than 95,000 two-year-old children have been immunized throughout the country, demonstrating a “very good safety profile.”
Finlay announced that it plans to develop an 11-valent pneumococcal conjugate vaccine candidate and this candidate is also being evaluated in a clinical trial in infants in the first half of life.
To date, 157 children have been vaccinated in Cienfuegos and Santiago de Cuba. In the central province, 102 children are part of this study that will end in 2025.
The Quimi-Vio project began in 2012 and is a very complex vaccine, which, when introduced in countries that have already used it, has made childhood health indicators significantly improve in terms of morbidity from respiratory diseases, and infant mortality from infections, said Dagmar García, IFV Research Director. The first study with Quimi-Vio was carried out in the central Cuban province of Cienfuegos in 2023 “and on that occasion more than 90 percent of all children between one and five years old were vaccinated. There were approximately 11,600 children,” the specialist explained.
Regarding the results of these interventions, García said that, in Cienfuegos, in 2018 and 2019, they also carried out a community clinical trial, in which they injected 93 percent of all children between one and five years of age.
“One year after having immunized them, a 63 percent reduction in hospitalization rates due to respiratory disease was observed; and a 73 percent reduction in invasive pneumococcal disease, due to the serotypes contained in the vaccine,” she added.
ef/jha/cdg
