Havana, Cuba: Vaccination of the first 40 children between the ages of two and 18 convalescing from Covid-19 in Cuba and belonging to the Soberana Plus-Pediatrics clinical trial begins today in this capital, Prensa Latina reports.
Soberana Plus, a drug designed by the Finlay Vaccine Institute (IFV), for those who have overcome this disease, in addition to having an authorization for emergency use in the adult population, received the green light for a study in children between two and 18 years of age in the Caribbean island.
Also used as a ‘booster’ (booster) in the IFV immunization scheme of two doses of Soberana 02, from this same center, plus one of Soberana Plus (0-28-56 days), the immunogen -to apply in a single dose – demonstrated that it increases the neutralizing response in convalescent Covid-19 patients and has an excellent safety profile.
The phase I / II clinical trial in pediatric ages will be open, adaptive, without placebo and will have a sample of 530 volunteers between the ages of two and 18 from the provinces of Havana and Cienfuegos, according to its organizers.
During the first stage, 40 children will be evaluated at the Juan Manuel Márquez Hospital in the Cuban capital.
They will be divided into two groups of 20 (two to 11 years and 12 to 18), which in turn, will be separated in half by those who were asymptomatic and patients with manifestations of the disease.
Explaining the details of the trial, the principal investigator, Dr. Rinaldo Puga, explained that all these children will be actively followed up after one hour of putting the vaccine, 24 hours, 48 and 72 hours to see the possible reactions. They will also randomly draw blood at 14 and 28 days for clinical-immunological analysis and also study the immunological variables of the process.
The closing of this first phase must coincide with the last blood draw, 28 days later (November 2).
To move on to the second stage, a certificate with the safety evidence of the vaccine will first be presented at 72 hours after the dose is administered to the 40 children to the Center for State Control of Medicines, Equipment and Medical Devices (Cecmed) , a national regulatory entity, explained Meiby Vicente, director of Clinical Research at IFV.
Once the start of the second phase has been approved, which will take place both in the aforementioned hospital in Havana and in its Cienfuegos counterpart Paquito González, some 240 infants will be evaluated in both centers, also divided according to the previous criteria.
Recruitment for that period is dated in the trial schedule between October 11 and 16; while the end, between November 8 and 13.
Puba explained that all the children included must be at least two months old since they passed the disease, in addition, they must have proof of their positive real-time CRP when they were infected.
Likewise, infants from two to 11 years old must present them with a voluntary document expressed through informed consent for participation in the study by parents or legal guardians; while those from 12 to 18, must also add their own approval.
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