About 40 children and adolescents between 2 and 18 years of age received a single dose of the Soberana Plus vaccine at the Juan Manuel Márquez Pediatric Hospital in Havana as part of phase I of Soberana Plus Pediatric clinical trial being developed in Covid -19 convalescents of pediatric ages.

Specialists from Public Health and the Finlay Vaccine Institute, promoter of the immunogenic, recently gave details to the press about the features of the clinical trial that will stablish the foundations to protect pediatric Covi-19 convalescents from a possible re-infection.

What are the particularities of the trial?

The trial is an open- label, adaptive phase I/II study to evaluate the safety, reactogenicity and immunogenicity of this formulation in this population group, which is possible to the emergency use clearance for this product issued on September 23rd, 2021 by the CEDMED.

Raynel Cisneros is the first vaccinated child in the #Soberana Plus Pediatric Phase I trial in Havana.

Following approval by @cubacedmed, the Phase II trial will be conducted both in Havana and Cienfuegos. #CubaForLife pic.twitter.com/n3Ffu02e94.

No placebo will be included in the trial, which involves 40 children and adolescents (20 aged between 2 and 11 years old and 20 aged between 12 and 18 years old), equally divided into symptomatic and asymptomatic, including those who suffered the disease as mild, severe and critical.

They will be followed up in the first 60 minutes after being shot, and in the following 24,48 and 72 hours. Their evolution will also be monitored on the seventh day and random blood test will be performed in the 14th and the 28th day after the injection.

In Phase II, once the evidence of the safety of the clinical trial has being gathered after the 72 hours of been administrated the product to subjects and after being approved by CEDMED, the remaining 480 subjects, for a total of 520 children and adolescents, will undergo the intervention.

The 480 volunteers will be divided into two groups of 240 individuals (a first group in the range of 12 to 18 years of age and a second group in the range of 2 to 11 years of age, with a distribution of 120 asymptomatic patients and 120 symptomatic with the disease for each segment). The trials will be conducted at the Juan Manuel Márquez Pediatric Hospital in Havana and at the Paquito González Cueto University Pediatric Hospital in Cienfuegos.

The@cubacedmed approves the emergency use of #Soberana 02 vaccine in children from 2 to 18 years of age.

Making progress together and in hand to hand in the fight against the epidemic.

Why are volunteers divided into symptomatic and asymptomatic?

The sample is divided into mild, moderate, severe and critical asymptomatic patients, under the purpose of looking for the best evidence of immune response in both cases, because each person develop a different immune response, those who went through moderate, severe and critical stages have a good response, even so it is necessary to vaccinate them.

Who will be able to take part of?

Children and adolescents who were diagnosed with Covid-19 by PCR test will tale part of the trial.

It is also necessary the volunteers ‘expressed consent, the approval of parents or legal guardians, nutritional assessment, physical exams, laboratory results and the use of contraceptive methods (in the case of adolescents of childbearing age).

In the same way, the center´s registry of convalescents, the voluntary request of the parents and the proximity to the facility where they will be treated, will be taken in consideration, due to the frequency with which they will be followed up, mainly in the first stage.

Why will Covid-19 patients with two or more moths of recovery be studied?

Because this is considered the minimum time lapse in which patients returns to his basal state, return to the degree of immune autonomy they had prior the infection with the disease, in addition to the fact that the immune response is more mature and presents fewer sequelae.

What are the exclusion criteria?

Those who have received at least a single dose of any of the vaccine candidates or vaccine against SARS-COV 2, have presented febrile or acute infectious disease in the seven days prior to the administration of the vaccine or at the time of its application, or have been treated with antimicrobials or non-steroidal anti-inflammatory drugs are excluded.

Subjects with uncontrolled chronic non-communicable diseases, with congenital or acquired immune system disorders, with a history of neoplastic disease, with abuse of toxic substances during the last 30 days or addictive disease to toxic substances will not be included either.

Other exclusion criteria are related to diminished mental faculties, severe allergies, participation in another clinical trial of preventive or therapeutic intervention in the last three months, treatment with immuno-modulators, blood or blood product transfusions, pregnancy, puerperium, lactation, tattoos in the deltoid region of both arms. 

What will happen once Soberana Plus Pediatric is over?

The researchers expect to have the results of clinical trial by mid-November. On the basis of the evidence gathered, the authorization of emergency use of the vaccine for the pediatric population convalescing from Covid-19 may be extended.

Soberana Plus consist of two molecules of RBD (dimeric form) adjuvanted in aluminum hydroxide, which is the same formulation used in the heterologous scheme of Soberana 02 Plus and the product used independently in the adult population convalescing from Covid-19

Taken from Radio Metropolitana