ArticleVaccine: X2025
Safety and durability of the immune response after vaccination with the heterologous schedule of anti-COVID-19 vaccines SOBERANA®02 and SOBERANA® Plus in children 3-18 years old.
Article in Vaccine: X, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: The heterologous three-dose schedule of the protein subunit anti-COVID-19 SOBERANA®02 and SOBERANA® Plus vaccines has proved its safety, immunogenicity and efficacy in pediatric population, but durability of immunogenicity is not yet dilucidated. This study reports the safety and durability of the humoral and cellular responses in children and adolescents 5-7 months after receiving the heterologous vaccine schedule of SOBERANA® 02 and SOBERANA® Plus. Methods: Children participating in a phase I/II clinical trial were followed-up for 5-7 months after the last dose. They were clinically examined by medical doctors, and their parents were interviewed searching for long-term adverse events. Blood samples were collected to evaluate the duration of humoral and cellular immune responses. Sera were tested for the presence of SARS-CoV-2 nucleocapsid (N) protein. Results: There were no reports of severe adverse events such as coagulation disorders, myocarditis, or pericarditis. None of the participants who withdrew from the trial during the follow-up period did so due to post-vaccination adverse events. The humoral response waned in time for N-negative children, but levels of specific and neutralizing antibodies remained similar to those attained after the second dose of SOBERANA® 02 in the heterologous schedule. Neutralizing antibodies against SARS-CoV-2 D614G and omicron BA.1 were detected 5-7 months post-vaccination. RBD-specific IFN-γ secreting cells showed no significant change compared to levels following primary immunization, in both N-negative and N-positive children. Conclusions: The vaccination regimen was safe over time, and both humoral and cellular immunity persisted in the vaccinated population aged 3-18 years, 5-7 months after receiving the heterologous SOBERANA® 02 and SOBERANA® Plus vaccine schedule.Trial registry: https://rpcec.sld.cu/trials/RPCEC00000374-En.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.