Soberana Plus (FINLAY-FR-1A) / Finlay Vaccine Institute - LARVOL DELTA

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. (PubMed, Vaccine X) - "RBD-specific IFN-γ secreting cells showed no significant change compared to levels following primary immunization, in both N-negative and N-positive children. 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."

Journal • Cardiovascular • Hematological Disorders • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pediatrics • Respiratory Diseases • IFNG

Comparative assessment of a COVID-19 vaccine after technology transfer to Iran from critical quality attributes to clinical and immunogenicity aspects. (PubMed, Sci Rep) - "Soberana Plus vaccine, a recombinant protein based vaccine (RBD dimer), with the trade name of PastoCovac Plus in Iran, is based on a protein subunit platform in Cuba and completed preclinical and toxicological assessments...Furthermore, the level of anti-spike and neutralizing antibodies in the both vaccine groups was not significantly different indicating the equality of performance between the two vaccines. According to the results of the quality and clinical assessment of this study, we achieved an acceptable quality attributes and acceptant limits in terms of safety and efficacy of the vaccines pre and post technology transfer."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease

Stability of Neutralizing Antibody of PastoCoAd Vaccine Candidates against a Variant of Concern of SARS-CoV-2 in Animal Models. (PubMed, Iran Biomed J) - "The results also showed that the PastoCoAd vaccine candidates Ad5 S & RBD-N and Ad5 S/SOBERANA could neutralize the VOC strains in the animal models. The ability of vaccine candidate to neutralize the VOC strains in animal models by generating neutralizing antibodies at different time points may be attributed to the use of the platform based on the Adenoviral vector, the N proteins in the Ad5 S & RBD-N vaccine candidate, and the SOBERANA Plus booster in the Ad5 S/SOBERANA vaccine candidate."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Real-world effectiveness of the heterologous SOBERANA-02 and SOBERANA-Plus vaccine scheme in 2-11 years-old children during the SARS-CoV-2 Omicron wave in Cuba: a longitudinal case-population study. (PubMed, Lancet Reg Health Am) - "Our results contrast with the observations in previous real-world vaccine effectiveness studies in children, which might be explained by the type of immunity a conjugated protein-based vaccine induces and the vaccination strategy used. National Fund for Science and Technology (FONCI-CITMA-Cuba)."

Journal • Real-world • Real-world effectiveness • Real-world evidence • Infectious Disease • Novel Coronavirus Disease • Pediatrics • Respiratory Diseases

Immunogenicity of a single booster dose of Soberana Plus (FINLAY-FR-1A) vaccine in adults with different previous history of COVID-19 vaccination (ECCMID 2024) - No abstract available

Clinical • Infectious Disease • Novel Coronavirus Disease

Development of a scalable single process for producing SARS-CoV-2 RBD monomer and dimer vaccine antigens. (PubMed, Front Bioeng Biotechnol) - "These antigens are featured in various COVID-19 vaccine formats, including SOBERANA 01 and the licensed SOBERANA 02, and SOBERANA Plus. We have determined that both the monomeric and dimeric RBD antigens possess the necessary quality attributes for vaccine production. By enabling the customizable production of both RBD forms, this unified manufacturing process provides the required flexibility to adapt rapidly to the ever-changing demands of emerging SARS-CoV-2 variants and different COVID-19 vaccine platforms."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Comparative Immune Response after Vaccination with SOBERANA 02 and SOBERANA plus Heterologous Scheme and Natural Infection in Young Children. (PubMed, Vaccines (Basel)) - "Cytotoxic-related proteins granzyme A and B, perforin, and granulin were also found in the supernatant after S1 stimulation in both vaccinated and recovered children. (4) Vaccination with the heterologous scheme of SOBERANA 02/SOBERANA Plus induces a stronger antibody and cellular immune response compared to natural infections in young children."

Journal • Infectious Disease • Novel Coronavirus Disease • Pediatrics • Respiratory Diseases • CD4 • CD8 • GZMA • GZMB • IFNG • IL10 • IL2 • IL4 • IL6