Finlay-FR-2 (Soberana 2) / Finlay Vaccine Institute - LARVOL DELTA

Parsonage-Turner Syndrome and Vocal Fold Paresis Following Soberana 2 FINLAY-FR-2 COVID-19 Vaccination: A Case Report. (PubMed, Clin Case Rep) - "This case report presents a 58-year-old male who developed Parsonage-Turner syndrome (PTS) and vocal cord paresis after receiving the Soberana 2 FINLAY-FR-2 COVID-19 vaccine. This patient was treated with intravenous methylprednisolone. Despite therapeutic intervention, the patient exhibited persistent neurological deficits during follow-up."

Journal • Gastrointestinal Disorder • Genetic Disorders • Infectious Disease • Novel Coronavirus Disease • Otorhinolaryngology • Pain • Pulmonary Disease • Turners Syndrome

LC-MS/MS Characterization of SOBERANA 02, a Receptor Binding Domain-Tetanus Toxoid Conjugate Vaccine Against SARS-CoV-2. (PubMed, Proteomics) - "The RBD was also conjugated, but to a lesser extent, to ten other low-abundance carrier proteins. This study represents the first report of a conjugation site assignment in a TT-based conjugate vaccine."

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

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

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

Comparative Analysis of SARS-CoV-2 Antibody Responses across Global and Lesser-Studied Vaccines. (PubMed, Vaccines (Basel)) - "The vaccines under comparison include well-known ones like Pfizer (BNT162b2) and AstraZeneca (ChAdOx1-S), alongside less-studied vaccines including Soberana (Soberana 02), Abdala (CIGB-66), and Sputnik V/Sputnik Light...Overall, we found no evidence of waning in the antibody magnitude across vaccines. Our study supports the conclusion that populations with high infection rates still benefit substantially from vaccination."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

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

Efficacy and Safety of a Protein-Based SARS-CoV-2 Vaccine: A Randomized Clinical Trial. (PubMed, JAMA Netw Open) - "The protein-based SARS-CoV-2 vaccines FINLAY-FR-2 (Soberana 02) and FINLAY-FR-1A (Soberana Plus) showed good safety and immunogenicity in phase 1 and 2 trials, but the clinical efficacy of the vaccine remains unknown...Therefore, Soberana may have utility as an option for mass vaccination of the population, especially in resource-limited settings, because of its storage condition and affordable price. isrctn.org Identifier: IRCT20210303050558N1."

Clinical • Journal • Hematological Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and efficacy of the two doses conjugated protein-based SOBERANA-02 COVID-19 vaccine and of a heterologous three-dose combination with SOBERANA-Plus: a double-blind, randomised, placebo-controlled phase 3 clinical trial. (PubMed, Lancet Reg Health Am) - "Our results indicate that the straightforward to manufacture SOBERANA vaccines are efficacious in a context of Beta and Delta VOC circulation, have a favourable safety profile, and may represent an attractive option for use in COVID-19 vaccination programmes. This study received funds from the National Fund for Science and Technology (FONCI-CITMA-Cuba, contract 2020-20) of the Ministry of Science, Technology and Environment of Cuba."

Journal • P3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Tetanus

Open-label phase I/II clinical trial of SARS-CoV-2 RBD-tetanus toxoid conjugate vaccine (FINLAY-FR-2) in combination with RBD-protein vaccine (FINLAY-FR-1A) in children. (PubMed, Int J Infect Dis) - "The heterologous scheme was safe and immunogenic in children 3-18 y/o."

Combination therapy • Journal • P1/2 data • Immunology • Infectious Disease • Novel Coronavirus Disease • Pain • Pediatrics • Respiratory Diseases • Tetanus

Safety and immunogenicity of anti-SARS-CoV-2 heterologous scheme with SOBERANA 02 and SOBERANA Plus vaccines: Phase IIb clinical trial in adults. (PubMed, Med (N Y)) - "Two doses of SOBERANA 02 were safe and immunogenic in adults. The heterologous combination with SOBERANA Plus increased neutralizing antibodies, detectable 7-8 months after the third dose."

Journal • P2b data • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases • Tetanus

Safety and immunogenicity of anti-SARS CoV-2 vaccine SOBERANA 02 in homologous or heterologous scheme: Open label phase I and phase IIa clinical trials. (PubMed, Vaccine) - "SOBERANA 02 was safe and immunogenic in persons aged 19-80 years, eliciting neutralizing antibodies and specific T-cell response. Highest immune responses were obtained in the heterologous three doses protocol."

Journal • P1 data • P2a data • Immunology • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases • Tetanus

SARS-CoV-2 RBD-Tetanus Toxoid Conjugate Vaccine Induces a Strong Neutralizing Immunity in Preclinical Studies. (PubMed, ACS Chem Biol) - "Some advantages of immunization with RBD-TT conjugates include a predominant IgG immune response due to affinity maturation and long-term specific B-memory cells. These result demonstrate the potential of the conjugate COVID-19 vaccine candidates and enable their advance to clinical evaluation under the name SOBERANA02, paving the way for other antiviral conjugate vaccines."

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

Cuba approves second homegrown COVID vaccine for late phase trials (Reuters) - "Cuba’s drug regulatory authority...approved a second COVID-19 vaccine candidate for late-stage clinical trials...Authorities will start recruiting about 48,000 volunteers between the ages of 19 and 80 in Cuba’s eastern provinces for a randomized, placebo-controlled trial of the three-shot vaccine next week...The study is to be completed in July, with first results due for publication in August."

New P3 trial • P3 data: top line • Trial completion date • Infectious Disease • Novel Coronavirus Disease

Cuba to collaborate with Iran on coronavirus vaccine (Reuters) - "Communist-run Cuba said...it had signed an accord with Iran to transfer the technology for its most advanced coronavirus vaccine candidate and carry out last-stage clinical trials of the shot in the Islamic Republic....Soberana (Sovereign) 2, has completed Phase II trials which started on Dec. 22, it will be tested in Phase III trials in around 150,000 people in Havana...Cuba’s Finlay Vaccine Institute...signed an accord with Iran’s Pasteur Institute to collaborate on testing of Soberana 2....50,000 volunteers would be recruited to carry out the Phase III clinical trials."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

SOBERANA, Cuba's COVID-19 Vaccine Candidates: Dagmar García-Rivera PhD. (PubMed, MEDICC Rev) - "Analysis of results and development of different formulations are currently under way and Phase III clinical trials are planned for early 2021. At the time of writing, a second vaccine candidate, SOBERANA 02, was in late-stage development and preparing to begin separate trials this fall."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease