Abdala (CIGB-66) / Center for Genetic Engineering and Biotechnology - LARVOL DELTA

Predicting the Etiology of Hearing Loss With a Joint (Reflection-Distortion) OAE Profile (ARO 2025) - "Reflection and distortion emissions arise via different cochlear generation mechanisms and have shown distinct sensitivities to hearing loss (Abdala et al., 2024)... The DPOAE and SFOAE show distinct sensitivities to the same hearing loss. Exploiting these differences (which likely reflect distinct generation mechanisms), appears to enhance the differential diagnosis of hearing loss, although it is likely that accuracy here was limited by our relatively small cohort. Using the Joint-OAE Profile in differential diagnosis of hearing loss warrants further development."

Otorhinolaryngology

The Effect of Undamping Feedback Force on Otoacoustic Emissions Derived From a Nonlinear Cochlear Model (ARO 2025) - "It was recently suggested to combine OAEs generated by reflection and distortion to create a joint reflection-distortion OAE profile [Abdala and Kalluri J Acoust Soc Am... The presented simulations indicates that the joint reflection-distortion OAE profile should be able to detect the change in cochlear amplification. In addition, it may also be useful for the detection of the OP shift especially towards positive values."

Otorhinolaryngology

Validation and Clinical Performance of a Non-Commercial ELISA for SARS-CoV-2 Anti-RBD IgA Antibodies. (PubMed, Anal Biochem) - "This assay was found to be highly accurate and reproducible for the quantification of anti-RBD IgA, met the most stringent acceptance criteria and is fit for purpose. It is currently being used to evaluate the immunogenicity of the Abdala and Mambisa vaccines."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Structural and Functional Glycosylation of the Abdala COVID-19 Vaccine. (PubMed, Glycobiology) - "Reduced receptor and antibody binding is attributed to changes in conformational dynamics resulting from N-glycosylation. These data highlight the critical importance of glycosylation in vaccine design and demonstrate how individual glycans can influence host interactions and immune recognition via protein structural dynamics."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Grafting glycoprotein-derived oligosaccharides structures onto non-glycosylated polypeptides. (PubMed, MicroPubl Biol) - "It consists on the digestion of the protein, followed by selective capture of the oligosaccharides bound to di-/tripeptides, and their grafting onto a non-glycosylated receptor protein by chemical crosslinking. Glycopeptides derived from C-RBD-H6 PP protein, the active ingredient of the Abdala vaccine were efficiently grafted onto a non-glycosylated protein as evidenced by western blotting."

Journal

Safety and Immunogenicity of the Intranasal Vaccine Candidate Mambisa and the Intramuscular Vaccine Abdala Used as Booster Doses for COVID-19 Convalescents: A Randomized Phase 1-2 Clinical Trial. (PubMed, Vaccines (Basel)) - "In both phases, anti-RBD IgG titers, inhibition percentages and neutralizing antibody titers increased significantly after the booster dose. Both vaccines were safe and their immunogenicity surpassed the study endpoints."

Journal • P1/2 data • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

Efficacy and safety of Abdala COVID-19 subunit vaccine in children and adolescents: An open-label, single-arm, phase 2 trial (MEÑIQUE). (PubMed, Vaccine) - "Conclusions The Abdala vaccine was safe and immunogenic in a paediatric population aged 3-18 years, with inferred efficacy based on non-inferior analysis. The vaccine is very suitable to fit into massive vaccination strategies, considering the advantages of using the same vaccine strength (RBD 50 μg) and schedule of administration for both adults and children, as well as the easy storage and handling conditions at 2-8 °C."

Journal • P2 data • Infectious Disease • Novel Coronavirus Disease • Pediatrics • Respiratory Diseases

Effect of Positive Allosteric Modulation and Orthosteric Agonism of Dopamine D2-like Receptors on Respiration in Mouse Models of Rett Syndrome. (PubMed, Respir Physiol Neurobiol) - "Sarizotan, a serotonin 5-HT1a and dopamine D2-like receptor agonist, reduces the incidence of apneas and irregular breathing in mouse models of RTT (Abdala et al., 2014). These results suggest that D2-like receptors could contribute to the positive effects of sarizotan in the correction of respiratory abnormalities in Rett syndrome. However, positive allosteric modulation of D2-like receptors alone was not sufficient to evoke these effects."

Journal • Preclinical • Autism Spectrum Disorder • Developmental Disorders • Genetic Disorders • Movement Disorders

Immunogenicity of Abdala COVID-19 vaccine in Vietnamese people after primary and booster vaccinations: a prospective observational study in Vietnam. (PubMed, Int J Infect Dis) - "Abdala COVID-19 vaccine is immunogenic in Vietnamese people. Enhanced antibody response after a booster dose could cross-neutralize 14 SARS-CoV-2 variants and SARS-CoV-1. Our results have added to the growing body of knowledge about the contribution of protein subunit vaccine platforms to pandemic control."

Journal • Observational data • Infectious Disease • Novel Coronavirus Disease • 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

Comparative efficacy and safety of COVID-19 vaccines in phase III trials: a network meta-analysis. (PubMed, BMC Infect Dis) - "None of the different types of vaccines were significantly superior in terms of efficacy, while mRNA vaccines were significantly inferior in safety to other types. BNT162b2 had the highest efficacy in preventing symptomatic SARS-CoV-2 infection in adults and the elderly, whereas BIV1-CovIran had the lowest incidence of SAEs in adults."

Journal • P3 data • Retrospective data • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Evaluation of the Abdala Vaccine: Antibody and Cellular Response to the RBD Domain of SARS-CoV-2. (PubMed, Vaccines (Basel)) - "Also, IL-2 and IFN-γ increased significantly in the supernatant of the RBD-stimulated cells. Our results suggest that Abdala vaccination, used as a booster, evokes antibody production and the activation of previously generated memory against the SARS-CoV-2 RBD domain."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD21 • CD27 • CD4 • CD69 • IFNG • IL2 • IL2RA

SARS-CoV-2 spike RBD-specific IgA and IgG antibodies in breast milk after vaccination with the protein subunit vaccine Abdala. (PubMed, Infect Med (Beijing)) - "This is the first report about the immune response in breast milk after the administration of a COVID-19 protein subunit vaccine, which could provide analogous protection to that conferred by SARS-CoV-2 infection. This implies a potential passive immunity that breastfed infants receive from their mothers vaccinated with Abdala."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

On the dentition, tooth replacement, and taxonomic status of Charruodon tetracuspidatus Abdala & Ribeiro, 2000: A bizarre cynodont from the middle upper Triassic of southern Brazil. (PubMed, Anat Rec (Hoboken)) - "Additionally, the specimen could potentially be an ontogenetically immature form of another taxon, or a yet unknown species of probainognathian cynodont. Therefore, Charruodon tetracuspidatus is here designated as a nomen dubium, given the challenges of maintaining the species as valid."

Journal

Immunogenicity and safety assessment of a SARS-CoV-2 recombinant spike RBD protein vaccine (Abdala) in paediatric ages 3-18 years old: a double-blinded, multicentre, randomised, phase 1/2 clinical trial (ISMAELILLO study). (PubMed, EClinicalMedicine) - "Regarding immunogenicity, Abdala Vaccine stimulated the production of specific IgG antibodies against the RBD of SARS-CoV-2 as well as the production of ACE2 inhibition titres and neutralising antibodies (Nab) in children and adolescents. Centre for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba."

Journal • P1/2 data • Infectious Disease • Novel Coronavirus Disease • Pain • Pediatrics • Respiratory Diseases

A phase 3, randomised, double-blind, placebo-controlled clinical trial evaluation of the efficacy and safety of a SARS-CoV-2 recombinant spike RBD protein vaccine in adults (ABDALA-3 study). (PubMed, Lancet Reg Health Am) - "Those results, along with its immunization schedule and the advantage of easy storage and handling conditions at 2-8 °C, make this vaccine an option for the use in immunization strategies as a key tool for the control of the pandemic. Centre for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba."

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

Cuban Abdala vaccine: Effectiveness in preventing severe disease and death from COVID-19 in Havana, Cuba; A cohort study. (PubMed, Lancet Reg Health Am) - "Cuban Ministry of Public Health. Genetic Engineering and Biotechnology Centre."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Demographic changes in an Atlantic Forest primate community following a yellow fever outbreak. (PubMed, Am J Primatol) - "We investigated demographic changes in three primate species (Alouatta guariba, Sapajus nigritus, and Callithrix flaviceps) at the Reserva Particular do Patrimônio Natural-Feliciano Miguel Abdala, Caratinga, Minas Gerais, Brazil, following a yellow fever outbreak (YFO) by comparing their population sizes before (2015) and after the outbreak (2017-2018), and by monitoring the size, composition, and reproductive status of groups from 2017 to 2021...The female-biased adult sex ratio and presence of infants and juveniles in the A. guariba and S. nigritus groups are encouraging signs, but there is still great concern, especially for C. flaviceps. Continued monitoring of the demographics of these primates is needed as their persistence appears to still be at risk."

Journal • Infectious Disease

Safety, tolerability, and immunogenicity of a SARS-CoV-2 recombinant spike RBD protein vaccine: A randomised, double-blind, placebo-controlled, phase 1-2 clinical trial (ABDALA Study). (PubMed, EClinicalMedicine) - "These results, in the context of the emergency COVID-19 pandemic, support the 50 μg dose, applied in a 0-14-28 days schedule, for further clinical trials to confirm vaccine efficacy. Centre for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba."

Journal • P1/2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

"I wonder why with so much needs, WHO continues boycotting Sputnik and Abdala vaccine is not bought to Cuba. West greed is filthy." (@SilviaMFerrand1)

Clinical

"Vietnam approves Abdala vaccine as president visits Cuba https://t.co/WgdwGIuovy" (@Reuters)

Clinical

Cuba's Abdala COVID-19 vaccine enters phase 3 clinical trial (XINHUANET.com) - "Cuba on Friday began phase 3 clinical trials of its Abdala COVID-19 vaccine...'Three doses will be administered to participants with two-week intervals' in-between...The inoculation of volunteers with the homegrown vaccine candidate is expected to start Monday...The study, which is due to be completed by July, plans to enroll some 48,000 participants aged 19-80 from the eastern provinces of Santiago de Cuba, Guantanamo and Granma."

Trial completion date • Trial status • Infectious Disease • Novel Coronavirus Disease