Cuban Abdala Vaccine: Effectiveness in Preventing Severe Disease and Death from COVID-19 in Havana, Cuba; a Cohort Study

Más-Bermejo, Pedro Inocencio; Dickinson-Meneses, Felix Orlando; Almenares-Rodríguez, Kenia; Sánchez, Lizet; Guinovart-Dı́az, Raúl; Vidal-Ledo, María; Galbán-García, Enrique; Olivera-Nodarse, Yadira; Morgado-Vega, Isabel; Dueñas‐Carrera, Santiago; Pujol, Merardo; Hernández-Bernal, Francisco; Limonta-Fernández, Miladys; Guillén-Nieto, Gerardo; Muzio-González, Verena L.; Ayala-Ávila, Marta

doi:10.2139/ssrn.4072478

Cited by 3 publications

(3 citation statements)

References 3 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The treatment with Jusvinza was determined by availability of this drug, during the period in which this study was carried out. This study coincided with the maximum peak of COVID-19 infections in Cuba [36].…”

Section: Plos Onesupporting

confidence: 75%

Jusvinza, an anti-inflammatory drug derived from the human heat-shock protein 60, for critically ill COVID-19 patients. An observational study

et al. 2023

View full text Add to dashboard Cite

This paper presents the results of an observational and retrospective study on the therapeutic effects of Jusvinza, an immunomodulatory peptide with anti-inflammatory properties for critically ill COVID-19 patients. This peptide induces regulatory mechanisms on the immune response in experimental systems and in patients with Rheumatoid Arthritis. Exploratory research in COVID-19 patients revealed that Jusvinza promotes clinical and radiological improvement. The aim of this study is to describe the clinical outcome and variations of several inflammatory biomarkers in a cohort of critically ill COVID-19 patients, divided into two groups during the observational research: one group received Jusvinza and the other did not. Research physicians extracted the patients´ data from their hospital’s clinical records. The study analyzed 345 medical records, and 249 records from critically ill patients were included. The data covered the demographic characteristics, vital signs, ventilatory parameters and inflammatory biomarkers. Survival outcome was significantly higher in the group receiving Jusvinza (90.4%) compared to the group without Jusvinza (39.5%). Furthermore, in patients treated with Jusvinza there was a significant improvement in ventilatory parameters and a reduction in inflammation and coagulation biomarkers. Our findings show that Jusvinza could control the extent of inflammation in COVID-19 patients. This study indicates that Jusvinza is a helpful drug for the treatment of diseases characterized by hyperinflammation.

show abstract

Section: Plos Onesupporting

confidence: 75%

Jusvinza, an anti-inflammatory drug derived from the human heat-shock protein 60, for critically ill COVID-19 patients. An observational study

et al. 2023

View full text Add to dashboard Cite

show abstract

“…Second, although in this report it is not possible to show results on the long-term protective effects of the vaccine during the phase 3 trial, a retrospective cohort study carried out in Havana (Cuba) in 1355638 persons, demonstrated that Abdala vaccine was highly effective in preventing severe illness and death from COVID-19 (primary outcomes of the study) under real-life conditions, during the third epidemic period, where Delta variant prevailed. 29 Third, this study did not assessed the efficacy in other populations as children, adolescents and pregnant and lactating women, but further studies in those populations were also conducted after EUA was granted. Fourth, in the current report data regarding neutralizing antibodies titters and other immunological variables are not included.…”

Section: Discussionmentioning

confidence: 99%

A phase 3, randomised, double-blind, placebo-controlled clinical trial for adult evaluation of the efficacy and safety of a SARS-CoV-2 recombinant spike RBD protein vaccine (ABDALA-3 Study)

Hernández-Bernal

Ricardo-Cobas²,

Martín-Bauta

et al. 2022

Preprint

Self Cite

View full text Add to dashboard Cite

Background: The pandemic of COVID-19 raised the urgent need of safe and efficacious vaccines against SARS-CoV-2. We evaluated the efficacy and safety of a new SARS-CoV-2 virus receptor-binding domain (RBD) vaccine. Methods: A phase 3, multicentre, randomised, double-blind, placebo-controlled trial was carried out at 18 clinical sites in three provinces of the south-eastern region of Cuba. Subjects (healthy or those with controlled chronic diseases) aged between 19 and 80 years, who gave written informed consent were eligible. Subjects were randomly assigned (1:1, in blocks) to two groups: placebo, and 50 mcg RBD vaccine (Abdala). The product was administered intramuscularly, 0.5 mL in the deltoid region, in a three dose immunization schedule at 0-14-28 days. The organoleptic characteristics and presentations of vaccine and placebo were identical. All participants (subjects, clinical researchers, statisticians, laboratory technicians, and monitors) remained blinded during the study period. The main endpoint was to evaluate the efficacy of the Abdala vaccine in the prevention of symptomatic COVID-19. The trial is registered with the Cuban Public Registry of Clinical Trials, RPCEC00000359. Findings: Between March 22 to April 03, 2021, 48290 subjects were included (24144 and 21146 in the placebo and Abdala groups, respectively). The product was well tolerated. No severe adverse events with demonstrated cause-effect relationship attributable to vaccine were reported. The incidence of adverse reactions in the placebo and Abdala vaccine arms were 446/24144 (1.9%) and 615/24146 (2.5%), respectively. Adverse reactions were mostly mild, and from the injection site, which resolved in the first 24-48 hours. The Abdala vaccine efficacy against symptomatic COVID-19 was 92.28% (95% CI 85.74-95.82). In the case of mild/moderate disease the vaccine efficacy was 91.96% (84.69-95.78) and 94.46% (58.52-99.28) for the severe forms (serious/critical disease). There were five critical patients (of which four died), all in the placebo group, indicating that Abdala vaccine efficacy for both conditions was of 100%. Interpretation: The Abdala vaccine was safe, well tolerated, and highly effective, fulfilling the WHO target product profile for COVID-19 vaccines. Funding: Centre for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba.

show abstract

“…To combat this pandemic effectively, the entire globe will most likely need a number of different licensed vaccines to meet the requirements of sufficient production volumes and broad population coverage, storage, and transit requirements, while maintaining a satisfactory vaccine safety profile. The information covered in this section was drawn from the following cumulative and overlapping reports [ 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 ].…”

Section: Vaccinesmentioning

confidence: 99%

Comprehensive Highlights of the Universal Efforts towards the Development of COVID-19 Vaccine

et al. 2022

View full text Add to dashboard Cite

The world has taken proactive measures to combat the pandemic since the coronavirus disease 2019 (COVID-19) outbreak, which was caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). These measures range from increasing the production of personal protective equipment (PPE) and highlighting the value of social distancing to the emergency use authorization (EUA) of therapeutic drugs or antibodies and their appropriate use; nonetheless, the disease is still spreading quickly and is ruining people’s social lives, the economy, and public health. As a result, effective vaccines are critical for bringing the pandemic to an end and restoring normalcy in society. Several potential COVID-19 vaccines are now being researched, developed, tested, and reviewed. Since the end of June 2022, several vaccines have been provisionally approved, whereas others are about to be approved. In the upcoming years, a large number of new medications that are presently undergoing clinical testing are anticipated to hit the market. To illustrate the advantages and disadvantages of their technique, to emphasize the additives and delivery methods used in their creation, and to project potential future growth, this study explores these vaccines and the related research endeavors, including conventional and prospective approaches.

show abstract

Cuban Abdala Vaccine: Effectiveness in Preventing Severe Disease and Death from COVID-19 in Havana, Cuba; a Cohort Study

Cited by 3 publications

References 3 publications

Jusvinza, an anti-inflammatory drug derived from the human heat-shock protein 60, for critically ill COVID-19 patients. An observational study

Jusvinza, an anti-inflammatory drug derived from the human heat-shock protein 60, for critically ill COVID-19 patients. An observational study

A phase 3, randomised, double-blind, placebo-controlled clinical trial for adult evaluation of the efficacy and safety of a SARS-CoV-2 recombinant spike RBD protein vaccine (ABDALA-3 Study)

Comprehensive Highlights of the Universal Efforts towards the Development of COVID-19 Vaccine

Contact Info

Product

Resources

About