Phase III, multicenter, randomized, double-blind, placebo-controlled clinical trial for the evaluation in adults of the efficacy, safety and immunogenicity of the vaccine candidate CIGB-66 against SARS-CoV-2. (COVID-19)

开始日期2021-03-22

申办/合作机构-

RPCEC00000346 / Suspended临床1/2期

Evaluation of the safety and immunogenicity of the vaccine candidate CIGB-66 against SARS-CoV-2. (COVID-19)

开始日期2020-12-07

申办/合作机构-

100 项与 Abdala 相关的临床结果

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100 项与 Abdala 相关的转化医学

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100 项与 Abdala 相关的专利（医药）

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项与 Abdala 相关的文献（医药）

2024-09-01·Vaccine

Efficacy and safety of Abdala COVID-19 subunit vaccine in children and adolescents: An open-label, single-arm, phase 2 trial (MEÑIQUE)

Article

作者: Hernández-Bernal, Francisco ; Cruz-Sui, Otto ; Salvato-Dueñas, Alena ; Cinza-Estévez, Zurina ; Cruz-Gómez, Yolanda ; Urrutia-Pérez, Klaudia ; Limonta-Fernández, Miladys ; Porta-Díaz, Mairalys ; Muzio-González, Verena L ; Felipe-Mallea, Danusia ; Alonso-Valdés, Marel ; Rodríguez-Triana, Aylin ; Alvaré-Alvaré, Laura ; Noa-Romero, Enrique ; Chávez-Chong, Cristina O ; Quintana-Guerra, Joel ; Rodríguez-Reinoso, José L ; Rodríguez-Acosta, Mireida ; Urrutia-Pérez, Karen ; Martín-Bauta, Yenima ; Ayala-Ávila, Marta

Objectives We evaluated the safety, immunogenicity and efficacy of Abdala, a protein subunit vaccine for 2019 coronavirus disease (COVID-19), in children and adolescents. Methods A phase 2, open-label, single-arm clinical trial was carried out. Subjects aged 3 to 18 years were eligible. Abdala vaccine was administered intramuscularly at 0-14-28 days. The main endpoints were safety and the immunobridging analysis with a non-inferiority design, to infer the efficacy of the vaccine in paediatric population based on the comparison of neutralizing antibodies (NAb) to SARS-CoV-2, with adults (19-21 years). The trial is registered with the Cuban Public Registry of Clinical Trials, RPCEC00000390. Results From September 13th to September 17th, 2021, 703 participants were included in the context of a predominantly SARS-CoV-2 Delta variant circulation. The number of individuals who experienced adverse reactions was 264/703 (37·6%). Adverse reactions were mostly mild and occurred at the injection site, which resolved within the first 24-48 h. There were no reports of severe adverse events. For the non-inferiority comparison of 297 children (3-11 years) with 297 adults, the geometric mean (GMT) ratio of SARS-CoV-2 NAb was 0·87 (95% CI 0·69-1·08) and 1·07 (0·82-1·39) in the same comparison for 203 adolescents (12-18 years) and 203 adults. For both age groups, the lower limit of GMT was higher than 0·67. The differences in seroresponse rates of Nab for children were 1% (-2%, 4%) and -3% (-7%, 1%) for adolescents, higher than -10% in both age groups. 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.

2023-05-01·Lancet regional health. Americas

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).

Article

作者: Hernández-Bernal, Francisco ; Soler-Díaz, Jalimy ; Meriño-Hechavarría, Tamara ; Catasús-Álvarez, Karem M ; Urrutia-Pérez, Karen ; Baladrón-Castrillo, Idania ; Rodríguez-Martínez, Ernesto ; Carmenaty-Campos, Norberto ; Laurencio-Vallina, Sandra ; Ricardo-Cobas, Maria C ; Muzio-González, Verena L ; Melo-Suárez, Grettel ; Martínez-Rodríguez, Maria C ; Navarro-Rodríguez, Zadis ; Mora-Betancourt, Ricardo ; Ayala-Ávila, Marta ; Velázquez-Pérez, Vivian M ; Bizet-Almeida, Jacqueline ; Quintana-Guerra, Joel ; Pimentel-Vázquez, Eulogio ; Cabrera-Núñez, Maria V ; Alonso-Valdés, Marel ; Chávez-Chong, Cristina O ; Piñera-Martínez, Marjoris ; Pupo-Micó, Alexis ; Limonta-Fernández, Miladys ; Rodríguez-Reinoso, José L ; Urrutia-Pérez, Klaudia ; Martín-Bauta, Yenima ; Lobaina-Lambert, Leonardo ; Batista-Izquierdo, Alejandro ; Rodríguez-Montero, Enri ; Hernández-Rodríguez, Reinier

BackgroundThe pandemic of COVID-19 raised the urgent need for 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.MethodsA 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 μg 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 the 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.FindingsBetween March 22 to April 03, 2021, 48,290 subjects were included (24,144 and 24,146 in the placebo and Abdala groups, respectively) in the context of predominant D614G variant circulation. The evaluation of the main efficacy outcomes occurred during May-June 2021, starting at May 3rd, in the context of high circulation of mutant viruses, predominantly VOC Beta. The incidence of adverse reactions for individuals in the placebo and Abdala vaccine groups were 1227/24,144 (5.1%) and 1621/24,146 (6.7%), respectively. Adverse reactions were mostly mild, and from the injection site, which resolved in the first 24-48 h. No severe adverse events with demonstrated cause-effect relationship attributable to the vaccine were reported. Symptomatic COVID-19 disease was confirmed in 142 participants in the placebo group (78.44 incidence per 1000 person-years, 95% confidence interval [CI], 66.07-92.46) and in 11 participants in Abdala vaccine group (6.05 incidence per 1000 person years; 95% CI 3.02-10.82). The Abdala vaccine efficacy against symptomatic COVID-19 was 92.28% (95% CI 85.74-95.82). Moderate/serious forms of COVID-19 occurred in 30 participants (28 in the placebo group and only 2 in the Abdala vaccine group) for a vaccine efficacy of 92.88% (95% CI 70.12-98.31). There were five critical patients (of which four died), all in the placebo group.InterpretationThe Abdala vaccine was safe, well tolerated, and highly effective, fulfilling the WHO target product profile for COVID-19 vaccines. 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.FundingCentre for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba.

2022-12-01·Infectious Medicine

SARS-CoV-2 spike RBD-specific IgA and IgG antibodies in breast milk after vaccination with the protein subunit vaccine Abdala

Article

作者: Valdivia, Onel ; Martínez, Midalis ; Soria, Migdiala ; Pérez, Enrique ; Cabrera, Yeosvany ; Pérez-Bernal, Maylin ; Domínguez, Andy ; Delgado, Magali ; Ibargollín, Rafael ; Dorta, Dayamí ; Hernández, Carlos

BackgroundCOVID-19 vaccines that trigger a strong secretory antibody response in breast milk may achieve effective passive protection of vulnerable newborns and breastfed infants of immunized mothers. The aim of this work was to investigate the presence of SARS-CoV-2 spike RBD-specific IgA and IgG antibodies in breast milk, 5 and 9 weeks after vaccination with 3 doses of the protein subunit vaccine Abdala, compared to those found in breast milk from COVID-19-recovered women, collected at least 40 days after the infection.MethodsSARS-CoV-2 spike RBD-specific IgA and IgG antibodies were semi-quantified by indirect ELISA, using a homemade standard generated by pooling twenty breast milk samples with high absorbance values according to preliminary data. The validity of the standard curves was proved following the European Medicines Agency Guideline. Two breast milk samples from 2 unvaccinated women who had not been infected with COVID-19 were included as negative controls. Potentially neutralizing antibodies was assessed by a SARS-CoV-2 surrogate virus neutralization test.ResultsHigh levels of anti-RBD IgA antibodies were detected in breast milk samples 9 weeks after vaccination and anti-RBD IgG antibodies rise from the fifth to the ninth week. In the post-COVID-19 time that was evaluated, the IgG-type response was notably higher compared to both post-vaccination periods. Neutralizing antibody titers were similar in breast milk from vaccinated and COVID-19 recovered women.ConclusionsThis 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.

100 项与 Abdala 相关的药物交易

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