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)

Hernández-Bernal, Francisco; Ricardo-Cobas, Maria C.; Martín-Bauta, Yenima; Navarro-Rodríguez, Zadis; Piñera-Martínez, Marjoris; Quintana-Guerra, Joel; Urrutia-Pérez, Karen; Urrutia-Pérez, Klaudia; Chávez-Chong, Cristina O.; Azor-Hernández, Jorge L.; Rodríguez-Reinoso, José L.; Lobaina-Lambert, Leonardo; Colina-Ávila, Elizabeth; Bizet-Almeida, Jacqueline; Rodríguez-Nuviola, Jeniffer; Valle-Piñera, Sergio del; Ramírez-Domínguez, Mayara; Tablada-Ferreiro, Elisangela; Alonso-Valdés, Marel; Lemos, Gilda; Guillén-Nieto, Gerardo; Palenzuela-Díaz, Ariel; Noa-Romero, Enrique; Limonta, Miladys; Fernández-Ávila, Juan M.; Ali-Mros, Nabil A.; Toro-Lahera, Lianne del; Remedios-Reyes, Rossana; Ayala-Ávila, Marta; Muzio-González, Verena L.

doi:10.1016/j.eclinm.2022.101383

Cited by 50 publications

(40 citation statements)

References 27 publications

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“…The excellent safety profile observed in the phase 1-2 clinical trial was confirmed in the present phase 3 study. 5 The Abdala vaccine, in its short three-dose regimen, was well tolerated, without any serious toxicity, and no deaths attributed to his administration. The adverse reactions reported were minimal, mostly mild and from the injection site, of short duration, resolved spontaneously.…”

Section: Discussionmentioning

confidence: 87%

“…This was also facilitated by the compact immunization schedule of three doses applied at 0-14-28 days, previously selected in the phase 2 trial, very useful to face the urgency of the pandemic situation. 5 Randomisation assured a homogenous demographic and baseline characteristics of the participants in both placebo and vaccine groups. Blinding was maintained along all the trial up to the estimation of clinical efficacy.…”

Section: Discussionmentioning

confidence: 99%

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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

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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.

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Section: Discussionmentioning

confidence: 87%

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

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“…The third animal experiment was addressed to assess the nasal bivalent formulation, composed by the N+ODN-39M preparation and the RBD from the Delta variant as inductor of neutralizing Abs. The recombinant RBD fragment, is a component of at least five approved vaccines for emerging use, such as the Cuban vaccines: Abdala and Soberana Series (01, 02 and Soberana Plus) (Hernández-Bernal et al, 2022), (Reed, 2022), and ZF001, a Chinese vaccine approved in China and Uzbekistan (Cao et al, 2022). Such vaccines have been capable of controlling the magnitude of the different infection's waves of SARS-CoV-2 variants, nevertheless, as for the other approved vaccines, their capacity to halt the virus transmission has been limited.…”

Section: Discussionmentioning

confidence: 99%

The Nucleocapsid Protein Of SARS-CoV-2, Combined With ODN-39M, Is A Potential Component For An Intranasal Bivalent Pancorona Vaccine

Lobaina

Chen²,

Suzarte

et al. 2022

Preprint

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Despite the rapid development of vaccines and their reported efficacy for controlling the COVID-19 waves, two key challenges remain: the scope of the immunity against upcoming variants and zoonosis events, and the induction of mucosal immunity able to clear the virus in the upper respiratory tract for halting the transmission. The present study is aiming at assessing a potential component for a new generation of vaccines so as to overcome such limitations. The recombinant nucleocapsid (N) protein from SARS-CoV-2 Delta variant was combined with a phosphodiester backbone CpG ODN (ODN-39M), forming high molecular weight aggregates. The evaluation of its immunogenicity in Balb/C mice revealed that only administration by intranasal route induced a systemic cross-reactive Cell-Mediated-Immunity (CMI). In turn, this combination was able to induce anti-N IgA in lungs, which along with the specific IgG in sera and CMI in spleen, resulted cross-reactive against the nucleocapsid protein of SARS-CoV-1. Furthermore, the nasal administration of the N+ODN-39M preparation combined with the RBD Delta protein, as inductor of neutralizing Abs, enhanced the local and systemic immune response against RBD with a modulation toward a Th1 pattern. Taken together, these results make the N+ODN-39M preparation a suitable component for a future intranasal pancorona vaccine against Sarbecoviruses. Particularly, the bivalent vaccine formulation N+ODN-39M+RBD could be used as an effective nasal booster in previously vaccinated population.

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“…12 In a phase 1/2, randomized, double-blind, placebo-controlled trial carried out in “Saturnino Lora” Hospital, Santiago de Cuba, Abdala vaccine was safe, well tolerated, and induced humoral immune responses against SARS-CoV-2 with a 50 mg dose, applied in a 0-14-28 days schedule. 14 In a multi-centre, randomized, double-blind placebo-controlled phase 3 study in 48 290 adult volunteers, Abdala demonstrated an efficacy of 92·3% (95% CI: 85·7‒95·8), but, so far, peer-reviewed manuscript of phase 3 randomized clinical trials from Abdala are still unpublished. 12…”

Section: Introductionmentioning

confidence: 99%

Cuban Abdala vaccine: Effectiveness in preventing severe disease and death from COVID-19 in Havana, Cuba; A cohort study

Más-Bermejo

Dickinson-Meneses

Almenares-Rodríguez³

et al. 2022

The Lancet Regional Health - Americas

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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)

Cited by 50 publications

References 27 publications

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)

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)

The Nucleocapsid Protein Of SARS-CoV-2, Combined With ODN-39M, Is A Potential Component For An Intranasal Bivalent Pancorona Vaccine

Cuban Abdala vaccine: Effectiveness in preventing severe disease and death from COVID-19 in Havana, Cuba; A cohort study

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