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

doi:10.2139/ssrn.4213351

Cited by 2 publications

(3 citation statements)

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“…After two doses, it was estimated to be very high (82.96%). Furthermore, it is important to note that during the phase 3 trial, beta, delta and gamma VOC of SARS-CoV-2 were circulating in Cuba, and a cross-protective response induced after Abdala vaccination was suggested [19]. The findings described in this study provide experimental evidence to support this notion.…”

Section: Discussionsupporting

confidence: 64%

“…Although several reports have previously shown that recombinant RBDs produced in yeast can be used to produce an effective subunit vaccine against COVID- 19 [5,17,18], the Abdala vaccine is one of the few products that have already reached phase 3 efficacy trials [1] COVID-19 at a dose of 50 µg using the regimen of 0-14-28 days of immunization was 92.28% (95% CI 85.74-95.82) [19]. After two doses, it was estimated to be very high (82.96%).…”

Section: Discussionmentioning

confidence: 99%

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The Effect of the Anti-Covid-19 Vaccine Abdala Dose Level and Dosing Interval in Rats and Cynomolgus Monkeys

2024

J Vaccines Immunol

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Several anti-Covid-19 vaccines have been developed corresponding to at least 11 vaccine platforms, including novel technology. The Abdala vaccine is based on the RBD fragment of the surface antigen of SARS-CoV-2 expressed in yeast. Previously, we demonstrated the immunogenicity of the recombinant antigen in animals. The present studies examined the impact of Abdala vaccination on the production of RBD-specific antibodies and their functional capacity using two immunization schedules (short 0-14-28 versus long 0-21-42) and two dose levels (10 and 50 µg) in rats and monkeys. The functional capacity of the antibody response was evaluated using an in vitro test to detect blocking antibodies to the ACE-2-RBD interaction and neutralizing activity versus the homologous Wuhan strain. For monkey sera, neutralization against variants of concern (VOC) beta (B.1.351), delta (B.1.617.2) and omicron (BA.1) was also evaluated. Taken together, the findings revealed previously unappreciated differences of the Abdala vaccine in the functional capacity of the antibody response according to the number of inoculations, the dose level, and the dose interval. In this regard, when using the short dose interval, three inoculations seem necessary to improve the functional antiviral response which is also favored with the higher dose level and a long dosing interval. The results in the NHP model also suggest that two doses using a long-time interval (0-21) could improve the efficacy of the Abdala vaccine compared to the short-interval regime (0-14). Cross-neutralization against variants of concern was also demonstrated.

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Section: Discussionsupporting

confidence: 64%

Section: Discussionmentioning

confidence: 99%

The Effect of the Anti-Covid-19 Vaccine Abdala Dose Level and Dosing Interval in Rats and Cynomolgus Monkeys

2024

J Vaccines Immunol

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“…Although we did not observe a significant reduction in viral genome copies in this model, it is possible that the infection clearance kinetics could differ at later time points and that the 4 day time point was too early to observe differences in viral clearance. However, humans that are given Spike protein-based vaccines also appear to have significantly reduced risk of severe disease, 88 , 89 while viral burden in the nasal passages appears similar between the vaccinated and unvaccinated in many studies, 90 , 91 although not all. 92 , 93 , 94 This also supports that protection from clinical disease could be linked to the phenotype of vaccine-induced immune responses.…”

Section: Discussionmentioning

confidence: 99%

Mucosal SARS-CoV-2 vaccination of rodents elicits superior systemic T central memory function and cross-neutralising antibodies against variants of concern

O’Neill,

Mantri,

Tan

et al. 2024

eBioMedicine

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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)

Cited by 2 publications

References 0 publications

The Effect of the Anti-Covid-19 Vaccine Abdala Dose Level and Dosing Interval in Rats and Cynomolgus Monkeys

The Effect of the Anti-Covid-19 Vaccine Abdala Dose Level and Dosing Interval in Rats and Cynomolgus Monkeys

Mucosal SARS-CoV-2 vaccination of rodents elicits superior systemic T central memory function and cross-neutralising antibodies against variants of concern

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