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)

Hernández-Bernal, Francisco; Ricardo-Cobas, Maria C.; 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; Mora-Betancourt, Ricardo; Bizet-Almeida, Jacqueline; Martínez-Rodríguez, Maria C.; Lobaina-Lambert, Leonardo; Velázquez-Pérez, Vivian M.; Soler-Díaz, Jalimy; Laurencio-Vallina, Sandra; Meriño-Hechavarría, Tamara; Carmenaty-Campos, Norberto; Rodríguez-Montero, Enri; Limonta-Fernández, Miladys; Alonso-Valdés, Marel; Hernández-Rodríguez, Reinier; Pimentel-Vázquez, Eulogio; Catasús-Álvarez, Karem M.; Cabrera-Núñez, Maria V.; Ayala-Ávila, Marta; Muzio-González, Verena L.

doi:10.1016/j.lana.2023.100497

Cited by 8 publications

(11 citation statements)

References 23 publications

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“…The early and effective development of COVID-19 vaccines based on several platforms resulted in a high demand for their global purchase, so some countries decided to develop their own vaccines to make this treatment more accessible to their population and to reduce the cost of acquiring other vaccines, as is the case of Cuba’s development of the Abdala vaccine. However, there are few reports on the effectiveness of this vaccine in generating immune protection or enhancing pre-existing immune memory against SARS-CoV-2 when used as a booster dose [ 11 , 12 , 13 ].…”

Section: Discussionmentioning

confidence: 99%

“…This vaccine, developed by the Cuban Genetic Engineering and Biotechnology Centre, includes SARS-CoV-2′s recombinant protein receptor-binding domain (RBD), with aluminum hydroxide gel as an adjuvant. Abdala’s clinical trials, assessing its safety, immunogenicity, and efficacy, showed that it was well tolerated, and no severe adverse events were reported; therefore, its safe use as a primary scheme or as a booster was suggested [ 11 , 12 , 13 ]. In conjunction with the low cost of each vaccine dose and the low storage, refrigeration, and distribution requirements, these results led to the decision to use the Abdala vaccine as a booster against COVID-19 in the Mexican population [ 10 ].…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of the Abdala Vaccine: Antibody and Cellular Response to the RBD Domain of SARS-CoV-2

Islas-Vazquez,

Alvarado-Alvarado,

Cruz-Aguilar

et al. 2023

Vaccines

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Abdala is a recently released RBD protein subunit vaccine against SARS-CoV-2. A few countries, including Mexico, have adopted Abdala as a booster dose in their COVID-19 vaccination schemes. Despite that, most of the Mexican population has received full-scheme vaccination with platforms other than Abdala; little is known regarding Abdala’s immunological features, such as its antibody production and T- and B-cell-specific response induction. This work aimed to study antibody production and the adaptive cellular response in the Mexican population that received the Abdala vaccine as a booster. We recruited 25 volunteers and evaluated their RBD-specific antibody production, T- and B-cell-activating profiles, and cytokine production. Our results showed that the Abdala vaccine increases the concentration of RBD IgG-specific antibodies. Regarding the cellular response, after challenging peripheral blood cultures with RBD, the plasmablast (CD19+CD27+CD38High) and transitional B-cell (CD19+CD21+CD38High) percentages increased significantly, while T cells showed an increased activated phenotype (CD3+CD4+CD25+CD69+ and CD3+CD4+CD25+HLA-DR+). 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.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Evaluation of the Abdala Vaccine: Antibody and Cellular Response to the RBD Domain of SARS-CoV-2

Islas-Vazquez,

Alvarado-Alvarado,

Cruz-Aguilar

et al. 2023

Vaccines

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“…Good safety, tolerability, and robust immune responses were obtained in phase I [ 56 ]. A 92.3% vaccine efficacy was demonstrated in phase III [ 57 ]. EUA was granted for CIGB-66 in Cuba in July 2021 [ 58 ].…”

Section: Covid-19 Vaccinesmentioning

confidence: 99%

COVID-19 Vaccines: Where Did We Stand at the End of 2023?

Lundstrom

2024

Viruses

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Vaccine development against SARS-CoV-2 has been highly successful in slowing down the COVID-19 pandemic. A wide spectrum of approaches including vaccines based on whole viruses, protein subunits and peptides, viral vectors, and nucleic acids has been developed in parallel. For all types of COVID-19 vaccines, good safety and efficacy have been obtained in both preclinical animal studies and in clinical trials in humans. Moreover, emergency use authorization has been granted for the major types of COVID-19 vaccines. Although high safety has been demonstrated, rare cases of severe adverse events have been detected after global mass vaccinations. Emerging SARS-CoV-2 variants possessing enhanced infectivity have affected vaccine protection efficacy requiring re-design and re-engineering of novel COVID-19 vaccine candidates. Furthermore, insight is given into preparedness against emerging SARS-CoV-2 variants.

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“…According to the WHO target product profile for COVID-19 vaccines, the vaccine in development should be indicated for active immunisation in all populations, including the elderly, in areas with an ongoing COVID-19 outbreak, and should be used in conjunction with other control measures to curtail or end such an outbreak [1][2][3][4]. The investment in SARS-CoV-2 vaccine development will contribute to the stabilisation of the supply of safe and affordable COVID-19 vaccines in the global market, particularly for distribution in low-and middle-income countries [2,[4][5][6]. The COVID-19 pandemic and the precipitously increased number of deaths worldwide necessitate the urgent development of SARS-CoV-2 vaccines, hence requiring a new pandemic paradigm [1,[3][4][5].…”

Section: Introductionmentioning

confidence: 99%

“…The investment in SARS-CoV-2 vaccine development will contribute to the stabilisation of the supply of safe and affordable COVID-19 vaccines in the global market, particularly for distribution in low-and middle-income countries [2,[4][5][6]. The COVID-19 pandemic and the precipitously increased number of deaths worldwide necessitate the urgent development of SARS-CoV-2 vaccines, hence requiring a new pandemic paradigm [1,[3][4][5].…”

Section: Introductionmentioning

confidence: 99%

Immunogenicity and Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (IndoVac®) as a Booster Dose against COVID-19 in Indonesian Adults

Rusmil,

Fadlyana,

Girsang

et al. 2024

Vaccines

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According to the WHO target product profile for COVID-19 vaccines, the vaccine in development should be indicated for active immunisation in all populations. Therefore, PT Bio Farma developed a candidate vaccine in a subunit protein recombinant platform to help overcome the issue. This trial was an observer-blind, randomised, prospective intervention study. This study targeted individuals who had received complete primary doses of the authorised/approved COVID-19 vaccine. The groups were divided into the primary inactivated vaccine (CoronaVac®) group, the primary viral vector vaccine (ChAdOx1) group, and the primary mRNA vaccine (BNT162b2) group that received the recombinant protein (IndoVac®). The groups were compared with the control and primary mRNA vaccine (BNT162b2). The participants enrolled in the study were from two primary care centres in Bandung City and three primary care centres in Denpasar City. A total of 696 participants were enrolled from 1 September to 31 October 2022. The demographic characteristics of the all-vaccine group showed a uniform distribution. The results showed that, compared with the control, the investigational product had inferior effectiveness 14 days after the booster dose was administered. However, 28 days after the booster dose, the investigational product exhibited non-inferior effectiveness compared with the primary groups that received CoronaVac® (GMR 0.76 (0.57–0.99)) and ChAdOx1 (GMR 0.72 (0.56–59.93)), but the BNT162b2 group (GMR 0.61 (0.39–0.94)) was inferior to the control. At 12 months follow-up after the booster dose, three serious adverse events (SAEs) were reported in three participants, with causality not correlated with the investigated products. Neither AEs of special interest nor severe COVID-19 cases were reported throughout the follow-up period; thus, the IndoVac® vaccine as a booster was immunogenic and safe. Until the 6-month follow-up after the booster dose, the IndoVac® vaccine was well tolerated and all reported AEs resolved. This vaccine is registered and can be included in the immunisation programme.

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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)

Cited by 8 publications

References 23 publications

Evaluation of the Abdala Vaccine: Antibody and Cellular Response to the RBD Domain of SARS-CoV-2

Evaluation of the Abdala Vaccine: Antibody and Cellular Response to the RBD Domain of SARS-CoV-2

COVID-19 Vaccines: Where Did We Stand at the End of 2023?

Immunogenicity and Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (IndoVac®) as a Booster Dose against COVID-19 in Indonesian Adults

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