Safety and immunogenicity of anti-SARS CoV-2 vaccine SOBERANA 02 in homologous or heterologous scheme: Open label phase I and phase IIa clinical trials

SOBERANA 02 is a COVID-19 vaccine based on SARS-CoV-2 recombinant RBD conjugated to tetanus toxoid (TT). SOBERANA Plus antigen is dimeric-RBD. Here we report safety and immunogenicity from phase I and IIa clinical trials using two-doses of SOBERANA 02 and three-doses (homologous) or heterologous (wi...

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Published inVaccine Vol. 40; no. 31; pp. 4220 - 4230
Main Authors Eugenia-Toledo-Romaní, María, Verdecia-Sánchez, Leslyhana, Rodríguez-González, Meiby, Rodríguez-Noda, Laura, Valenzuela-Silva, Carmen, Paredes-Moreno, Beatriz, Sánchez-Ramírez, Belinda, Pérez-Nicado, Rocmira, González-Mugica, Raul, Hernández-García, Tays, Bergado-Baez, Gretchen, Pi-Estopiñán, Franciscary, Cruz-Sui, Otto, Fraga-Quintero, Anitza, García-Montero, Majela, Palenzuela-Díaz, Ariel, Baró-Román, Gerardo, Mendoza-Hernández, Ivis, Fernandez-Castillo, Sonsire, Climent-Ruiz, Yanet, Santana-Mederos, Darielys, Ramírez Gonzalez, Ubel, García-Vega, Yanelda, Pérez-Massón, Beatriz, Guang-Wu-Chen, Boggiano-Ayo, Tammy, Ojito-Magaz, Eduardo, Rivera, Daniel G., Valdés-Balbín, Yury, García-Rivera, Dagmar, Vérez-Bencomo, Vicente, Gómez-Maceo, Yanet, Reyes-Matienzo, Radamet, Manuel Coviella-Artime, José, Morffi-Cinta, Irania, Martínez-Pérez, Marisel, Castillo-Quintana, Ismavy, Garcés-Hechavarría, Aniurka, Valera-Fernández, Rodrigo, Martínez-Bedoya, Dayle, Garrido-Arteaga, Raine, Cardoso-SanJorge, Félix, Quintero Moreno, Lauren, Ontivero-Pino, Ivis, Teresa Pérez-Guevara, María, Morales-García, Marilin, Noa-Romero, Enrique, Orosa-Vázquez, Ivette, Díaz-Hernández, Marianniz, Rojas, Gertrudis, Tundidor, Yaima, García-López, Elena, Muñoz-Morejon, Yaima, Galano-Frutos, Evelyn, Rodríguez-Alvarez, Julián, Arteaga, Amaylid, Medina Nápoles, Maite, Espi Ávila, Jennifer, Fontanies Fernández, Marcos
Format Journal Article
LanguageEnglish
Published Netherlands Elsevier Ltd 29.07.2022
Elsevier Limited
Subjects
Online AccessGet full text
ISSN0264-410X
1873-2518
1873-2518
DOI10.1016/j.vaccine.2022.05.082

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Abstract SOBERANA 02 is a COVID-19 vaccine based on SARS-CoV-2 recombinant RBD conjugated to tetanus toxoid (TT). SOBERANA Plus antigen is dimeric-RBD. Here we report safety and immunogenicity from phase I and IIa clinical trials using two-doses of SOBERANA 02 and three-doses (homologous) or heterologous (with SOBERANA Plus) protocols. We performed an open-label, sequential and adaptive phase I to evaluate safety and explore the immunogenicity of SOBERANA 02 in two formulations (15 or 25 μg RBD-conjugated to 20 μg of TT) in 40 subjects, 19–59-years-old. Phase IIa was open-label including 100 volunteers 19–80-years, receiving two doses of SOBERANA 02–25 μg. In both trials, half of volunteers were selected to receive a third dose of the corresponding SOBERANA 02 and half received a heterologous dose of SOBERANA Plus. Primary outcome was safety. The secondary outcome was immunogenicity evaluated by anti-RBD IgG ELISA, molecular neutralization of RBD:hACE2 interaction, live-virus-neutralization and specific T-cells response. The most frequent adverse event (AE) was local pain, other AEs had frequencies ≤ 5%. No serious related-AEs were reported. Phase IIa confirmed the safety in 60 to 80-years-old subjects. In phase-I SOBERANA 02–25 µg elicited higher immune response than SOBERANA 02–15 µg and progressed to phase IIa. Phase IIa results confirmed the immunogenicity of SOBERANA 02–25 µg even in 60–80-years. Two doses of SOBERANA02-25 µg elicited an immune response similar to that of the Cuban Convalescent Serum Panel and it was higher after the homologous and heterologous third doses. The heterologous scheme showed a higher immunological response. Anti-RBD IgG neutralized the delta variant in molecular assay, with a 2.5-fold reduction compared to D614G neutralization. SOBERANA 02 was safe and immunogenic in persons aged 19–80 years, eliciting neutralizing antibodies and specific T-cell response. Highest immune responses were obtained in the heterologous three doses protocol. Trial registry: https://rpcec.sld.cu/trials/RPCEC00000340, https://rpcec.sld.cu/trials/RPCEC00000347
AbstractList SOBERANA 02 is a COVID-19 vaccine based on SARS-CoV-2 recombinant RBD conjugated to tetanus toxoid (TT). SOBERANA Plus antigen is dimeric-RBD. Here we report safety and immunogenicity from phase I and IIa clinical trials using two-doses of SOBERANA 02 and three-doses (homologous) or heterologous (with SOBERANA Plus) protocols. We performed an open-label, sequential and adaptive phase I to evaluate safety and explore the immunogenicity of SOBERANA 02 in two formulations (15 or 25 μg RBD-conjugated to 20 μg of TT) in 40 subjects, 19–59-years-old. Phase IIa was open-label including 100 volunteers 19–80-years, receiving two doses of SOBERANA 02–25 μg. In both trials, half of volunteers were selected to receive a third dose of the corresponding SOBERANA 02 and half received a heterologous dose of SOBERANA Plus. Primary outcome was safety. The secondary outcome was immunogenicity evaluated by anti-RBD IgG ELISA, molecular neutralization of RBD:hACE2 interaction, live-virus-neutralization and specific T-cells response. The most frequent adverse event (AE) was local pain, other AEs had frequencies ≤ 5%. No serious related-AEs were reported. Phase IIa confirmed the safety in 60 to 80-years-old subjects. In phase-I SOBERANA 02–25 µg elicited higher immune response than SOBERANA 02–15 µg and progressed to phase IIa. Phase IIa results confirmed the immunogenicity of SOBERANA 02–25 µg even in 60–80-years. Two doses of SOBERANA02-25 µg elicited an immune response similar to that of the Cuban Convalescent Serum Panel and it was higher after the homologous and heterologous third doses. The heterologous scheme showed a higher immunological response. Anti-RBD IgG neutralized the delta variant in molecular assay, with a 2.5-fold reduction compared to D614G neutralization. SOBERANA 02 was safe and immunogenic in persons aged 19–80 years, eliciting neutralizing antibodies and specific T-cell response. Highest immune responses were obtained in the heterologous three doses protocol. Trial registry: https://rpcec.sld.cu/trials/RPCEC00000340, https://rpcec.sld.cu/trials/RPCEC00000347
SOBERANA 02 is a COVID-19 vaccine based on SARS-CoV-2 recombinant RBD conjugated to tetanus toxoid (TT). SOBERANA Plus antigen is dimeric-RBD. Here we report safety and immunogenicity from phase I and IIa clinical trials using two-doses of SOBERANA 02 and three-doses (homologous) or heterologous (with SOBERANA Plus) protocols. We performed an open-label, sequential and adaptive phase I to evaluate safety and explore the immunogenicity of SOBERANA 02 in two formulations (15 or 25 μg RBD-conjugated to 20 μg of TT) in 40 subjects, 19-59-years-old. Phase IIa was open-label including 100 volunteers 19-80-years, receiving two doses of SOBERANA 02-25 μg. In both trials, half of volunteers were selected to receive a third dose of the corresponding SOBERANA 02 and half received a heterologous dose of SOBERANA Plus. Primary outcome was safety. The secondary outcome was immunogenicity evaluated by anti-RBD IgG ELISA, molecular neutralization of RBD:hACE2 interaction, live-virus-neutralization and specific T-cells response. The most frequent adverse event (AE) was local pain, other AEs had frequencies ≤ 5%. No serious related-AEs were reported. Phase IIa confirmed the safety in 60 to 80-years-old subjects. In phase-I SOBERANA 02-25 µg elicited higher immune response than SOBERANA 02-15 µg and progressed to phase IIa. Phase IIa results confirmed the immunogenicity of SOBERANA 02-25 µg even in 60-80-years. Two doses of SOBERANA02-25 µg elicited an immune response similar to that of the Cuban Convalescent Serum Panel and it was higher after the homologous and heterologous third doses. The heterologous scheme showed a higher immunological response. Anti-RBD IgG neutralized the delta variant in molecular assay, with a 2.5-fold reduction compared to D614G neutralization. SOBERANA 02 was safe and immunogenic in persons aged 19-80 years, eliciting neutralizing antibodies and specific T-cell response. Highest immune responses were obtained in the heterologous three doses protocol. https://rpcec.sld.cu/trials/RPCEC00000340, https://rpcec.sld.cu/trials/RPCEC00000347.
BackgroundSOBERANA 02 is a COVID-19 vaccine based on SARS-CoV-2 recombinant RBD conjugated to tetanus toxoid (TT). SOBERANA Plus antigen is dimeric-RBD. Here we report safety and immunogenicity from phase I and IIa clinical trials using two-doses of SOBERANA 02 and three-doses (homologous) or heterologous (with SOBERANA Plus) protocols.MethodWe performed an open-label, sequential and adaptive phase I to evaluate safety and explore the immunogenicity of SOBERANA 02 in two formulations (15 or 25 μg RBD-conjugated to 20 μg of TT) in 40 subjects, 19–59-years-old. Phase IIa was open-label including 100 volunteers 19–80-years, receiving two doses of SOBERANA 02–25 μg. In both trials, half of volunteers were selected to receive a third dose of the corresponding SOBERANA 02 and half received a heterologous dose of SOBERANA Plus. Primary outcome was safety. The secondary outcome was immunogenicity evaluated by anti-RBD IgG ELISA, molecular neutralization of RBD:hACE2 interaction, live-virus-neutralization and specific T-cells response.ResultsThe most frequent adverse event (AE) was local pain, other AEs had frequencies ≤ 5%. No serious related-AEs were reported. Phase IIa confirmed the safety in 60 to 80-years-old subjects.In phase-I SOBERANA 02–25 µg elicited higher immune response than SOBERANA 02–15 µg and progressed to phase IIa. Phase IIa results confirmed the immunogenicity of SOBERANA 02–25 µg even in 60–80-years. Two doses of SOBERANA02-25 µg elicited an immune response similar to that of the Cuban Convalescent Serum Panel and it was higher after the homologous and heterologous third doses. The heterologous scheme showed a higher immunological response. Anti-RBD IgG neutralized the delta variant in molecular assay, with a 2.5-fold reduction compared to D614G neutralization.ConclusionsSOBERANA 02 was safe and immunogenic in persons aged 19–80 years, eliciting neutralizing antibodies and specific T-cell response. Highest immune responses were obtained in the heterologous three doses protocol.Trial registry: https://rpcec.sld.cu/trials/RPCEC00000340, https://rpcec.sld.cu/trials/RPCEC00000347
SOBERANA 02 is a COVID-19 vaccine based on SARS-CoV-2 recombinant RBD conjugated to tetanus toxoid (TT). SOBERANA Plus antigen is dimeric-RBD. Here we report safety and immunogenicity from phase I and IIa clinical trials using two-doses of SOBERANA 02 and three-doses (homologous) or heterologous (with SOBERANA Plus) protocols.BACKGROUNDSOBERANA 02 is a COVID-19 vaccine based on SARS-CoV-2 recombinant RBD conjugated to tetanus toxoid (TT). SOBERANA Plus antigen is dimeric-RBD. Here we report safety and immunogenicity from phase I and IIa clinical trials using two-doses of SOBERANA 02 and three-doses (homologous) or heterologous (with SOBERANA Plus) protocols.We performed an open-label, sequential and adaptive phase I to evaluate safety and explore the immunogenicity of SOBERANA 02 in two formulations (15 or 25 μg RBD-conjugated to 20 μg of TT) in 40 subjects, 19-59-years-old. Phase IIa was open-label including 100 volunteers 19-80-years, receiving two doses of SOBERANA 02-25 μg. In both trials, half of volunteers were selected to receive a third dose of the corresponding SOBERANA 02 and half received a heterologous dose of SOBERANA Plus. Primary outcome was safety. The secondary outcome was immunogenicity evaluated by anti-RBD IgG ELISA, molecular neutralization of RBD:hACE2 interaction, live-virus-neutralization and specific T-cells response.METHODWe performed an open-label, sequential and adaptive phase I to evaluate safety and explore the immunogenicity of SOBERANA 02 in two formulations (15 or 25 μg RBD-conjugated to 20 μg of TT) in 40 subjects, 19-59-years-old. Phase IIa was open-label including 100 volunteers 19-80-years, receiving two doses of SOBERANA 02-25 μg. In both trials, half of volunteers were selected to receive a third dose of the corresponding SOBERANA 02 and half received a heterologous dose of SOBERANA Plus. Primary outcome was safety. The secondary outcome was immunogenicity evaluated by anti-RBD IgG ELISA, molecular neutralization of RBD:hACE2 interaction, live-virus-neutralization and specific T-cells response.The most frequent adverse event (AE) was local pain, other AEs had frequencies ≤ 5%. No serious related-AEs were reported. Phase IIa confirmed the safety in 60 to 80-years-old subjects. In phase-I SOBERANA 02-25 µg elicited higher immune response than SOBERANA 02-15 µg and progressed to phase IIa. Phase IIa results confirmed the immunogenicity of SOBERANA 02-25 µg even in 60-80-years. Two doses of SOBERANA02-25 µg elicited an immune response similar to that of the Cuban Convalescent Serum Panel and it was higher after the homologous and heterologous third doses. The heterologous scheme showed a higher immunological response. Anti-RBD IgG neutralized the delta variant in molecular assay, with a 2.5-fold reduction compared to D614G neutralization.RESULTSThe most frequent adverse event (AE) was local pain, other AEs had frequencies ≤ 5%. No serious related-AEs were reported. Phase IIa confirmed the safety in 60 to 80-years-old subjects. In phase-I SOBERANA 02-25 µg elicited higher immune response than SOBERANA 02-15 µg and progressed to phase IIa. Phase IIa results confirmed the immunogenicity of SOBERANA 02-25 µg even in 60-80-years. Two doses of SOBERANA02-25 µg elicited an immune response similar to that of the Cuban Convalescent Serum Panel and it was higher after the homologous and heterologous third doses. The heterologous scheme showed a higher immunological response. Anti-RBD IgG neutralized the delta variant in molecular assay, with a 2.5-fold reduction compared to D614G neutralization.SOBERANA 02 was safe and immunogenic in persons aged 19-80 years, eliciting neutralizing antibodies and specific T-cell response. Highest immune responses were obtained in the heterologous three doses protocol.CONCLUSIONSSOBERANA 02 was safe and immunogenic in persons aged 19-80 years, eliciting neutralizing antibodies and specific T-cell response. Highest immune responses were obtained in the heterologous three doses protocol.https://rpcec.sld.cu/trials/RPCEC00000340, https://rpcec.sld.cu/trials/RPCEC00000347.TRIAL REGISTRYhttps://rpcec.sld.cu/trials/RPCEC00000340, https://rpcec.sld.cu/trials/RPCEC00000347.
SOBERANA 02 is a COVID-19 vaccine based on SARS-CoV-2 recombinant RBD conjugated to tetanus toxoid (TT). SOBERANA Plus antigen is dimeric-RBD. Here we report safety and immunogenicity from phase I and IIa clinical trials using two-doses of SOBERANA 02 and three-doses (homologous) or heterologous (with SOBERANA Plus) protocols. We performed an open-label, sequential and adaptive phase I to evaluate safety and explore the immunogenicity of SOBERANA 02 in two formulations (15 or 25 μg RBD-conjugated to 20 μg of TT) in 40 subjects, 19–59-years-old. Phase IIa was open-label including 100 volunteers 19–80-years, receiving two doses of SOBERANA 02–25 μg. In both trials, half of volunteers were selected to receive a third dose of the corresponding SOBERANA 02 and half received a heterologous dose of SOBERANA Plus. Primary outcome was safety. The secondary outcome was immunogenicity evaluated by anti-RBD IgG ELISA, molecular neutralization of RBD:hACE2 interaction, live-virus-neutralization and specific T-cells response. The most frequent adverse event (AE) was local pain, other AEs had frequencies ≤ 5%. No serious related-AEs were reported. Phase IIa confirmed the safety in 60 to 80-years-old subjects. In phase-I SOBERANA 02–25 µg elicited higher immune response than SOBERANA 02–15 µg and progressed to phase IIa. Phase IIa results confirmed the immunogenicity of SOBERANA 02–25 µg even in 60–80-years. Two doses of SOBERANA02-25 µg elicited an immune response similar to that of the Cuban Convalescent Serum Panel and it was higher after the homologous and heterologous third doses. The heterologous scheme showed a higher immunological response. Anti-RBD IgG neutralized the delta variant in molecular assay, with a 2.5-fold reduction compared to D614G neutralization. SOBERANA 02 was safe and immunogenic in persons aged 19–80 years, eliciting neutralizing antibodies and specific T-cell response. Highest immune responses were obtained in the heterologous three doses protocol. Trial registry: https://rpcec.sld.cu/trials/RPCEC00000340, https://rpcec.sld.cu/trials/RPCEC00000347
AbstractBackgroundSOBERANA 02 is a COVID-19 vaccine based on SARS-CoV-2 recombinant RBD conjugated to tetanus toxoid (TT). SOBERANA Plus antigen is dimeric-RBD. Here we report safety and immunogenicity from phase I and IIa clinical trials using two-doses of SOBERANA 02 and three-doses (homologous) or heterologous (with SOBERANA Plus) protocols. MethodWe performed an open-label, sequential and adaptive phase I to evaluate safety and explore the immunogenicity of SOBERANA 02 in two formulations (15 or 25 μg RBD-conjugated to 20 μg of TT) in 40 subjects, 19–59-years-old. Phase IIa was open-label including 100 volunteers 19–80-years, receiving two doses of SOBERANA 02–25 μg. In both trials, half of volunteers were selected to receive a third dose of the corresponding SOBERANA 02 and half received a heterologous dose of SOBERANA Plus. Primary outcome was safety. The secondary outcome was immunogenicity evaluated by anti-RBD IgG ELISA, molecular neutralization of RBD:hACE2 interaction, live-virus-neutralization and specific T-cells response. ResultsThe most frequent adverse event (AE) was local pain, other AEs had frequencies ≤ 5%. No serious related-AEs were reported. Phase IIa confirmed the safety in 60 to 80-years-old subjects. In phase-I SOBERANA 02–25 µg elicited higher immune response than SOBERANA 02–15 µg and progressed to phase IIa. Phase IIa results confirmed the immunogenicity of SOBERANA 02–25 µg even in 60–80-years. Two doses of SOBERANA02-25 µg elicited an immune response similar to that of the Cuban Convalescent Serum Panel and it was higher after the homologous and heterologous third doses. The heterologous scheme showed a higher immunological response. Anti-RBD IgG neutralized the delta variant in molecular assay, with a 2.5-fold reduction compared to D614G neutralization. ConclusionsSOBERANA 02 was safe and immunogenic in persons aged 19–80 years, eliciting neutralizing antibodies and specific T-cell response. Highest immune responses were obtained in the heterologous three doses protocol. Trial registry: https://rpcec.sld.cu/trials/RPCEC00000340, https://rpcec.sld.cu/trials/RPCEC00000347
Author Cruz-Sui, Otto
Teresa Pérez-Guevara, María
Espi Ávila, Jennifer
Ontivero-Pino, Ivis
Pérez-Nicado, Rocmira
Fraga-Quintero, Anitza
González-Mugica, Raul
Valera-Fernández, Rodrigo
Díaz-Hernández, Marianniz
Tundidor, Yaima
Quintero Moreno, Lauren
Eugenia-Toledo-Romaní, María
Verdecia-Sánchez, Leslyhana
Muñoz-Morejon, Yaima
García-Rivera, Dagmar
Ojito-Magaz, Eduardo
Gómez-Maceo, Yanet
Mendoza-Hernández, Ivis
Palenzuela-Díaz, Ariel
Sánchez-Ramírez, Belinda
Morffi-Cinta, Irania
García-Montero, Majela
Cardoso-SanJorge, Félix
Morales-García, Marilin
Pérez-Massón, Beatriz
Paredes-Moreno, Beatriz
Fernandez-Castillo, Sonsire
Fontanies Fernández, Marcos
Garrido-Arteaga, Raine
Noa-Romero, Enrique
Valdés-Balbín, Yury
Ramírez Gonzalez, Ubel
Guang-Wu-Chen
Manuel Coviella-Artime, José
Rojas, Gertrudis
Santana-Mederos, Darielys
Orosa-Vázquez, Ivette
Martínez-Pérez, Marisel
García-López, Elena
Hernández-García, Tays
Valenzuela-Silva, Carmen
Medina Nápoles, Maite
Rivera, Daniel G.
Pi-Estopiñán, Franciscary
Martínez-Bedoya, Dayle
Rodríguez-Noda, Laura
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  organization: Clinic #1. 21 St. and 190, La Lisa, Habana, Cuba
– sequence: 34
  givenname: José
  surname: Manuel Coviella-Artime
  fullname: Manuel Coviella-Artime, José
  organization: Clinic #1. 21 St. and 190, La Lisa, Habana, Cuba
– sequence: 35
  givenname: Irania
  surname: Morffi-Cinta
  fullname: Morffi-Cinta, Irania
  organization: Clinic #1. 21 St. and 190, La Lisa, Habana, Cuba
– sequence: 36
  givenname: Marisel
  surname: Martínez-Pérez
  fullname: Martínez-Pérez, Marisel
  organization: Finlay Vaccine Institute, 21st Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba
– sequence: 37
  givenname: Ismavy
  surname: Castillo-Quintana
  fullname: Castillo-Quintana, Ismavy
  organization: Finlay Vaccine Institute, 21st Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba
– sequence: 38
  givenname: Aniurka
  surname: Garcés-Hechavarría
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  organization: Finlay Vaccine Institute, 21st Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba
– sequence: 39
  givenname: Rodrigo
  surname: Valera-Fernández
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  organization: Finlay Vaccine Institute, 21st Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba
– sequence: 40
  givenname: Dayle
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  organization: Finlay Vaccine Institute, 21st Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba
– sequence: 41
  givenname: Raine
  surname: Garrido-Arteaga
  fullname: Garrido-Arteaga, Raine
  organization: Finlay Vaccine Institute, 21st Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba
– sequence: 42
  givenname: Félix
  surname: Cardoso-SanJorge
  fullname: Cardoso-SanJorge, Félix
  organization: Finlay Vaccine Institute, 21st Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba
– sequence: 43
  givenname: Lauren
  surname: Quintero Moreno
  fullname: Quintero Moreno, Lauren
  organization: Finlay Vaccine Institute, 21st Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba
– sequence: 44
  givenname: Ivis
  surname: Ontivero-Pino
  fullname: Ontivero-Pino, Ivis
  organization: Finlay Vaccine Institute, 21st Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba
– sequence: 45
  givenname: María
  surname: Teresa Pérez-Guevara
  fullname: Teresa Pérez-Guevara, María
  organization: Centre of Molecular Immunology, 15th Ave. and 216 Street, Siboney, Playa, Havana, Cuba
– sequence: 46
  givenname: Marilin
  surname: Morales-García
  fullname: Morales-García, Marilin
  organization: Centre of Molecular Immunology, 15th Ave. and 216 Street, Siboney, Playa, Havana, Cuba
– sequence: 47
  givenname: Enrique
  surname: Noa-Romero
  fullname: Noa-Romero, Enrique
  organization: Centre of Molecular Immunology, 15th Ave. and 216 Street, Siboney, Playa, Havana, Cuba
– sequence: 48
  givenname: Ivette
  surname: Orosa-Vázquez
  fullname: Orosa-Vázquez, Ivette
  organization: Centre of Molecular Immunology, 15th Ave. and 216 Street, Siboney, Playa, Havana, Cuba
– sequence: 49
  givenname: Marianniz
  surname: Díaz-Hernández
  fullname: Díaz-Hernández, Marianniz
  organization: Centre of Molecular Immunology, 15th Ave. and 216 Street, Siboney, Playa, Havana, Cuba
– sequence: 50
  givenname: Gertrudis
  surname: Rojas
  fullname: Rojas, Gertrudis
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– sequence: 51
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  fullname: Tundidor, Yaima
  organization: Centre of Molecular Immunology, 15th Ave. and 216 Street, Siboney, Playa, Havana, Cuba
– sequence: 52
  givenname: Elena
  surname: García-López
  fullname: García-López, Elena
  organization: National Clinical Trials Coordinating Center, 5th Ave and 62, Miramar, Playa, Havana, Cuba
– sequence: 53
  givenname: Yaima
  surname: Muñoz-Morejon
  fullname: Muñoz-Morejon, Yaima
  organization: National Clinical Trials Coordinating Center, 5th Ave and 62, Miramar, Playa, Havana, Cuba
– sequence: 54
  givenname: Evelyn
  surname: Galano-Frutos
  fullname: Galano-Frutos, Evelyn
  organization: National Clinical Trials Coordinating Center, 5th Ave and 62, Miramar, Playa, Havana, Cuba
– sequence: 55
  givenname: Julián
  surname: Rodríguez-Alvarez
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– sequence: 56
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  organization: National Clinical Trials Coordinating Center, 5th Ave and 62, Miramar, Playa, Havana, Cuba
– sequence: 58
  givenname: Jennifer
  surname: Espi Ávila
  fullname: Espi Ávila, Jennifer
  organization: Finlay Vaccine Institute, 21st Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba
– sequence: 59
  givenname: Marcos
  surname: Fontanies Fernández
  fullname: Fontanies Fernández, Marcos
  organization: Finlay Vaccine Institute, 21st Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba
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Issue 31
Keywords COVID-19
SARS-CoV-2
Heterologous immunization scheme
Conjugate vaccine
Subunit vaccine
Language English
License Copyright © 2022 Elsevier Ltd. All rights reserved.
Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
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Snippet SOBERANA 02 is a COVID-19 vaccine based on SARS-CoV-2 recombinant RBD conjugated to tetanus toxoid (TT). SOBERANA Plus antigen is dimeric-RBD. Here we report...
AbstractBackgroundSOBERANA 02 is a COVID-19 vaccine based on SARS-CoV-2 recombinant RBD conjugated to tetanus toxoid (TT). SOBERANA Plus antigen is...
BackgroundSOBERANA 02 is a COVID-19 vaccine based on SARS-CoV-2 recombinant RBD conjugated to tetanus toxoid (TT). SOBERANA Plus antigen is dimeric-RBD. Here...
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StartPage 4220
SubjectTerms Adult
Aged
Aged, 80 and over
Allergy and Immunology
Antibodies
Antibodies, Neutralizing
Antibodies, Viral
Antigens
blood serum
Clinical medicine
Clinical trials
Conjugate vaccine
Coronaviruses
COVID-19
COVID-19 - prevention & control
COVID-19 - therapy
COVID-19 infection
COVID-19 Serotherapy
COVID-19 vaccines
COVID-19 Vaccines - adverse effects
Enzyme-linked immunosorbent assay
Heterologous immunization scheme
Homology
Humans
Immune response
Immune system
Immunization, Passive
Immunogenicity
Immunogenicity, Vaccine
Immunoglobulin G
Immunology
Laboratory animals
Lymphocytes T
Middle Aged
Neutralization
pain
Proteins
Safety
SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2
Subunit vaccine
T-lymphocytes
Tetanus
Vaccines
Young Adult
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Title Safety and immunogenicity of anti-SARS CoV-2 vaccine SOBERANA 02 in homologous or heterologous scheme: Open label phase I and phase IIa clinical trials
URI https://www.clinicalkey.com/#!/content/1-s2.0-S0264410X22007174
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