Safety and immunogenicity of heterologous COVID-19 vaccine regimens to deal with product shortage: A randomised clinical trial in an elderly population
Objectives: In a context of COVID-19 vaccine shortages, this study sought to evaluate the safety and efficacy of receiving one dose of Gam-COVID-Vac rAd26 followed by a second COVID-19 vaccine dose of either Gam-COVID-Vac rAd5, ChAdOx1 nCoV-19 or BBIBP-CorV in a cohort of older adults. Study design:...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-12-01
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| Series: | Public Health in Practice |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666535222000891 |
| _version_ | 1798006065939349504 |
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| author | M.A. Kundro M.H. Losso A. Macchia I. Pastor M. Alonso Serena C. Gestoso L. Moreno Macías F. Crupi M.C. Acosta S. Ivalo M. Ghioldi M.B. Bouzas L. Mammana I. Zapiola I. Mazzitelli A. Varese J. Geffner C. Biscayart P. Angeleri E. Lopez A. Gentile D. Ferrante F. Gonzalez B. de Quiros |
| author_facet | M.A. Kundro M.H. Losso A. Macchia I. Pastor M. Alonso Serena C. Gestoso L. Moreno Macías F. Crupi M.C. Acosta S. Ivalo M. Ghioldi M.B. Bouzas L. Mammana I. Zapiola I. Mazzitelli A. Varese J. Geffner C. Biscayart P. Angeleri E. Lopez A. Gentile D. Ferrante F. Gonzalez B. de Quiros |
| author_sort | M.A. Kundro |
| collection | DOAJ |
| description | Objectives: In a context of COVID-19 vaccine shortages, this study sought to evaluate the safety and efficacy of receiving one dose of Gam-COVID-Vac rAd26 followed by a second COVID-19 vaccine dose of either Gam-COVID-Vac rAd5, ChAdOx1 nCoV-19 or BBIBP-CorV in a cohort of older adults. Study design: Single-centre, randomised, open label, non-inferiority trial. Methods: Adults aged ≥65 years who had received one dose of Gam-COVID-Vac rAd26 were randomised in a 1:1:1 ratio to receive a second-dose COVID-19 vaccination of either Gam-COVID-Vac rAd5, ChAdOx1 nCoV-19 or BBIBP-CorV. The primary outcome was the assessment of the humoral immune response to vaccination (i.e. antibody titres of SARS-CoV-2 spike protein at 28 days after second-dose vaccination). In addition, neutralising antibody titres at day 28 for the three schedules were measured. Results: Of 85 participants who were enrolled in the study between 26 and July 30, 2021, 31 individuals were randomised to receive Gam-COVID-Vac rAd5, 27 to ChAdOx1 nCoV-19 and 27 to BBIBP-CorV. The mean age of participants was 68.2 years (SD 2.9) and 49 (57.6%) were female. Participants who received Gam-COVID-Vac rAd5 and ChAdOx1 nCoV1-19 showed significantly increased anti-S titres at 28 days after second-dose vaccination, but this magnitude of difference was not observed for those who received BBIBP-CorV. The ratio between the geometric mean at day 28 and baseline within each group was 11.8 (6.98–19.89) among patients assigned to Gam-COVID-Vac rAd26/rAd5, 4.81 (2.14–10.81) for the rAd26/ChAdOx1 nCoV-19 group and 1.53 (0.74–3.20) for the rAd26/BBIBP-CorV group. All of the schedules were shown to be safe. Conclusions: The findings in this study contribute to the scarce information published on the safety and immunogenicity of Gam-COVID-Vac heterologous regimens and will help the development of guidelines and vaccine programme management. |
| first_indexed | 2024-04-11T12:49:02Z |
| format | Article |
| id | doaj.art-e2c63d2f7ab445798d1de379cb42a02c |
| institution | Directory Open Access Journal |
| issn | 2666-5352 |
| language | English |
| last_indexed | 2024-04-11T12:49:02Z |
| publishDate | 2022-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Public Health in Practice |
| spelling | doaj.art-e2c63d2f7ab445798d1de379cb42a02c2022-12-22T04:23:15ZengElsevierPublic Health in Practice2666-53522022-12-014100313Safety and immunogenicity of heterologous COVID-19 vaccine regimens to deal with product shortage: A randomised clinical trial in an elderly populationM.A. Kundro0M.H. Losso1A. Macchia2I. Pastor3M. Alonso Serena4C. Gestoso5L. Moreno Macías6F. Crupi7M.C. Acosta8S. Ivalo9M. Ghioldi10M.B. Bouzas11L. Mammana12I. Zapiola13I. Mazzitelli14A. Varese15J. Geffner16C. Biscayart17P. Angeleri18E. Lopez19A. Gentile20D. Ferrante21F. Gonzalez B. de Quiros22Área de Investigación en Enfermedades Emergentes, Hospital General de Agudos “J.M. Ramos Mejía”, Ciudad Autónoma de Buenos Aires, Argentina; Corresponding author. Área de Investigación en Enfermedades Emergentes Departamento de Medicina Hospital J.M. Ramos Mejía Urquiza 609.Buenos Aires. Argentina.Área de Investigación en Enfermedades Emergentes, Hospital General de Agudos “J.M. Ramos Mejía”, Ciudad Autónoma de Buenos Aires, ArgentinaMinisterio de Salud del Gobierno de la Ciudad Autónoma de Buenos Aires, ArgentinaÁrea de Investigación en Enfermedades Emergentes, Hospital General de Agudos “J.M. Ramos Mejía”, Ciudad Autónoma de Buenos Aires, ArgentinaÁrea de Investigación en Enfermedades Emergentes, Hospital General de Agudos “J.M. Ramos Mejía”, Ciudad Autónoma de Buenos Aires, ArgentinaÁrea de Investigación en Enfermedades Emergentes, Hospital General de Agudos “J.M. Ramos Mejía”, Ciudad Autónoma de Buenos Aires, ArgentinaÁrea de Investigación en Enfermedades Emergentes, Hospital General de Agudos “J.M. Ramos Mejía”, Ciudad Autónoma de Buenos Aires, ArgentinaÁrea de Investigación en Enfermedades Emergentes, Hospital General de Agudos “J.M. Ramos Mejía”, Ciudad Autónoma de Buenos Aires, ArgentinaÁrea de Investigación en Enfermedades Emergentes, Hospital General de Agudos “J.M. Ramos Mejía”, Ciudad Autónoma de Buenos Aires, ArgentinaÁrea de Investigación en Enfermedades Emergentes, Hospital General de Agudos “J.M. Ramos Mejía”, Ciudad Autónoma de Buenos Aires, ArgentinaÁrea de Investigación en Enfermedades Emergentes, Hospital General de Agudos “J.M. Ramos Mejía”, Ciudad Autónoma de Buenos Aires, ArgentinaUnidad de Virología, División Análisis Clínicos, Hospital de Infecciosas “Francisco J. Muñiz'', Ciudad Autónoma de Buenos Aires, ArgentinaUnidad de Virología, División Análisis Clínicos, Hospital de Infecciosas “Francisco J. Muñiz'', Ciudad Autónoma de Buenos Aires, ArgentinaUnidad de Virología, División Análisis Clínicos, Hospital de Infecciosas “Francisco J. Muñiz'', Ciudad Autónoma de Buenos Aires, ArgentinaInstituto de Investigaciones Biomédicas en Retrovirus y SIDA (INBIRS), Facultad de Medicina, Universidad de Buenos Aires, ArgentinaInstituto de Investigaciones Biomédicas en Retrovirus y SIDA (INBIRS), Facultad de Medicina, Universidad de Buenos Aires, ArgentinaInstituto de Investigaciones Biomédicas en Retrovirus y SIDA (INBIRS), Facultad de Medicina, Universidad de Buenos Aires, ArgentinaSubsecretaría de Planificación Sanitaria, Ministerio de Salud de la Ciudad de Buenos Aires, Ciudad Autónoma de Buenos Aires, ArgentinaSubsecretaría de Planificación Sanitaria, Ministerio de Salud de la Ciudad de Buenos Aires, Ciudad Autónoma de Buenos Aires, ArgentinaDepartamento de Medicina, Hospital de Niños “Ricardo Gutiérrez”, Ciudad Autónoma de Buenos Aires, ArgentinaDepartamento de Epidemiología, Hospital de Niños “Ricardo Gutiérrez”, Ciudad Autónoma de Buenos Aires, ArgentinaMinisterio de Salud del Gobierno de la Ciudad Autónoma de Buenos Aires, ArgentinaMinisterio de Salud del Gobierno de la Ciudad Autónoma de Buenos Aires, ArgentinaObjectives: In a context of COVID-19 vaccine shortages, this study sought to evaluate the safety and efficacy of receiving one dose of Gam-COVID-Vac rAd26 followed by a second COVID-19 vaccine dose of either Gam-COVID-Vac rAd5, ChAdOx1 nCoV-19 or BBIBP-CorV in a cohort of older adults. Study design: Single-centre, randomised, open label, non-inferiority trial. Methods: Adults aged ≥65 years who had received one dose of Gam-COVID-Vac rAd26 were randomised in a 1:1:1 ratio to receive a second-dose COVID-19 vaccination of either Gam-COVID-Vac rAd5, ChAdOx1 nCoV-19 or BBIBP-CorV. The primary outcome was the assessment of the humoral immune response to vaccination (i.e. antibody titres of SARS-CoV-2 spike protein at 28 days after second-dose vaccination). In addition, neutralising antibody titres at day 28 for the three schedules were measured. Results: Of 85 participants who were enrolled in the study between 26 and July 30, 2021, 31 individuals were randomised to receive Gam-COVID-Vac rAd5, 27 to ChAdOx1 nCoV-19 and 27 to BBIBP-CorV. The mean age of participants was 68.2 years (SD 2.9) and 49 (57.6%) were female. Participants who received Gam-COVID-Vac rAd5 and ChAdOx1 nCoV1-19 showed significantly increased anti-S titres at 28 days after second-dose vaccination, but this magnitude of difference was not observed for those who received BBIBP-CorV. The ratio between the geometric mean at day 28 and baseline within each group was 11.8 (6.98–19.89) among patients assigned to Gam-COVID-Vac rAd26/rAd5, 4.81 (2.14–10.81) for the rAd26/ChAdOx1 nCoV-19 group and 1.53 (0.74–3.20) for the rAd26/BBIBP-CorV group. All of the schedules were shown to be safe. Conclusions: The findings in this study contribute to the scarce information published on the safety and immunogenicity of Gam-COVID-Vac heterologous regimens and will help the development of guidelines and vaccine programme management.http://www.sciencedirect.com/science/article/pii/S2666535222000891COVID-19VaccinationOlder adultsVaccines shortage |
| spellingShingle | M.A. Kundro M.H. Losso A. Macchia I. Pastor M. Alonso Serena C. Gestoso L. Moreno Macías F. Crupi M.C. Acosta S. Ivalo M. Ghioldi M.B. Bouzas L. Mammana I. Zapiola I. Mazzitelli A. Varese J. Geffner C. Biscayart P. Angeleri E. Lopez A. Gentile D. Ferrante F. Gonzalez B. de Quiros Safety and immunogenicity of heterologous COVID-19 vaccine regimens to deal with product shortage: A randomised clinical trial in an elderly population Public Health in Practice COVID-19 Vaccination Older adults Vaccines shortage |
| title | Safety and immunogenicity of heterologous COVID-19 vaccine regimens to deal with product shortage: A randomised clinical trial in an elderly population |
| title_full | Safety and immunogenicity of heterologous COVID-19 vaccine regimens to deal with product shortage: A randomised clinical trial in an elderly population |
| title_fullStr | Safety and immunogenicity of heterologous COVID-19 vaccine regimens to deal with product shortage: A randomised clinical trial in an elderly population |
| title_full_unstemmed | Safety and immunogenicity of heterologous COVID-19 vaccine regimens to deal with product shortage: A randomised clinical trial in an elderly population |
| title_short | Safety and immunogenicity of heterologous COVID-19 vaccine regimens to deal with product shortage: A randomised clinical trial in an elderly population |
| title_sort | safety and immunogenicity of heterologous covid 19 vaccine regimens to deal with product shortage a randomised clinical trial in an elderly population |
| topic | COVID-19 Vaccination Older adults Vaccines shortage |
| url | http://www.sciencedirect.com/science/article/pii/S2666535222000891 |
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