Vaccination With COMIRNATY in Subjects With a VAXZEVRIA First Dose

Summary

CombiVacS is a phase 2 randomized, adaptive trial developed to evaluate the immunogenicity of a dose of COMIRNATY after a previous single dose of VAXZEVRIA. A stratification will be made based on the following factors: study site, sex and age. This protocol allows to test the immunogenicity and safety of a heterologous vaccination strategy after a previous single dose of VAXZEVRIA.

Timeline

Start

2021-04-22

Primary completion

2022-08-22

Completion

2022-12-30

Publications

• Garcia-Perez J, Borobia AM, Perez-Olmeda M, Portoles A, Castano L, Campins-Arti M, Bertran MJ, Bermejo M, Arribas JR, Lopez A, Ascaso-Del-Rio A, Arana-Arri E, Fuentes Camps I, Vilella A, Cascajero A, Garcia-Morales MT, Castillo de la Osa M, Perez Ingidua C, Lora D, Jimenez-Santana P, Pino-Rosa S, Gomez de la Camara A, De La Torre-Tarazona E, Calonge E, Cruces R, Belda-Iniesta C, Alcami J, Frias J, Carcas AJ, Diez-Fuertes F; CombiVacS Study Group. Immunogenicity of a third dose with mRNA-vaccines in the ChAdOx1-S/BNT162b2 vaccination regimen against SARS-CoV-2 variants. iScience. 2024 Aug 14;27(9):110728. doi: 10.1016/j.isci.2024.110728. eCollection 2024 Sep 20.
• Garcia-Perez J, Gonzalez-Perez M, Castillo de la Osa M, Borobia AM, Castano L, Bertran MJ, Campins M, Portoles A, Lora D, Bermejo M, Conde P, Hernandez-Gutierrez L, Carcas A, Arana-Arri E, Tortajada M, Fuentes I, Ascaso A, Garcia-Morales MT, Erick de la Torre-Tarazona H, Arribas JR, Imaz-Ayo N, Mellado-Pau E, Agusti A, Perez-Ingidua C, Gomez de la Camara A, Ochando J, Belda-Iniesta C, Frias J, Alcami J, Perez-Olmeda M; CombiVacS study Group. Immunogenic dynamics and SARS-CoV-2 variant neutralisation of the heterologous ChAdOx1-S/BNT162b2 vaccination: Secondary analysis of the randomised CombiVacS study. EClinicalMedicine. 2022 Jul 1;50:101529. doi: 10.1016/j.eclinm.2022.101529. eCollection 2022 Aug.
• Borobia AM, Carcas AJ, Perez-Olmeda M, Castano L, Bertran MJ, Garcia-Perez J, Campins M, Portoles A, Gonzalez-Perez M, Garcia Morales MT, Arana-Arri E, Aldea M, Diez-Fuertes F, Fuentes I, Ascaso A, Lora D, Imaz-Ayo N, Baron-Mira LE, Agusti A, Perez-Ingidua C, Gomez de la Camara A, Arribas JR, Ochando J, Alcami J, Belda-Iniesta C, Frias J; CombiVacS Study Group. Immunogenicity and reactogenicity of BNT162b2 booster in ChAdOx1-S-primed participants (CombiVacS): a multicentre, open-label, randomised, controlled, phase 2 trial. Lancet. 2021 Jul 10;398(10295):121-130. doi: 10.1016/S0140-6736(21)01420-3. Epub 2021 Jun 25.

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