Safety, reactogenicity, and immunogenicity of Ad26.COV2.S co-administered with a quadrivalent standard-dose or high-dose seasonal influenza vaccine: a non-inferiority randomised controlled trialResearch in context
Summary: Background: Vaccine co-administration can increase vaccination coverage. We assessed the safety, reactogenicity, and immunogenicity of concomitant administration of Ad26.COV2.S COVID-19 vaccine with seasonal influenza vaccines. Methods: This non-inferiority, Phase 3, randomised, double-bli...
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Elsevier
2025-01-01
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| Series: | EClinicalMedicine |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589537024005959 |
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| author | Gabriela Tapia-Calle Gloria Aguilar Nathalie Vaissiere Carla Truyers Pedro Ylisastigui Erik Buntinx Mathieu Le Gars Frank Struyf Gert Scheper Macaya Douoguih Javier Ruiz-Guiñazú Robert Patrizi Wai Ling Sanne de Ridder Marit de Groot Maria Grazia Pau Gerald Weidinger Srividya Pradeep Nadine Salisch Sophie Cambre |
| author_facet | Gabriela Tapia-Calle Gloria Aguilar Nathalie Vaissiere Carla Truyers Pedro Ylisastigui Erik Buntinx Mathieu Le Gars Frank Struyf Gert Scheper Macaya Douoguih Javier Ruiz-Guiñazú Robert Patrizi Wai Ling Sanne de Ridder Marit de Groot Maria Grazia Pau Gerald Weidinger Srividya Pradeep Nadine Salisch Sophie Cambre |
| author_sort | Gabriela Tapia-Calle |
| collection | DOAJ |
| description | Summary: Background: Vaccine co-administration can increase vaccination coverage. We assessed the safety, reactogenicity, and immunogenicity of concomitant administration of Ad26.COV2.S COVID-19 vaccine with seasonal influenza vaccines. Methods: This non-inferiority, Phase 3, randomised, double-blind study enrolled 859 healthy adults and was conducted between 02 November 2021 and 28 November 2022. Participants aged ≥18–64 years were randomised to receive a seasonal quadrivalent standard dose (SD) influenza vaccine (Afluria Quadrivalent, Seqirus) concomitantly with Ad26.COV2.S (Coad_SD) or placebo (0.9% NaCl; Control_SD) on Day 1 and placebo or Ad26.COV2.S on Day 29. Participants aged ≥65-years were randomised to the Coad_SD or Control_SD groups, or to Coad_HD or Control_HD groups that received a seasonal quadrivalent HD (high-dose) influenza vaccine (Fluzone High-Dose Quadrivalent, Sanofi Pasteur Inc) in the same schedules. The primary outcomes were haemagglutinin inhibition titres against the four influenza vaccine strains at Day 29, and SARS-CoV-2 Spike-specific antibodies at Day 29 in the Coad_SD group and Day 57 in the Control-SD group, with a non-inferiority margin (Control-SD group/Coad_SD group) of 1.5. Reactogenicity and safety were assessed in all participants (NCT05091307). Findings: Non-inferiority criteria for concomitant administration in the SD groups were met for SARS-CoV-2 Spike-specific antibodies (ratio 1.11, 95% CI 0.97–1.26) and haemagglutinin inhibition titres for all influenza strains (A/H3N2 1.23, 95% CI 1.05–1.45; B/Victoria 0.99, 95% CI 0.84–1.19; B/Yamagata, 1.03, 95% CI 0.88–1.21) except A/H1N1 (1.28, 95% CI 1.09–1.53) for which the upper limit of the 95% CI was >1.5. Concomitant administration of Ad26.COV2.S and SD influenza vaccine induced robust immune responses in terms of SARS-CoV-2 Spike-specific antibodies and haemagglutinin inhibition to all four influenza strains. Seroconversion and seroprotection rates against all influenza vaccine strains were comparable in the Coad and Control groups. Anti-Spike antibodies 28 days after receiving Ad26.COV2.S were similar whether administered with influenza vaccine or alone. Antibody responses persisted at least 6 months post-vaccination in all groups. The reactogenicity and safety profile following co-administration was consistent with the known safety profiles of the study vaccines. No safety concerns were identified. Coadministration was immunogenic and well tolerated in adults aged ≥65 years who received HD influenza vaccine. Interpretation: Co-administration of seasonal influenza vaccine with Ad26.COV2.S was immunogenic with an acceptable safety profile, supporting co-administration of these vaccines. Funding: Janssen Vaccines & Prevention BV and Biomedical Advanced Research and Development Authority. |
| format | Article |
| id | doaj-art-50348e9b5558443db60d7039e28f3312 |
| institution | Kabale University |
| issn | 2589-5370 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | EClinicalMedicine |
| spelling | doaj-art-50348e9b5558443db60d7039e28f33122025-01-22T05:43:42ZengElsevierEClinicalMedicine2589-53702025-01-0179103016Safety, reactogenicity, and immunogenicity of Ad26.COV2.S co-administered with a quadrivalent standard-dose or high-dose seasonal influenza vaccine: a non-inferiority randomised controlled trialResearch in contextGabriela Tapia-Calle0Gloria Aguilar1Nathalie Vaissiere2Carla Truyers3Pedro Ylisastigui4Erik Buntinx5Mathieu Le Gars6Frank Struyf7Gert Scheper8Macaya Douoguih9Javier Ruiz-Guiñazú10Robert PatriziWai LingSanne de RidderMarit de GrootMaria Grazia PauGerald WeidingerSrividya PradeepNadine SalischSophie CambreJanssen Vaccines and Prevention BV, Leiden, the Netherlands; Corresponding author.Janssen Vaccines and Prevention BV, Leiden, the NetherlandsJanssen Research and Development, Beerse, BelgiumJanssen Research and Development, Beerse, BelgiumAlliance for Multispecialty Research, Fort Myers, Florida, USAAnimal Research Center, Alken, BelgiumJanssen Vaccines and Prevention BV, Leiden, the NetherlandsJanssen Research and Development, Beerse, BelgiumJanssen Vaccines and Prevention BV, Leiden, the NetherlandsJanssen Vaccines and Prevention BV, Leiden, the NetherlandsJanssen Research and Development, Beerse, BelgiumSummary: Background: Vaccine co-administration can increase vaccination coverage. We assessed the safety, reactogenicity, and immunogenicity of concomitant administration of Ad26.COV2.S COVID-19 vaccine with seasonal influenza vaccines. Methods: This non-inferiority, Phase 3, randomised, double-blind study enrolled 859 healthy adults and was conducted between 02 November 2021 and 28 November 2022. Participants aged ≥18–64 years were randomised to receive a seasonal quadrivalent standard dose (SD) influenza vaccine (Afluria Quadrivalent, Seqirus) concomitantly with Ad26.COV2.S (Coad_SD) or placebo (0.9% NaCl; Control_SD) on Day 1 and placebo or Ad26.COV2.S on Day 29. Participants aged ≥65-years were randomised to the Coad_SD or Control_SD groups, or to Coad_HD or Control_HD groups that received a seasonal quadrivalent HD (high-dose) influenza vaccine (Fluzone High-Dose Quadrivalent, Sanofi Pasteur Inc) in the same schedules. The primary outcomes were haemagglutinin inhibition titres against the four influenza vaccine strains at Day 29, and SARS-CoV-2 Spike-specific antibodies at Day 29 in the Coad_SD group and Day 57 in the Control-SD group, with a non-inferiority margin (Control-SD group/Coad_SD group) of 1.5. Reactogenicity and safety were assessed in all participants (NCT05091307). Findings: Non-inferiority criteria for concomitant administration in the SD groups were met for SARS-CoV-2 Spike-specific antibodies (ratio 1.11, 95% CI 0.97–1.26) and haemagglutinin inhibition titres for all influenza strains (A/H3N2 1.23, 95% CI 1.05–1.45; B/Victoria 0.99, 95% CI 0.84–1.19; B/Yamagata, 1.03, 95% CI 0.88–1.21) except A/H1N1 (1.28, 95% CI 1.09–1.53) for which the upper limit of the 95% CI was >1.5. Concomitant administration of Ad26.COV2.S and SD influenza vaccine induced robust immune responses in terms of SARS-CoV-2 Spike-specific antibodies and haemagglutinin inhibition to all four influenza strains. Seroconversion and seroprotection rates against all influenza vaccine strains were comparable in the Coad and Control groups. Anti-Spike antibodies 28 days after receiving Ad26.COV2.S were similar whether administered with influenza vaccine or alone. Antibody responses persisted at least 6 months post-vaccination in all groups. The reactogenicity and safety profile following co-administration was consistent with the known safety profiles of the study vaccines. No safety concerns were identified. Coadministration was immunogenic and well tolerated in adults aged ≥65 years who received HD influenza vaccine. Interpretation: Co-administration of seasonal influenza vaccine with Ad26.COV2.S was immunogenic with an acceptable safety profile, supporting co-administration of these vaccines. Funding: Janssen Vaccines & Prevention BV and Biomedical Advanced Research and Development Authority.http://www.sciencedirect.com/science/article/pii/S2589537024005959SARS-CoV-2COVID-19VaccineAdenoviral vectorsInfluenza vaccinesCo-administration |
| spellingShingle | Gabriela Tapia-Calle Gloria Aguilar Nathalie Vaissiere Carla Truyers Pedro Ylisastigui Erik Buntinx Mathieu Le Gars Frank Struyf Gert Scheper Macaya Douoguih Javier Ruiz-Guiñazú Robert Patrizi Wai Ling Sanne de Ridder Marit de Groot Maria Grazia Pau Gerald Weidinger Srividya Pradeep Nadine Salisch Sophie Cambre Safety, reactogenicity, and immunogenicity of Ad26.COV2.S co-administered with a quadrivalent standard-dose or high-dose seasonal influenza vaccine: a non-inferiority randomised controlled trialResearch in context EClinicalMedicine SARS-CoV-2 COVID-19 Vaccine Adenoviral vectors Influenza vaccines Co-administration |
| title | Safety, reactogenicity, and immunogenicity of Ad26.COV2.S co-administered with a quadrivalent standard-dose or high-dose seasonal influenza vaccine: a non-inferiority randomised controlled trialResearch in context |
| title_full | Safety, reactogenicity, and immunogenicity of Ad26.COV2.S co-administered with a quadrivalent standard-dose or high-dose seasonal influenza vaccine: a non-inferiority randomised controlled trialResearch in context |
| title_fullStr | Safety, reactogenicity, and immunogenicity of Ad26.COV2.S co-administered with a quadrivalent standard-dose or high-dose seasonal influenza vaccine: a non-inferiority randomised controlled trialResearch in context |
| title_full_unstemmed | Safety, reactogenicity, and immunogenicity of Ad26.COV2.S co-administered with a quadrivalent standard-dose or high-dose seasonal influenza vaccine: a non-inferiority randomised controlled trialResearch in context |
| title_short | Safety, reactogenicity, and immunogenicity of Ad26.COV2.S co-administered with a quadrivalent standard-dose or high-dose seasonal influenza vaccine: a non-inferiority randomised controlled trialResearch in context |
| title_sort | safety reactogenicity and immunogenicity of ad26 cov2 s co administered with a quadrivalent standard dose or high dose seasonal influenza vaccine a non inferiority randomised controlled trialresearch in context |
| topic | SARS-CoV-2 COVID-19 Vaccine Adenoviral vectors Influenza vaccines Co-administration |
| url | http://www.sciencedirect.com/science/article/pii/S2589537024005959 |
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