Safety and immunogenicity of Ad26.COV2.S in adolescents: Phase 2 randomized clinical trial
We conducted a randomized, Phase 2 trial to assess the safety and humoral immunogenicity of reduced doses/dose volume of the standard dose of Ad26.COV2.S COVID-19 vaccine (5 × 1010 viral particles [vp]) in healthy adolescents aged 12–17 years. Participants were randomly assigned to receive Ad26.COV2...
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Taylor & Francis Group
2025-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2025.2450120 |
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| author | Jelena Tica Veronica V. Rezelj Benoit Baron Vitalija van Paassen Javier Zaidman Lee Fairlie Gert Scheper Mathieu Le Gars Frank Struyf Macaya Douoguih Javier Ruiz-Guiñazú |
| author_facet | Jelena Tica Veronica V. Rezelj Benoit Baron Vitalija van Paassen Javier Zaidman Lee Fairlie Gert Scheper Mathieu Le Gars Frank Struyf Macaya Douoguih Javier Ruiz-Guiñazú |
| author_sort | Jelena Tica |
| collection | DOAJ |
| description | We conducted a randomized, Phase 2 trial to assess the safety and humoral immunogenicity of reduced doses/dose volume of the standard dose of Ad26.COV2.S COVID-19 vaccine (5 × 1010 viral particles [vp]) in healthy adolescents aged 12–17 years. Participants were randomly assigned to receive Ad26.COV2.S at reduced dose levels of 0.625 × 1010 (0.5 mL), 1.25 × 1010 (0.5 mL) or 2.5 × 1010 (0.5 mL or low volume 0.25 mL) vp in a 1- or 2-dose (56-day interval) primary schedule. Adolescents who received a 1-dose primary schedule received a 2.5 × 1010 vp booster dose 6 months later. Safety and humoral immunogenicity were assessed up to 6 months post-last vaccination. All regimens were well tolerated, with no safety concerns identified. Local and systemic solicited AEs in adolescents were consistent with the known safety profile in adults. All 1- and 2-dose Ad26.COV2.S primary schedules elicited robust peak Spike-binding antibody responses and virus neutralizing titers against the reference strain, in participants with and without preexisting SARS-CoV-2 immunity. Immune responses were durable for at least 6 months. Spike-binding antibody responses were comparable to those elicited in young adults aged 18–25 years who received a standard dose of Ad26.COV2.S in Phase 3 efficacy studies Reduced doses/dose volume of Ad26.COV2.S had an acceptable safety profile and elicited robust humoral immune responses in adolescents aged 12–17 years. All 1- and 2-dose schedules elicited Spike-binding antibody responses that were comparable to an adult population in whom efficacy has been demonstrated using a higher vaccine dose. (clinicaltrials.gov NCT05007080). |
| format | Article |
| id | doaj-art-44dd1cde637a45348c70ac4867965295 |
| institution | Kabale University |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-44dd1cde637a45348c70ac48679652952025-01-27T13:44:30ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2025-12-0121110.1080/21645515.2025.2450120Safety and immunogenicity of Ad26.COV2.S in adolescents: Phase 2 randomized clinical trialJelena Tica0Veronica V. Rezelj1Benoit Baron2Vitalija van Paassen3Javier Zaidman4Lee Fairlie5Gert Scheper6Mathieu Le Gars7Frank Struyf8Macaya Douoguih9Javier Ruiz-Guiñazú10Scientific Affairs and Late Development, Janssen-Cilag GmbH, Neuss, GermanyBiomarkers, Viral Vaccines, Janssen Vaccines and Prevention, Leiden, The NetherlandsBiostatistics – Vaccines, Janssen Vaccines and Prevention, Leiden, The NetherlandsBiostatistics – Vaccines, Janssen Vaccines and Prevention, Leiden, The NetherlandsCIPREC, Centro Medico Arenales, Caba, ArgentinaMaternal and Child Health, Wits RHI Shandukani, Johannesburg, South AfricaVaccine Research, Janssen Vaccines and Prevention, Leiden, The NetherlandsBiomarkers, Viral Vaccines, Janssen Vaccines and Prevention, Leiden, The NetherlandsScientific Affairs and Late Development, Janssen Research and Development, Beerse, BelgiumClinical Development and Medical Affairs, Janssen Vaccines and Prevention, Leiden, The NetherlandsCrucell Integration, Janssen Research and Development, Beerse, BelgiumWe conducted a randomized, Phase 2 trial to assess the safety and humoral immunogenicity of reduced doses/dose volume of the standard dose of Ad26.COV2.S COVID-19 vaccine (5 × 1010 viral particles [vp]) in healthy adolescents aged 12–17 years. Participants were randomly assigned to receive Ad26.COV2.S at reduced dose levels of 0.625 × 1010 (0.5 mL), 1.25 × 1010 (0.5 mL) or 2.5 × 1010 (0.5 mL or low volume 0.25 mL) vp in a 1- or 2-dose (56-day interval) primary schedule. Adolescents who received a 1-dose primary schedule received a 2.5 × 1010 vp booster dose 6 months later. Safety and humoral immunogenicity were assessed up to 6 months post-last vaccination. All regimens were well tolerated, with no safety concerns identified. Local and systemic solicited AEs in adolescents were consistent with the known safety profile in adults. All 1- and 2-dose Ad26.COV2.S primary schedules elicited robust peak Spike-binding antibody responses and virus neutralizing titers against the reference strain, in participants with and without preexisting SARS-CoV-2 immunity. Immune responses were durable for at least 6 months. Spike-binding antibody responses were comparable to those elicited in young adults aged 18–25 years who received a standard dose of Ad26.COV2.S in Phase 3 efficacy studies Reduced doses/dose volume of Ad26.COV2.S had an acceptable safety profile and elicited robust humoral immune responses in adolescents aged 12–17 years. All 1- and 2-dose schedules elicited Spike-binding antibody responses that were comparable to an adult population in whom efficacy has been demonstrated using a higher vaccine dose. (clinicaltrials.gov NCT05007080).https://www.tandfonline.com/doi/10.1080/21645515.2025.2450120Ad26.COV2.SCOVID-19 vaccineadolescentimmunogenicitysafetyvirus vector vaccine |
| spellingShingle | Jelena Tica Veronica V. Rezelj Benoit Baron Vitalija van Paassen Javier Zaidman Lee Fairlie Gert Scheper Mathieu Le Gars Frank Struyf Macaya Douoguih Javier Ruiz-Guiñazú Safety and immunogenicity of Ad26.COV2.S in adolescents: Phase 2 randomized clinical trial Human Vaccines & Immunotherapeutics Ad26.COV2.S COVID-19 vaccine adolescent immunogenicity safety virus vector vaccine |
| title | Safety and immunogenicity of Ad26.COV2.S in adolescents: Phase 2 randomized clinical trial |
| title_full | Safety and immunogenicity of Ad26.COV2.S in adolescents: Phase 2 randomized clinical trial |
| title_fullStr | Safety and immunogenicity of Ad26.COV2.S in adolescents: Phase 2 randomized clinical trial |
| title_full_unstemmed | Safety and immunogenicity of Ad26.COV2.S in adolescents: Phase 2 randomized clinical trial |
| title_short | Safety and immunogenicity of Ad26.COV2.S in adolescents: Phase 2 randomized clinical trial |
| title_sort | safety and immunogenicity of ad26 cov2 s in adolescents phase 2 randomized clinical trial |
| topic | Ad26.COV2.S COVID-19 vaccine adolescent immunogenicity safety virus vector vaccine |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2025.2450120 |
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