Safety and immunogenicity of an mRNA-1273 vaccine booster in adolescents
Safety, immunogenicity, and effectiveness of an mRNA-1273 50-μg booster were evaluated in adolescents (12–17 years), with and without pre-booster SARS-CoV-2 infection. Participants who had received the 2-dose mRNA-1273 100-µg primary series in the TeenCOVE trial (NCT04649151) were offered the mRNA-1...
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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/10.1080/21645515.2024.2436714 |
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| author | Amparo L. Figueroa Kashif Ali Gary Berman Wenqin Xu Weiping Deng Bethany Girard Anne Yeakey Karen Slobod Jacqueline Miller Rituparna Das Frances Priddy |
| author_facet | Amparo L. Figueroa Kashif Ali Gary Berman Wenqin Xu Weiping Deng Bethany Girard Anne Yeakey Karen Slobod Jacqueline Miller Rituparna Das Frances Priddy |
| author_sort | Amparo L. Figueroa |
| collection | DOAJ |
| description | Safety, immunogenicity, and effectiveness of an mRNA-1273 50-μg booster were evaluated in adolescents (12–17 years), with and without pre-booster SARS-CoV-2 infection. Participants who had received the 2-dose mRNA-1273 100-µg primary series in the TeenCOVE trial (NCT04649151) were offered the mRNA-1273 50-μg booster. Primary objectives included safety and inference of effectiveness by establishing noninferiority of neutralizing antibody (nAb) responses after the booster compared with the nAb post-primary series of mRNA-1273 among young adults in COVE (NCT04470427). Binding antibody (bAb) responses against SARS-CoV-2 variants of interest and COVID-19 incidence after vaccination were also evaluated. Median boosting interval was 315 days. The mRNA-1273 booster was well-tolerated, with an acceptable safety profile. Relative to pre-booster, nAb geometric mean levels increased after the booster by 17.8-fold and 4.7-fold among pre-booster SARS-CoV-2–negative and –positive participants, respectively. Effectiveness was successfully inferred based on noninferiority of nAb levels from mRNA-1273 booster dose (Day 29) compared with nAb levels after mRNA-1273 primary series (Day 57) among young adults in COVE. Further, the booster increased bAb levels relative to pre-booster baseline against SARS-CoV-2 variants (alpha [B.1.1.7], beta [B.1.351], gamma [P.1], and delta [B.1.617.2]), regardless of pre-booster SARS-CoV-2 status. COVID-19 incidence (cases per 1000 person-months) was lower among boosted (0 cases) than non-boosted (95.766 cases) participants in January 2022, a peak period during the early omicron transmission. In summary, the mRNA-1273 50-μg booster induced robust nAb responses in previously vaccinated adolescents, regardless of SARS-CoV-2 serostatus. Effectiveness was successfully inferred and the booster was well-tolerated, with no new safety concerns identified. |
| format | Article |
| id | doaj-art-0b4f209b7e684005895f768b9f23416c |
| 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-0b4f209b7e684005895f768b9f23416c2025-01-21T16:48:54ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2025-12-0121110.1080/21645515.2024.2436714Safety and immunogenicity of an mRNA-1273 vaccine booster in adolescentsAmparo L. Figueroa0Kashif Ali1Gary Berman2Wenqin Xu3Weiping Deng4Bethany Girard5Anne Yeakey6Karen Slobod7Jacqueline Miller8Rituparna Das9Frances Priddy10Clinical Development, Infectious Diseases, Moderna, Inc., Cambridge, MA, USAKool Kids Pediatrics, DM Clinical Research, Houston, TX, USAClinical Research Institute, Allergy and Immunology, Minneapolis, MN, USABiostatistics, Moderna, Inc., Cambridge, MA, USABiostatistics, Moderna, Inc., Cambridge, MA, USAClinical Biomarkers, Moderna, Inc., Cambridge, MA, USABioPoint Contracting, Peabody, MA, USACambridge ID & Immunology Consulting, LLC, Somerville, MA, USAResearch and Development, Infectious Disease, Moderna, Inc., Cambridge, MA, USAResearch and Development, Infectious Disease, Moderna, Inc., Cambridge, MA, USAResearch and Development, Infectious Disease, Moderna, Inc., Cambridge, MA, USASafety, immunogenicity, and effectiveness of an mRNA-1273 50-μg booster were evaluated in adolescents (12–17 years), with and without pre-booster SARS-CoV-2 infection. Participants who had received the 2-dose mRNA-1273 100-µg primary series in the TeenCOVE trial (NCT04649151) were offered the mRNA-1273 50-μg booster. Primary objectives included safety and inference of effectiveness by establishing noninferiority of neutralizing antibody (nAb) responses after the booster compared with the nAb post-primary series of mRNA-1273 among young adults in COVE (NCT04470427). Binding antibody (bAb) responses against SARS-CoV-2 variants of interest and COVID-19 incidence after vaccination were also evaluated. Median boosting interval was 315 days. The mRNA-1273 booster was well-tolerated, with an acceptable safety profile. Relative to pre-booster, nAb geometric mean levels increased after the booster by 17.8-fold and 4.7-fold among pre-booster SARS-CoV-2–negative and –positive participants, respectively. Effectiveness was successfully inferred based on noninferiority of nAb levels from mRNA-1273 booster dose (Day 29) compared with nAb levels after mRNA-1273 primary series (Day 57) among young adults in COVE. Further, the booster increased bAb levels relative to pre-booster baseline against SARS-CoV-2 variants (alpha [B.1.1.7], beta [B.1.351], gamma [P.1], and delta [B.1.617.2]), regardless of pre-booster SARS-CoV-2 status. COVID-19 incidence (cases per 1000 person-months) was lower among boosted (0 cases) than non-boosted (95.766 cases) participants in January 2022, a peak period during the early omicron transmission. In summary, the mRNA-1273 50-μg booster induced robust nAb responses in previously vaccinated adolescents, regardless of SARS-CoV-2 serostatus. Effectiveness was successfully inferred and the booster was well-tolerated, with no new safety concerns identified.https://www.tandfonline.com/doi/10.1080/21645515.2024.2436714mRNA vaccinemRNA-1273booster doseimmunogenicityvaccine effectivenessadolescents |
| spellingShingle | Amparo L. Figueroa Kashif Ali Gary Berman Wenqin Xu Weiping Deng Bethany Girard Anne Yeakey Karen Slobod Jacqueline Miller Rituparna Das Frances Priddy Safety and immunogenicity of an mRNA-1273 vaccine booster in adolescents Human Vaccines & Immunotherapeutics mRNA vaccine mRNA-1273 booster dose immunogenicity vaccine effectiveness adolescents |
| title | Safety and immunogenicity of an mRNA-1273 vaccine booster in adolescents |
| title_full | Safety and immunogenicity of an mRNA-1273 vaccine booster in adolescents |
| title_fullStr | Safety and immunogenicity of an mRNA-1273 vaccine booster in adolescents |
| title_full_unstemmed | Safety and immunogenicity of an mRNA-1273 vaccine booster in adolescents |
| title_short | Safety and immunogenicity of an mRNA-1273 vaccine booster in adolescents |
| title_sort | safety and immunogenicity of an mrna 1273 vaccine booster in adolescents |
| topic | mRNA vaccine mRNA-1273 booster dose immunogenicity vaccine effectiveness adolescents |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2024.2436714 |
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