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      367. Safety and Immunogenicity of a 50-μg mRNA-1273 Vaccine Booster for Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) in Adolescents

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          Abstract

          Background

          Increased community COVID-19 cases prompted the clinical evaluation of an mRNA-1273 booster dose (BD) in TeenCOVE adolescent participants (12-17 years) who received a 2-dose mRNA-1273 primary series. At ≥5 months after dose 2 (coinciding with the omicron wave peak in Jan 2022), TeenCOVE participants were offered an optional 50-µg mRNA-1273 BD. Here, we inferred BD effectiveness in adolescents by demonstrating non-inferiority (NI) of neutralizing antibody (nAb) responses post-BD vs young adults (18-25 years) post-dose 2 of 100-μg mRNA-1273 primary series in the pivotal phase 3 COVE study, where efficacy was established.

          Methods

          Up to 6 months post-BD, 1405 participants were monitored for COVID-19 and safety (solicited adverse reactions [≤7 days post-BD]; unsolicited AEs [≤28 days post-BD]; and medically attended, serious [SAEs], of special interest [AESI], or leading to discontinuation [throughout study]). At Day 29 post-BD, nAb geometric mean concentrations (GMCs) were measured against ancestral D614G SARS-CoV-2 spike protein. Binding antibodies (bAbs) against spike protein of ancestral strain or alpha, beta, delta, and gamma variants were measured.

          Results

          An mRNA-1273 BD was generally well-tolerated; reactogenicity profiles were consistent to the phase 3 COVE study in young adults. There were no severe COVID-19 cases, deaths, or investigator-reported vaccine-related SAEs or AESIs. In pre-booster SARS-CoV-2 negative participants, the ratio of adolescent (n=264) BD-Day 29 GMC (7102; 95% CI, 6553.2-7696.8) to young adult (n=294) Day 57 GMC (1400.4; 1272.7-1541.0) was 5.1 (4.5-5.7), meeting NI criterion for GMR ( Fig 1; Table 1). The group difference in seroresponse rate (SRR) between adolescents and young adults was 0.7% (95% CI, -0.8 to 2.4), meeting NI criterion for SRR difference ( Table 1). Robust bAb responses were observed, including against variants.

          Conclusion

          Effectiveness of an mRNA-1273 BD against COVID-19 in adolescents was inferred by successful immunobridging to young adults in the pivotal phase 3 trial. The benefits of variant-containing mRNA-1273 boosters demonstrated in adults is also anticipated to be conferred to adolescents. The overall benefit-risk profile of an mRNA-1273 BD is favorable in adolescents.

          Disclosures

          Amparo Figueroa, MD, MPH, Moderna, Inc.: salary|Moderna, Inc.: Stocks/Bonds Gary Berman, MD, Moderna, Inc.: Grant/Research Support Honghong Zhou, Ph.D., Moderna, Inc.: salary|Moderna, Inc.: Stocks/Bonds Weiping Deng, PhD, Moderna, Inc.: salary|Moderna, Inc.: Stocks/Bonds Monali Patel, MS, Moderna, Inc.: salary|Moderna, Inc.: Stocks/Bonds Bethany Girard, Ph.D., Moderna, Inc.: salary|Moderna, Inc.: Stocks/Bonds Anne Yeakey, MD, Moderna, Inc.: Advisor/Consultant Karen Slobod, MD, Moderna, Inc.: Advisor/Consultant Frances Priddy, MD, MPH, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Jacqueline Miller, MD, Moderna, Inc.: salary|Moderna, Inc.: Stocks/Bonds Rituparna Das, M.D., Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds

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          Author and article information

          Contributors
          Journal
          Open Forum Infect Dis
          Open Forum Infect Dis
          ofid
          Open Forum Infectious Diseases
          Oxford University Press (US )
          2328-8957
          December 2023
          27 November 2023
          27 November 2023
          : 10
          : Suppl 2 , IDWeek 2023 Abstracts
          : ofad500.437
          Affiliations
          Moderna, Inc. , Cambridge, Massachusetts
          Kool Kids Pediatrics, DM Clinical Research , Houston, Texas
          Clinical Research Institute, Allergy and Immunology , Minneapolis, Minnesota
          Moderna, Inc. , Cambridge, Massachusetts
          Moderna, Inc. , Cambridge, Massachusetts
          Moderna, Inc. , Cambridge, Massachusetts
          Moderna, Inc. , Cambridge, Massachusetts
          Moderna, Inc. , Cambridge, Massachusetts
          Moderna, Inc. , Cambridge, Massachusetts
          Moderna, Inc. , Cambridge, Massachusetts
          Moderna, Inc. , Cambridge, Massachusetts
          Moderna, Inc. , Cambridge, Massachusetts
          Author notes

          Session: 43. Clinical Trials

          Thursday, October 12, 2023: 12:15 PM

          Article
          ofad500.437
          10.1093/ofid/ofad500.437
          10676862
          2e4f2d97-a483-4a6b-beea-620c424fe237
          © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

          This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

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          AcademicSubjects/MED00290

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