We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Interim Report of the Reactogenicity and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 XBB–Containing Vaccines.
- Authors
Chalkias, Spyros; McGhee, Nichole; Whatley, Jordan L; Essink, Brandon; Brosz, Adam; Tomassini, Joanne E; Girard, Bethany; Edwards, Darin K; Wu, Kai; Nasir, Arshan; Lee, Diana; Avena, Laura E; Feng, Jing; Deng, Weiping; Montefiori, David C; Baden, Lindsey R; Miller, Jacqueline M; Das, Rituparna
- Abstract
Background Monovalent Omicron XBB.1.5–containing vaccines were approved for coronavirus disease 2019 (COVID-19) 2023–2024 immunizations. Methods This ongoing, open-label, phase 2/3 study evaluated messenger RNA (mRNA)-1273.815 monovalent (50-µg Omicron XBB.1.5 spike mRNA) and mRNA-1273.231 bivalent (25-µg each Omicron XBB.1.5 and BA.4/BA.5 spike mRNAs) vaccines, administered as fifth doses to adults who previously received primary series, third doses of an original mRNA COVID-19 vaccine, and fourth doses of an Omicron BA.4/BA.5 bivalent vaccine. Interim safety and immunogenicity 29 days after vaccination are reported. Results Participants (randomized 1:1) received 50-µg of mRNA-1273.815 (n = 50) or mRNA-1273.231 (n = 51); median intervals (interquartile range) from prior BA.4/BA.5 bivalent doses were 8.2 (8.1–8.3) and 8.3 (8.1–8.4) months, respectively. Fold increases in neutralizing antibody (nAb) against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants from prebooster nAb levels were numerically higher against XBB.1.5, XBB.1.16, EG.5.1, BA.2.86, and JN.1 than BA.4/BA.5, BQ.1.1, or D614G on day 29. Monovalent vaccine also cross-neutralized FL.1.5.1, EG.5.1, BA.2.86, HK.3.1, HV.1, and JN.1 variants in a participant subset (n = 20) 15 days after vaccination. Reactogenicity was similar to that of mRNA-1273 vaccines. Conclusions XBB.1.5-containing mRNA-1273 vaccines elicit robust, diverse nAb responses against more recent SARS-CoV-2 variants, including JN.1, supporting the XBB.1.5-spike update for COVID-19 vaccines.
- Subjects
SARS-CoV-2; SARS-CoV-2 Omicron variant; COVID-19; MESSENGER RNA; COVID-19 vaccines
- Publication
Journal of Infectious Diseases, 2024, Vol 230, Issue 2, pe279
- ISSN
0022-1899
- Publication type
Article
- DOI
10.1093/infdis/jiae067