Interim Report of the Reactogenicity and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 XBB–Containing Vaccines.

Autor: 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
Předmět:
Zdroj: Journal of Infectious Diseases; 8/15/2024, Vol. 230 Issue 2, pe279-e286, 8p
Abstrakt: 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. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index