| Autor: |
Chalkias, Spyros, Whatley, Jordan L., Eder, Frank, Essink, Brandon, Khetan, Shishir, Bradley, Paul, Brosz, Adam, McGhee, Nichole, Tomassini, Joanne E., Chen, Xing, Zhao, Xiaoping, Sutherland, Andrea, Shen, Xiaoying, Girard, Bethany, Edwards, Darin K., Feng, Jing, Zhou, Honghong, Walsh, Stephen, Montefiori, David C., Baden, Lindsey R., Miller, Jacqueline M., Das, Rituparna |
| Zdroj: |
Nature Medicine; September 2023, Vol. 29 Issue: 9 p2325-2333, 9p |
| Abstrakt: |
This ongoing, open-label, phase 2/3 trial compared the safety and immunogenicity of the Omicron BA.4/BA.5-containing bivalent mRNA-1273.222 vaccine with the ancestral Wuhan-Hu-1 mRNA-1273 as booster doses. Two groups of adults who previously received mRNA-1273 as primary vaccination series and booster doses were enrolled in a sequential, nonrandomized manner and received single-second boosters of mRNA-1273 (n= 376) or bivalent mRNA-1273.222 (n= 511). Primary objectives were safety and the noninferiority or superiority of neutralizing antibody (nAb) responses against Omicron BA.4/BA.5 and ancestral SARS-CoV-2 with the D614G mutation (ancestral SARS-CoV-2 (D614G)), 28 days post boost. Superiority and noninferiority were based on prespecified success criteria (lower bounds of 95% CI > 1 and < 0.677, respectively) of the mRNA-1273.222:mRNA-1273 geometric mean ratios. Bivalent Omicron BA.4/BA.5-containing mRNA-1273.222 elicited superior nAb responses against BA.4/BA.5 versus mRNA-1273 and noninferior responses against ancestral SARS-CoV-2 (D614G) at day 29 post boost in participants without detectable prior SARS-CoV-2 infection. Day 29 seroresponses against Omicron BA.4/BA.5 were higher for mRNA-1273.222 than for mRNA-1273 and similar against ancestral SARS-CoV-2 (D614G), both meeting noninferiority criterion. The safety profile of mRNA-1273.222 was similar to that previously reported for mRNA-1273 with no new safety concerns identified. Continued monitoring of neutralization and real-world vaccine effectiveness are needed as additional divergent-virus variants emerge. ClinicalTrials.gov registration: NCT04927065. |
| Databáze: |
Supplemental Index |
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