tetano
Editor, Senior Moderator
Nat Commun
. 2023 Aug 23;14(1):5125.
doi: 10.1038/s41467-023-38892-w. Three-month antibody persistence of a bivalent Omicron-containing booster vaccine against COVID-19
Spyros Chalkias[SUP] 1 [/SUP], Charles Harper[SUP] 2 [/SUP], Keith Vrbicky[SUP] 2 [/SUP], Stephen R Walsh[SUP] 3 [/SUP], Brandon Essink[SUP] 4 [/SUP], Adam Brosz[SUP] 5 [/SUP], Nichole McGhee[SUP] 6 [/SUP], Joanne E Tomassini[SUP] 6 [/SUP], Xing Chen[SUP] 6 [/SUP], Ying Chang[SUP] 6 [/SUP], Andrea Sutherland[SUP] 6 [/SUP], David C Montefiori[SUP] 7 [/SUP], Bethany Girard[SUP] 6 [/SUP], Darin K Edwards[SUP] 6 [/SUP], Jing Feng[SUP] 6 [/SUP], Honghong Zhou[SUP] 6 [/SUP], Lindsey R Baden[SUP] 3 [/SUP], Jacqueline M Miller[SUP] 6 [/SUP], Rituparna Das[SUP] 6 [/SUP]
Affiliations
We previously presented day 29 interim safety and immunogenicity results from a phase 2/3 study (NCT04927065) comparing the Omicron-BA.1-containing bivalent vaccine mRNA-1273.214 (50-µg) to the 50-µg mRNA-1273 booster in adults who previously received the mRNA-1273 primary series (100-µg) and mRNA-1273 first booster (50-µg) dose. Primary endpoints were safety, non-inferiority of the neutralizing antibody (nAb) and seroresponse against Omicron BA.1, superiority of the nAb response against Omicron-BA.1, and non-inferiority of the nAb response against ancestral SARS-CoV-2 for second boosters of mRNA-1273.214 versus mRNA-1273 at days 29 and 91. The key secondary endpoint was the seroresponse difference of mRNA-1273.214 versus mRNA-1273 against ancestral SARS-CoV-2 at days 29 and day 91. Participants were sequentially enrolled and dosed with 50-µg of mRNA-1273 (n = 376) or mRNA-1273.214 (n = 437) as second booster doses. Here we present day 91 post-booster results. In participants with no pre-booster, severe acute respiratory syndrome coronavirus 2-infection (SARS-CoV-2), mRNA-1273.214 elicited Omicron-BA.1-nAb titers (95% confidence interval [CI]) that were significantly higher (964.4 [834.4-1114.7]) than those of mRNA-1273 (624.2 [533.1-730.9]) and similar to those of mRNA-1273 against ancestral SARS-CoV-2 at day 91. mRNA-1273.214 also induced higher binding antibody responses against Omicron BA.1 and alpha, gamma and delta variants than mRNA-1273. Safety profiles were similar for both vaccines. The Omicron-BA.1 bivalent vaccine improved antibody responses compared to mRNA-1273 through 90 days post-booster.
. 2023 Aug 23;14(1):5125.
doi: 10.1038/s41467-023-38892-w. Three-month antibody persistence of a bivalent Omicron-containing booster vaccine against COVID-19
Spyros Chalkias[SUP] 1 [/SUP], Charles Harper[SUP] 2 [/SUP], Keith Vrbicky[SUP] 2 [/SUP], Stephen R Walsh[SUP] 3 [/SUP], Brandon Essink[SUP] 4 [/SUP], Adam Brosz[SUP] 5 [/SUP], Nichole McGhee[SUP] 6 [/SUP], Joanne E Tomassini[SUP] 6 [/SUP], Xing Chen[SUP] 6 [/SUP], Ying Chang[SUP] 6 [/SUP], Andrea Sutherland[SUP] 6 [/SUP], David C Montefiori[SUP] 7 [/SUP], Bethany Girard[SUP] 6 [/SUP], Darin K Edwards[SUP] 6 [/SUP], Jing Feng[SUP] 6 [/SUP], Honghong Zhou[SUP] 6 [/SUP], Lindsey R Baden[SUP] 3 [/SUP], Jacqueline M Miller[SUP] 6 [/SUP], Rituparna Das[SUP] 6 [/SUP]
Affiliations
- PMID: 37612300
- DOI: 10.1038/s41467-023-38892-w
We previously presented day 29 interim safety and immunogenicity results from a phase 2/3 study (NCT04927065) comparing the Omicron-BA.1-containing bivalent vaccine mRNA-1273.214 (50-µg) to the 50-µg mRNA-1273 booster in adults who previously received the mRNA-1273 primary series (100-µg) and mRNA-1273 first booster (50-µg) dose. Primary endpoints were safety, non-inferiority of the neutralizing antibody (nAb) and seroresponse against Omicron BA.1, superiority of the nAb response against Omicron-BA.1, and non-inferiority of the nAb response against ancestral SARS-CoV-2 for second boosters of mRNA-1273.214 versus mRNA-1273 at days 29 and 91. The key secondary endpoint was the seroresponse difference of mRNA-1273.214 versus mRNA-1273 against ancestral SARS-CoV-2 at days 29 and day 91. Participants were sequentially enrolled and dosed with 50-µg of mRNA-1273 (n = 376) or mRNA-1273.214 (n = 437) as second booster doses. Here we present day 91 post-booster results. In participants with no pre-booster, severe acute respiratory syndrome coronavirus 2-infection (SARS-CoV-2), mRNA-1273.214 elicited Omicron-BA.1-nAb titers (95% confidence interval [CI]) that were significantly higher (964.4 [834.4-1114.7]) than those of mRNA-1273 (624.2 [533.1-730.9]) and similar to those of mRNA-1273 against ancestral SARS-CoV-2 at day 91. mRNA-1273.214 also induced higher binding antibody responses against Omicron BA.1 and alpha, gamma and delta variants than mRNA-1273. Safety profiles were similar for both vaccines. The Omicron-BA.1 bivalent vaccine improved antibody responses compared to mRNA-1273 through 90 days post-booster.