tetano
Editor, Senior Moderator
J Infect Dis
. 2024 Feb 13:jiae067.
doi: 10.1093/infdis/jiae067. Online ahead of print. Interim report of the reactogenicity and immunogenicity of SARS-CoV-2 XBB-containing vaccines
Spyros Chalkias[SUP] 1 [/SUP], Nichole McGhee[SUP] 1 [/SUP], Jordan L Whatley[SUP] 2 [/SUP], Brandon Essink[SUP] 3 [/SUP], Adam Brosz[SUP] 4 [/SUP], Joanne E Tomassini[SUP] 1 [/SUP], Bethany Girard[SUP] 1 [/SUP], Darin K Edwards[SUP] 1 [/SUP], Kai Wu[SUP] 1 [/SUP], Arshan Nasir[SUP] 1 [/SUP], Diana Lee[SUP] 1 [/SUP], Laura E Avena[SUP] 1 [/SUP], Jing Feng[SUP] 1 [/SUP], Weiping Deng[SUP] 1 [/SUP], David C Montefiori[SUP] 5 [/SUP], Lindsey R Baden[SUP] 6 [/SUP], Jacqueline M Miller[SUP] 1 [/SUP], Rituparna Das[SUP] 1 [/SUP]
Affiliations
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 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 5th doses to adults who previously received a primary series, a 3rd dose of an original mRNA COVID-19 vaccine, and a 4th dose of an Omicron BA.4/BA.5 bivalent vaccine. Interim safety and immunogenicity results 29 days post-vaccination are reported.
Results: Participants (randomized 1:1) received 50-µg mRNA-1273.815(n=50) or mRNA-1273.231(n=51); median (interquartile range) months from the prior BA.4/BA.5-bivalent dose were 8.2 (8.1-8.3) and 8.3 (8.1-8.4), respectively. Neutralizing antibody (nAb) increased from pre-booster levels against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants tested. Day 29 nAb fold-increases from pre-booster 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 and D614G. The 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 (n=20) subset, 15 days post-vaccination. Reactogenicity was similar to previously reported mRNA-1273 original and bivalent 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 sequence selection for the 2023-2024 COVID-19 vaccine update.
Keywords: BA.2.86; COVID-19; EG.5.1; HK.3.1; HV.1; JN 1; Omicron; SARS-CoV-2 variants; XBB.1.5; immune response; mRNA vaccine; neutralizing antibody.
. 2024 Feb 13:jiae067.
doi: 10.1093/infdis/jiae067. Online ahead of print. Interim report of the reactogenicity and immunogenicity of SARS-CoV-2 XBB-containing vaccines
Spyros Chalkias[SUP] 1 [/SUP], Nichole McGhee[SUP] 1 [/SUP], Jordan L Whatley[SUP] 2 [/SUP], Brandon Essink[SUP] 3 [/SUP], Adam Brosz[SUP] 4 [/SUP], Joanne E Tomassini[SUP] 1 [/SUP], Bethany Girard[SUP] 1 [/SUP], Darin K Edwards[SUP] 1 [/SUP], Kai Wu[SUP] 1 [/SUP], Arshan Nasir[SUP] 1 [/SUP], Diana Lee[SUP] 1 [/SUP], Laura E Avena[SUP] 1 [/SUP], Jing Feng[SUP] 1 [/SUP], Weiping Deng[SUP] 1 [/SUP], David C Montefiori[SUP] 5 [/SUP], Lindsey R Baden[SUP] 6 [/SUP], Jacqueline M Miller[SUP] 1 [/SUP], Rituparna Das[SUP] 1 [/SUP]
Affiliations
- PMID: 38349280
- DOI: 10.1093/infdis/jiae067
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 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 5th doses to adults who previously received a primary series, a 3rd dose of an original mRNA COVID-19 vaccine, and a 4th dose of an Omicron BA.4/BA.5 bivalent vaccine. Interim safety and immunogenicity results 29 days post-vaccination are reported.
Results: Participants (randomized 1:1) received 50-µg mRNA-1273.815(n=50) or mRNA-1273.231(n=51); median (interquartile range) months from the prior BA.4/BA.5-bivalent dose were 8.2 (8.1-8.3) and 8.3 (8.1-8.4), respectively. Neutralizing antibody (nAb) increased from pre-booster levels against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants tested. Day 29 nAb fold-increases from pre-booster 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 and D614G. The 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 (n=20) subset, 15 days post-vaccination. Reactogenicity was similar to previously reported mRNA-1273 original and bivalent 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 sequence selection for the 2023-2024 COVID-19 vaccine update.
Keywords: BA.2.86; COVID-19; EG.5.1; HK.3.1; HV.1; JN 1; Omicron; SARS-CoV-2 variants; XBB.1.5; immune response; mRNA vaccine; neutralizing antibody.