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Dynamic Monitoring of Seroconversion using a Multianalyte Immunobead Assay for Covid-19
Published on: February 16, 2022
Three-month antibody persistence of a bivalent Omicron-containing booster vaccine against COVID-19
Spyros Chalkias1, Charles Harper2, Keith Vrbicky2
1Moderna, Inc., Cambridge, MA, USA. spyros.chalkias@modernatx.com.
Abstract:
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.
Insights
The Omicron-BA.1 bivalent vaccine (mRNA-1273.214) showed superior neutralizing antibody responses against Omicron BA.1 compared to the original mRNA-1273 vaccine. Both vaccines demonstrated similar safety profiles 91 days post-booster.
Area of Science:
- Vaccinology
- Immunology
- Virology
Background:
- The emergence of SARS-CoV-2 variants like Omicron necessitates updated vaccine formulations.
- Previous studies evaluated the safety and immunogenicity of bivalent vaccines against SARS-CoV-2 variants.
Purpose of the Study:
- To compare the safety and immunogenicity of an Omicron-BA.1-containing bivalent vaccine (mRNA-1273.214) with the original mRNA-1273 vaccine as a second booster.
- To assess antibody responses against Omicron BA.1 and ancestral SARS-CoV-2 at 91 days post-vaccination.
Main Methods:
- A Phase 2/3 study (NCT04927065) involving adults who received primary series and a first booster of mRNA-1273.
- Participants received a second booster of either mRNA-1273 (50-µg) or mRNA-1273.214 (50-µg).
- Safety and immunogenicity, including neutralizing antibody (nAb) titers and seroresponse, were measured at days 29 and 91.
Main Results:
- mRNA-1273.214 elicited significantly higher Omicron-BA.1 nAb titers compared to mRNA-1273 at day 91 (964.4 vs. 624.2).
- Antibody responses against ancestral SARS-CoV-2 were similar between the two vaccines at day 91.
- mRNA-1273.214 also induced higher binding antibody responses against Omicron BA.1 and other variants (alpha, gamma, delta).
- Safety profiles were comparable for both vaccine groups.
Conclusions:
- The Omicron-BA.1 bivalent vaccine (mRNA-1273.214) offers improved antibody responses against Omicron BA.1 compared to the original mRNA-1273 vaccine.
- The bivalent vaccine maintains a similar safety profile to the original vaccine.
- These findings support the use of bivalent vaccines for enhanced protection against circulating SARS-CoV-2 variants.
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