Three-month Antibody Persistence of a Bivalent Omicron-containing Booster Vaccine Against COVID-19

Chalkias, Spyros; Harper, Charles; Vrbicky, Keith; Walsh, Stephen R.; Essink, Brandon; Brosz, Adam; McGhee, Nicole; Tomassini, Joanne E.; Chen, Xing; Chang, Ying; Sutherland, Andrea; Montefiori, David C.; Girard, Bethany; Edwards, Darin K.; Feng, Jing; Zhou, Honghong; Baden, Lindsey R.; Miller, Jacqueline M.; Das, Rituparna

doi:10.21203/rs.3.rs-2239682/v1

Cited by 25 publications

(29 citation statements)

References 11 publications

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“…5,[9][10][11][12] The BA.1 bivalent vaccine was well-tolerated and increased the magnitude and the durability of the neutralizing antibody responses against BA.1 compared to the original booster mRNA-1273. 5,6 Additionally, mRNA-1273.214 exhibited cross-neutralization ability against omicron BA.4/BA.5, BA.2.75 and other variants. 5,6 An omicron BA.4/BA.5 bivalent booster (mRNA-1273.222) has been authorized in the United States and elsewhere for the fall 2022 immunization campaign.…”

Section: Introductionmentioning

confidence: 96%

“…5,6 Additionally, mRNA-1273.214 exhibited cross-neutralization ability against omicron BA.4/BA.5, BA.2.75 and other variants. 5,6 An omicron BA.4/BA.5 bivalent booster (mRNA-1273.222) has been authorized in the United States and elsewhere for the fall 2022 immunization campaign. 13 Early effectiveness data demonstrate that recipients of an omicron-containing bivalent booster have improved protection against Covid-19 relative to immunization with the original mRNA-1273 vaccine only.…”

Section: Introductionmentioning

confidence: 96%

“…Booster immunization against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) improves immune responses and vaccine effectiveness against coronavirus disease 2019 (Covid- 19). [1][2][3][4][5][6][7][8] The emergence of antigenically-divergent omicron variants required variant-targeting immunization strategies and we previously evaluated the safety and immunogenicity of an omicron BA.1-containing bivalent booster (mRNA-1273.214) that has been deployed in multiple geographies. 5,[9][10][11][12] The BA.1 bivalent vaccine was well-tolerated and increased the magnitude and the durability of the neutralizing antibody responses against BA.1 compared to the original booster mRNA-1273.…”

Section: Introductionmentioning

confidence: 99%

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Safety and Immunogenicity of Omicron BA.4/BA.5 Bivalent Vaccine Against Covid-19

Chalkias

Whatley

Eder

et al. 2022

Preprint

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Background Information on the safety and immunogenicity of the omicron BA.4/BA.5-containing bivalent booster mRNA-1273.222 are needed. Methods In this ongoing, phase 2/3 trial, 50-μg mRNA-1273.222 (25-μg each ancestral Wuhan-Hu-1 and omicron BA.4/BA.5 spike mRNAs) is compared to 50-μg mRNA-1273, administered as second boosters in adults who previously received a 2-injection (100-μg) primary series and first booster (50-μg) dose of mRNA-1273. The primary objectives were safety and immunogenicity 28 days post-boost. Results Participants received 50-μg of mRNA-1273 (n=376) or mRNA-1273.222 (n=511) as second booster doses. Omicron BA.4/BA.5 and ancestral SARS-CoV-2 D614G neutralizing antibody geometric mean titers (GMTs [95% confidence interval]) after mRNA-1273.222 (2324.6 [1921.2-2812.7] and 7322.4 [6386.2-8395.7]) were significantly higher than mRNA-1273 (488.5 [427.4-558.4] and 5651.4 (5055.7-6317.3) respectively, at day 29 post-boost in participants with no prior SARS-CoV-2-infection. A randomly selected subgroup (N=60) of participants in the mRNA-1273.222 group also exhibited cross-neutralization against the emerging omicron variants BQ.1.1 and XBB.1. No new safety concerns were identified with mRNA-1273.222. Vaccine effectiveness was not assessed in this study; in an exploratory analysis 1.6% of mRNA-1273.222 recipients had Covid-19 post-boost. Conclusion The bivalent omicron BA.4/BA.5-containing vaccine mRNA-1273.222 elicited superior neutralizing antibody responses against BA.4/BA.5 compared to mRNA-1273, with no safety concerns identified.

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Section: Introductionmentioning

confidence: 96%

Section: Introductionmentioning

confidence: 96%

Section: Introductionmentioning

confidence: 99%

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Safety and Immunogenicity of Omicron BA.4/BA.5 Bivalent Vaccine Against Covid-19

Chalkias

Whatley

Eder

et al. 2022

Preprint

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“…To this end, S-specific antibodies and T-cells will be measured and compared on day 7 and 28 post boost. Clinical trials involving bivalent vaccines thus far only measured neutralizing antibodies at day 28 after the booster ( 15 , 22 ). The analysis of the response at day 7 has two advantages: i) rapid recall responses after vaccination could be a proxy for recall upon infection, indicative of whether booster vaccinations are required or not, and ii) early immunogenicity evaluation can accelerate the interpretation of future studies.…”

Section: Outcomementioning

confidence: 99%

“…Bivalent vaccines that contain both the ancestral S protein, to boost previously induced immune responses, and the Omicron BA.1 or BA.5 S protein, to specifically boost antibodies recognizing viruses from the Omicron sub-lineage, have been designed for that reason. A study on one bivalent vaccine reported superiority in the induction of neutralizing antibodies to omicron sub-lineage variant BA.1 compared to the previously approved monovalent vaccine ( 15 ). Although the seasonality of SARS-CoV-2 outbreaks has not been determined yet and varies across different climates, more frequent surges have been observed in colder months ( 16 ).…”

Section: Introductionmentioning

confidence: 99%

Analyzing the immunogenicity of bivalent booster vaccinations in healthcare workers: The SWITCH ON trial protocol

et al. 2022

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Vaccination against coronavirus disease 2019 (COVID-19) has contributed greatly to providing protection against severe disease, thereby reducing hospital admissions and deaths. Several studies have reported reduction in vaccine effectiveness over time against the Omicron sub-lineages. However, the willingness to receive regular booster doses in the general population is declining. To determine the need for repeated booster vaccinations in healthy individuals and to aid policymakers in future public health interventions for COVID-19, we aim to gain insight into the immunogenicity of the additional bivalent booster vaccination in a representative sample of the healthy Dutch population. The SWITCH ON study was initiated to investigate three main topics: i) immunogenicity of bivalent vaccines after priming with adenovirus- or mRNA-based vaccines, ii) immunological recall responses and reactivity with relevant variants after booster vaccination, and iii) the necessity of booster vaccinations for the healthy population in the future.Clinical trial registrationhttps://clinicaltrials.gov/, identifier NCT05471440.

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Infection and Vaccine Induced Spike Antibody Responses Against SARS-CoV-2 Variants of Concern in COVID-19-Naïve Children and Adults

et al. 2023

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Although a more efficient adaptive humoral immune response has been proposed to underlie the usually favorable outcome of pediatric COVID-19, the breadth of viral and vaccine cross-reactivity toward the ever-mutating Spike protein among variants of concern (VOCs) has not yet been compared between children and adults. We assessed antibodies to conformational Spike in COVID-19-naïve children and adults vaccinated by BNT162b2 and ChAdOx1, and naturally infected with SARS-CoV-2 Early Clade, Delta, and Omicron. Sera were analyzed against Spike including naturally occurring VOCs Alpha, Beta, Gamma, Delta, and Omicron BA.1, BA.2, BA.5, BQ.1.1, BA2.75.2, and XBB.1, and variants of interest Epsilon, Kappa, Eta, D.2, and artificial mutant Spikes. There was no notable difference between breadth and longevity of antibody against VOCs in children and adults. Vaccinated individuals displayed similar immunoreactivity profiles across variants compared with naturally infected individuals. Delta-infected patients had an enhanced cross-reactivity toward Delta and earlier VOCs compared to patients infected by Early Clade SARS-CoV-2. Although Omicron BA.1, BA.2, BA.5, BQ.1.1, BA2.75.2, and XBB.1 antibody titers were generated after Omicron infection, cross-reactive binding against Omicron subvariants was reduced across all infection, immunization, and age groups. Some mutations, such as 498R and 501Y, epistatically combined to enhance cross-reactive binding, but could not fully compensate for antibody-evasive mutations within the Omicron subvariants tested. Our results reveal important molecular features central to the generation of high antibody titers and broad immunoreactivity that should be considered in future vaccine design and global serosurveillance in the context of limited vaccine boosters available to the pediatric population.

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Three-month Antibody Persistence of a Bivalent Omicron-containing Booster Vaccine Against COVID-19

Cited by 25 publications

References 11 publications

Safety and Immunogenicity of Omicron BA.4/BA.5 Bivalent Vaccine Against Covid-19

Safety and Immunogenicity of Omicron BA.4/BA.5 Bivalent Vaccine Against Covid-19

Analyzing the immunogenicity of bivalent booster vaccinations in healthcare workers: The SWITCH ON trial protocol

Infection and Vaccine Induced Spike Antibody Responses Against SARS-CoV-2 Variants of Concern in COVID-19-Naïve Children and Adults

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