A Randomized Trial Comparing Omicron-Containing Boosters with the Original Covid-19 Vaccine mRNA-1273

Lee, Ivan T.; Cosgrove, Catherine; Moore, Patrick; Bethune, Claire; Nally, Rhiannon; Bula, Marcin; Kalra, Philip A.; Clark, Rebecca A.; Dargan, Paul I.; Boffito, Marta; Sheridan, Ray; Moran, Ed; Darton, Thomas C.; Burns, Fiona; Saralaya, Dinesh; Duncan, Christopher; Lillie, Patrick; Ramos, Alberto San Francisco; Galiza, Eva; Heath, Paul T.; Chalkias, Spyros; Girard, Bethany; Parker, George; Rust, Dondi; Mehta, Shraddha; Windt, Elizabeth de; Sutherland, Andrea; Tomassini, Joanne E.; Dutko, Frank J.; Deng, Weiping; Chen, Xing; Tracy, LaRee; Zhou, Honghong; Millier, Jacqueline M.; Das, Rituparna

doi:10.1101/2023.01.24.23284869

Cited by 8 publications

(12 citation statements)

References 18 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…As of March 2023, 20 studies were identified for the systematic review (Figure 1) [15,16,[22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39]. A total of nine studies investigated the effectiveness of a BA.5-containing BV, five studies explored a BA.1-containing BV, and two studies examined a BA.1-or BA.5-containing BV (Table 1).…”

Section: A Flowchart Of the Systematic Reviewmentioning

confidence: 99%

See 2 more Smart Citations

The Effectiveness of Bivalent COVID-19 Vaccination: A Preliminary Report

Chen,

Lin,

Chi

et al. 2023

Life

View full text Add to dashboard Cite

Vaccination has been a game-changer in the long battle against COVID-19. However, waning vaccine-induced immunity and the immune evasion of emerging variants create challenges. The rapid-fire development of bivalent vaccines (BVs), comprising ancestral strains and a new variant, was authorized to prevent COVID-19, but the effectiveness of the updated vaccines remains largely unclear. Electronic databases were searched to investigate the immunogenicity and reactogenicity of BVs in humans. As of March 2023, 20 trials were identified. Compared with monovalent vaccination, the induced immunogenicity against ancestral strains was similar. The BVs demonstrated approximately 33–50% higher immunogenicity values against additional variant strains. An observational cohort study showed the additional clinical effectiveness of the BVs. The adverse events were similar. In conclusion, our systematic review found that the BVs had equal immunogenicity against ancestral strains without safety concerns. Approximately 33–50% increased additional antibody titers and clinical effectiveness against additional variant strains were observed in subjects with a BV vaccine with moderate heterogeneity, especially for BA.1-containing BVs.

show abstract

Section: A Flowchart Of the Systematic Reviewmentioning

confidence: 99%

“…Figure 2. Forest plot of the geometric titer against ancestral strains of bivalent and monovalent vaccines[15,16,25,[27][28][29]34,36].…”

mentioning

confidence: 99%

See 1 more Smart Citation

The Effectiveness of Bivalent COVID-19 Vaccination: A Preliminary Report

Chen,

Lin,

Chi

et al. 2023

Life

View full text Add to dashboard Cite

show abstract

“…Our study was not designed to assess vaccine effectiveness (VE). Though recent data suggest possibly higher VE against Omicron subvariants with bivalent vaccine boosts (Prototype + Omicron BA.4/5, Prototype + Omicron BA.1) compared with the Prototype vaccine, 18 , 39 our findings highlight concerns that variant vaccines are unlikely to keep pace with virus evolution and that other immune correlates of protection beyond antibody responses need to be explored.…”

Section: Discussionmentioning

confidence: 58%

Bivalent and Monovalent SARS-CoV-2 Variant Vaccine Boosters Improve coverage of the known Antigenic Landscape: Results of the COVID-19 Variant Immunologic Landscape (COVAIL) Trial

Branche

Rouphael

Diemert

et al. 2023

Preprint

View full text Add to dashboard Cite

Vaccine protection against COVID-19 wanes over time and has been impacted by the emergence of new variants with increasing escape of neutralization. The COVID-19 Variant Immunologic Landscape (COVAIL) randomized clinical trial (clinicaltrials.gov NCT 05289037) compares the breadth, magnitude and durability of antibody responses induced by a second COVID-19 vaccine boost with mRNA (Moderna mRNA-1273 and Pfizer-BioNTech BNT162b2), or adjuvanted recombinant protein (Sanofi CoV2 preS DTM-AS03) monovalent or bivalent vaccine candidates targeting ancestral and variant SARS-CoV-2 spike antigens (Beta, Delta and Omicron BA.1). We found that boosting with a variant strain is not associated with loss in neutralization against the ancestral strain. However, while variant vaccines compared to the prototype/wildtype vaccines demonstrated higher neutralizing activity against Omicron BA.1 and BA.4/5 subvariants for up to 3 months after vaccination, neutralizing activity was lower for more recent Omicron subvariants. Our study, incorporating both antigenic distances and serologic landscapes, can provide a framework for objectively guiding decisions for future vaccine updates.

show abstract

“…Recent data from a large, phase 3, randomized trial in the United Kingdom support these recommendations, wherein the efficacy, immunogenicity, and safety of a booster dose of the original mRNA-based COVID-19 vaccine (mRNA-1273) or variant-containing omicron (BA.1) booster vaccines (mRNA-1273.529 or mRNA-1273.214) administered after any COVID-19 primary vaccination schedule (primarily BNT162b2 or ChAdOx1-SARS-CoV-2 vaccines) were compared. 3 Overall, all mRNA-based vaccine booster regimens induced robust immune responses against omicron BA.1, with COVID-19 incidence numerically lower for the BA.1-containing vaccines than the original vaccine. These data highlight the utility of a heterologous booster regimen for continued protection against COVID-19.…”

mentioning

confidence: 92%