Immunogenicity and safety of DS-5670d, an mRNA-based COVID-19 vaccine targeting omicron XBB.1.5: Results from a phase 3, randomized, active-controlled study in adults and children aged ≥12 years DOI Creative Commons
Ami Kawamoto, Masaki Hashida,

Katsuyasu Ishida

и другие.

medRxiv (Cold Spring Harbor Laboratory), Год журнала: 2024, Номер unknown

Опубликована: Ноя. 15, 2024

Abstract Background Many people worldwide have now acquired immune responses against the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) following previous vaccination and/or infection. As a result, national programs are implementing simplified schedule of single-dose administration and seasonal boosters. In this phase 3 non-inferiority study, we assessed immunogenicity safety single dose lipid nanoparticle-messenger ribonucleic acid vaccine DS-5670d, monovalent composition for 2023/24 season, containing an omicron XBB.1.5-derived antigen. Methods Findings Adults children aged ≥12 years were stratified according to their history both prior SARS-CoV-2 infection plus coronavirus disease 2019 (COVID-19) (subpopulation A), only B), C), or no either D), randomly assigned (1:1) receive DS-5670d BNT162b2 XBB.1.5. combined ABC subpopulations (DS-5670d, n = 362 vs BNT162b2, 363), adjusted geometric mean titer ratio blood neutralizing activity (omicron XBB.1.5) was 1.218 (95% confidence interval [CI], 1.059, 1.401) seroresponse rates 87.3% (DS-5670d) 82.9% (BNT162b2) with difference 4.5% CI, –0.70, 9.71). Both results exceeded prespecified margins study met primary endpoint. Immunogenicity data in overall ABCD population also criteria. There apparent differences age sex, analyses suggested that even unvaccinated persons achieved adequate response DS-5670d. major incidence severity adverse events between groups. Conclusions A immunogenically non-inferior acceptably safe without vaccination. Trial Registration Japan Registry Clinical Trials (jRCT2031230424) Author summary Why done? The global emergency pandemic is being superseded by annual immunization using updated reduce burden associated newly emerging variants. We conducted comparative two authorized compositions antigen derived from XBB.1.5, which recommended season. intended assess compared Japanese adults years. What did researchers do find? who had received vaccination, previously COVID-19, both, terms rates, not influenced sex. Among persons, those been exposed DS-5670d; however, group exposure at all too small properly evaluate. frequency groups, there DS-5670d-related serious events. these findings mean? has already widely administered Japan. new critical concerns suggesting it could be useful option. Taken together, studies evaluating other DS-5670, i.e., antigens different strains SARS-CoV-2, provide corroborating evidence DS-5670 platform can applied produce effective vaccines future strains.

Язык: Английский

Transformative Approaches in SARS-CoV-2 Management: Vaccines, Therapeutics and Future Direction DOI
Ankita Saha,

Shweta Choudhary,

Priyanshu Walia

и другие.

Virology, Год журнала: 2025, Номер 604, С. 110394 - 110394

Опубликована: Янв. 11, 2025

Язык: Английский

Процитировано

1
Immunogenicity and safety of DS-5670d, an mRNA-based COVID-19 vaccine targeting omicron XBB.1.5: Results from a phase 3, randomized, active-controlled study in adults and children aged ≥12 years DOI Creative Commons
Ami Kawamoto, Masaki Hashida,

Katsuyasu Ishida

и другие.

medRxiv (Cold Spring Harbor Laboratory), Год журнала: 2024, Номер unknown

Опубликована: Ноя. 15, 2024

Abstract Background Many people worldwide have now acquired immune responses against the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) following previous vaccination and/or infection. As a result, national programs are implementing simplified schedule of single-dose administration and seasonal boosters. In this phase 3 non-inferiority study, we assessed immunogenicity safety single dose lipid nanoparticle-messenger ribonucleic acid vaccine DS-5670d, monovalent composition for 2023/24 season, containing an omicron XBB.1.5-derived antigen. Methods Findings Adults children aged ≥12 years were stratified according to their history both prior SARS-CoV-2 infection plus coronavirus disease 2019 (COVID-19) (subpopulation A), only B), C), or no either D), randomly assigned (1:1) receive DS-5670d BNT162b2 XBB.1.5. combined ABC subpopulations (DS-5670d, n = 362 vs BNT162b2, 363), adjusted geometric mean titer ratio blood neutralizing activity (omicron XBB.1.5) was 1.218 (95% confidence interval [CI], 1.059, 1.401) seroresponse rates 87.3% (DS-5670d) 82.9% (BNT162b2) with difference 4.5% CI, –0.70, 9.71). Both results exceeded prespecified margins study met primary endpoint. Immunogenicity data in overall ABCD population also criteria. There apparent differences age sex, analyses suggested that even unvaccinated persons achieved adequate response DS-5670d. major incidence severity adverse events between groups. Conclusions A immunogenically non-inferior acceptably safe without vaccination. Trial Registration Japan Registry Clinical Trials (jRCT2031230424) Author summary Why done? The global emergency pandemic is being superseded by annual immunization using updated reduce burden associated newly emerging variants. We conducted comparative two authorized compositions antigen derived from XBB.1.5, which recommended season. intended assess compared Japanese adults years. What did researchers do find? who had received vaccination, previously COVID-19, both, terms rates, not influenced sex. Among persons, those been exposed DS-5670d; however, group exposure at all too small properly evaluate. frequency groups, there DS-5670d-related serious events. these findings mean? has already widely administered Japan. new critical concerns suggesting it could be useful option. Taken together, studies evaluating other DS-5670, i.e., antigens different strains SARS-CoV-2, provide corroborating evidence DS-5670 platform can applied produce effective vaccines future strains.

Язык: Английский

Процитировано

0