Immunogenicity Results
zoster, Zoster Vaccine
ZOSTER
Noninferiority of the humoral immune response to the gE and S antigens was demonstrated according to the protocol-specified criteria. For the PPS, the adjusted GMC ratio (Seq over Coad) was 1.01 (95% CI, .89–1.13) for anti-gE antibodies 1 month post-RZV2 (Analysis of Anti–Glycoprotein E Antibody Responses 1 Month After the Second Dose of Recombinant Zoster Vaccine When the First Dose Was Coadministered With an mRNA-1273 Booster Dose or Administered Sequentially 2 Weeks Later (Per-Protocol Set)Data in parentheses indicate the 95% confidence interval. The Seq group received the mRNA-1273 booster dose followed 2 weeks later by the first dose of recombinant zoster vaccine (RZV). The Coad group received coadministration of the mRNA-1273 booster and the first dose of RZV.Abbreviations: aGMC, adjusted geometric mean concentration ratio (Seq/Coad); GMC, geometric mean concentration of antibody; MGI, mean geometric increase, defined as the within-subject ratios of the postvaccination antibody concentration to the prevaccination (day 1) antibody concentration; mRNA-1273, Moderna's mRNA COVID-19 vaccine.Seropositivity is the percentage of participants whose anti–glycoprotein E (gE) antibody concentration is equal to or greater than the assay cutoff value (97 milli-international units [mIU]/mL).Vaccine response post–dose 2 is the percentage of participants who have at least a 4-fold greater anti-gE antibody concentration postdose compared to prevaccination for initially seropositive participants or compared to the antibody cutoff value (97 mIU/mL) for participants who are seronegative at prevaccination.Analysis of Anti-Spike Antibody Responses 1 Month After the mRNA-1273 Booster Dose When Coadministered With the First Dose of Recombinant Zoster Vaccine or When Administered Sequentially 2 Weeks Earlier (Per-Protocol Set)Data in parentheses indicate the 95% confidence interval. The Seq group received the mRNA-1273 booster dose followed 2 weeks later by the first dose of recombinant zoster vaccine (RZV). The Coad group received coadministration of the mRNA-1273 booster and the first dose of RZV.Abbreviations: aGMC, adjusted geometric mean concentration ratio (Seq/Coad); GMC, geometric mean concentration of antibody; MGI, mean geometric increase, defined as the within-subject ratios of the postvaccination antibody concentration to the prevaccination (day 1) antibody concentration; mRNA-1273, Moderna's mRNA COVID-19 vaccine.Two doses of RZV induced robust antibody responses in all age groups and in both study groups (One month post–mRNA-1273 booster, the MGI in anti-S antibodies was 18.7 (95% CI, 15.2–22.9) in the Seq group and 16.6 (95% CI, 13.7–20.0) in the Coad group (