Table 1.
Immunogenicity analysis of ancestral SARS-CoV-2 (D614G) and Omicron BA.1 after 50 µg of mRNA-1273.214 and mRNA-1273 administered as second booster doses in participants with no prior SARS-CoV-2 infection
| Ancestral SARS-CoV-2 (D614G) | Omicron BA.1 | |||
|---|---|---|---|---|
| 50 µg mRNA-1273.214 booster dose | 50 µg mRNA-1273 booster dose | 50 µg mRNA-1273.214 booster dose | 50 µg mRNA-1273 booster dose | |
| N = 335 | N = 259 | N = 335 | N = 259 | |
| Pre-booster, na | 335 | 259 | 335 | 259 |
| Observed GMT (95% CI)b |
1265.9 (1119.9 to 1431.0) |
1515.4 (1347.5 to 1704.2) |
297.6 (258.4 to 342.8) |
329.5 (280.0 to 387.9) |
| Day 29, na | 335 | 259 | 335 | 259 |
| Observed GMT (95% CI)b |
5968.1 (5315.4 to 6700.9) |
5651.4 (5055.7 to 6317.3) |
2366.6 (2066.2 to 2710.7) |
1468.7 (1266.2 to 1703.6) |
| GMFR (95% CI)b | 4.7 (4.4 to 5.1) | 3.7 (3.4 to 4.1) | 8.0 (7.2 to 8.8) | 4.5 (4.0 to 5.0) |
| Estimated GMT (95% CI)c |
6406.1 (5975.5 to 6867.8) |
5291.1 (4890.5 to 5724.5) |
2469.7 (2255.5 to 2704.3) |
1419.1 (1280.8 to 1572.3) |
| GMR (97.5% CI)c | 1.21 (1.07 to 1.37) | 1.74 (1.49 to 2.04)g | ||
| Day 91, na | 328 | 243 | 324 | 243 |
| Observed GMT (95% CI)b |
3428.3 (3062.7 to 3837.6) |
3447.1 (3054.7 to 3889.9) |
964.4 (834.4 to 1114.7) |
624.2 (533.1 to 730.9) |
| GMFR (95% CI)b | 2.7 (2.5 to 2.9) | 2.3 (2.2 to 2.5) | 3.2 (2.8 to 3.6) | 1.9 (1.7 to 2.1) |
| Estimated GMT (95% CI)c |
3595.6 (3334.8 to 3876.8) |
3257.3 (2986.3 to 3552.9) |
997.5 (898.4 to 1107.4) |
602.7 (534.7 to 679.4) |
| GMR (97.5% CI)c | 1.10 (0.97 to 1.26) | 1.66 (1.38 to 1.99)g | ||
| Day 29 SRR, n/N1 %d | 335/335, 100 | 259/259, 100 | 334/334, 100 | 255/257, 99.2 |
| (95% CI)e | (98.9 to 100) | (98.6 to 100) | (98.9 to 100) | (97.2 to 99.9) |
| Difference, % (97.5% CI)f | 0 | 1.5 (−1.1 to 4.1) | ||
| Day 91 SRR, n/N1 %d | 328/328, 100 | 242/243, 99.6 | 318/323, 98.5 | 232/241, 96.3 |
| (95% CI)e | (98.9 to 100.0) | (97.7 to 100.0) | (96.4 to 99.5) | (93.0 to 98.3) |
| Difference, % (97.5% CI)f | 0.9 (−1.6 to 3.5) | 2.1 (−1.6 to 5.8) | ||
Unadjusted observed antibody values assessed by pseudovirus neutralizing antibody assay reported as below the LLOQ (18.5 for ancestral [D614G] and 19.9 for Omicron BA.1) are replaced by 0.5 × LLOQ. Values greater than ULOQ (45,118 for ancestral SARS-CoV-2 [D614G] and 15,502.7) for Omicron BA.1 are replaced by the ULOQ if actual values are not available. Includes participants in the per-protocol immunogenicity set without evidence of pre-booster SARS-CoV-2 infection (PPIS-negative). Participant immune response data is censored at the last date of study participation (study discontinuation, study completion, or death), non-study COVID-19 vaccination date, or data cutoff/extraction date, whichever is the earliest.
ANCOVA analysis of covariance, CI confidence interval, GMT geometric mean titer, GMFR geometric mean fold rise (days 29 and 91 post-baseline timepoint over pre-booster baseline), GMR geometric mean ratio, mRNA-1273.214 versus mRNA-1273, LLOQ lower limit of quantification, LS least squares, SRR seroresponse rate, ULOQ upper limit of quantification.
aNumber of participants with non-missing data at the timepoint (baseline or post-baseline). Estimated GMTs from an ANCOVA model, adjusted for covariates were used for assessments of differences in antibody responses (GMRs, SRRs).
b95% CI based on the t-distribution of log-transformed values or difference in the log-transformed values for GMT value and GMFR, respectively, then back transformed to the original scale.
cLog-transformed antibody levels are analyzed using an ANCOVA model with the treatment variable as fixed effect, adjusting for age group (<65, ≥65 years) and pre-booster titers. The resulting LS means, difference of LS means, and 95% CI and 97.5% CI are back transformed to the original scale.
dSeroresponse at a participant level based on pre-injection 1 baseline, defined as a change from <LLOQ to ≥4 × LLOQ, or at least a fourfold rise if baseline is ≥LLOQ; comparison to pre-vaccination baseline for participants without pre-injection 1 antibody titer information who had a corresponding day 29 post-boost assessment and negative SARS-CoV-2 status at pre-injection 1 of the primary series, seroresponse was defined as ≥4 x LLOQ and antibody titers were imputed as <LLOQ at pre-injection 1 of the primary series. For participants who were without SARS-CoV-2 status information at pre-injection 1 of primary series, their pre-booster SARS-CoV-2 status was used to impute their SARS-CoV-2 status at their pre-injection 1 of the primary series. Percentages were based on the number of participants with non-missing data at baseline and the corresponding time point.
e95% CI is calculated using the Clopper–Pearson method.
f97.5% CI was calculated by stratified Miettinen–Nurminen method adjusted by age group. The stratified Miettinen–Nurminen estimate and the CI cannot be calculated when the seroresponse rate in both groups is 100%, absolute difference is reported.
gExceeded non-inferiority criteria and met superiority criteria including lower bound CI > 1 and testing sequence.