Table 2 Primary immunogenicity analysis of Omicron BA.4/BA.5 and ancestral SARS-CoV-2 (D614G) after 50 µg of mRNA-1273.222 and mRNA-1273 administered as second booster doses in participants with no prior SARS-CoV-2 infection

From: Original SARS-CoV-2 monovalent and Omicron BA.4/BA.5 bivalent COVID-19 mRNA vaccines: phase 2/3 trial interim results

 

Ancestral SARS-CoV-2 (D614G)

Omicron BA.4/BA.5

50 µg mRNA-1273.222 booster dose

50 μg mRNA-1273 booster dose

50 µg mRNA-1273.222 booster dose

50 μg mRNA-1273 booster dose

 

N = 209

N = 259

N = 209

N = 259

Prebooster na

209

259

209

259

   Observed GMT (95% CI)b

796.9 (678.7–935.8)

1,515.4 (1347.5–1704.2)

87.9 (72.2–107.1)

136.1 (116.3–159.3)

Day 29, na

209

259

209

259

   Observed GMT (95% CI)b

7,322.4 (6,386.2–8,395.7)

5,651.4 (5055.7–6317.3)

2,324.6 (1,921.2–2,812.7)

488.5 (427.4–558.4)

   GMFR (95% CI)b

9.2 (7.9–10.6)

3.7 (3.4–4.1)

26.4 (22.0–31.9)

3.6 (3.3–4.0)

   Estimated GMT (95% CI)c

9,555.8 (8,593.6–10,625.7)

4,882.2 (4,457.7–5,347.1)

2,747.3 (2,399.2–3,145.9)

436.7 (389.1–490.0)

   GMR (95% CI)c,d

1.96 (1.70–2.25)

6.29 (5.27–7.51)e

Day 29 SRR, injection 1, n/N1, %f

209/209, 100

259/259, 100

205/209, 98.1

222/257, 86.4

   (95% CI)

(98.3–100.0)

(98.6–100.0)

(95.2–99.5)

(81.6–90.3)

   Difference (95% CI)d,g

0

12.1 (6.9–17.3)

Day 29 SRR, prebooster, n/N1, %f

168/209, 80.4

111/259, 42.9

190/209, 90.9

98/259, 37.8

   (95% CI)

(74.3–85.5)

(36.7–49.1)

(86.2–94.4)

(31.9–44.0)

   Difference (95% CI)d,g

37.3 (29.0–45.6)

53.9 (46.7–61.2)

  1. Antibody values assessed by pseudovirus neutralizing antibody assay reported as below the LLOQ (18.5 for ancestral SARS-CoV-2 (D614G) and 36.7 for Omicron BA.4/BA.5) are replaced by 0.5 × LLOQ. Values greater than ULOQ (45,118 for ancestral SARS-CoV-2 (D614G) and 13,705 for Omicron BA.4/BA.5) are replaced by the ULOQ if actual values are not available. Includes participants with no prior SARS-CoV-2 infection, primary analysis set.
  2. N1 = Number of participants with nonmissing data at baseline (prebooster) and the corresponding post baseline timepoint.
  3. aNumber of participants with nonmissing data at the timepoint (prebooster baseline or post baseline).
  4. bGMT, GM FR of nAb at day 29 post baseline timepoint over predose day 1 with corresponding 95% CI based on the t-distribution of log-transformed values or difference in the log-transformed values for GMT value and GMT fold-rise, respectively, then back-transformed to the original scale.
  5. 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 prebooster titers. The resulting least squares (LS) means, difference of LS means and 95% CI are back-transformed to the original scale.
  6. d95% CI was calculated by stratified Miettinen–Nurminen method adjusted by age group.
  7. eExceeded noninferiority criteria and met superiority criteria including lower bound CI > 1 and testing sequence.
  8. fSeroresponse at a participant level defined as a change from <LLOQ to ≥4 × LLOQ, or at least a fourfold rise if baseline (preinjection 1/prebooster is ≥LLOQ; comparison to preinjection 1/prebooster baselines as indicated. Percentages were based on the number of participants with nonmissing data at baseline and the corresponding timepoint, 95% CI was calculated using the Clopper–Pearson method.
  9. gThe SRR difference is a calculated common risk difference using inverse-variance stratum weights and the middle point of Miettinen–Nurminen confidence limits of each one of the stratum risk differences. The stratified Miettinen–Nurminen estimate and the CI cannot be calculated when the SRR in both groups is 100%, absolute difference is reported.
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