Table 2 Non-inferiority of SII-NVX-CoV2373 heterologous booster to homologous booster in terms for Anti-S IgG and neutralizing antibodies at Visit 2-Day 29 - Per Protocol Population.

From: A Phase 3, randomized, non-inferiority study of a heterologous booster dose of SARS CoV-2 recombinant spike protein vaccine in adults

 

ChAdOx1 nCoV-19 Prime Cohort

BBV152 prime cohort

SII-NVX-CoV2373

(N = 92)

ChAdOx1 nCoV-19

(N = 93)

SII-NVX-CoV2373

(N = 91)

BBV152

(N = 93)

Anti-S IgG

GMEU [1] with 95% CI

65,550.37

(58,155.85, 73,885.11)

31,945.42

(28,366.25, 35,976.20)

65,155.31

(56,348.14, 75,339.04)

12,719.72

(11,063.37, 14,624.05)

GMEU Ratio (GMR) [1] with 95% CI

2.05 (1.73, 2.43)

5.12 (4.20, 6.24)

Seroresponse

n (%)

95% CI

80 (86.96)

(78.32, 93.07)

35 (37.63)

(27.79, 48.28)

86 (94.51)

(87.64, 98.19)

19 (20.43)

(12.77, 30.05)

Difference in Proportions 95% CI

49.32 (36.49, 60.45)

74.08 (63.24, 82.17)

Neutralizing antibodies

GMT [1]

95% Confidence Interval

3883.22

(3363.26, 4483.56)

2050.29

(1777.55, 2364.88)

2654.90

(2221.75, 3172.49)

553.59

(466.46, 657.00)

GMT Ratio (GMR) [1]

95% Confidence Interval

1.89 (1.55, 2.32)

4.80 (3.76, 6.12)

Seroresponse

n (%)

95% CI

87 (94.57)

(87.77, 98.21)

74 (79.57)

(69.95, 87.23)

90 (98.90)

(94.03, 99.97)

69 (74.19)

(64.08, 82.71)

Difference in Proportions 95% CI

15.00 (5.65, 25.05)

24.71 (16.26, 34.62)

  1. LS least squares, GMT geometric mean titer, GMR geometric mean ratio.
  2. [1] ANCOVA results, LS Mean and it's 95% CI values by treatment were used to generate the GMEU/GMT and 95% CI and the differences in LS Means and corresponding 95% CI limits were used to obtain GMEU/GMT Ratio and 95% CI using back transforming to the original scale.
  3. ANCOVA model includes vaccine group, log baseline titer, age, sex, duration between first and second dose of the prime vaccine, duration between second dose of the prime vaccine to booster dose of the study vaccine.
  4. The 95% CIs for seroresponse for each vaccine group were calculated by using the Clopper-Pearson method.
  5. Estimate of difference in proportion along with associated 95% CI was obtained using Miettinen and Nurminen method.