Table 2 RBD-specific IgG response results (PPS)

From: Immunogenicity and safety of NVSI-06-07 as a heterologous booster after priming with BBIBP-CorV: a phase 2 trial

 

14 days after boosting

28 days after boosting

 

NVSI-06-07

BBIBP-CorV

P value

NVSI-06-07

BBIBP-CorV

P value

1–3 months

N (missing)

267 (0)

270 (0)

 

255 (0)

247 (0)

 

Pre-booster antibody GMCa (95%CI)

110.14 (93.50, 129.74)

109.50 (94.24, 127.24)

0.9591

106.64 (90.17, 126.10)

106.30 (90.89, 124.33)

0.9785

Post-booster antibody GMC (95%CI)

4780.76 (4106.48, 5565.76)

301.71 (274.96, 331.07)

 

3304.37 (2870.60, 3803.68)

254.79 (231.81, 280.04)

 

Post-booster adjusted antibody GMC (95%CI)

4776.34 (4255.49, 5360.94)

301.99 (269.23, 338.73)

 

3302.54 (2974.17, 3667.17)

254.93 (229.20, 283.55)

 

Ratio of adjusted GMC between two groups (95%CI)b

15.82 (13.44, 18.61)

 

<0.0001c

12.95 (11.16, 15.04)

 

<0.0001c

Rate of seroconversiond, n (%)

249 (93.26)

64 (23.70)

 

237 (92.94)

54 (21.86)

 

95%CI (%)

89.55, 95.96

18.76, 29.24

 

89.07, 95.76

16.87, 27.54

 

Rate difference between two groups (%, 95%CI)e

69.55 (63.66,75.45)

 

<0.0001

71.08 (65.04,77.12)

 

<0.0001

Post-booster antibody GMC fold rise (95%CI)

43.41 (36.54, 51.56)

2.76(2.39, 3.17)

<0.0001

30.99 (26.47, 36.27)

2.40 (2.09, 2.75)

<0.0001

4–6 months

N (missing)

279 (0)

290 (0)

 

249 (0)

250 (0)

 

Pre-booster antibody GMCa (95%CI)

152.16 (127.35, 181.81)

170.87 (142.36, 205.09)

0.3714

150.77 (124.60, 182.44)

185.48 (152.36, 225.80)

0.1370

Post-booster antibody GMC (95%CI)

6798.51 (5985.06, 7722.52)

448.93 (401.59, 501.84)

 

4925.67 (4361.44, 5562.89)

364.90 (324.38, 410.49)

 

Post-booster adjusted antibody GMC (95%CI)

6901.42 (6174.88, 7713.43)

442.48 (396.75, 493.49)

 

5074.81 (4564.26, 5642.48)

354.22 (318.65, 393.76)

 

Ratio of adjusted GMC between two groups (95%CI)b

15.60 (13.35, 18.23)

 

<0.0001c

14.33 (12.33, 16.64)

 

<0.0001c

Rate of seroconversiond, n (%)

252 (90.32)

73 (25.17)

 

223 (89.56)

44 (17.60)

 

95%CI (%)

86.23, 93.53

20.28, 30.58

 

85.08, 93.06

13.09, 22.90

 

Rate difference between two groups (%, 95%CI)e

65.15 (59.07,71.23)

 

<0.0001

71.96 (65.90,78.02)

 

<0.0001

Post-booster antibody GMC fold rise (95%CI)

44.68 (36.79, 54.26)

2.63 (2.26, 3.06)

<0.0001

32.67 (26.94, 39.62)

1.97 (1.69, 2.29)

<0.0001

≥6 months

N (missing)

281 (0)

285 (0)

 

241 (0)

251 (0)

 

Pre-booster antibody GMCa (95%CI)

104.94 (82.03, 134.24)

125.99 (98.29, 161.50)

0.3039

114.54 (88.18, 148.78)

132.80 (102.75, 171.63)

0.4268

Post-booster antibody GMC (95%CI)

6039.76 (5238.91, 6963.03)

593.53 (519.22, 678.47)

 

4774.32 (4157.08, 5483.21)

473.53 (410.98, 545.60)

 

Post-booster adjusted antibody GMC (95%CI)

6148.08 (5399.43, 7000.53)

583.21 (512.67, 663.47)

 

4846.54 (4249.18, 5527.88)

466.76 (410.31, 530.97)

 

Ratio of adjusted GMC between two groups (95%CI)b

10.54 (8.78, 12.66)

 

<0.0001c

10.38 (8.64, 12.48)

 

<0.0001c

Rate of seroconversiond, n (%)

241 (85.77)

103 (36.14)

 

203 (84.23)

74 (29.48)

 

95%CI (%)

81.12, 89.63

30.56, 42.01

 

79.01, 88.59

23.91, 35.54

 

Rate difference between two groups (%, 95%CI)e

49.62 (42.71, 56.54)

 

<0.0001

54.75 (47.47, 62.03)

 

<0.0001

Post-booster antibody GMC fold rise (95%CI)

57.56 (44.72, 74.07)

4.71 (3.77, 5.89)

<0.0001

41.68 (32.05, 54.22)

3.57 (2.84, 4.48)

<0.0001

  1. aGMC represents geometric mean concentration, and the unit of GMC is BAU/ml
  2. bThe ratio of adjusted GMC between two groups was calculated by “NVSI-06-07/ BBIBP-CorV”
  3. cCovariance analysis with least square method was used to calculate the adjusted GMC and P value
  4. dSeroconversion was defined as more than or equal to 4-fold rise form baseline in IgG concentration
  5. eRate difference = (NVSI-06-07) − (BBIBP-CorV). Rate difference and 95%CI were estimated by CMH method considering stratification factors
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