Table 2 Geometric mean SARS-CoV-2 neutralizing titers (GMT with 95% CI) against ancestral strain at Days 0 (baseline) and Day 56, 8 weeks after the booster dose. Data were shown for all participants and according to baseline serostatus (<10; ≥10; ≤100; & >100)

From: Effect of heterologous intranasal iNCOVACC® vaccination as a booster to two-dose intramuscular Covid-19 vaccination series: a randomized phase 3 clinical trial

Primary EUA vaccine

Covaxin-primed

Covishield-primed

Booster vaccine

  

Group 1 intranasal BBV154

Group 2 covaxin

Group 3 intranasal BBV154

Group 4 covaxin

Group 5 covishield

A: Group-wise data (GMT with 95% CI, at Days 0 and 56) shown from all participants

All Subjects

Day 0

N =

249

125

249

125

125

 

GMT$ (95% CI)

289·6 (204·8, 409·5)

388·7 (243·8, 619·5)

372·2 (270·2, 512·8)

320·9 (185·1, 556·3)

451·6 (289·7, 703·8)

Day 56

N =

244

121

248

124

123

 

GMT (95% CI)

564·1 (479·1, 664·1)

578·1 (436·9, 764·9)

655·5 (533·3, 805·8)

625·4 (474·7, 824·0)

650·1 (519·7, 813·1)

#p value Day 0 vs Day 56

0.883

0.222

0.125

0.284

0.205

B: Group-wise data are shown below are the baseline titers based on serostatus the three categories (<10; ≥10 & ≤100; and >100 PRNT50).

<10 PRNT50*

Day 0

N =

21

9

16

13

7

 

GMT (95%CI)

0·09 (0·09, 0·09)

0.09 (0.09,0.09)

0.09 (0.09,0.09)

0.09 (0.09,0.09)

0.09 (0.09,0.09)

Day 56

N =

21

9

16

13

7

 

GMT (95% CI)

486·3 (381·5, 620·0)

185·8 (19·1,1810.4)

284·5 (72·4, 1118.2)

293·1 (65·0, 1321.8)

352·1 (189·1, 655·4)

#p value Day 0 vs Day 56

<0.001

0.014

0.001

0.003

0.022

≥10 & ≤100 PRNT50 *

Day 0

N =

25

10

27

8

12

 

GMT (95% CI)

32.4 (23.9,43.9)

53.9 (34.3,84.9)

38.2 (29.4,49.6)

26.7 (13.9,51.3)

44.8 30.4,66.1)

Day 56

N =

23

10

27

8

12

 

GMT (95% CI)

509.8 (324.9,799.9)

502.6 (312.3,808.9)

502.5 (310.5,813.2)

406.4 (177.9,928.6)

572.3 (423.3,773.7)

#p value Day 0 vs Day 56

<0.001

0.002

<0.001

0.008

<0.001

>100 PRNT50 *

Day 0

N =

203

106

206

104

106

 

GMT (95% CI)

874·8 (773·7, 989·1)

953·1 (788·7, 1151.8)

957·8 (839·4,1093.0)

1079.8 (874·2, 1333.9)

1029.6 (830·3, 1276.7)

Day 56

N =

199

102

204

103

104

 

GMT (95% CI)

587·4 (485·3, 711·1)

647·8 (490·3, 855·9)

731·0 (586·5, 911·1)

711·6 (539·8, 938·1)

687·5 (530·4, 891·2)

#p value Day 0 vs Day 56

0.014

0.010

0.728

0.013

0.016

  1. *Baseline titer (PRNT50); $GMT - Geometric Mean Titer
  2. #p value is calculated by Mann–Whitney U-test (paired)
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