Table 3.
Changes in anti-RBD antibodies concentrations and NT50 response between visits (intra-group) and study groups (inter-group); mITT population.
| Control group (n=27) (BNT162b2) |
Test group (n= 90) (CVnCoV & BNT162b2) |
Inter-group comparisons |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Absolute intragroup change |
Absolute intragroup change |
||||||||||
| n | Mean (SD) | Median (IQR) | ZW | n | Mean (SD) | Median (IQR) | ZW | WW | Z | p -value | |
| SARS-CoV-2 anti-RBD (BAU/mL) | |||||||||||
| Visit 2 - Visit 1 | 26 | 54·8 (74·1) | 29·4 (14·1-47·4) | 4·46 (p <0·00001) | 90 | ≥ 8267·3 (4202·0) | 8911·1 (≥ 4235·9-12413·4) | 8·24 (p <0·00001) | 377 | -7·57 | <0·00001 |
| Visit 3 - Visit 1 | 22 | 2516·8 (1985·8) | 1858·6 (915·0-38919·6) | 4·11 (p<0·00001) | 86 | ≥ 10953·3 (2444·3) | 12317·4 (≥ 9374·0-12465·5) | 8·05 (p <0·00001) | 287 | -6·96 | <0·00001 |
| Visit 3 - Visit 2 | 21 | 2405·2 (1969·6) | 1643·9 (890·6-3566·9) | 4·02 (p <0·00001) | 86 | ≥ 2642·8 (3301·4) | 347 (≥ 0-4766·9) | 6·26 (p <0·00001) | 1309 | 1·41 | <0·1615 |
| NT50 _ G614 | |||||||||||
| Visit 2 - Visit 1 | 26 | 107·1 (154·9) | 47·0 (0-107·1) | 4·15 (p<0·00001) | 90 | 3572·1 (3452·7) | 2567 (1755·4-3981·0) | 7·94 (p<0·00001) | 392 | -7·48 | <0·00001 |
| Visit 3 - Visit 1 | 22 | 1154·9 (75438) | 834·4 (509·1-1592·0) | 4·11 (p<0·00001) | 86 | 4363·7 (5911·7) | 2523·5 (1737·0-5456·0) | 7·75 (p<0·00001) | 554 | -4·92 | <0·00001 |
| Visit 3 - Visit 2 | 21 | 1025·7 (706·7) | 810·6 (469·1-1510·1) | 4·02 (p<0·00001) | 86 | 745·8 (5175·4) | 34·0 (-704·0-1280·0) | 0·80 (p=0·4282) | 1497 | 2·85 | 0·0039 |
| NT50 _ Delta | |||||||||||
| Visit 2 - Visit 1 | 26 | 185·8 (358·9) | 23·6 (0-236·1) | 3·66 (p=0·0001) | 90 | 3180·0 (4523·6) | 1822·0 (996·0-2966·0) | 8·24 (p<0·00001) | 474 | -6·94 | <0·00001 |
| Visit 3 - Visit 1 | 22 | 803·3 (920·7) | 490·8 (219·5-1065·0) | 4·11 (p<0·00001) | 86 | 3643·8 (4743·9) | 2236·2 (1089·0-3950·0) | 8·05 (p<0·00001) | 541 | -5·02 | <0·00001 |
| Visit 3 - Visit 2 | 21 | 586·9 (930·1) | 364 (151·0-1192·4) | 3·77 (p=0·0001) | 86 | 410·6 (5243·0) | 233·5 (-686·0-880·0) | 1·38 (p=0·1704) | 1263 | 1·01 | 0·3159 |
| NT50 _ Beta | |||||||||||
| Visit 2 - Visit 1 | 26 | 10·1 (26·1) | 0 (0-0) | 2·00 (p=0·1250) | 90 | 1413·3 (1389·5) | 1069·0 (456·5-2003·3) | 8·06 (p<0·00001) | 387 | -7·53 | <0·00001 |
| Visit 3 - Visit 1 | 22 | 174·3 (196·1) | 108·7 (34·3-256·3) | 4·06 (p<0·00001) | 86 | 1649·4 (1642·6) | 1114·5 (548·8-2223·5) | 7·88 (p<0·00001) | 367 | -6·35 | <0·00001 |
| Visit 3 - Visit 2 | 21 | 157·9 (200·5) | 105·8 (32·6-149·5) | 3·83 (p<0·00001) | 86 | 230·9 (1426·1) | 28·6 (-455·0-511·2) | 0·93 (p=0·3552) | 1239 | 0·82 | 0·4152 |
| NT50 _ Mu | |||||||||||
| Visit2 - Visit 1 | 26 | 12·1 (30·3) | 0 (0-0) | 2·23 (p=0·0625) | 90 | 1550·0 (1514·5) | 1165·5 (551·1-1979·0) | 8·24 (p<0·00001) | 374·5 | -7·62 | <0·00001 |
| Visit 3 - visit 1 | 22 | 253·9 (282·6) | 141·6 (92·7-353·2) | 4·09 (p<0·00001) | 86 | 1837·4 (1821·5) | 1387·0 (535·4-2251·0) | 7·93 (p<0·00001) | 409 | -6·03 | <0·00001 |
| Visit 3 - visit 2 | 21 | 234·9 (291·21) | 128·2 (73·59-267·1) | 3·93 (p<0·00001) | 86 | 278·24 (1365·87) | 166·7 (-338·8-542·0) | 1·96 (p=0·0497) | 1187 | 0·42 | 0·6826 |
| NT50 _ Omicron | |||||||||||
| Visit2 - Visit 1 | 26 | 1·8 (9·2) | 0 (0-0) | 1·0 (p=0·3173) | 90 | 833·3 (955·8) | 489·1 (270·9-1238·0) | 8·11 (p<0·00001) | 393 | -7·21 | <0·00001 |
| Visit 3 - Visit 1 | 22 | 81·8 (107·2) | 38·8 (0-103·1) | 3·72 (p=0·0001) | 86 | 1086·4 (1394·1) | 554·25 (289·4-1408·0) | 7·86 (p<0·00001) | 398 | -6·11 | <0·00001 |
| Visit 3 - Visit 2 | 21 | 82·5 (111·4) | 37·7 (0-99·7) | 3·59 (p=0·0001) | 86 | 233·5 (846·0) | 63·26 (-163·0-323·9) | 2·12 (p=0·0337) | 1079 | 0·07 | 0·9442 |
mITT: modified intention-to-treat; SD: standard deviation; IQR: interquartile range; IC: confidence interval; NT50: 50% neutralising antibody titre; WMW = Mann Whitney U test. WW= Wilcoxon W test. ZW= Wilcoxon signed-rank test.