Table 1 Baseline and Day 29 antibody marker GMT or GMC level by case/non-case strata and by vaccine and placebo in the Day 29 case-cohort set for RSV-LRTD-2+
From: Immune correlates analysis of mRNA-1345 RSV vaccine efficacy clinical trial
Immunologic marker | Treatment group or ratio of GM | Cases GMC or GMT (95% CI) | Non-cases GMC or GMT (95% CI) | Ratio of GM (cases/non-cases) (95% CI) | |||||
|---|---|---|---|---|---|---|---|---|---|
n | Baseline | Day 29 | n | Baseline | Day 29 | Baseline | Day 29 | ||
RSV-A nAb (IU/mL) | mRNA-1345 | 44 | 1014 (757, 1358) | 13,900 (10,216, 18,913) | 1516 | 2231 (2040, 2441) | 19,429 (17,655, 21,381) | 0.5 (0.3, 0.6) | 0.7 (0.5, 1.0) |
Placebo | 114 | 1303 (1117, 1520) | 1292 (1110, 1504) | 385 | 1950 (1636, 2325) | 2061 (1729, 2456) | 0.7 (0.5, 0.8) | 0.6 (0.5, 0.8) | |
Ratio of GM (mRNA-1345/Placebo) (95% CI) | 0.8 (0.6, 1.1) | 10.8 (7.6, 15.2) | 1.1 (0.9, 1.4) | 9.4 (7.7, 11.5) | |||||
RSV-B nAb (IU/mL) | mRNA-1345 | 44 | 627 (474, 830) | 3996 (2883, 5539) | 1516 | 1250 (1143, 1367) | 6568 (5993, 7198) | 0.5 (0.4, 0.7) | 0.6 (0.4, 0.9) |
Placebo | 114 | 716 (596, 860) | 733 (606, 887) | 385 | 1091 (941, 1266) | 1143 (972, 1343) | 0.7 (0.5, 0.8) | 0.6 (0.5, 0.8) | |
Ratio of GM (mRNA-1345/Placebo) (95% CI) | 0.9 (0.6, 1.2) | 5.5 (3.7, 8.0) | 1.1 (1.0, 1.4) | 5.7 (4.8, 6.9) | |||||
RSV preF IgG bAb (AU/mL) | mRNA-1345 | 44 | 5827 (4613, 7360) | 57,822 (46,888, 71,306) | 1516 | 9509 (8932, 10,123) | 76,735 (71,768, 82,046) | 0.6 (0.5, 0.8) | 0.8 (0.6, 0.9) |
Placebo | 114 | 7041 (6153, 8057) | 6853 (6024, 7796) | 385 | 8747 (7776, 9839) | 9316 (8220, 10,558) | 0.8 (0.7, 1.0) | 0.7 (0.6, 0.9) | |
Ratio of GM (mRNA-1345/Placebo) (95% CI) | 0.8 (0.6, 1.1) | 8.4 (6.6, 10.8) | 1.1 (1.0, 1.2) | 8.2 (7.1, 9.5) | |||||
RSV postF IgG bAb (AU/mL) | mRNA-1345 | 44 | 8652 (6796, 11,015) | 60,649 (44,774, 82,153) | 1516 | 12,885 (11,988, 13,848) | 78,222 (72,339, 84,584) | 0.7 (0.5, 0.9) | 0.8 (0.6, 1.1) |
Placebo | 114 | 10,326 (8887, 11,998) | 10,185 (8758, 11,844) | 385 | 12,405 (10,859, 14,170) | 13,165 (11,493, 15,080) | 0.8 (0.7, 1.0) | 0.8 (0.6, 0.9) | |
Ratio of GM (mRNA-1345/Placebo) (95% CI) | 0.8 (0.6, 1.1) | 6.0 (4.2, 8.4) | 1.0 (0.9, 1.2) | 5.9 (5.1, 6.9) | |||||
