Table 2.
Type of AE | SARS-CoV-2 Antibody Assay | Participants with AEs after 1st Dose | p-Value | Participants with AEs after 2nd Dose | p-Value | |||
---|---|---|---|---|---|---|---|---|
No | Yes | No | Yes | |||||
Any local AE | Anti-S IgG (U/mL) | T1 | N = 3 | N = 174 | 0.332 | |||
274.92 (48.00–1575.07) | 176.77 (157.65–198.20) | |||||||
T2 | N = 3 | N = 168 | 0.394 | N = 7 | N = 164 | 0.658 | ||
3435.58 (1395.40–8460.58) | 4428.94 (4096.38–4788.51) | 4054.15 | 4424.86 (4090.72–4787.40) | |||||
ND50 | T1 | N = 2 | N = 98 | 0.66 | ||||
652.38 (0.001–534195223) | 476.87 (391.29–581.17) | |||||||
T2 | N = 2 | N = 98 | 0.938 | N = 1 | N = 99 | 0.967 | ||
2962.78 (24.46–358921.93) | 2849.71 (2474.00–3282.46) | 2934.95 | 2851.02 (2477.42–3434.79) | |||||
Injection site pain | Anti-S IgG (U/mL) | T1 | N = 7 | N = 170 | 0.263 | |||
244.74 (145.64–411.24) | 175.75 (156.42–197.51) | |||||||
T2 | N = 7 | N = 164 | 0.765 | N = 10 | N = 161 | 0.836 | ||
4166.77 (3113.15–5576-99) | 4419.77 (4081.31–4787.40) | 4267.76 (3067.61–5937.45) | 4418.76 (4078.50–4786.30) | |||||
ND50 | T1 | N = 4 | N = 96 | 0.373 | ||||
310.89 (44.33–2184.74) | 488.65 (400.50–596.21) | |||||||
T2 | N = 4 | N = 96 | 0.957 | N = 2 | N = 98 | 0.912 | ||
2798.98 (1629.67–4807.29) | 2854.30 (2470.59–3296.86) | 3011.62 (2171.20–4177.34) | 2848.39 (2472.29–3282.46) | |||||
Injection site redness/ swelling | Anti-S IgG (U/mL) | T1 | N = 150 | N = 27 | 0.206 | |||
181.97 (159.81–207.25) | 157.91 (131.46–189.71) | |||||||
T2 | N = 144 | N = 27 | 0.762 | N = 133 | N = 38 | 0.213 | ||
4432.00 (4088.96–4807.29) | 4290.42 (3377.54–5450.04) | 4296.35 (3946.39–4676.27) | 4830.59 (4018.83–5804.97) | |||||
ND50 | T1 | N = 80 | N = 20 | 0.454 | ||||
462.38 (367.45–581.70) | 557.06 (382.65–810.96) | |||||||
T2 | N = 80 | N = 20 | 0.664 | N = 75 | N = 25 | 0.153 | ||
2808.67 (2386.16–3305.98) | 3031.80 (2329.16–3947.30) | 3022.04 (2569.21–3553.86) | 2397.18 (1818.86–3158.64) | |||||
Injection site motion limitation | Anti-S IgG (U/mL) | T1 | N = 19 | N = 158 | 0.758 | |||
187.46 (131.95–266.32) | 177.01 (156.82–199.76) | |||||||
T2 | N = 19 | N = 152 | 0.138 | N = 19 | N = 152 | 0.535 | ||
3743.69 (3111.72–4504.02) | 4500.91 (4140.00–4892.15) | 4116.23 (3269.64–5183.22) | 4447.34 (4095.43–4829.48) | |||||
ND50 | T1 | N = 8 | N = 92 | 0.696 | ||||
420.53 (154.06–1147.63) | 485.51 (396.64–594.16) | |||||||
T2 | N = 8 | N = 92 | 0.919 | N = 4 | N = 96 | 0.891 | ||
2783.56 (1886.69–4105.82) | 2857.59 (2462.63–3316.65) | 2990.20 (659.63–13551.89) | 2846.43 (2472.86–3276.42) | |||||
Any systemic AE | Anti-S IgG (U/mL) | T1 | N = 22 | N = 155 | 0.769 | |||
186.29 (132.65–261.64) | 176.97 (156.71–199.80) | |||||||
T2 | N = 22 | N = 149 | 0.758 | N = 8 | N = 163 | 0.46 | ||
4273.66 (3506.71–5208.35) | 4429.96 (4071.93–4819.48) | 3869.90 (2622.41–5710.84) | 4438.13 (4099.21–4803.97) | |||||
ND50 | T1 | N = 12 | N = 88 | 0.417 | ||||
385.57 (175.15–848.79) | 494.42 (403.92–605.34) | |||||||
T2 | N = 12 | N = 88 | 0.06 | N = 2 | N = 98 | 0.912 | ||
1998.02 (1256.90–3176.14) | 2993.64 (2588.81–3461.78) | 3011.62 (2171.20–4177.34) | 2848.39 (2472.29–3282.46) | |||||
Fever (≥37.5 °C) | Anti-S IgG (U/mL) | T1 | N = 139 | N = 38 | 0.764 | |||
179.72 (157.58–204.97) | 172.31 (137.09–216.52) | |||||||
T2 | N = 136 | N = 35 | 0.056 | N = 46 | N = 125 | 0.056 | ||
4245.22 (3900.32–4621.68) | 5108.58 (4259.91–6124.91) | 3899.42 (3316.65–4584.58) | 4613.18 (4228.63–5032.69) | |||||
ND50 | T1 | N = 79 | N = 21 | 0.227 | ||||
451.13 (360.08–565.20) | 605.62 (400.50–916.01) | |||||||
T2 | N = 79 | N = 21 | 0.866 | N = 22 | N = 78 | 0.842 | ||
2834.00 (2414.90–3326.60) | 2918.77 (2162.72–3939.13) | 2777.15 (2071.57–3723.92) | 2873.43 (2445.68–3375.20) | |||||
Chills | Anti-S IgG (U/mL) | T1 | N = 140 | N = 37 | 0.309 | |||
183.53 (161.36–208.74) | 158.93 (124.17–203.38) | |||||||
T2 | N = 137 | N = 34 | 0.658 | N = 50 | N = 121 | 0.117 | ||
4371.19 (4002.21–4775.29) | 4565.62 (3885.08–5365.37) | 4008.67 (3434.00–4679.51) | 4586.70 (4197.59–5011.87) | |||||
ND50 | T1 | N = 79 | N = 21 | 0.267 | ||||
453.42 (362.41–567.28) | 594.43 (387.61–911.59) | |||||||
T2 | N = 79 | N = 21 | 0.698 | N = 24 | N = 76 | 0.731 | ||
2811.90 (2407.13–3284.73) | 3007.46 (2148.33–4210.17) | 2731.49 (2128.63–3505.10) | 2890.68 (2444.56–3419.01) | |||||
Headache | Anti-S IgG (U/mL) | T1 | N = 121 | N = 56 | 0.266 | |||
170.49 (148.15–196.25) | 195.66 (161.18–237.52) | |||||||
T2 | N = 117 | N = 54 | 0.034 | N = 51 | N = 120 | 0.212 | ||
4168.69 (3796.65–4577.20) | 4979.66 (4353.11–5696.39) | 4091.66 (3483.37–4805.07) | 4551.98 (4173.50–4964.78) | |||||
ND50 | T1 | N = 72 | N = 28 | 0.399 | ||||
455.41 (358.53–581.70) | 549.16 (396.10–761.20) | |||||||
T2 | N = 72 | N = 28 | 0.399 | N = 25 | N = 75 | 0.99 | ||
2747.89 (2329.7–3241.90) | 3136.90 (2395.52–4106.77) | 2847.08 (2099.91–3861.00) | 2852.99 (2433.32–3345.80) | |||||
Muscle pain | Anti-S IgG (U/mL) | T1 | N = 47 | N = 130 | 0.401 | |||
193.02 (160.10–232.65) | 172.98 (150.42–198.93) | |||||||
T2 | N = 46 | N = 125 | 0.676 | N = 30 | N = 141 | 0.958 | ||
4308.24 (3837.96–4837.27) | 4447.34 (4035.52–4901.17) | 4425.88 (3809.78–5141.62) | 4405.55 (4032.74–4813.93) | |||||
ND50 | T1 | N = 26 | N = 74 | 0.162 | ||||
379.75 (237.41–607.30) | 521.07 (421.50–644.17) | |||||||
T2 | N = 26 | N = 74 | 0.018 | N = 9 | N = 91 | 0.949 | ||
2159.73 (1715.54–2718.94) | 3144.13 (2661.95–3713.64) | 2870.12 (2396.07–3438.75) | 2849.71 (2447.37–3318.18) | |||||
Fatigue | Anti-S IgG (U/mL) | T1 | N = 73 | N = 104 | 0.576 | |||
185.05 (157.80–217.02) | 173.34 (147.84–203.24) | |||||||
T2 | N = 72 | N = 99 | 0.593 | N = 37 | N = 134 | 0.885 | ||
4519.60 (4017.91–5082.76) | 4331.12 (3905.71–4803.97) | 4362.14 (3634.96–5234.80) | 4422.83 (4058.82–4818.37) | |||||
ND50 | T1 | N = 39 | N = 61 | 0.902 | ||||
472.61 (356.78–626.04) | 484.62 (368.81–636.94) | |||||||
T2 | N = 39 | N = 61 | 0.69 | N = 18 | N = 82 | 0.868 | ||
2752.96 (2195.84–3452.23) | 2916.76 (2433.88–3494.62) | 2780.99 (1957.49–3951.85) | 2867.48 (2456.97–3346.57) | |||||
Joint pain | Anti-S IgG (U/mL) | T1 | N = 160 | N = 17 | 0.46 | |||
175.63 (155.52–198.34) | 202.91 (147.84–278.48) | |||||||
T2 | N = 155 | N = 16 | 0.298 | N = 126 | N = 45 | 0.481 | ||
4352.11 (4015.13–4717.37) | 5004.95 (3778.33–6629.79) | 4337.11 (3948.21–4765.41) | 4617.43 (4045.76–5271.08) | |||||
ND50 | T1 | N = 92 | N = 8 | 0.352 | ||||
466.98 (380.72–572.80) | 657.05 (277.27–1557.04) | |||||||
T2 | N = 92 | N = 8 | 0.886 | N = 72 | N = 28 | 0.639 | ||
2843.15 (2456.97–3290.03) | 2951.89 (1661.50–5243.24) | 2793.83 (2365.92–3298.37) | 3006.77 (2298.79–3932.78) | |||||
Vomiting | Anti-S IgG (U/mL) | T1 | N = 174 | N = 3 | 0.267 | |||
179.60 (160.10–201.42) | 109.42 (43.590 274.73) | |||||||
T2 | N = 168 | N = 3 | 0.646 | N = 155 | N = 16 | 0.386 | ||
4419.77 (4086.96–4779.69) | 3853.90 (2535.71–5858.68) | 4457.59 (4105.82–4839.49) | 3967.35 (3168.11–4967.07) | |||||
ND50 | T1 | N = 98 | N = 2 | 0.649 | ||||
476.87 (390.30–582.51) | 659.02 (97.54–4451.43) | |||||||
T2 | N = 98 | N = 2 | 0.321 | N = 90 | N = 10 | 0.549 | ||
2880.71 (2506.11–3310.55) | 1748.24 (0.07–41409501) | 2811.90 (2426.61–3258.37) | 3236.68 (1976.97–5299.07) | |||||
Rash | Anti-S IgG (U/mL) | T1 | N = 164 | N = 13 | 0.872 | |||
178.57 (158.60–201.00) | 172.31 (110.71–268.16) | |||||||
T2 | N = 158 | N = 13 | 0.688 | N = 160 | N = 11 | 0.548 | ||
4428.94 (4099.21–4786.30) | 4173.50 (2720.19–6404.72) | 4382.28 (4045.76–4746.79) | 4822.81 (3450.64–6742.17) | |||||
ND50 | T1 | N = 92 | N = 8 | 0.16 | ||||
460.57 (375.06–565.46) | 770.19 (365.76–1622.18) | |||||||
T2 | N = 92 | N = 8 | 0.558 | N = 91 | N = 9 | 0.516 | ||
2886.69 (2494.59–3340.41) | 2479.70 (1410.26–4360.14) | 2893.34 (2490.00–3362.02) | 2465.47 (1758.73–3455.41) |
Data are presented as geometric mean titers (95% confidence interval). AE, adverse event; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; IgG, immunoglobulin G; ND50, median neutralizing titer.