Association of Reactogenicity with Immunogenicity of the ChAdOx1 nCoV-19 Vaccine in Patients Undergoing Hemodialysis
Abstract
:1. Introduction
2. Methods
2.1. Study Design and Participants
2.2. Reactogenicity Assessments
2.3. Immunogenicity Assessments
2.4. Exposure and Outcome
2.5. Statistical Analysis
3. Results
3.1. Baseline Participant Characteristics
3.2. Reactogenicity
3.3. Immunogenicity
3.4. Primary Outcome
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Variables | All (n = 206) | Nonresponders (n = 68) | Responders (n = 138) | p Value |
---|---|---|---|---|
Demographic data | ||||
Age (year) | 66.9 ± 12.5 | 72.5 ± 10.9 | 64.1 ± 12.4 | <0.001 |
Male sex, n (%) | 104 (50.5%) | 37 (54.4%) | 67 (48.6%) | 0.429 |
Smoking history, n (%) | 39 (18.9%) | 15 (22.1%) | 24 (17.4%) | 0.421 |
Dialysis vintage (year) | 8.4 ± 5.8 | 9.3 ± 6.6 | 7.9 ± 5.3 | 0.102 |
Kt/V | 1.7 ± 0.3 | 1.7 ± 0.3 | 1.7 ± 0.2 | 0.391 |
URR (%) | 75.9 ± 5.4 | 76.2 ± 6.7 | 75.8 ± 4.7 | 0.618 |
nPCR (g/kg/day) | 1.07 (0.92–1.24) | 1.05 (0.91–1.16) | 1.09 (0.93–1.27) | 0.106 |
Body mass index (kg/m2) | 23.4 ± 3.8 | 22.6 ± 4.1 | 23.8 ± 3.6 | 0.032 |
Diabetes mellitus, n (%) | 112 (54.4%) | 42 (61.8%) | 70 (50.7%) | 0.135 |
Hypertension, n (%) | 186 (90.3%) | 62 (91.2%) | 124 (89.9%) | 0.763 |
CAD, n (%) | 52 (25.2%) | 27 (39.7%) | 25 (18.1%) | 0.001 |
Stroke, n (%) | 8 (3.9%) | 4 (5.9%) | 4 (2.9%) | 0.297 |
Malignancy, n (%) | 24 (11.7%) | 10 (14.7%) | 14 (10.1%) | 0.337 |
Use of IS, n (%) | 5 (2.4%) | 4 (5.9%) | 1 (0.7%) | 0.024 |
Laboratory data | ||||
Albumin (g/dL) | 3.8 (3.6–4.0) | 3.7 (3.5–4.0) | 3.9 (3.7–4.0) | 0.073 |
Fasting glucose (mg/dL) | 143 (114–192) | 151 (125–201) | 138 (114–191) | 0.221 |
Lymphocyte (×109/L) | 1.1 (0.9–1.4) | 1.0 (0.7–1.2) | 1.2 (1.0–1.5) | <0.001 |
Hemoglobin (g/dL) | 10.4 (9.5–11.0) | 10.4 (9.3–11.2) | 10.4 (9.6–11.0) | 0.707 |
Ferritin (ng/mL) | 461 (250–644) | 443 (279–645) | 474 (225–644) | 0.868 |
Calcium (mg/dL) | 9.4 (8.8–10.0) | 9.4 (8.8–10.0) | 9.4 (8.9–10.1) | 0.432 |
Phosphate (mg/dL) | 4.4 (3.6–5.3) | 4.2 (3.6–5.6) | 4.5 (3.7–5.2) | 0.691 |
iPTH (pg/mL) | 326 (140–593) | 348 (126–600) | 326 (141–593) | 0.931 |
Variables | All (n = 206) | Nonresponders (n = 68) | Responders (n = 138) | p Value |
---|---|---|---|---|
Any local reaction, n (%) | 80 (38.8%) | 18 (26.5%) | 62 (44.9%) | 0.011 |
Pain, n (%) | 77 (37.4%) | 18 (26.5%)) | 59 (42.8%) | 0.023 |
Redness, n (%) | 19 (9.2%) | 4 (5.9%) | 15 (10.9%) | 0.245 |
Swelling, n (%) | 25 (12.1%) | 5 (7.4%) | 20 (14.5%) | 0.140 |
Any systemic reaction, n (%) | 119 (57.8%) | 31 (45.6%) | 88 (63.8%) | 0.013 |
Fatigue, n (%) | 62 (30.1%) | 15 (22.1%) | 47 (34.1%) | 0.077 |
Headache, n (%) | 34 (16.5%) | 7 (10.3%) | 27 (19.6%) | 0.092 |
Muscle and joint pain, n (%) | 47 (22.8%) | 9 (13.2%) | 38 (27.5%) | 0.021 |
Nausea or vomiting, n (%) | 4 (1.9%) | 1 (1.5%) | 3(2.2%) | 0.073 |
Abdominal pain, n (%) | 11 (5.3%) | 3 (4.4%) | 8 (5.8%) | 0.677 |
Diarrhea, n (%) | 14 (6.8%) | 2 (2.9%) | 12 (8.7%) | 0.123 |
Fever, n (%) | 60 (29.1%) | 11 (16.2%) | 49 (35.5%) | 0.004 |
Symptom score a | 1.0 (0.0–3.0) | 1.0 (0.0–1.0) | 1.0 (0.0–3.0) | 0.002 |
Variables | Univariate | Multivariate | ||
---|---|---|---|---|
OR (95% CI) | p Value | OR (95% CI) | p Value | |
Age (year) | 0.94 (0.92–0.97) | <0.001 | 0.93 (0.90–0.97) | <0.001 |
Male sex | 0.79 (0.44–1.42) | 0.429 | 0.57 (0.27–1.20) | 0.139 |
Body mass index (kg/m2) | 1.09 (1.01–1.18) | 0.033 | 1.00 (0.91–1.10) | 0.963 |
Diabetes mellitus | 0.64 (0.35–1.15) | 0.136 | 0.67 (0.32–1.39) | 0.279 |
CAD | 0.34 (0.18–0.64) | 0.001 | 0.26 (0.11–0.59) | 0.001 |
Use of IS | 0.12 (0.01–1.07) | 0.057 | 0.02 (0.00–0.24) | 0.002 |
Albumin (g/dL) | 3.19 (1.14–8.96) | 0.027 | 3.03 (0.78–11.81) | 0.110 |
Lymphocyte (×109/L) | 5.21 (2.31–11.71) | <0.001 | 4.14 (1.69–10.17) | 0.002 |
Variables | Univariate | Multivariate | ||
---|---|---|---|---|
OR (95% CI) | p Value | OR (95% CI) | p Value | |
Local reaction | 2.27 (1.20–4.28) | 0.012 | 2.11 (0.98–4.54) | 0.056 |
Pain | 2.08 (1.10–3.92) | 0.024 | 1.92 (0.89–4.13) | 0.096 |
Redness | 1.95 (0.62–6.12) | 0.252 | 2.48 (0.61–10.10) | 0.205 |
Swelling | 2.14 (0.77–5.96) | 0.147 | 1.72 (0.49–6.04) | 0.399 |
Systemic reaction | 2.10 (1.16–3.79) | 0.014 | 1.60 (0.79–3.23) | 0.193 |
Fatigue | 1.83 (0.93–3.58) | 0.080 | 1.74 (0.79–3.85) | 0.169 |
Headache | 2.12 (0.87–5.15) | 0.097 | 1.32 (0.46–3.85) | 0.606 |
Muscle and joint pain | 2.49 (1.13–5.51) | 0.024 | 1.43 (0.54–3.75) | 0.471 |
Nausea or vomiting | 1.49 (0.15–14.59) | 0.732 | 2.54 (0.11–58.71) | 0.564 |
Abdominal pain | 1.33 (0.34–5.19) | 0.678 | 1.78 (0.34–9.31) | 0.494 |
Diarrhea | 3.14 (0.68–14.46) | 0.141 | 4.03 (0.59–27.35) | 0.154 |
Fever | 2.85 (1.37–5.94) | 0.005 | 2.70 (1.12–6.50) | 0.026 |
Symptom score (per one increase) | 1.37 (1.13–1.66) | 0.002 | 1.33 (1.05–1.68) | 0.019 |
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Lin, T.-Y.; Hung, N.-K.; Hung, S.-C. Association of Reactogenicity with Immunogenicity of the ChAdOx1 nCoV-19 Vaccine in Patients Undergoing Hemodialysis. Vaccines 2022, 10, 1366. https://doi.org/10.3390/vaccines10081366
Lin T-Y, Hung N-K, Hung S-C. Association of Reactogenicity with Immunogenicity of the ChAdOx1 nCoV-19 Vaccine in Patients Undergoing Hemodialysis. Vaccines. 2022; 10(8):1366. https://doi.org/10.3390/vaccines10081366
Chicago/Turabian StyleLin, Ting-Yun, Nai-Kuan Hung, and Szu-Chun Hung. 2022. "Association of Reactogenicity with Immunogenicity of the ChAdOx1 nCoV-19 Vaccine in Patients Undergoing Hemodialysis" Vaccines 10, no. 8: 1366. https://doi.org/10.3390/vaccines10081366
APA StyleLin, T. -Y., Hung, N. -K., & Hung, S. -C. (2022). Association of Reactogenicity with Immunogenicity of the ChAdOx1 nCoV-19 Vaccine in Patients Undergoing Hemodialysis. Vaccines, 10(8), 1366. https://doi.org/10.3390/vaccines10081366