Immunogenicity Parameters of Cancer Patients Receiving the mRNA Vaccine BNT162b2 While Obtaining Radiotherapy: A Longitudinal Cohort Evaluation
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Protocol
2.2. Immunogenicity Assay
2.3. SARS-CoV-2-Specific T-Cell Assay
2.4. Statistical Analysis
2.5. Ethics
3. Results
3.1. Patient Characteristics
3.2. Seroconversion
3.3. Humoral Immune Response
3.4. Kinetics
3.5. SARS-CoV-2-Specific T-Cell Measurements
3.6. Third Vaccine Dose
3.7. Vaccination Side Effects
3.8. Binding Antibody Persistence
4. Discussion
5. Conclusions
6. Limitations
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Abbreviations
bAB | binding antibody |
CTh | chemotherapy |
HIR | humoral immune response |
RT | radiotherapy |
Appendix A
Variables | Cohort 1 RT Alone | Cohort 2 RT and CTh | Cohort 3 Healthy Controls |
---|---|---|---|
Comorbidities | |||
None | 3 (13.0) | 5 (21.7) | 16 (100) |
Diabetes | 6 (26.1) | 6 (26.1) | 0 (0) |
Hypertension | 10 (48.5) | 11 (47.8) | 0 (0) |
Cardiovascular | 9 (39.1) | 8 (34.8) | 0 (0) |
Respiratory | 1 (4.4) | 5 (21.74 | 0 (0) |
Neuropsychiatric | 3 (13.0) | 2 (8.7) | 0 (0) |
Renal insufficiency | 5 (21.74) | 0 (0) | 0 (0) |
Immune related | 2 (8.7) | 2 (8.7) | 0 (0) |
Other malignancies | 4 (17.4) | 5 (21.7) | 0 (0) |
History of thrombosis | 2 (8.7) | 2 (8.7) | 0 (0) |
Further | 1 (4.4) | 3 (13.0) | 0 (0) |
Concomitant medication | |||
None | 6 (26.1) | 1 (4.4) | 16 (100) |
Aggregation inhibitors | 6 (26.1) | 9 (39.1) | 0 (0) |
Metabolic | 6 (26.1) | 5 (21.7) | 0 (0) |
Antidiabetics/insulin | 4 (17.4) | 5 (21.7) | 0 (0) |
Antihypertensives | 10 (43.5) | 11 (47.8) | 0 (0) |
Diuretics | 6 (26.1) | 3 (13.0) | 0 (0) |
Painkiller/NSARs | 4 (17.4) | 8 (34.8) | 0 (0) |
NOAKs | 5 (21.7) | 2 (8.7) | 0 (0) |
Psychotropic agents | 0 (0) | 6 (26.1) | 0 (0) |
PPI | 3 (13.0) | 8 (34.8) | 0 (0) |
Statins | 5 (21.7) | 8 (34.8) | 0 (0) |
Steroids | 1 (4.4) | 3 (13.0) | 0 (0) |
Further | 10 (43.5) | 13 (56.5) | 0 (0) |
Side effects of initial dose | |||
n | 15 | 13 | 16 |
None | 10 (66.7) | 10 (76.9) | 10 (62.5) |
Injection site pain | 4 (26.6) | 1 (7.7) | 3 (18.8) |
Fatigue | 0 (0) | 1 (7.7) | 1 (6.3) |
Pyrexia | 1 (6.7) | 0 (0) | 2 (12.6) |
Injection site redness | 0 (0) | 1 (7.7) | 0 (0) |
Side effects of boost dose | |||
n | 15 | 13 | 16 |
None | 13 (86.7) | 9 (60) | 14 (87.5) |
Injection site pain | 0 (0) | 2 (15.4) | 2 (12.5) |
Pyrexia | 1 (6.7) | 2 (15.4) | 0 (0) |
Headache | 1 (6.7) | 0 (0) | 0 (0) |
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Variables | Cohort 1 RT Alone | Cohort 2 RT and CTh | Cohort 3 Healthy Controls |
---|---|---|---|
Sex | |||
Female | 6 (26.1) | 9 (39.1) | 5 (31.3) |
Male | 17 (73.9) | 14 (60.9) | 11 (68.6) |
Age (years) | |||
Min | 39 | 50 | 27 |
Max | 92 | 81 | 70 |
Mean (SD) | 72.0 (11.3) | 66.6 (9.7) | 45.9 (11.8) |
ECOG | |||
0 | 13 | 12 | 16 |
1 | 9 | 8 | 0 |
2 | 1 | 2 | 0 |
3 | 0 | 1 | 0 |
4 | 0 | 0 | 0 |
Survival | |||
Alive | 17 (73.9) | 17 (73.9) | 16 (100) |
Deceased | 6 (26.1) | 6 (26.1) | 0 (0) |
Cancer entity | n.a. | ||
Prostate | 15 | 3 | |
Mean radiation dose | 57.4 Gy | 49.3 Gy | |
Breast | 2 | 5 | |
Mean radiation dose | 47.0 Gy | 37.8 Gy | |
Lung | 3 | 4 | |
Mean radiation dose | 42.5 Gy | 45 Gy | |
Brain | 1 | 3 | |
Mean radiation dose | 60 Gy | 60 Gy | |
Skin (squamous cell) | 2 | 3 | |
Mean radiation dose | 57.5 Gy | 62.1 Gy | |
Esophagus | 0 | 2 | |
Mean radiation dose | 47.0 Gy | ||
Rectal | 0 | 2 | |
Mean radiation dose | 7.5 Gy | ||
Pancreas | 0 | 1 | |
Mean radiation dose | 54 Gy | ||
Stage | n.a. | ||
Localized | 18 (78.3) | 20 (87) | |
Metastatic disease | 5 (21.7) | 3 (13) | |
Treatment intention | n.a. | ||
Curative | 18 (78.3) | 20 (87) | |
Palliative | 5 (21.7) | 3 (13) |
Humoral Response of Antibodies (U/mL) | Cohort 1 Pure RT | Cohort 2 CTh and RT | Cohort 3 Healthy Controls |
---|---|---|---|
n day 0 | 23 | 23 | 16 |
Min | 0 | 0 | 0 |
Max | 0 | 0 | 0 |
Mean (SD) | n.a. | n.a. | n.a. |
Median (IQR) | n.a. | n.a. | n.a. |
n day 7 | 16 | 19 | 16 |
Min | 0 | 0 | 0 |
Max | 1.60 | 0 | 0 |
Mean (SD) | 0.13 (0.40) | 0 (0) | 0 (0) |
Median (IQR) | 0 (0–0) | 0 (0–0) | 0 (0–0) |
n day 14 | 16 | 16 | 16 |
Min | 0 | 0 | 0.86 |
Max | 112 | 2.06 | 381 |
Mean (SD) | 12.95 (29.25) | 0.36 (0.70) | 69.30 (96.46) |
Median (IQR) | 0.91 (0–3.61) | 0 (0–0.12) | 26.85 (3.46–104.50) |
n day 21 | 14 | 16 | 16 |
Min | 0 | 0 | 5.35 |
Max | 358 | 138 | 1129 |
Mean (SD) | 82.22 (110.29) | 14.75 (35.21) | 217.03 (291.63) |
Median (IQR) | 38 (11.78–85.35) | 0.75 (0–3.95) | 112.5 (24.73–249.50) |
n day 28 | 12 | 10 | 16 |
Min | 0 | 0 | 437 |
Max | 5161 | 237 | 5747 |
Mean (SD) | 2001.34 (1615.49) | 57.76 (75.57) | 1640.06 (1351.12) |
Median (IQR) | 2334.5 (299.25–2962.5) | 14.10 (0–104.1) | 1236 (806.75–1834) |
n day 35 | 21 | 18 | 16 |
Min | 0 | 0 | 804 |
Max | 20,698 | 1055 | 6716 |
Mean (SD) | 3165.71 (4588.48) | 395.33 (382.82) | 2994.13 (1855.27) |
Median (IQR) | 2135 (338–3920) | 285.50 (64.8–783.75) | 2509 (1562–4253.25) |
n long term persistency | 9 | 8 | 16 |
Min | 64.2 | 65.7 | 55 |
Max | 2017 | 869 | 1936 |
Mean (SD) | 587.5 (563.7) | 267.5 (242.6) | 694.4 (408.0) |
Median (IQR) | 481.5 (344.25–528.75) | 188 (120–265.75) | 646 (441.25–836.5) |
Days after d35 | |||
Mean (SD) | 1203.9 (31.2) | 152.13 (56.5) | 196.4 (44.6) |
Median (IQR) | 185 (182–202) | 131 (50.5–170) | 174 (149.5–180.5) |
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Thöne, P.; Egger, M.; Geroldinger-Simic, M.; Kindermann, H.; Kocik, L.; Karasek, N.; Fischerlehner, B.; Spiegl, K.; Gruber, G.; Aschacher, B.; et al. Immunogenicity Parameters of Cancer Patients Receiving the mRNA Vaccine BNT162b2 While Obtaining Radiotherapy: A Longitudinal Cohort Evaluation. Vaccines 2024, 12, 275. https://doi.org/10.3390/vaccines12030275
Thöne P, Egger M, Geroldinger-Simic M, Kindermann H, Kocik L, Karasek N, Fischerlehner B, Spiegl K, Gruber G, Aschacher B, et al. Immunogenicity Parameters of Cancer Patients Receiving the mRNA Vaccine BNT162b2 While Obtaining Radiotherapy: A Longitudinal Cohort Evaluation. Vaccines. 2024; 12(3):275. https://doi.org/10.3390/vaccines12030275
Chicago/Turabian StyleThöne, Paul, Margot Egger, Marija Geroldinger-Simic, Harald Kindermann, Lukas Kocik, Nicola Karasek, Barbara Fischerlehner, Kurt Spiegl, Georg Gruber, Bernhard Aschacher, and et al. 2024. "Immunogenicity Parameters of Cancer Patients Receiving the mRNA Vaccine BNT162b2 While Obtaining Radiotherapy: A Longitudinal Cohort Evaluation" Vaccines 12, no. 3: 275. https://doi.org/10.3390/vaccines12030275