An Immunobridging Study to Evaluate the Neutralizing Antibody Titer in Adults Immunized with Two Doses of Either ChAdOx1-nCov-19 (AstraZeneca) or MVC-COV1901
Abstract
:1. Introduction
2. Methods
2.1. Clinical Trials and Sample Population
2.2. Vaccines
2.3. Immunobridging Study
- Immunogenicity data: immunobridging study to evaluate the immunogenicity of a locally developed vaccine against a comparator vaccine which has already been approved in Taiwan.
- Safety data: at least 3000 subjects were required to be tracked for at least one month after the last dose and all subjects to be followed for a median of two months after the last dose.
- The lower limit of the 95% CI of the geometric mean titer ratio (GMTR) of the prototype strain live virus neutralizing antibodies for the MVC-COV1901 vaccine group to the external control group must be greater than 0.67;
- The sero-response level (the proportion of subjects whose neutralizing antibody titers against the prototype strain live virus at 28 days after receiving the second dose of the MVC-COVID19 vaccine) was defined as the proportion of subjects with neutralizing antibody titers against the prototype strain live virus at 60% of the reverse cumulative distribution curve for the external control group. The lower limit of the 95% CI for the sero-response rate must be greater than 50%.
2.4. Live SARS-CoV-2 Neutralization Assay
2.5. Statistical Analysis
3. Results
3.1. Demographics
3.2. Immunogenicity
4. Sensitivity Analysis
5. Discussion
6. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Item | <65 Years | All Ages | ||
---|---|---|---|---|
AZD1222 | MVC-COV1901 | AZD1222 | MVC-COV1901 | |
n = 194 | PPI Subset n = 682 | n = 200 | PPI Subset n = 903 | |
Age (years) | ||||
Mean (SD) | 42.2 (11.1) | 38.02 (11.03) | 42.9 (11.7) | 45.68 (16.64) |
Median (IQR) | 41(16.75) | 37.0 (17.0) | 41.5(17.2) | 42.0 (32.0) |
Min–Max | 22.0–64.0 | 20.0–64.0 | 22.0–69.0 | 20.0–87.0 |
Gender | ||||
Male | 78 (40.2) | 386 (56.6) | 80 (40.0) | 521 (57.7) |
Female | 116 (59.8) | 296 (43.4) | 120 (60.0) | 382 (42.3) |
BMI (kg/m2) | ||||
Mean (SD) | 25.3 (4.5) | 24.9 (4.3) | 25.2(4.6) | 24.9 (4.1) |
Median (IQR) | 24.6 (5.97) | 24.3 (5.7) | 24.5(5.97) | 24.4 (5.3) |
Min–Max | 16.6–39.6 | 14.3–45.2 | 17.01–37.5 | 17.7–36.9 |
BMI group | ||||
<30 kg/m2 | 159 (81.96) | 594 (87.1) | 798 (88.4) | 164 (82.0) |
≥30 kg/m2 | 35 (18.04) | 88 (12.9) | 105 (11.6) | 36 (18.0) |
Pre-vaccination neutralizing antibody status | ||||
Seropositive | 2 (1.03) | 8 (1.17) | 2 (1.0) | 10 (1.11) |
Seronegative | 192 (98.97) | 674 (98.83) | 198 (99.0) | 893 (98.9) |
Comorbidity Category | ||||
At least one comorbidity | 74 (38.1) | 89 (13.0) | 123 (61.5) | 729 (80.7) |
No comorbidity | 120 (61.9) | 593 (87.0) | 77 (38.5) | 174 (19.3) |
Item | <65 Years | All Ages | ||||
---|---|---|---|---|---|---|
AZD1222 n = 192 | MVC-COV1901 (PPI Subset) n = 674 | p-Value (GMT Ratio) | AZD1222 n = 198 | MVC-COV1901 (PPI Subset) n = 893 | p-Value (GMT Ratio) | |
GMT (95% CI) | 185.97 (167.3–206.7) | 723.6 (683.7–765.8) | 184.05 (166.5–204.7) | 654.07 (620.9–689.03) | ||
GMT Ratio of MVC/AZ (95% CI) | 3.89 (3.45–4.4) | <0.0001 | 3.55 (3.2–3.97) | <0.0001 | ||
Adjusted GMT Ratio * (95% CI) | 3.78 (3.3–4.3) | <0.0001 | 3.8 (3.4–4.3) | <0.0001 |
Item | <65 Years | All Ages | ||||
---|---|---|---|---|---|---|
AstraZeneca AZD1222 n = 192 | MVC-COV1901 (PPI Subset) n = 458 | p-Value (GMT Ratio) | AstraZeneca AZD1222 n = 198 | MVC-COV1901 (PPI Subset) n = 635 | p-Value (GMT Ratio) | |
GMT (95% CI) | 185.97 (167.3–206.7) | 492.6 (470.1–516.1) | 184.05 (166.5–204.7) | 453.7 (433.8–474.7) | ||
GMT Ratio of MVC/AZ (95% CI) | 2.65 (2.4~2.97) | <0.0001 | 2.46 (2.2–2.7) | <0.0001 | ||
Adjusted GMT Ratio * (95% CI) | 2.6 (2.3–2.9) | <0.0001 | 2.62 (2.3–2.9) | <0.0001 |
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Estrada, J.A.; Cheng, C.-Y.; Ku, S.-Y.; Hu, H.-C.; Yeh, H.-W.; Lin, Y.-C.; Chen, C.-P.; Cheng, S.-H.; Janssen, R.; Lin, I.-F. An Immunobridging Study to Evaluate the Neutralizing Antibody Titer in Adults Immunized with Two Doses of Either ChAdOx1-nCov-19 (AstraZeneca) or MVC-COV1901. Vaccines 2022, 10, 655. https://doi.org/10.3390/vaccines10050655
Estrada JA, Cheng C-Y, Ku S-Y, Hu H-C, Yeh H-W, Lin Y-C, Chen C-P, Cheng S-H, Janssen R, Lin I-F. An Immunobridging Study to Evaluate the Neutralizing Antibody Titer in Adults Immunized with Two Doses of Either ChAdOx1-nCov-19 (AstraZeneca) or MVC-COV1901. Vaccines. 2022; 10(5):655. https://doi.org/10.3390/vaccines10050655
Chicago/Turabian StyleEstrada, Josue Antonio, Chien-Yu Cheng, Shin-Yen Ku, Hui-Chun Hu, Hsiu-Wen Yeh, Yi-Chun Lin, Cheng-Pin Chen, Shu-Hsing Cheng, Robert Janssen, and I-Feng Lin. 2022. "An Immunobridging Study to Evaluate the Neutralizing Antibody Titer in Adults Immunized with Two Doses of Either ChAdOx1-nCov-19 (AstraZeneca) or MVC-COV1901" Vaccines 10, no. 5: 655. https://doi.org/10.3390/vaccines10050655