Long-Term Safety and Immunogenicity of AZD1222 (ChAdOx1 nCoV-19): 2-Year Follow-Up from a Phase 3 Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Participants
2.2. Treatment, Randomization, and Masking
2.3. Procedures
2.4. Outcomes
2.5. Analysis Populations
2.6. Statistics
3. Results
3.1. Participants
3.2. Long-Term Safety
3.3. Exploratory Efficacy
3.4. Long-Term Immunogenicity
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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AEs, Participants (%) Events/Adj. Rate | AZD1222 (Safety Population) | ||
---|---|---|---|
Prior to Non-Study COVID-19 Vaccination N = 21,587 Patient Years = 20,223 | After Non-Study COVID-19 Vaccination N = 14,667 Patient Years = 17,088 | Overall N = 21,587 Patient Years = 37,311 | |
AEs with outcome of death Related AEs with outcome of death | 42 (0.2) 46/< 0.01 0 | 20 (0.1) 22/< 0.01 0 | 62 (0.3) 68/< 0.01 0 |
AEs leading to study discontinuation 1 Related AEs leading to study discontinuation 1 | 43 (0.2) 46/< 0.01 0 | 20 (0.1) 20/< 0.01 0 | 63 (0.3) 66/< 0.01 0 |
SAEs 2 Related SAEs 2 | 621 (2.9) 870/0.03 7 (<0.1) 9/< 0.01 | 456 (3.1) 622/0.03 0 | 1039 (4.8) 1492/0.03 7 (<0.1) 9/< 0.01 |
MAAEs 2 Related MAAEs 2 | 4750 (22.0) 8300/0.23 107 (0.5) 176/< 0.01 | 3344 (22.8) 5660/0.20 2 (<0.1) 2/< 0.01 | 6955 (32.2) 13,960/0.19 108 (0.5) 178/< 0.01 |
AESIs 2 Related AESIs 2 | 2516 (11.7) 2787/0.12 68 (0.3) 83/< 0.01 | 4369 (29.8) 4710/0.26 1 (<0.1) 1/< 0.01 | 6622 (30.7) 7497/0.18 68 (0.3) 84/< 0.1 |
Time Period | AZD1222 (FVAS, Censored at Non-Study COVID-19 Vaccination) | ||
---|---|---|---|
n/N (%) 1 | Follow-Up Time 2 | Incidence Rate 2 | |
≥15 days post-second dose | 2925/19,409 (15.1) | 15.47 | 189.05 |
≥15 days post-second dose to <6 months post-first dose | 421/19,409 (2.2) | 6.31 | 66.72 |
≥6 months post-first dose | 2504/14,520 (17.2) | 9.16 | 273.28 |
≥1 year post-first dose | 1678/6850 (24.5) | 3.44 | 487.90 |
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Shoemaker, K.; Soboleva, K.; Branche, A.; Shankaran, S.; Theodore, D.A.; Bari, M.; Ezeh, V.; Green, J.; Kelly, E.; Lan, D.; et al. Long-Term Safety and Immunogenicity of AZD1222 (ChAdOx1 nCoV-19): 2-Year Follow-Up from a Phase 3 Study. Vaccines 2024, 12, 883. https://doi.org/10.3390/vaccines12080883
Shoemaker K, Soboleva K, Branche A, Shankaran S, Theodore DA, Bari M, Ezeh V, Green J, Kelly E, Lan D, et al. Long-Term Safety and Immunogenicity of AZD1222 (ChAdOx1 nCoV-19): 2-Year Follow-Up from a Phase 3 Study. Vaccines. 2024; 12(8):883. https://doi.org/10.3390/vaccines12080883
Chicago/Turabian StyleShoemaker, Kathryn, Karina Soboleva, Angela Branche, Shivanjali Shankaran, Deborah A. Theodore, Muhammad Bari, Victor Ezeh, Justin Green, Elizabeth Kelly, Dongmei Lan, and et al. 2024. "Long-Term Safety and Immunogenicity of AZD1222 (ChAdOx1 nCoV-19): 2-Year Follow-Up from a Phase 3 Study" Vaccines 12, no. 8: 883. https://doi.org/10.3390/vaccines12080883