Safety and Immunogenicity of the BBIBP-CorV Vaccine in Adolescents Aged 12 to 17 Years in the Thai Population: An Immunobridging Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Trial Design and Participants
2.2. Interventions
2.3. Safety
2.4. Immunogenicity
2.5. Outcomes
2.6. Sample Size
2.7. Statistical Methods
3. Results
3.1. Participants
3.2. Safety
3.2.1. Reactogenicity
3.2.2. Adverse Events
3.3. Immunogenicity
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Adolescent Cohort 12–17 Years | Adult Cohort 18–30 Years | |
---|---|---|
Participants in safety analysis | 234 | 249 |
Female sex | 108 (46.2) | 118 (47.4) |
Age, years | 14 (13–16) | 25 (22–28) |
Participants in immunogenicity analysis | 190 | 203 |
Female sex | 90 (47.4) | 97 (47.8) |
Age, years | 14 (13–16) | 25 (23–28) |
Underlying disease | 0 | 0 |
Adverse Event | Adolescents 12–17 Years Old (n = 234) | Adults 18–30 Years Old (n = 249) |
---|---|---|
n (%) | n (%) | |
Any event | 8 (3.4%) | 5 (2.0%) |
Related | 0 (0%) | 2 (0.8%) |
Severe | 0 (0%) | 0 (0%) |
Life-threatening | 0 (0%) | 0 (0%) |
Any serious adverse event | 0 (0%) | 0 (0%) |
Related | ||
Severe | ||
Life-threatening | ||
Any adverse event leading to discontinuation | 0 (0%) | 0 (0%) |
Related | ||
Severe | ||
Life-threatening | ||
Death | 0 (0%) | 0 (0%) |
12–17 Years | 18–30 Years | |
---|---|---|
Number of participants a | 190 | 203 |
GMC (95% CI), BAU/mL | 102.9 (91.0–116.4) | 36.9 (30.9–44.0) |
GMR (95% CI) | 2.79 (2.25–3.46) * | reference |
Number of participants b | 198 | 203 |
GMC (95%CI) (BAU/mL) | 102.49 (90.81–115.68) | 36.9 (30.9–44.0) |
GMR (95%CI) | 2.78 (2.25–3.44) * | reference |
12–14 Years | 15–17 Years | 18–30 Years | |
---|---|---|---|
Number of participants a | 99 | 91 | 203 |
GMC (95% CI), BAU/mL | 124.2 (105.8–145.7) | 83.9 (69.8–100.7) | 36.9 (30.9–44.0) |
GMR (95% CI) | 3.37 (2.59–4.38) * | 2.27 (1.74–2.98) * | reference |
Number of participants b | 103 | 95 | 203 |
GMC (95%CI) (BAU/mL) | 125.3 (107.2–146.7) | 82.4 (68.9–98.5) | 36.9 (30.9–44.0) |
GMR (95%CI) | 3.4 (2.53–4.56) * | 2.23 (1.65–3.02) * | reference |
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Tawinprai, K.; Siripongboonsitti, T.; Porntharukchareon, T.; Vanichsetakul, P.; Thonginnetra, S.; Niemsorn, K.; Promsena, P.; Tandhansakul, M.; Kasemlawan, N.; Ruangkijpaisal, N.; Banomyong, N.; Phattraprayoon, N.; Ungtrakul, T.; Wittayasak, K.; Thonwirak, N.; Soonklang, K.; Sornsamdang, G.; Mahanonda, N. Safety and Immunogenicity of the BBIBP-CorV Vaccine in Adolescents Aged 12 to 17 Years in the Thai Population: An Immunobridging Study. Vaccines 2022, 10, 807. https://doi.org/10.3390/vaccines10050807
Tawinprai K, Siripongboonsitti T, Porntharukchareon T, Vanichsetakul P, Thonginnetra S, Niemsorn K, Promsena P, Tandhansakul M, Kasemlawan N, Ruangkijpaisal N, Banomyong N, Phattraprayoon N, Ungtrakul T, Wittayasak K, Thonwirak N, Soonklang K, Sornsamdang G, Mahanonda N. Safety and Immunogenicity of the BBIBP-CorV Vaccine in Adolescents Aged 12 to 17 Years in the Thai Population: An Immunobridging Study. Vaccines. 2022; 10(5):807. https://doi.org/10.3390/vaccines10050807
Chicago/Turabian StyleTawinprai, Kriangkrai, Taweegrit Siripongboonsitti, Thachanun Porntharukchareon, Preeda Vanichsetakul, Saraiorn Thonginnetra, Krongkwan Niemsorn, Pathariya Promsena, Manunya Tandhansakul, Naruporn Kasemlawan, Natthanan Ruangkijpaisal, Narin Banomyong, Nanthida Phattraprayoon, Teerapat Ungtrakul, Kasiruck Wittayasak, Nawarat Thonwirak, Kamonwan Soonklang, Gaidganok Sornsamdang, and Nithi Mahanonda. 2022. "Safety and Immunogenicity of the BBIBP-CorV Vaccine in Adolescents Aged 12 to 17 Years in the Thai Population: An Immunobridging Study" Vaccines 10, no. 5: 807. https://doi.org/10.3390/vaccines10050807