Safety and Immunogenicity of COVID-19 BBIBP-CorV Vaccine in Children 3–12 Years Old
Abstract
:1. Introduction
2. Methods
2.1. Study Design and Participants
2.2. Procedures
2.3. Immunogenicity
2.4. Outcomes
2.5. Statistical Analysis
3. Results
Immunogenicity
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Acknowledgments
Conflicts of Interest
Appendix A. Extra Tables
(a) | |||||
Items | Age Group | Total No | Events | No. of Subjects | Incidence % |
Local adverse effect (injection site) | 3–<6 | 93 | 5 | 5 | 5.4 |
6–<9 | 204 | 20 | 19 | 9.3 | |
9–<12 | 285 | 25 | 24 | 8.4 | |
Total | 582 | 50 | 48 | 8.2 | |
Systemic adverse effects | 3–<6 | 93 | 1 | 1 | 1.1 |
6–<9 | 204 | 7 | 7 | 3.4 | |
9–<12 | 285 | 11 | 11 | 3.9 | |
Total | 582 | 19 | 19 | 3.3 | |
Fever | 3–<6 | 93 | 10 | 9 | 9.7 |
6–<9 | 204 | 12 | 10 | 4.9 | |
9–<12 | 285 | 11 | 11 | 3.9 | |
Total | 582 | 33 | 30 | 5.2 | |
Other adverse effects | 3–<6 | 93 | 2 | 2 | 2.2 |
6–<9 | 204 | 6 | 5 | 2.5 | |
9–<12 | 285 | 3 | 3 | 1.1 | |
Total | 582 | 11 | 10 | 1.7 | |
Overall AE | 3–<6 | 93 | 18 | 13 | 14.0 |
6–<9 | 204 | 45 | 33 | 16.2 | |
9–<12 | 285 | 50 | 40 | 14.0 | |
Total | 582 | 113 | 86 | 14.8 | |
(b) | |||||
Items | Age Group | Total No | Events | No. of Subjects | Incidence % |
Local adverse effect (injection site) | 3–<6 | 93 | 6 | 5 | 5.4 |
6–<9 | 204 | 19 | 18 | 8.8 | |
9–<12 | 285 | 35 | 33 | 11.6 | |
Total | 582 | 60 | 56 | 9.6 | |
Systemic adverse effects | 3–<6 | 93 | 4 | 4 | 4.3 |
6–<9 | 204 | 4 | 4 | 2.0 | |
9–<12 | 285 | 9 | 8 | 2.8 | |
Total | 582 | 17 | 16 | 2.7 | |
Fever | 3–<6 | 93 | 4 | 4 | 4.3 |
6–<9 | 204 | 16 | 14 | 6.9 | |
9–<12 | 285 | 19 | 13 | 4.6 | |
Total | 582 | 39 | 31 | 5.3 | |
Other adverse effects | 3–<6 | 93 | 5 | 5 | 5.4 |
6–<9 | 204 | 13 | 11 | 5.4 | |
9–<12 | 285 | 9 | 9 | 3.2 | |
Total | 582 | 27 | 25 | 4.3 | |
Overall AE | 3–<6 | 93 | 19 | 11 | 11.8 |
6–<9 | 204 | 52 | 37 | 18.1 | |
9–<12 | 285 | 72 | 51 | 17.9 | |
Total | 582 | 143 | 99 | 17.0 |
(a) | ||||||||
Items | Females (n = 264) | Males (n = 318) | Total (n = 582) | |||||
cases | Events | No. Subjects | Incidence % | Events | No. of Subjects | Incidence % | No. | % |
Local AE | 21 | 21 | 8.0 | 29 | 27 | 8.5 | 48 | 8.2 |
Systematic AE | 6 | 6 | 2.3 | 13 | 13 | 4.1 | 19 | 3.3 |
Fever | 12 | 11 | 4.2 | 21 | 19 | 6.0 | 30 | 5.2 |
Other AE | 5 | 4 | 1.5 | 6 | 6 | 1.9 | 10 | 1.7 |
Total | 44 | 42 | 15.9 | 69 | 65 | 20.4 | 107 | 18.4 |
(b) | ||||||||
Items | Females (n = 264) | Males (n = 318) | Total (n = 582) | |||||
Cases | Events | No. Subjects | Incidence % | Events | No. of Subjects | Incidence % | No. | % |
Local AE | 29 | 27 | 10.2 | 31 | 29 | 9.1 | 56 | 9.6 |
Systematic AE | 10 | 10 | 3.8 | 7 | 6 | 1.9 | 16 | 2.7 |
Fever | 16 | 12 | 4.5 | 23 | 19 | 6.0 | 31 | 5.3 |
Other AE | 8 | 7 | 2.7 | 19 | 18 | 5.7 | 25 | 4.3 |
Total | 63 | 56 | 21.2 | 80 | 72 | 22.6 | 128 | 22.0 |
(a) | ||||
3 to <6 Year | 6 to <9 Year | 9 to <12 Year | Total | |
Number | 42 | 98 | 134 | 274 |
Mean value (95% C.I) D0 anti-S | ND | ND | ND | ND |
Mean value (95% C.I) D35 anti-S | 531.34 (400.44–685.86) | 432.44 (355.58–523.78) | 354.72 (294.81–429.53) | 409.14 (364.23–460.91) |
Mean value (95% C.I) D0 anti-N | ND | ND | ND | ND |
Mean value (95% C.I) D35 anti-N | 34.43 (26.29-43.77) | 38.97 (31.10-47.47) | 23.92 (25.26-42.28) | 30.98 (31.98–41.47) |
Mean value (95% C.I) Neutralizing Ab D35 | 81.81 (78.09–85.31) | 78.42 (75.18–81.41) | 74.71 (71.81–77.42) | 77.11 (75.31–79.01) |
(b) | ||||
3 to <6 Year | 6 to <9 Year | 9 to <12 Year | Total | |
Number (%) | 18 | 49 | 60 | 127 |
Mean value (95% C.I) D0 anti-S | 411.10 (232.99–619.77) | 542.12 (436.75–653.52) | 576.51 (431.61–752.98) | 538.79 (459.28–633.61) |
Mean value (95% C.I) D35 anti-S | 2124.74 (1660.2–2618.70) | 2758 (2302.41–3265.68) | 2151.1 (1814.49–2516.72) | 2379.80 (2123–2650.93) |
Mean value (95% C.I) D0 anti-N | 80.4 (40.96–122.32) | 86.80 (60.35–111.31) | 86.39 (64.26–107.86) | 85.66 (71.07–100.39) |
Mean value (95% C.I) D35 anti-N | 173.58 (150.29–191.65) | 183.93 (173.87–192.51) | 174.03 (163.15–185.61) | 177.76 (170.56–184.82) |
Mean value (95% C.I) Neutralizing Ab | 92.6 5(89.44–95.39) | 94.32 (92.09–95.81) | 93.52 (92.29–94.62) | 93.70 (92.71–94.54) |
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Reactogenicity | Immunogenicity | ||||
---|---|---|---|---|---|
No. | % | No. | % | ||
Gender | Female | 264 | 45.4 | 188 | 46.9 |
Male | 318 | 54.6 | 213 | 53.1 | |
Age | 3–<6 | 93 | 16.0 | 60 | 15.0 |
6–<9 | 204 | 35.1 | 147 | 36.6 | |
9–<12 | 285 | 49.0 | 194 | 48.4 | |
Total | 582 | 100.0 | 401 | 100.0 |
Items | Age Group | Total No. | Events | No. of Subjects | Incidence % | Chi-Square p Value |
---|---|---|---|---|---|---|
Local Adverse Events (injection site) | 3–<6 | 93 | 11 | 10 | 10.8 | 0.320 |
6–<9 | 204 | 39 | 34 | 16.7 | ||
9–<12 | 285 | 60 | 49 | 17.2 | ||
Total | 582 | 110 | 93 | 16.0 | ||
Systemic Adverse Events | 3–<6 | 93 | 5 | 5 | 5.4 | 0.892 |
6–<9 | 204 | 11 | 11 | 5.4 | ||
9–<12 | 285 | 20 | 18 | 6.3 | ||
Total | 582 | 36 | 34 | 5.8 | ||
Fever | 3–<6 | 93 | 14 | 13 | 14.0 | 0.194 |
6–<9 | 204 | 28 | 20 | 9.8 | ||
9–<12 | 285 | 30 | 21 | 7.4 | ||
Total | 582 | 72 | 54 | 9.3 | ||
Other Adverse Events | 3–<6 | 93 | 7 | 7 | 7.5 | 0.199 |
6–<9 | 204 | 19 | 16 | 7.8 | ||
9–<12 | 285 | 12 | 12 | 4.2 | ||
Total | 582 | 38 | 35 | 6.0 | ||
Overall AE | 3–<6 | 93 | 37 | 23 | 24.7 | 0.522 |
6–<9 | 204 | 97 | 62 | 30.4 | ||
9–<12 | 285 | 122 | 76 | 26.7 | ||
Total | 582 | 256 | 161 | 27.7 |
Adverse Event Number | Total | ||
---|---|---|---|
Dose 1 | Dose 2 | ||
Day 0 | 2 | 2 | |
Day 1 | 82 | 82 | |
Day 7 | 15 | 15 | |
Day 14 | 8 | 8 | |
Day 21 | 6 | 2 | 8 |
Day 22 | 79 | 79 | |
Day 28 | 36 | 36 | |
Day 35 | 26 | 26 | |
Total | 113 | 143 | 256 |
Item | Female | Male | Total | Chi-Square p Value | |||||
---|---|---|---|---|---|---|---|---|---|
Age | No of Events | Non Exposed | Exposed | Non Exposed | Exposed | Non Exposed | Exposed | ||
Local Adverse Events (injection site) | 3–<6 Year | 10 | 5 | 3 | 1 | 1 | 6 | 4 | 0.920 |
6–<9 Year | 31 | 14 | 4 | 6 | 7 | 20 | 11 | ||
9–<12 Year | 45 | 13 | 4 | 17 | 11 | 30 | 15 | ||
Total | 86 | 32 | 11 | 24 | 19 | 56 | 30 | ||
Systemic Adverse Events | 3–<6 Year | 4 | 1 | 0 | 3 | 0 | 4 | 0 | NA |
6–<9 Year | 6 | 4 | 0 | 1 | 1 | 5 | 1 | ||
9–<12 Year | 14 | 5 | 0 | 5 | 4 | 10 | 4 | ||
Total | 24 | 10 | 0 | 9 | 5 | 19 | 5 | ||
Fever | 3–<6 Year | 11 | 2 | 2 | 4 | 3 | 6 | 5 | 0.476 |
6–<9 Year | 17 | 5 | 1 | 8 | 3 | 13 | 4 | ||
9–<12 Year | 16 | 5 | 3 | 6 | 2 | 11 | 5 | ||
Total | 44 | 12 | 6 | 18 | 8 | 30 | 14 | ||
Other Adverse Events | 3–<6 Year | 1 | 0 | 0 | 1 | 0 | 1 | 0 | NA |
6–<9 Year | 9 | 2 | 0 | 3 | 4 | 5 | 4 | ||
9–<12 Year | 9 | 2 | 1 | 4 | 2 | 6 | 3 | ||
Total | 19 | 4 | 1 | 8 | 6 | 12 | 7 | ||
Overall AE | 3–<6 Year | 22 | 7 | 4 | 7 | 4 | 14 | 8 | 0.965 |
6–<9 Year | 59 | 23 | 5 | 17 | 14 | 40 | 19 | ||
9–<12 Year | 75 | 22 | 6 | 29 | 18 | 51 | 24 | ||
Total | 156 | 52 | 15 | 53 | 36 | 105 | 51 |
Age (Years) | ||||||||
---|---|---|---|---|---|---|---|---|
3 to <6 Year | 6 to <9 Year | 9 to <12 Year | Total | |||||
Female | Male | Female | Male | Female | Male | Female | Male | |
Number (%) | 28 (46.7) | 22 (53.3) | 74 (50.3) | 73 (49.7) | 86 (44.3) | 108 (55.7) | 188 | 213 |
Seroconversion rate | 22 (100%) | 20 (100%) | 49 (100%) | 49 (100%) | 62 (100%) | 72 (100%) | 133 | 141 |
Mean value (95% C.I) D0 anti-S | 85.57 (8.98–208.04) | 169.73 (71.91–293.60) | 197.87 (121.41–277.73) | 163.84 (101.59–242.68) | 186.20 (94.88–310.35) | 172.51 (108.80–246.13) | 175.81 (119.65–241.67) | 169.12 (126.11–213.98) |
Mean value (95% C.I) D35 anti-S | 866.89 (519.96–1320.12) | 1183.81 (862.35–1539.74) | 1171.04 (859.02–1498.37) | 1245.22 (906.66–1647.42) | 898.13 (645.19–1198.56) | 919.99 (726.58–1129.98) | 1000.9 (819.66–1191.69) | 1071.09 (907.74–1252.13) |
Mean value (95% C.I) D0 anti-N | 22.99 (1.03–50.11) | 27.74 (10.25–49.11) | 29.48 (15.87–45.13) | 28.50 (14.68–47.44) | 21.83 (10.13–35.01) | 30.72 (18.81–43.77) | 25.01 (16.70–33.72) | 29.51 (21.38–38.76) |
Mean value (95% C.I) D35 anti-N | 64.69 (41.58–90.66) | 90.75 (65.53–118.75) | 89.79 (73.33–107.03) | 80.55 (72.23–86.89) | 64.94 (49.06–82.34) | 81.74 (72.81–88.69) | 74.69 (63.26–84.86) | 80.53 (70.19–92.09) |
Mean value (95% C.I) Neutralizing Ab | 82.74 (77.80–87.56) | 87.49 (84.11–90.60) | 82.37 (78.75–85.79) | 85.09 (81.85–88.16) | 78.51 (74.22–82.30) | 82.13 (79.2–84.82) | 80.66 (78.05–82.91) | 83.95 (81.99–85.90) |
(a) | |||
Variables | Delta Mean (post–pre) | Statistics | p Value |
Mean value anti- S | |||
Gender Male (n = 213) | 901.97 ± 1112.67 | T = 0.718 | 0.473 a |
Female (n = 188) | 825.09 ± 1017.72 | ||
Age 3 to < 6 (n = 60) | 905.46 ± 872.22 | F = 3.276 | p < 0.05b |
6 to < 9 (n = 147) | 1026.91 ± 1283.83 | ||
9 to < 12 (n = 194) | 865.93 ± 1068.57 | ||
Exposure Negative (n = 274) | 408.74 ± 413.35 | T = 16.018 | p < 0.001a |
Positive (n = 127) | 1841.10 ± 1350.13 | ||
(b) | |||
Variables | Delta Mean (post–pre) | Statistics | p Value |
GMT anti-N | |||
Gender Male (n = 213) | 51.02 ± 64.63 | T = 0.216 | 0.829 a |
Female (n = 188) | 49.67 ± 59.77 | ||
Age 3 to < 6 (n = 60) | 53.07 ± 57.99 | F = 2.425 | 0.090 b |
6 to < 9 (n = 147) | 58.30 ± 66.07 | ||
9 to < 12 (n = 194) | 43.57 ± 60.02 | ||
Exposure Negative (n = 274) | 30.83 ± 36.97 | T = 10.331 | p < 0.001a |
Positive (n = 127) | 92.09 ± 81.84 | ||
(c) | |||
Variables | Mean | Statistics | p Value |
Neutralizing Antibody | |||
Exposure Negative (n = 274) | 77.11 ± 15.8 | T = 11.507 | p < 0.001a |
Positive (n = 127) | 93.70 ± 5.79 |
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Share and Cite
Greish, K.; Alawadhi, A.; Jaradat, A.; Almarabheh, A.; AlMadhi, M.; Jawad, J.; Alsaffar, B.; Alalawi, E.; Alsayyad, A.; Merza, A.; Alalawi, B.; Qayed, D.; Humaidan, A.; Al Qahtani, M. Safety and Immunogenicity of COVID-19 BBIBP-CorV Vaccine in Children 3–12 Years Old. Vaccines 2022, 10, 586. https://doi.org/10.3390/vaccines10040586
Greish K, Alawadhi A, Jaradat A, Almarabheh A, AlMadhi M, Jawad J, Alsaffar B, Alalawi E, Alsayyad A, Merza A, Alalawi B, Qayed D, Humaidan A, Al Qahtani M. Safety and Immunogenicity of COVID-19 BBIBP-CorV Vaccine in Children 3–12 Years Old. Vaccines. 2022; 10(4):586. https://doi.org/10.3390/vaccines10040586
Chicago/Turabian StyleGreish, Khaled, Abdulla Alawadhi, Ahmed Jaradat, Amer Almarabheh, Marwa AlMadhi, Jaleela Jawad, Basma Alsaffar, Ejlal Alalawi, Adel Alsayyad, Afaf Merza, Batool Alalawi, Donia Qayed, Ahmed Humaidan, and Manaf Al Qahtani. 2022. "Safety and Immunogenicity of COVID-19 BBIBP-CorV Vaccine in Children 3–12 Years Old" Vaccines 10, no. 4: 586. https://doi.org/10.3390/vaccines10040586