A Retrospective Study of the Safety and Immunogenicity of MVC-COV1901 Vaccine for People Living with HIV
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design and Participants
2.2. Statistical Analysis
3. Results
3.1. Study Population
3.2. Safety
3.3. Immunogenicity
3.4. Correlation of GMT and CD4/CD8 Ratio
4. Discussion
5. Limitation
6. 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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Item | HIV Positive N = 57 | Main Study N = 326 | p-Value |
---|---|---|---|
Age (years) | |||
Mean (SD) | 38.6 (13.1) | 42.8 (14.9) | 0.058 |
Median (IQR) | 36 (19.0) | 41 (23.0) | |
Min~Max | 23.0~72.0 | 23.0~72.0 | |
Gender | |||
N (Missing) | 57 (0) | 326 (0) | |
Male | 54 (94.7%) | 310 (95.1%) | 1 |
Female | 3 (5.3%) | 16 (4.9%) | |
BMI (kg/m2) | |||
Mean (SD) | 25.3 (4.9) | 25.9(4.0) | 0.167 |
Median (IQR) | 24.5 (6.2) | 25.4 (5.1) | |
BMI group | |||
<30 kg/m2 | 46 (80.7%) | 277 (84.9%) | 0.413 |
≥30 kg/m2 | 11 (19.3%) | 49 (15.0%) | |
Comorbidity Category | |||
Yes | 6 (10.5%) | 59 (18.1%) | 0.16 |
No | 51 (89.5%) | 267 (81.9%) |
(a) | ||||||
All, n (%) | ≥20 to <65 Years, n (%) | ≥65 Years, n (%) | ||||
MVC-COV1901 (N = 3295) | HIV (N = 58) | MVC-COV1901 (N = 2575) | HIV (N = 54) | MVC-COV1901 (N = 720) | HIV (N = 4) | |
Any Solicited Local AEs | 2381 (72.3) | 39 (58.6) | 2030 (78.8) | 37 (59.3) | 351 (48.8) | 2 (50.0) |
Pain/Tenderness | 2346 (71.2) | 39 (67.2) | 2009 (78.0) | 37 (68.5) | 337 (46.8) | 2 (50.0) |
Grade 1 | 2237 (67.9) | 37 (63.8) | 1907 (74.1) | 35 (64.8) | 330 (45.8) | 2 (50.0) |
Grade 2 | 97 (2.9) | 2 (34.4) | 91 (3.5) | 2 (3.7) | 6 (0.8) | 0 |
Grade 3 | 12 (0.4) | 0 | 11 (0.4) | 0 | 1 (0.1) | 0 |
Induration/Swelling | 347 (10.5) | 1 (1.7) | 286 (11.1) | 1 (1.9) | 61 (8.5) | 0 |
Grade 1 | 303 (9.2) | 1 (1.7) | 246 (9.6) | 1 (1.9) | 57 (7.9) | 0 |
Grade 2 | 42 (1.3) | 0 | 38 (1.5) | 0 | 4 (0.6) | 0 |
Grade 3 | 2 (0.1) | 0 | 2 (0.1) | 0 | 0 | 0 |
Erythema/Redness | 161 (4.9) | 0 | 138 (5.4) | 0 | 23 (3.2) | 0 |
Grade 1 | 155 (4.7) | 0 | 132 (5.1) | 0 | 23 (3.2) | 0 |
Grade 2 | 6 (0.2) | 0 | 6 (0.2) | 0 | 0 | 0 |
Any Solicited Systemic AEs | 1774 (53.8) | 37 (63.8) | 1484 (57.6) | 35 (65.8) | 290 (40.3) | 2 (50.0) |
Malaise/Fatigue | 1186 (36.0) | 25 (43.1) | 1036 (40.2) | 24 (44.4) | 150 (20.8) | 1 (25.0) |
Grade 1 | 961 (29.2) | 22 (43.1) | 831 (32.3) | 24 (44.4) | 130 (18.1) | 1 (25.0) |
Grade 2 | 203 (6.2) | 3 (5.2) | 185 (7.2) | 2 (3.7) | 18 (2.5) | 1 (25.0) |
1Grade 3 | 22 (0.7) | 0 | 20 (0.8) | 0 | 2 (0.3) | 0 |
Myalgia | 908 (27.6) | 10 (16.7) | 757 (29.4) | 14 (25.9) | 151 (21.0) | 2 (50.0) |
Grade 1 | 764 (23.2) | 9 (16.7) | 629 (24.4) | 7 (13.0) | 135 (18.8) | 2 (50.0) |
Grade 2 | 126 (3.8) | 1 (1.7) | 112 (4.3) | 1 (1.9) | 14 (1.9) | 0 |
Grade 3 | 18 (0.5) | 0 | 16 (0.6) | 0 | 2 (0.3) | 0 |
Headache | 730 (22.2) | 13 (22.4) | 631 (24.5) | 12 (22.2) | 99 (13.8) | 1 (25.0) |
Grade 1 | 630 (19.1) | 12 (20.7) | 537 (20.9) | 11 (20.4) | 93 (12.9) | 1 (25.0) |
Grade 2 | 93 (2.8) | 1 (1.7) | 87 (3.4) | 1 (1.9) | 6 (0.8) | 0 |
Grade 3 | 7 (0.2) | 0 | 7 (0.3) | 0 | 0 | 0 |
Diarrhoea | 497 (15.1) | 14 (24.1) | 422 (16.4) | 14 (25.9) | 75 (10.4) | 0 |
Grade 1 | 411 (12.5) | 12 (20.7) | 350 (13.6) | 12 (22.2) | 61 (8.5) | 0 |
Grade 2 | 75 (2.3) | 2 (3.4) | 62 (2.4) | 2 (3.7) | 13 (1.8) | 0 |
Grade 3 | 11 (0.3) | 0 | 10 (0.4) | 0 | 1 (0.1) | 0 |
Nausea/Vomiting | 254 (7.7) | 6 (10.3) | 219 (8.5) | 6 (11.1) | 35 (4.9) | 0 |
Grade 1 | 226 (6.9) | 6 (10.3) | 192 (7.5) | 6 (11.1) | 34 (4.7) | 0 |
Grade 2 | 26 (0.8) | 0 | 25 (1.0) | 0 | 1 (0.1) | 0 |
Grade 3 | 2 (0.1) | 0 | 2 (0.1) | 0 | 0 | 0 |
Fever | 23 (0.7) | 0 | 16 (0.6) | 0 | 7 (1.0) | 0 |
Grade 1 | 14 (0.4) | 0 | 8 (0.3) | 0 | 6 (0.8) | 0 |
Grade 2 | 6 (0.2) | 0 | 6 (0.2) | 0 | 0 | 0 |
Grade 3 | 2 (0.1) | 0 | 2 (0.1) | 0 | 0 | 0 |
Grade 4 | 1 (<0.1) | 0 | 0 | 0 | 1 (<0.1) | 0 |
(b) | ||||||
All, n (%) | ≥20 to <65 Years, n (%) | ≥65 Years, n (%) | ||||
MVC-COV1901 (N = 3295) | HIV in MVC-COV1901 (N = 58) | MVC-COV1901 (N = 2575) | HIV in MVC-COV1901 (N = 54) | MVC-COV1901 (N = 720) | HIV in MVC-COV1901 (N = 4) | |
Unsolicited AEs | 932 (28.3) | 17 (29.3) | 767 (29.8) | 17 (29.6) | 165 (22.9) | 0 |
Related unsolicited AEs | 406 (12.3) | 8 (13.8) | 340 (13.2) | 396 (13.2) | 66 (9.2) | 0 |
Unsolicited AEs ≥ Grade 3 | 93 (2.8) | 3 (5.2) | 86 (3.3) | 96 (3.2) | 7 (1.0) | 0 |
Related unsolicited AEs ≥ Grade 3 | 21 (0.6) | 0 | 20 (0.8) | 24 (0.8) | 1 (0.1) | 0 |
SAEs | 18 (0.5) | 1 (1.7) | 16 (0.6) | 17 (0.6) | 2 (0.3) | 0 |
Related SAEs | 0 | 0 | 0 | 0 | 0 | 0 |
AESI | 1 (<0.1) | 0 | 0 | 0 | 1 (0.1) | 0 |
VAED | 0 | 0 | 0 | 0 | 0 | 0 |
AEs leading to study intervention discontinuation | 2 (0.1) | 0 | 0 | 1 (<0.1) | 2 (0.3) | 0 |
AEs leading to study withdrawal | 1 (<0.1) | 0 | 0 | 0 | 1 (0.1) | 0 |
Death | 0 | 0 | 0 | 0 | 0 | 0 |
Item | Nab Titer (GMT), IU/mL | a Nab GMT Ratio | a,b Adjusted GMT Ratio | |
---|---|---|---|---|
HIV-Positive (n = 57) | HIV-Negative (n = 326) | |||
Estimate | 137.7 | 412.0 | 3.0 | 3.2 |
95% CI | 110.7~171.3 | 378.7~448.3 | 2.4~3.8 | 2.5~4.0 |
HIV Classification Stage | n | Nab GMT (in IU/mL) | 95% CI | * p-Value |
---|---|---|---|---|
Stage 1 | 25 | 142.55 | 105.34–192.90 | 0.3486 |
Stage 2 | 19 | 108.54 | 71.00–165.94 | |
Stage 3 | 10 | 169.05 | 85.40–334.65 |
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Cheng, S.-H.; Lien, C.E.; Hsieh, S.-M.; Cheng, C.-Y.; Liu, W.-D.; Lo, C.-L.; Ko, W.-C.; Chen, Y.-H.; Huang, C.-T.; Chang, H.-T.; et al. A Retrospective Study of the Safety and Immunogenicity of MVC-COV1901 Vaccine for People Living with HIV. Vaccines 2023, 11, 18. https://doi.org/10.3390/vaccines11010018
Cheng S-H, Lien CE, Hsieh S-M, Cheng C-Y, Liu W-D, Lo C-L, Ko W-C, Chen Y-H, Huang C-T, Chang H-T, et al. A Retrospective Study of the Safety and Immunogenicity of MVC-COV1901 Vaccine for People Living with HIV. Vaccines. 2023; 11(1):18. https://doi.org/10.3390/vaccines11010018
Chicago/Turabian StyleCheng, Shu-Hsing, Chia En Lien, Szu-Min Hsieh, Chien-Yu Cheng, Wang-Da Liu, Ching-Lung Lo, Wen-Chien Ko, Yen-Hsu Chen, Ching-Tai Huang, Hsiao-Ting Chang, and et al. 2023. "A Retrospective Study of the Safety and Immunogenicity of MVC-COV1901 Vaccine for People Living with HIV" Vaccines 11, no. 1: 18. https://doi.org/10.3390/vaccines11010018
APA StyleCheng, S.-H., Lien, C. E., Hsieh, S.-M., Cheng, C.-Y., Liu, W.-D., Lo, C.-L., Ko, W.-C., Chen, Y.-H., Huang, C.-T., Chang, H.-T., Hwang, S.-J., Wang, N.-C., Liu, M.-C., Lee, Y.-L., Tai, I.-C., Estrada, J. A. G., Lin, T.-Y., & Lee, W.-S. (2023). A Retrospective Study of the Safety and Immunogenicity of MVC-COV1901 Vaccine for People Living with HIV. Vaccines, 11(1), 18. https://doi.org/10.3390/vaccines11010018