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Frontiers of Medicine

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Front. Med.    2023, Vol. 17 Issue (5) : 867-877    https://doi.org/10.1007/s11684-023-0995-9
RESEARCH ARTICLE
Protection of inactivated vaccine against SARS-CoV-2 infections in patients with comorbidities: a prospective cohort study
Kanchana Ngaosuwan1(), Kamonwan Soonklang2, Chawin Warakul1, Chirayu Auewarakul1, Nithi Mahanonda3
1. Princess Srisavangavadhana College of Medicine, Chulabhorn Royal Academy, Bangkok 10210, Thailand
2. Data Management Unit, Centre of Learning and Research in Celebration of HRH Princess Chulabhorn's 60th Birthday Anniversary, Chulabhorn Royal Academy, Bangkok 10210, Thailand
3. Chulabhorn Hospital, Chulabhorn Royal Academy, Bangkok 10210, Thailand
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Abstract

Protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection of inactivated vaccines is not well characterized in people with comorbidities, who are at high risk of severe infection. We compared the risk of SARS-CoV-2 infection after complete vaccination with Sinopharm/BBIBP in people with comorbidities (e.g., autoimmune diseases, cardiovascular disease, chronic lung disease, and diabetes) with healthy individuals using a Cox-proportional hazard model. In July–September 2021, a total of 10 548 people (comorbidities, 2143; healthy, 8405) receiving the complete primary series of vaccination with Sinopharm/BBIBP in Bangkok, Thailand were prospectively followed for SARS-CoV-2 infection through text messaging and telephone interviewing for 6 months. A total of 295 infections from 284 participants were found. HRs (95% CI) of individuals with any comorbidities did not increase (unadjusted, 1.02 (0.77–1.36), P = 0.89; adjusted, 1.04 (0.78–1.38), P = 0.81). HRs significantly increased in the subgroup of autoimmune diseases (unadjusted, 2.64 (1.09–6.38), P = 0.032; adjusted, 4.45 (1.83–10.83), P = 0.001) but not in cardiovascular disease, chronic lung disease, or diabetes. The protection against SARS-CoV-2 infection of the Sinopharm vaccine was similar in participants with any comorbidities vs. healthy individuals. However, the protection appeared lower in the subgroup of autoimmune diseases, which may reflect suboptimal immune responses among these people.
Keywords COVID-19      Sinopharm/BBIBP vaccine      immunocompromised patients      real-world     
Corresponding Author(s): Kanchana Ngaosuwan   
Just Accepted Date: 30 May 2023   Online First Date: 04 July 2023    Issue Date: 07 December 2023
 Cite this article:   
Kanchana Ngaosuwan,Kamonwan Soonklang,Chawin Warakul, et al. Protection of inactivated vaccine against SARS-CoV-2 infections in patients with comorbidities: a prospective cohort study[J]. Front. Med., 2023, 17(5): 867-877.
 URL:  
https://academic.hep.com.cn/fmd/EN/10.1007/s11684-023-0995-9
https://academic.hep.com.cn/fmd/EN/Y2023/V17/I5/867
Fig.1  Participant flow chart.
Whole cohort Matched cohort
Total(N = 10 548) Comorbidities(N = 2143) No comorbidities(N = 8405) P Total(N = 5040) Comorbidities(N = 1260) No comorbidities(N = 3780) P
Sex
Male; n (%) 4767 (45.19) 844 (39.38) 3923 (46.67) < 0.001 2096 (41.59) 524 (41.59) 1572 (41.59) 1.00
Female; n (%) 5781 (54.81) 1299 (60.62) 4482 (53.33) 2944 (58.41) 736 (58.41) 2208 (58.41)
Median age (IQR); year 41 (29–52) 38 (27–48) 54 (45–61) < 0.001 49 (40–55) 49 (40–55) 49 (40–55) 0.61
BMI; mean ± SD; kg/m2 24.49 ± 4.92 26.20 ± 5.16 24.05 ± 4.77 < 0.001 24.89 ± 4.42 24.94 ± 4.39 24.87 ± 4.43 0.62
Diabetes mellitus; n (%) 645 (6.11) 645 (30.10) − 293 (5.81) 293 (23.25) −
Hypertension; n (%) 1432 (13.58) 1432 (66.82) − 723 (14.35) 723 (57.38) −
Chronic lung disease (%) 188 (1.78) 188 (8.77) − 148 (2.94) 148 (11.75) −
Cardiac disease; n (%) 121 (1.15) 121 (5.65) − 55 (1.09) 55 (4.37) −
Stroke; n (%) 59 (0.56) 59 (2.75) − 27 (0.54) 27 (2.14) −
Chronic kidney disease; n (%) 36 (0.34) 36 (1.68) − 19 (0.38) 19 (1.51) −
Cancer; n (%) 58 (0.55) 58 (2.71) − 33 (0.65) 33 (2.62) −
Autoimmune disease; n (%) 68 (0.64) 68 (3.17) − 64 (1.27) 64 (5.08) −
Tab.1  Baseline characteristics
Participant cohort No. of participants with events/Total participants (%) P Number of eventsa Incidence rate (95% CI)b, No. event per 1 000 000 person-days P
Comorbidities No comorbidities Comorbidities No comorbidities Comorbidities No comorbidities
Any comorbidities 57/2143(2.66%) 227/8405(2.70%) 0.91 60 235 148.6(115.4–191.4) 149.2(131.3–169.5) 0.99
Autoimmune disease 5/68(7.35%) 279/10480(2.66%) 0.017 5 290 387.8(161.4–931.6) 147.5(131.5–165.5) 0.058
Cardiovascular disease 5/164(3.05%) 279/10384(2.69%) 0.77 7 288 226.7(108.1–475.5) 147.8(131.7–165.9) 0.27
Chronic lung disease 4/188(2.13%) 280/10360(2.70%) 0.62 4 291 113.4(42.6–302.2) 149.7(133.5–167.9) 0.62
Diabetes mellitus 11/645(1.71%) 273/9903(2.76%) 0.11 13 282 106.8(62.0–184.0) 151.8(135.1–170.6) 0.20
Tab.2  Incidence rates of laboratory-confirmed SARS-CoV-2 infection of participants following the primary series of Sinopharm vaccination in the whole cohort.
Fig.2  Cumulative incidence of laboratory-confirmed SARS-CoV-2 infection following a primary series of Sinopharm vaccination in participants having any comorbidities compared with healthy individuals.
Fig.3  Cumulative incidence of laboratory-confirmed SARS-CoV-2 infection following a primary series of Sinopharm vaccination in participants with (A) autoimmune disease, (B) cardiovascular disease (CVD), (C) chronic lung disease (CLD), and (D) diabetes mellitus (DM). Each was compared with participants without diseases.
Participant cohort Total number of participants Total number of events Incidence rate (95% CI), No. of event per 1 000 000 person-days P Unadjusted HR(95% CI) a, b P Adjusted HR(95% CI) a, b, c P
Comorbid No comorbid Comorbid No comorbid Comorbid No comorbid
Any Comorbidities 1260 3780 38 95 160.5 (116.8–220.6) 134.3 (109.9–164.3) 0.35 1.21 (0.83–1.77) 0.31 1.17 (0.80–1.71) 0.40
Autoimmune disease 64 192 4 5 328.9 (123.4–876.2) 139.1 (57.9–334.2) 0.22 2.32 (0.62–8.69) 0.21 5.90 (1.08–32.33) 0.041
Cardiovascular disease 73 219 3 6 218.9 (70.6–678.7) 146.1 (65.6–325.2) 0.56 1.60 (0.40–6.43) 0.50 2.02 (0.48–8.45) 0.33
Chronic lung disease 148 444 3 11 108.3 (34.9–335.9) 132.7 (73.5–239.6) 0.79 0.80 (0.22–2.85) 0.72 0.82 (0.23–2.95) 0.76
Diabetes mellitus 293 879 7 23 127.2 (60.6–266.9) 139.4 (92.7–209.8) 0.86 0.92 (0.39–2.14) 0.84 0.99 (0.42–2.31) 0.97
Tab.3  Hazard ratios of laboratory-confirmed SARS-CoV-2 infection following the primary series of Sinopharm vaccination in the matched cohort
Fig.4  Median (IQR) days of the first laboratory-confirmed SARS-CoV-2 infection after complete vaccination in participants with autoimmune disease, comorbidities without autoimmune disease, and no comorbidities.
Participant cohort No. of participants with events/Total participants (%) Unadjusted HR a P Adjusted HR a, b P
Comorbidities No comorbidities
Any comorbidities 87/2143 (4.06%) 314/8405 (3.74%) 1.06 (0.84–1.35) 0.60 1.10 (0.87–1.39) 0.41
Autoimmune disease 6/68 (8.82%) 395/10480 (3.77%) 1.84 (0.76–4.46) 0.17 2.78 (1.15–6.73) 0.024
Cardiovascular disease 7/164 (4.27%) 394/10384 (3.79%) 1.40 (0.72–2.71) 0.31 1.63 (0.84–3.16) 0.14
Chronic lung disease 6/188 (3.19%) 395/10360 (3.81%) 0.81 (0.36–1.81) 0.60 0.82 (0.37–1.85) 0.63
Diabetes mellitus 17/645 (2.64%) 384/9903 (3.88%) 0.73 (0.46–1.16) 0.18 0.80 (0.51–1.27) 0.34
Tab.4  Hazard ratios of laboratory-confirmed SARS-CoV-2 infection or having symptoms suspected COVID-19 infection following the primary series of Sinopharm vaccination in the whole cohort
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