Evaluation of Immunogenicity and Safety of Vero Cell-Derived Inactivated COVID-19 Vaccine in Older Patients with Hypertension and Diabetes Mellitus

Abstract

Background: To evaluate the immunogenicity and safety of the COVID-19 vaccine (Vero cell), inactivated, in a population aged ≥60 years with hypertension or(/and) diabetes mellitus. Methods: A total of 1440 participants were enrolled and divided into four groups, 330 in the hypertension group, 330 in the diabetes group, 300 in the hypertensive combined with diabetes group (combined disease group), and 480 in the healthy population group. Two doses of the COVID-19 vaccine (Vero cell), inactivated, were administered at a 21-day interval and blood samples were collected before vaccination and 28 days after the second dose to evaluate the immunogenicity. The adverse events and changes in blood pressure and blood glucose levels after vaccination were recorded. Results: The seroconversion rate of the COVID-19 neutralizing antibodies was 100% for all participants. The post-inoculation geometric mean titer (GMT) in the four groups of the hypertension, diabetes, combined disease, and healthy populations were 73.41, 69.93, 73.84, and 74.86, respectively. The seroconversion rates and post-vaccination GMT in the hypertension, diabetes, and combined disease groups were non-inferior to the healthy population group. The rates of vaccine-related adverse reactions were 11.93%, 14.29%, 12.50%, and 9.38%, respectively. No serious adverse events were reported during the study. No apparent abnormal fluctuations in blood pressure and blood glucose values were observed after vaccination in participants with hypertension or(/and) diabetes. Conclusions: The COVID-19 vaccine (Vero cell), inactivated, showed good immunogenicity and safety in patients aged ≥60 years suffering from hypertension or(/and) diabetes mellitus.

Uptake of Heterologous or Homologous COVID-19 Booster Dose and Related Adverse Events Among Diabetic Patients: A Multicenter Cross-Sectional Study — China, 2022

“…Social factors have been highlighted in many health behavior theories, such as the Theory of Planned Behavior (TPB) since they change people's health behaviors. Nevertheless, Ai et al showed that the heterologous booster dose produces higher SARS-CoV-2 neutralizing antibodies and similar adverse events than the homologous booster dose vaccination in healthy adults (10). In this study, heterologous booster dose and homologous booster dose produced similar adverse events in diabetic patients.…”

A systematic review and meta-analysis of the effectiveness and safety of COVID-19 vaccination in older adults

“…However, the number of articles reporting on RCTs examining T-cell responses and cytokine production after COVID-19 vaccination was insufficient, and these measures were not included in the analysis of protective immunity in the current study. Additionally, a number of older adults with diabetes or high blood pressure showed little difference in titer levels of neutralizing antibodies after vaccination when compared with healthy adults (69). Overall, the outcomes analysis of the retrospective studies showed that vaccination was effective in providing protection from SARS-CoV-2 infection, as well as in increasing the antibody positive conversion rate after vaccination.…”

“…Finally, the same indicators (including author, year of publication, number of participants, and vaccination efficacy and safety) could be extracted from eight qualitative analysis articles (62)(63)(64)(65)(66)(67)(68)(69), which are shown in Appendix 6. However, these studies could not be included in the meta-analysis due to insufficient data and/or descriptive explanations of vaccination efficacy and safety without the use of a parallel control, among other reasons.…”

“…However, these studies could not be included in the meta-analysis due to insufficient data and/or descriptive explanations of vaccination efficacy and safety without the use of a parallel control, among other reasons. One article reported the VE (63), three articles reported antibody titer levels after vaccination (64,65,69), and six articles reported the occurrence of vaccine-related adverse events in the elderly (62,(64)(65)(66)(67)(68).…”

Immune Response to CoronaVac and Its Safety in Patients with Type 2 Diabetes Compared with Healthcare Workers

“…Conversely, another study reported no statistically significant differences in immunogenicity between patients with diabetes and healthy controls. For example, a study on the Vero-cell-derived inactivated COVID-19 vaccine in older patients with hypertension and diabetes mellitus found no statistically significant differences in GMT-neutralizing antibody post-vaccination between groups, including elderly patients with hypertension (n = 325), diabetes (n = 328), combined hypertension and diabetes (n = 292) and healthy controls (n = 468) [ 32 ]. Another study involving 76 patients with diabetes (26.4%), who received Pfizer-BioNTech and Sinopharm vaccines and underwent multivariable regression analysis, found no statistically significant negative impact of diabetes mellitus on IgG titre [ 33 ].…”