The safety and immunogenicity of inactivated COVID-19 vaccine in old pulmonary tuberculosis patients

Abstract

The immunogenicity and safety of vaccines against coronavirus disease 2019 (COVID-19) remain unknown in patients with a history of pulmonary tuberculosis (OPTB). Therefore, the safety and effectiveness of inactivated vaccines against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) were assessed in patients with a history of PTB. The study cohort included 106 healthy controls and 93 adult patients with OPTB who received a two-dose vaccination. The study period was 21 to 105 days. Concentrations of antibodies (Abs) against receptor-binding domain (RBD) IgG and SARS-CoV-2 neutralizing Abs (NAbs) were measured, in addition to the frequencies of SARS-CoV-2-specific B and a portion T cells. The incidence of adverse events was similar between the OPTB patients and healthy controls. No severe adverse events occurred. Concentrations of Abs against RBD-IgG and CoV-2 neutralizing Abs in addition to the frequencies of RBD-specific memory B cells proportions were lower in OPTB patients than the healthy controls (all, p < 0.05), while the frequencies of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4 + ) cells were higher ( p = 0.023). There was no obvious correlation between age and blood concentrations of Abs against RBD-IgG and CoV-2 neutralizing Abs, while immune responses were similar in the fibrosis and calcification groups. The period of time following full-course vaccination and lymphocyte counts were associated to anti-RBD-IgG responses. Inactivated COVID-19 vaccinations were well tolerated in OPTB patients, although immunogenicity was limited in this population. This study has been registered at ClinicalTrials.gov (NCT05043246). Supplementary Information The online version contains supplementary material available at 10.1007/s10096-023-04566-0.

A Review of Inactivated COVID-19 Vaccine Development in China: Focusing on Safety and Efficacy in Special Populations

“…However, it is equally important to gather safety and efficacy data for specific populations, such as children/adolescents, the elderly, chronically ill individuals, and cancer patients, to ensure comprehensive coverage of COVID-19 vaccines. Some studies have shown heterogeneity in the antibody responses of SARS-CoV-2 vaccine recipients with underlying diseases, including cancer, autoimmune disease, and HIV infection [ 46 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 ] ( Table 1 ). Table 1 provides a detailed overview of various COVID-19 vaccines, including their targeted populations, drug names, titles of clinical trials, clinical trial phases, current status, sample sizes, trial durations, immunogenicity data, safety data, and adverse effects.…”

“…Antibody responses and memory B-cell responses were significantly lower in patients with type 2 diabetes compared to healthy controls [ 84 ]. The frequency of Ab concentrations of anti-RBD IgG and CoV-2 neutralizing Abs and the proportion of RBD-specific memory B cells were lower in elderly TB patients than in healthy controls, with limited immunogenicity [ 65 ]. Inactivated vaccines provide limited protection against progression from asymptomatic infection to moderate to mild disease in infected populations and durable protection against the progression of non-severe disease to severe disease caused by Omicron BA.…”