Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (BBIBP-CorV) in Hypertensive and/or Diabetic People Aged over 60 Years: A Prospective Open-Label Study.

AIMS: Severe acute respiratory syndrome coronavirus type 2 (SARS-COV-2) infection may increase the risk of developing dangerous symptoms among the elderly with underlying medical conditions. The aim of this study was to evaluate the safety and immunogenicity of the SARS-CoV-2 inactivated vaccine (Vero) in patients over 60 years of age with hypertension and/or diabetes. METHODS: An open-label, multi-center, prospective clinical trial was conducted at three medical sites in Fujian, China. Participants aged 60 years and above with hypertension, diabetes, and healthy controls were included in four groups: hypertension, diabetes, combined disease, and healthy controls. Volunteers received two doses of the inactivated SARS-COV-2 vaccine (BBIBP-CorV) on days 0 and 21. Adverse events were recorded for 21 days after each dose. Blood samples were taken before the first vaccination and 28 days after the second vaccination to detect the serum conversion rate and geometric mean titer (GMT) of neutralizing antibodies. RESULTS: A total of 480 participants (110 hypertension, 110 diabetes, 100 combined hypertension and diabetes, and 160 healthy controls) were recruited. The incidences of adverse events in the four groups were 10 (9.1%) in the hypertension group, 19 (17.3%) in the diabetes group, 11 (11.0%) in the combined disease group, and 11 (6.9%) in healthy controls, with no statistical significance (P > 0.05). At 28 days after the second vaccination, the positive conversion rates of serum neutralizing antibody in the four groups were 97.3%(107/110), 97.3% (107/110), 100.0% (99/99),and 98.7%(155/157), respectively, and the GMTs were 75.28 (95% CI 64.03-88.50), 69.4 (95% CI 59-81.63), 77.21 (95% CI 66.68-89.41), and 78.64 (95% CI 69.87-88.50), respectively. There was no significant difference in neutralizing antibody responses among the four groups (P > 0.05). Additionally, the GMT after immunization was higher in females than in males (OR = 2.59, 95% CI 1.31-5.12). CONCLUSIONS: The BBIBP-CorV vaccine is safe and elicits an adequate antibody response in patients over 60 years of age with hypertension and/or diabetes. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT05065879.

Safety of primary immunization using inactivated SARS-CoV-2 vaccine (CoronaVac®) among population aged 3 years and older in a large-scale use: A multi-center open-label study in China.

OBJECTIVE: To evaluate the safety of primary immunization using CoronaVac® among population aged 3 years and above in a large-scale use. METHOD: A multi-center open-label study was carried out in 11 provinces of China. Individuals aged 3 years and older who had no history of COVID-19 vaccination or had received only one dose of CoronaVac® were enrolled in this study. Adults and elderly with or without underlying medical conditions(UMCs) were also recruited. Eligible participants received one or two doses of CoronaVac® with an interval of 28 days. Demographic information, vaccination and the occurrence of adverse events were recorded by participants or guardians using data collection system designed for this study. All adverse events occurred within 6 months after the second dose of vaccination were collected. The incidence of adverse events that cannot be ruled out as being caused by the vaccine were calculated to assess the safety of CoronaVac®. This study is registered with ClinicalTrials. Gov (NCT04911790 and NCT04992208). RESULTS: A total of 162,691 participants have been included in this study and 89.50 % had finished primary immunization. Among adults and elderly, people with UMCs accounted for 25.85 %, with the top five disease being hypertension, diabetes, chronic gastritis, coronary heart disease(CHD) and kidney stone. The overall incidence of adverse reactions (ARs) within 6 months after the second vaccination was 2.70 %, with incidence for children and adolescents, adults, and elderly being 2.03 %, 3.46 %, and 1.90 %, respectively. Most ARs were mild (grade 1). Pain at the injection sites, fatigue, induration/swelling, and headache were the most common symptoms, occurring in 1.64 %, 0.46 %, 0.31 % and 0.24 %, respectively. No serious adverse events related to vaccines were reported. No adverse events of special interest (AESIs) were identified. For children and adolescents, children aged 3-5 years had the highest incidence of ARs of 3.29 %. The incidence of ARs among those aged 18 years and older with and without UMCs were 2.81 % and 2.99 %, respectively, with no statistical significance between two groups(P = 0.089). And people with coronary heart disease had higher AR incidence compared to those with other UMCs, but the most common symptoms was pain at the injection site. CONCLUSION: CoronaVac® is safe in a large-scale use and shows well-tolerance for children and adolescents and people with underlying medical conditions. Further studies need to be conducted to explore the relation of ARs incidence to age or different kinds of UMCs.

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

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.

Comparison of Safety of Different Vaccine Boosters Following Two-Dose Inactivated Vaccines: A Parallel Controlled Prospective Study.

A vaccine booster to maintain high antibody levels and provide effective protection against COVID-19 has been recommended. However, little is known about the safety of a booster for different vaccines. We conducted a parallel controlled prospective study to compare the safety of a booster usingfour common vaccines in China. In total, 320 eligible participants who had received two doses of an inactivated vaccine were equally allocated to receive a booster of the same vaccine (Group A), a different inactivated vaccine (Group B), an adenovirus type-5 vectored vaccine (Group C), or a protein subunit vaccine (Group D). A higher risk of adverse reactions, observed up to 28 days after injection, was found in Groups C and D, compared to Group A, with odds ratios (OR) of 11.63 (95% confidence interval (CI): 4.22-32.05) and 4.38 (1.53-12.56), respectively. Recipients in Group C were more likely to report ≥two reactions (OR = 29.18, 95% CI: 3.70-229.82), and had a higher risk of injection site pain, dizziness, and fatigue. A gender and age disparity in the risk of adverse reactions was identified. Despite the majority of reactions being mild, heterologous booster strategies do increase the risk of adverse reactions, relative to homologous boosters, in subjects who have had two doses of inactive vaccine.