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Vaccine ; 39(20): 2746-2754, 2021 05 12.
Article in English | MEDLINE | ID: covidwho-1174522


BACKGROUND: This study examined the safety and immunogenicity of an inactivated SARS-CoV-2 vaccine. METHOD: In a phase I randomized, double-blinded, placebo-controlled trial involving 192 healthy adults 18-59 years old, two injections of three doses (50 EU, 100 EU, 150 EU) of an inactivated SARS-CoV-2 vaccine or placebo were administered intramuscularly at a 2- or 4-week interval. The safety and immunogenicity of the vaccine were evaluated. RESULTS: Vaccination was completed in 191 subjects. Forty-four adverse reactions occurred within 28 days, most commonly mild pain and redness at the injection site or slight fatigue. At days 14 and 28, the seroconversion rates were 87.5% and 79.2% (50 EU), 100% and 95.8% (100 EU), and 95.8% and 87.5% (150 EU), respectively, with geometric mean titers (GMTs) of 18.1 and 10.6, 54.5 and 15.4, and 37.1 and 18.5, respectively, for the schedules with 2-week and 4-week intervals. Seroconversion was associated with synchronous upregulation of antibodies against the S protein, N protein and virion and a cytotoxic T lymphocyte (CTL) response. No cytokines and immune cells related to immunopathology were observed. Transcriptome analysis revealed the genetic diversity of immune responses induced by the vaccine. INTERPRETATION: In a population aged 18-59 years in this trial, this inactivated SARS-CoV-2 vaccine was safe and immunogenic. TRIAL REGISTRATION: CTR20200943 and NCT04412538.

COVID-19 Vaccines , COVID-19 , Vaccines , Adolescent , Adult , Antibodies, Viral , China , Double-Blind Method , Humans , Immunogenicity, Vaccine , Middle Aged , SARS-CoV-2 , Young Adult
Health Soc Care Community ; 29(6): e249-e258, 2021 11.
Article in English | MEDLINE | ID: covidwho-1171136


This study aimed to establish a new COVID-19 Fear (Higher Education) scale to investigate the relationship between fear and generalised anxiety symptoms among Chinese students in mainland China, Hong Kong, and other countries. 219 Chinese university students studying in universities in mainland China (n = 76, 34.7%), Hong Kong (n = 66, 30.1%), and overseas (i.e., outside of China as international students, n = 77, 35.2%) participated in an online study from March 31, 2020 to April 4. Participants completed a newly developed COVID-19 Fear (Higher Education) scale to measure three domains of fear including fear of infection, fear of instability and fear of insecurity related to the COVID-19 pandemic. They also completed the Generalized Anxiety Disorder 7-item scale (GAD-7) on the severity of anxiety symptoms. About 9.6% of the participants could be classified as exhibiting high anxiety level according to the GAD-7. More students studying overseas (about 15%) were classified into the high GAD group when compared to students studying in both mainland China (6.6%) and Hong Kong (6.1%). MANOVA results showed that students studying in Hong Kong and overseas had more concerns related to preventive measures related to COVID-19 than their mainland counterparts did. We concluded that international students studying away from their home country would have higher risk to develop anxiety problems during a collective trauma such as the COVID-19 pandemic. Education institutions should provide support services including online support groups, social media groups for mutual support to alleviate the fear and anxiety of international students.

COVID-19 , Universities , Anxiety , Anxiety Disorders , China/epidemiology , Cross-Sectional Studies , Fear , Humans , Pandemics , SARS-CoV-2 , Students