ABSTRACT
Severe acute respiratory syndrome coronavirus 2 breakthrough infection in highly vaccinated populations raises study on the effectiveness for inactivated vaccine, including effectiveness of the vaccine dose, the continuance of effectiveness, the effectiveness against severe/critical coronavirus disease 2019 and against secondary attacks. A population of 10 870 close contacts were investigated in a Delta variant's epidemic. The effectiveness of vaccination was estimated in a test-negative case-control study. In addition, serum was used to detect neutralizing antibodies, to explore their correlation to effectiveness. The vaccine effectiveness (VE) values were estimated for populations aged 12 years or older. The overall adjusted VE was 56.2% and a two-dose vaccine was more effective than a one-dose vaccine (56.7% vs. 43.8%). In addition, the population that got the second dose vaccine within 2 months showed higher VE than the population vaccinated for longer than 2 months (61.5% vs. 52.3%). Among the population who vaccinated 2 doses or within 2 months, a higher level of neutralizing antibodies was observed. For infected cases, vaccinated populations showed lower rates of transmission (2.63% vs. 4.36%). Further, those vaccinated cases, who were not found causing transmission, had a higher level of antibodies. The study provided a full view of the effectiveness of inactivated vaccines in a real-world setting. The time-related VE against infection and lower transmission of breakthrough vaccinated cases were observed, which may indicate that a necessity of a booster vaccine to maintain the effectiveness and high level of neutralizing antibody.
ABSTRACT
BACKGROUND: Nucleic acid detection represents limitations due to its false-negative rate and technical complexity in the COVID-19 pandemic. Anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody tests are widely spread all over the world presently. However, there is no report on the effectiveness of anti-SARS-CoV-2 antibody testing methods in China. METHODS: We gathered 10776 serum samples from close contacts of the SARS-CoV-2 infections in Fujian of China and used 2 chemiluminescence immunoassays (Wantai Bio., Yahuilong Bio.) and 2 lateral flow immunoassays (Lizhu Bio. and Dongfang Bio.) to perform the anti-SARS-CoV-2 antibody tests in China. RESULTS: The 4 antibody tests have great diagnostic value for infected or uninfected, especially in the neutralizing antibodies tests, the AUC can reach 0.939 (Wantai Bio.) and 0.916 (Yahuilong Bio.). Furthermore, we used pseudoviruses and euvirus neutralization assay to validate the effectiveness of these antibody test, the results of pseudoviruses neutralization assay or euvirus neutralization assay shows a considerable correlation with the 4 antibody detection respectively, particularly in euvirus neutralization assay, neutralizing antibodies detected by Wantai Bio. or Yahuilong Bio., the correlation can get the level of 0.93 or 0.82. CONCLUSIONS: The findings of this study demonstrate that the detections of antibodies have profound value in the diagnosis of COVID-19.
Subject(s)
COVID-19 , Humans , COVID-19/diagnosis , SARS-CoV-2 , Pandemics , Antibodies, Viral , Antibodies, NeutralizingABSTRACT
SARS-CoV-2 breakthrough infections have been reported because of the reduced efficacy of vaccines against the emerging variants globally. However, an accurate model to predict SARS-CoV-2 breakthrough infection is still lacking. In this retrospective study, 6,189 vaccinated individuals, consisting of SARS-CoV-2 test-positive cases (n = 219) and test-negative controls (n = 5970) during the outbreak of the Delta variant in September 2021 in Xiamen and Putian cities, Fujian province of China, were included. The vaccinated individuals were randomly split into a training (70%) cohort and a validation (30%) cohort. In the training cohort, a visualized nomogram was built based on the stepwise multivariate logistic regression. The area under the curve (AUC) of the nomogram in the training and validation cohorts was 0.819 (95% CI, 0.780-0.858) and 0.838 (95% CI, 0.778-0.897). The calibration curves for the probability of SARS-CoV-2 breakthrough infection showed optimal agreement between prediction by nomogram and actual observation. Decision curves indicated that nomogram conferred high clinical net benefit. In conclusion, a nomogram model for predicting SARS-CoV-2 breakthrough infection based on the real-world setting was successfully constructed, which will be helpful in the management of SARS-CoV-2 breakthrough infection.