Effectiveness of COVID-19 Vaccines Against the SARS-COV-2 Delta (B.1.617.2) (FASTER)

Effectiveness of COVID-19 Vaccines Against the SARS-COV-2 Delta (B.1.617.2) in China-A Real World Study

Up to now, Corona Virus Disease 2019 (COVID-19) continues to spread rapidly around the world. From the beginning of the epidemic to the present, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has continuously evolved and mutated, producing transmissible and virulent variants. At present, the infection rate of Delta variant strains is still increasing globally. The epidemic strain of novel coronavirus infection in Xi 'an city is δ (B.1.617.2). SARS-CoV-2 Delta has more infectious, higher viral load and shorter incubation period than other SARS-COV-2 delta strains. Several studies have shown that the protective efficacy of vaccines against different SARS-COV-2 virus variants is different, and SARS-COV-2 viral load is closely related to transmission, clinical phenotype and prognosis of infected patients. According to the notice of Xi'an Municipal Health Commission, a total of 2,139 local confirmed cases were reported in Xi 'an on January 10,2022, and the proportion of severe cases was 2.36%, which was significantly lower than the 7% of nation since the second half of 2020. According to the preliminary investigation by the applicant's team, the severe illness rate in Xi'an has decreased significantly, which benefits from the active promotion of domestic vaccination, early intervention, and use of neutralizing antibodies. The purpose of this study is to analyze the effects of vaccination on nucleic acid turning negative, clinical characteristics and prognosis of patients infected with SARS-COV-2 delta, and to clarify the protective effects of vaccination, which is of great significance for the prevention and control of the SARS-COV-2 delta (B.1.617.2) in Xi' an.

Study Overview

• Status: Completed
• Conditions: SARS CoV 2 Infection
• Intervention / Treatment: Other

Detailed Description

In this study, through follow-up of SARS-COV-2 Delta infection patients in Xi 'an, Shaanxi Province, China, exploring the effects of vaccination on nucleic acid turning negative, clinical characteristics and prognosis of patients infected with SARS-COV-2 Delta, so as to clarify the protective effects of vaccination on SARS-COV-2 Delta.

• Study Type: Observational
• Enrollment (Actual): 1500

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • First Affiliated Hospital of Xian JiaotongUniversity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with SARS-COV-2 Delta infection in Xi'an, Shaanxi Province, China, from December 2021 to January 2022

Description

Inclusion Criteria:

• Diagnosed with SARS-COV-2 Delta infection
• Clear vaccination information
• Plasma viral load measurements within 24 hours of admission to the hospital
• Performing continuous plasma viral load measurements
• Obtaining informed consent

Exclusion Criteria:

• Pregnant women
• Clinical diagnosis of organ dysfunction or failure before infection
• Long-term use of immunosuppressants or immunodeficiency patients

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Partial vaccination; One dose of vaccine received at least 7 days prior to study enrollment
Full vaccination; Two doses of COVID-19 vaccine received at least 7 days prior to study enrollment
Unvaccinated; No dose of COVID-19 vaccine for at least 7 days prior to study enrollment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the proportion of severe and critical cases	the proportion of severe and critical cases during hospitalization	during hospitalization, an average of 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the duration of viral shedding	the duration of SARS-COV-2 Delta (B.1.617.2) shedding	during hospitalization, an average of 1 month

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Study Director: Kai Qu, Doctor, First Affiliated Hospital Xi'an Jiaotong University; Study Director: Guoliang Li, Doctor, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Actual): January 15, 2022
• Study Completion (Actual): January 15, 2022

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: China; vaccine; protective effect; SARS-COV-2 Delta (B.1.617.2 )
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: XJTU1AF2022LSK-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No