Clinical Trials Logo
  1. Home
  2. Covid19
  3. NCT04729374
  4. Details
NCT04729374 Clinical Trial

COVID-19 Vaccine Induced Adaptive Immune Responses

COVID-19 Clinical Trial

Official title:
Longidutinal, Dynamic Analysis of COVID-19 Vaccine Induced Adaptive Immune Responses

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04729374
Other study ID # NJGLVAC-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 27, 2021
Est. completion date December 31, 2023

Study information
Verified date February 2021
Source The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Contact Chao Wu, M.D., Ph.D
Phone +8613809022921
Email dr.wu@nju.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The coronavirus disease 2019 (COVID-19) caused by the infection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)，resulting in more than 82 million confirmed cases and caused around 1.8 million deaths, as of 2 January 2021. The ongoing pandemic still poses unprecedented global threat to public health system worldwide. On December 31, 2020, the joint prevention and control agency of China Council announced that Sinopharm SARS-CoV-2 inactivated vaccine had been conditionally approved by National Medical Products Administration, and the protection rate was 79.34%. So far, more than 198 vaccines were currently in preclinical or clinical development. The investigators aimed to initiate an observational cohort of healthy individuals injected with SARS-CoV-2 Vaccine, which will perform a longitudinal, comprehensive analysis of the SARS-CoV-2 vaccine Induced adaptive immune responses.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 59 Years
Eligibility Inclusion Criteria: - Healthy and aged between 18 to 59 years Exclusion Criteria: - High-risk epidemiology history within 14 days before enrollment - SARS-CoV-2 specific IgG or IgM positive in serum - Positive PCR test for SARS-CoV-2 from pharyngeal or anal swab samples - Axillary temperature of more than 37·0°C - Known allergy to any vaccine component - Thyroid disease

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Nanjing Drum Tower Hospital Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Concentration of anti-SARS-CoV-2 neutralizing antibody in serum 2 years
Primary Concentration of serum anti-SARS-CoV-2 binding antibody 2 years
Primary Rate of anti-SARS-CoV-2 T cell response 2 years
Primary The rate of SARS-CoV-2 infection 2 years
Secondary Rate of anti-SARS-CoV-2 B cell response 2 years
See also
  Status Clinical Trial Phase
Withdrawn NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Booster Study of SpikoGen COVID-19 Vaccine Phase 3
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure