COVID-19 Vaccine Induced Adaptive Immune Responses

Nanjing University

Status: Unknown

Conditions: COVID-19; Vaccine; SARS-CoV-2

Study type: Observational

Funder types: Other

Identifiers

NCT04729374

NJGLVAC-001

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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