NCT05087277

Correlation Study of Isotype Switching and Neutralizing Capacity to the COVID-19 Variants Strain

Study on the Correlation of Isotype Switching, Neutralizing Antibody Titer and Cross Immunity Against COVID-19 Variants After Primary and Booster Vaccination

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Centers for Disease Control and Prevention, China · Other Government
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

The level of neutralizing antibody was detected by using the constructed pseudovirus covid-19 variant at baseline , 1 month , 6 months and 12 months after primary vaccination, within 15 days after booster immunization at 12 months . and the ability of IgG subclasses to neutralize and cross immunization of variant strains was analyzed.

Detailed description

In 150 individuals who received primary and booster COVID-19 inactivated vaccine, the neutralization ability of antibodies against covid-19 mutant after primary and booster immunization was evaluated by constructing pseudotyped SARS-CoV-2 variants. The contribution and influence of IgG subclasses on neutralization capacity were assessed by Elisa assay. All participants were recruited aged between 18 and 59 years old. Every participant was familiarized with the aim of the study and asked to sign an informed consent agreement and was required blood sampling at the day 0 of first dose vaccine and 1 month, 6 months after 2nd dose of primary immunization. All participants had received 1 dose of booster immunization at 12 months after fully primary vaccination. Then 150 people were divided into four groups, Blood samples were taken on days 0,3,7,10 and 14 to detect neutralizing antibodies and IgG subclasses separately. every sample was detected SARS-CoV-2 variants strain Alpha, Beta and Delta neutralizing antibody, and RBD-IgG1, IgG2, IgG3, and IgG4. every individual was conducted a detailed analysis correlation of isotype switching, neutralizing antibody titer and cross immunity against COVID-19 variants after primary and booster vaccination.

Conditions

• COVID-19

Timeline

• Start date: 2020-07-20
• Primary completion: 2021-10-10
• Completion: 2021-10-30
• First posted: 2021-10-21
• Last updated: 2021-10-21

Locations

1 site across 1 country: China