NCT05492643

The Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (SYS6006) as Heterologous Booster in Participants Aged 18 Years and Older Vaccinated With Inactivated SARS-CoV-2 Vaccine

A Single Center, Open Label Clinical Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (SYS6006) as Heterologous Booster in Participants Aged 18 Years and Older Vaccinated With Inactivated SARS-CoV-2 Vaccine

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Zhongnan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study plans to enrol 1000 participants 18 years and above, with ≥10% participants ≥60 years old. According to SARS-CoV-2 vaccine vaccination history, they will be evenly divided into 2 groups, Group A and Group B. Group A: will enrol 500 participants who have received 2 doses of inactivated SARS-CoV-2 vaccine according to national immunization planning, whose last dose was given at least 6 months ago. They will be given one dose of the study vaccine (SYS6006) after enrolment. Group B: will enrol 500 participants who have received 3 doses of inactivated SARS-CoV-2 vaccine according to national immunization planning, whose last dose was given at least 6 months ago. They will be given one dose of the study vaccine (SYS6006) after enrolment. The study is devided into two stages, the first stage will enrol 200 participants with 100 in Group A and 100 in Group B. They will undergo laboratory examination, immunogenicity observation and safety observation. The first 30 participants in each group will take extra cellular immune testing; the second stage will enrol the remaining 800 participants for safety observation.

Detailed description

All participants: all the 1000 participants enrolled will undergo safety observation. Immunogenicity Subgroup: the first 100 participants enrolled in group A will be assigned to Group A1; the first 100 participants enrolled in group B will be assigned to Group B1. Blood samples will be taken from Group A1 and Group B1 participants (200 in total) for humoral immunity testing and laboratory examination. Laboratory examination include blood routine examination, urine routine test, blood biochemistry, coagulation, thyroid function, cardiac enzymes and troponin. Humoral immunity testing include serum SARS-CoV-2 neutralizing antibody detection as measured by live virus and pseudovirus assay, S1 protein specific IgG binding antibody detection as measured by ELISA. Cellular immunity Subgroup: the first 30 participants enrolled in Group A1 and Group B1 will take extra blood samples for specific cellular immune response (60 in total) as measured by ELISpot.

Conditions

• SARS-CoV-2
• Safety
• Immunotoxicity

Interventions

Type	Name	Description
BIOLOGICAL	one dose of the study SARS-CoV-2 mRNA Vaccine (SYS6006)	all the 1000 participants enrolled will be given one dose of the study SARS-CoV-2 mRNA Vaccine (SYS6006)
OTHER	Cellular Immunity	the first 30 participants enrolled in each group will take extra blood samples for specific cellular immune response as measured by ELISpot.
OTHER	Humoral Immunity	the first 100 participants enrolled in each group will take extra blood samples for humoral immunity testing and laboratory examination.
OTHER	Safety	all the 500 participants enrolled will undergo safety observation

Timeline

• Start date: 2022-08-13
• Primary completion: 2023-02-27
• Completion: 2023-03-01
• First posted: 2022-08-08
• Last updated: 2022-10-12

Locations

1 site across 1 country: China