NCT05198102

ZF2001 Booster Immunization Clinical Trials of 12 Months After the Completion of Basic Immunization

To Evaluate the Immunogenicity and Safety of Booster Immunization 12 Months After the Completion of Basic Immunization of Recombinant Novel Coronavirus Vaccine (CHO Cell) in People 18 Years Old and Above

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the immunogenicity and safety of the recombinant novel coronavirus vaccine (CHO cells) after the booster immunization. It is planned to screen 300 subjects of 18 years old and above who have completed the basic immunization of recombinant novel coronavirus vaccine (CHO cells), to evaluate the immunogenicity and safety of the booster immunization of 12 months (window period ± 3 months) after the basic immunization. Investigate the geometric mean titer (GMT), GMI and 4 times growth rate of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody 14 days, 30 days, and 6 months after booster vaccination; the incidence of all AEs within 1 month after the booster vaccination, the incidence of all serious adverse events (SAE) within 6 months after the booster vaccination.

Detailed description

This study adopts an open experimental design. It is planned to screen 300 subjects of 18 years old and above who have completed the basic immunization of recombinant novel coronavirus vaccine (CHO cells), to evaluate the immunogenicity and safety of the booster immunization of 12 months (window period ± 3 months) after the basic immunization. Immunogenicity observation: the geometric mean titer (GMT), GMI and 4 times growth rate of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody 14 days, 30 days, and 6 months after booster vaccination. Safety observation: All adverse events (AE) were collected within 30 minutes after the booster immunization, all AEs (including both solicited and unsolicited AEs) 0-7 days after the booster immunization, and all AEs (unsolicited AEs) 8-30 days after the booster immunization. Solicited AE (the following events occurring within 7 days of vaccination) : Adverse events at the inoculation site (local) : pain, pruritus, redness, swelling, rash, induration; Non-inoculated site (systemic) adverse events: fever, headache, fatigue, diarrhea, nausea, vomiting, muscle pain (non-inoculated site), acute allergic reactions, cough. All SAEs were collected within 6 months after the booster immunization.

Conditions

• Prevention of COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant novel coronavirus vaccine (CHO cells)	At 12 months after the basic immunization (window period ± 3 months), 1 dose of recombinant novel coronavirus vaccine (CHO cells) is vaccinated.

Timeline

• Start date: 2021-12-29
• Primary completion: 2022-07-19
• Completion: 2022-07-19
• First posted: 2022-01-20
• Last updated: 2022-09-29

Locations

1 site across 1 country: China