NCT05205096

Immunogenicity and Safety of Booster Immunization of ZF2001 After Inoculation With Two Doses of CoronaVac

Study on the Immunogenicity and Safety of Booster Immunization of Recombinant Novel Coronavirus Vaccine (CHO Cells) After Inoculation With Two Doses of Inactivated Vaccine (CoronaVac) in People Over 18 Years Old

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Study objectives: To evaluate the immunogenicity and immunity persistence and safety of recombinant novel coronavirus vaccine (CHO cells) after booster immunization in populations vaccinated with two doses of marketed novel coronavirus inactivated vaccine (CoronaVac). Study method: For the subjects who have been vaccinated with two doses (the interval between two doses ≥ 3 weeks) of the novel coronavirus inactivated vaccine (CoronaVac) for 3 to 9 months, 1 dose of the recombinant novel coronavirus vaccine (CHO cells) was administered. Blood samples were collected before booster immunization, 14 days, 30 days and 180 days after booster immunization for neutralizing antibody detection. All AEs were collected within 1 month after the booster immunization. All SAEs were collected within 6 months after the booster immunization.

Detailed description

This trial plans to enroll 480 subjects, who will be divided into 3 groups according to the interval between booster immunization and basic immunization: group A (3-4 months), group B (5-6 months), group C (7-9 months) each with 160 subjects (including 120 subjects aged 18-59 years and 40 subjects aged 60 years and above). The recombinant novel coronavirus vaccine (CHO cells) was thoroughly mixed and injected intramuscularly at the deltoid muscle of the upper arm according to the instructions. Blood samples were collected before booster immunization, 14 days, 30 days and 180 days after booster immunization for neutralizing antibody detection. All AEs were collected within 1 month after the booster immunization. Solicited AEs (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

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant novel coronavirus vaccine (CHO cells)	At 3-9 months after the immunization with 2 doses of inactivated vaccine (CoronaVac), 1 dose of recombinant novel coronavirus vaccine (CHO cells) is vaccinated.

Timeline

• Start date: 2021-11-10
• Primary completion: 2022-06-03
• Completion: 2022-07-31
• First posted: 2022-01-24
• Last updated: 2023-09-18

Locations

1 site across 1 country: China