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

NCT05205096 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2023-09-18

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Zhejiang Provincial Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Huakun Lv · Zhejiang Provincial Center for Disease Control and Prevention

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-10
Primary Completion
2022-06-03
Completion
2022-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05205096 on ClinicalTrials.gov