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

NCT05205096 | Completed Phase 1

• 1 other identifier: IIT-LKM-2021-NCV03-02
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19

Outcome Measures

Primary Outcomes (1)

• Immunogenicity endpoint

  Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody

  14 days after booster vaccination

Secondary Outcomes (4)

• Immunogenicity endpoint

  30, 180 days after booster vaccination

• Immunogenicity endpoint

  14 days, 30 days, and 180 days after booster vaccination

• Safety endpoint

  Within 1 month after booster vaccination

• Safety endpoint

  Within 6 months after booster vaccination

Study Arms (1)

Investigational vaccine group

EXPERIMENTAL

Recombinant novel coronavirus vaccine (CHO cells) injection, Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose.

Biological: Recombinant novel coronavirus vaccine (CHO cells)

Interventions

Recombinant novel coronavirus vaccine (CHO cells) BIOLOGICAL

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.

Investigational vaccine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy people over 18 years old, and can provide vaccination information to prove that they have completed 2 doses of inactivated novel coronavirus vaccine (CoronaVac) within the past 3-9 months;
• The subjects voluntarily participate in the research, sign the informed consent form, and can provide valid identification, understand and comply with the requirements of the study protocol;
• Female subjects of childbearing age agree to use effective contraception from the start of the study to 2 months after vaccination.

You may not qualify if:

• Suspected or confirmed fever (fever ≥38.5℃) within 72 hours before enrollment, or axillary body temperature ≥37.3℃ on the day of enrollment;
• Diastolic blood pressure ≥ 100 mmHg and/or systolic blood pressure ≥ 160 mmHg without or after drug control;
• Have a history of previous infection with new coronary pneumonia or a positive nucleic acid test history;
• Those who currently suffer from the following diseases: 1.Thrombocytopenia, any coagulation disorder, or receiving anticoagulant therapy, etc.; 2.History of congenital or acquired immunodeficiency or autoimmune disease; asplenia, or history of spleen surgery, trauma, or treatment with immunomodulatory agents within 6 months, such as: immunosuppressive doses of glucocorticoids (dose reference: equivalent or prednisone 20mg/day for more than one week); or monoclonal antibody; or thymosin; or interferon, etc.; 3.Those suffering from acute infectious diseases or using antipyretic/analgesic/antiallergic drugs within 3 days before enrollment, or acute exacerbation of chronic diseases; 4.Cancer patients (except basal cell carcinoma) who have been off treatment for less than 6 months; 5.Serious chronic diseases such as congenital heart disease, severe liver and kidney disease, severe diabetes (with complications) that may interfere with the conduct or completion of the study; 6.Active tuberculosis, viral hepatitis patients with obvious liver damage (excluding virus carriers) and/or HIV-positive or syphilis-specific antibody-positive;
• Previous history of severe hypersensitivity to any vaccine, or severe hypersensitivity history to any component of the investigational vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, dyspnea, vascular nerve edema, etc.;
• Administer subunit vaccine and inactivated vaccine within 14 days before the trial vaccine, and receive live attenuated vaccine within 28 days;
• Received blood or blood-related products, including immune globulin, within 3 months prior to screening; or planned use within 6 months after study initiation to full vaccination;
• In addition to completing 2 doses of inactivated novel coronavirus vaccine within the past 3-9 months, participating in other COVID-19 related clinical trials;
• Pregnant women (including women of childbearing age with positive urine pregnancy test);
• Investigators believe that the presence of any disease or condition in the subject may put the subject at unacceptable risk; the subject cannot meet protocol requirements; interfere with the assessment of vaccine response, etc.

Sponsors & Collaborators

• Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.: lead
• Zhejiang Provincial Center for Disease Control and Prevention: collaborator

Study Sites (1)

Zhejiang Provincial Center for Disease Control and Prevention

Hangzhou, Zhejiang, 310051, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Huakun Lv

  Zhejiang Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 24, 2022
• Study Start: November 10, 2021
• Primary Completion: June 3, 2022
• Study Completion: July 31, 2022
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)