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COVID-19Phase 1/2NCT05205083

Immunogenicity and Safety of Booster Immunization of ZF2001 After Inoculation With Two Doses of BBIBP-CorV

A Phase 1/2 study testing Recombinant novel coronavirus vaccine (CHO cells) in people with COVID-19, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 (BBIBP-CorV). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Recombinant novel coronavirus vaccine (CHO cells)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
480 participants
Where
1 siteChina
Study dates
10 Nov 2021to Jul 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy subjects over 18 years old, and can provide vaccination information to prove that they have completed 2 doses of inactivated novel coronavirus vaccine (BBIBP-CorV) 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

Huakun Lv contact

13588458021

hklv@cdc.zj.cn

China1 site, 1 recruiting

  • Zhejiang Provincial Center for Disease Control and Prevention

    Hangzhou, Zhejiang, 310051

    Huakun Lv, 13588458021, hklv@cdc.zj.cn

    Recruiting

Other trials in China

About this study

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

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 (BBIBP-CorV).

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 (BBIBP-CorV) 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.

Read the 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
Being tested
Recombinant novel coronavirus vaccine (CHO cells)
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant novel coronavirus vaccine (CHO cells)Biological

    At 3-9 months after the immunization with 2 doses of inactivated vaccine (BBIBP-CorV), 1 dose of recombinant novel coronavirus vaccine (CHO cells) is vaccinated.

Study groups in NCT05205083
Study groupRoleWhat they receive
Investigational vaccine groupExperimentalRecombinant novel coronavirus vaccine (CHO cells) injection, Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose.
Receives: Biological: Recombinant novel coronavirus vaccine (CHO cells)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immunogenicity endpoint

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

    Measured: 14 days after booster vaccination

Secondary outcomes (4)

  1. Immunogenicity endpoint

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

    Measured: 30, 180 days after booster vaccination

  2. Immunogenicity endpoint

    4 times growth rate of SARS-CoV-2 neutralizing antibody

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

  3. Safety endpoint

    Incidence of AEs

    Measured: Within 1 month after booster vaccination

  4. Safety endpoint

    Incidence of SAEs

    Measured: Within 6 months after booster vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2022
  2. Study start10 Nov 2021
  3. Primary completionMar 2022 (estimated)
  4. Study completionJul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
480 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05205083
Sponsor's protocol ID
IIT-LKM-2021-NCV03-01
Status last verified
Jan 2022
First submitted
11 Jan 2022
Last updated
24 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen Y, Zhang X, Gong L, Liang Z, Hu X, Xing B, Liao Y, Yuan L, Chen G, Lv H. Safety, immunogenicity and immune-persistence of heterologous prime-boost immunization with BBIBP-CorV and ZF2001 against SARS-CoV-2 in healthy adults aged 18 years or older. Expert Rev Vaccines. 2023 Jan-Dec;22(1):1079-1090. doi: 10.1080/14760584.2023.2274491. Epub 2023 Nov 8.

    PubMed 37877219

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Recombinant novel coronavirus vaccine (CHO cells) in people with COVID-19, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Huakun Lv (13588458021, hklv@cdc.zj.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immunogenicity endpoint (time frame: 14 days after booster vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05205083, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.

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