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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 May 2024 |
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Main ID: |
NCT06381843 |
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Date of registration:
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23/04/2024 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Clinical Study to Evaluate the Safety and Immunogenicity of the Recombinant COVID-19 Vaccine (Sf9 Cell) as a Booster
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Scientific title:
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A Clinical Study to Evaluate the Safety and Immunogenicity of the Recombinant COVID-19 Vaccine (Sf9 Cell) as a Booster in People Aged 18-60 Years |
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Date of first enrolment:
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August 2, 2022 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT06381843 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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China
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- (1) Aged 18-60 years old, voluntarily sign the ICF approved by the ethics committee
before any research procedure begins, and agree to participate in this research;
- (2) Subjects who are in line with the immunization of this product after medical
history, physical examination and clinical judgment are healthy;
- (3) Participate in this clinical trial after completing 3 doses of immunization = 6
months (calculated based on the date of the last vaccination as 0) in accordance with
the domestically approved inactivated vaccine vaccination program, and can provide
relevant vaccination certificates;
- (4) The subjects are able and willing to comply with the requirements of the clinical
trial protocol, and can complete the study follow-up of about 12 months;
- (5) Males and females of childbearing age who are fertile voluntarily use effective
contraceptive measures (such as condoms, intrauterine devices, spermicides) from the
signing of the informed letter to 6 months after the completion of vaccination, and
contraceptive use is not allowed medicine. Female subjects had a negative pregnancy
test and agreed not to breastfeed during the study period and for at least 3 months
after vaccination with the experimental vaccine.
- (6) Underarm body temperature <37.3?.
Exclusion Criteria:
- (1) Positive SARS-CoV-2 RT-PCR test at screening;
- (2) A history of human coronavirus infection or disease history such as novel
coronavirus (SARS-CoV-2), severe acute respiratory syndrome (SARS), and Middle East
respiratory syndrome (MERS);
- (3) Those with previous medical history or family history of convulsions, epilepsy,
encephalopathy or mental illness;
- (4) Persons with fainting needles;
- (5) Those who plan to become pregnant or perform sperm and egg donation during the
trial period;
- (6) History of allergy or allergic reaction to any vaccine and its excipients, such
as: allergy, urticaria, severe skin eczema, dyspnea, laryngeal edema, angioedema,
etc.;
- (7) Have received any vaccine within 30 days before vaccination of this research
vaccine or plan to receive any other vaccine other than this research vaccine during
this research;
- (8) Participate in any other interventional experimental device or drug research
within 30 days before screening, or are currently using other experimental drugs or
within 5 half-lives after the last administration of the research drug;
- (9) Hereditary bleeding tendency or abnormal coagulation function (such as cytokine
deficiency, coagulation disorder or platelet disorder), or a history of severe
bleeding, or a history of massive bleeding or ecchymosis after intramuscular injection
or venipuncture;
- (10) According to known medical history or diagnosis, it is confirmed to have diseases
that affect the function of the immune system, including cancer, congenital or
acquired immunodeficiency (eg: human immunodeficiency virus (HIV) infection),
uncontrolled autoimmune diseases;
- (11) There are serious or uncontrollable diseases of the respiratory system,
cardiovascular diseases, nervous system diseases, blood and lymphatic system diseases,
liver and kidney diseases, metabolic and skeletal diseases that are judged by the
investigator to affect the evaluation of the results of this study;
- (12) Asplenia or functional asplenia;
- (13) Long-term use (=14 days of continuous use) of immunosuppressive drugs or other
immunomodulatory drugs (such as corticosteroids: prednisone or similar drugs) within 6
months before the vaccine for this trial, but topical drugs are allowed ( Such as
ointment, eye drops, inhalation or nasal spray), topical application should not exceed
the dose recommended in the instructions or have any signs of systemic exposure;
- (14) Received immunoglobulin and/or blood products within 3 months before the vaccine
for this trial;
- (15) Patients undergoing anti-tuberculosis treatment;
- (16) According to the judgment of the investigator, due to various medical,
psychological, social or other conditions, it is contrary to the experimental
protocol, or affects the subject's signing of informed consent.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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SARS-CoV-2 Infection
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COVID-19
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Intervention(s)
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Biological: COVID-19 Vaccine (Vero Cell), Inactivated
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Biological: Recombinant COVID-19 Vaccine (Sf9 Cell)
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Primary Outcome(s)
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Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 prototype strain
[Time Frame: Day 30 post-boost dose.]
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Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 Omicron variant
[Time Frame: Day 30 post-boost dose.]
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Incidence of adverse drug reactions (ADRs)
[Time Frame: Day 0-30 post-boost dose.]
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Secondary Outcome(s)
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GMT and GMI of specific neutralizing antibody against SARS-CoV-2 prototype strain
[Time Frame: Day 7, day 14, month 3 and month 6 after the booster dose.]
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GMT and GMI of specific neutralizing antibody against SARS-CoV-2 omicron variant
[Time Frame: Day 7, day 14, month 3 and month 6 after the booster dose.]
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GMT and GMI of IgG antibodies against SARS-CoV-2 S protein RBD
[Time Frame: Day 7, day 14, day 30, month 3 and month 6 after the booster dose.]
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Geometric mean increase (GMI) of specific neutralizing antibody against SARS-CoV-2 Omicron variant
[Time Frame: Day 30 post-boost dose.]
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Geometric mean increase (GMI) of specific neutralizing antibody against SARS-CoV-2 prototype strain
[Time Frame: Day 30 post-boost dose.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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