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A Phase Ⅱ Clinical Trial of Recombinant Corona Virus Disease-19 (COVID-19) Vaccine (Sf9 Cells)

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ClinicalTrials.gov Identifier: NCT04640402
Recruitment Status : Recruiting
First Posted : November 23, 2020
Last Update Posted : March 30, 2021
Sponsor:
Collaborator:
West China Hospital
Information provided by (Responsible Party):
Jiangsu Province Centers for Disease Control and Prevention

Study Description
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Brief Summary:
This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with different immunization procedures (0, 21 days and 0, 14, 28 days) and doses (20μg/40μg).

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen Biological: Low-dose placebo (18-59 years) & Two dose regimen Biological: Low-dose placebo (18-59 years) & Three dose regimen Biological: High-dose placebo (18-59 years) & Two dose regimen Biological: High-dose placebo (18-59 years) & Three dose regimen Biological: Low-dose placebo (60-85 years) & Two dose regimen Biological: Low-dose placebo (60-85 years) & Three dose regimen Biological: High-dose placebo (60-85 years) & Two dose regimen Biological: High-dose placebo (60-85 years) & Three dose regimen Phase 2

Detailed Description:
This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) . The phase Ⅱ clinical trials designed 8 research group, including two immunization procedures (0, 21 days and 0, 14, 28 days), two doses (20μg/0.5ml, 40μg/1.0ml) and two ages group (adults and elder): Each group including 120 participants. Vaccination or placebo group will be randomly assigned to receive in a 5:1 ratio, 960 in total.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 960 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Single-center, Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱ Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells), in the Subjects From Healthy Aged 18 Years and Above
Actual Study Start Date : November 17, 2020
Actual Primary Completion Date : February 18, 2021
Estimated Study Completion Date : November 18, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Low-dose vaccine (18-59 years) & Two dose regimen
two doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
 Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen
18-59 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
Experimental: Low-dose vaccine (18-59 years) & Three dose regimen
three doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
 Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen
18-59 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Experimental: High-dose vaccine (18-59 years) & Two dose regimen
two doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
 Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen
18-59 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
Experimental: High-dose vaccine (18-59 years) & Three dose regimen
three doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
 Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen
18-59 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Experimental: Low-dose vaccine (60-85 years) & Two dose regimen
two doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
 Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen
60-85 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
Experimental: Low-dose vaccine (60-85 years) & Three dose regimen
three doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
 Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen
60-85 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Experimental: High-dose vaccine (60-85 years) & Two dose regimen
two doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
 Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen
60-85 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
Experimental: High-dose vaccine (60-85 years) & Three dose regimen
three doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
 Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen
60-85 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Placebo Comparator: Low-dose placebo (18-59 years) & Two dose regimen
two doses of placebo at the schedule of day 0, 21.
 Biological: Low-dose placebo (18-59 years) & Two dose regimen
18-59 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.
Placebo Comparator: Low-dose placebo (18-59 years) & Three dose regimen
three doses of placebo at the schedule of day 0, 14, 28.
 Biological: Low-dose placebo (18-59 years) & Three dose regimen
18-59 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.
Placebo Comparator: High-dose placebo (18-59 years) & Two dose regimen
two doses of placebo at the schedule of day 0, 21.
 Biological: High-dose placebo (18-59 years) & Two dose regimen
18-59 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.
Placebo Comparator: High-dose placebo (18-59 years) & Three dose regimen
three doses of placebo at the schedule of day 0, 14, 28.
 Biological: High-dose placebo (18-59 years) & Three dose regimen
18-59 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.
Placebo Comparator: Low-dose placebo (60-85 years) & Two dose regimen
two doses of placebo at the schedule of day 0, 21.
 Biological: Low-dose placebo (60-85 years) & Two dose regimen
60-85 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.
Placebo Comparator: Low-dose placebo (60-85 years) & Three dose regimen
three doses of placebo at the schedule of day 0, 14, 28.
 Biological: Low-dose placebo (60-85 years) & Three dose regimen
60-85 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.
Placebo Comparator: High-dose placebo (60-85 years) & Two dose regimen
two doses of placebo at the schedule of day 0, 21.
 Biological: High-dose placebo (60-85 years) & Two dose regimen
60-85 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.
Placebo Comparator: High-dose placebo (60-85 years) & Three dose regimen
three doses of placebo at the schedule of day 0, 14, 28.
 Biological: High-dose placebo (60-85 years) & Three dose regimen
60-85 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.


Outcome Measures
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Primary Outcome Measures :
  1. Geometric mean (GMT) of specific antibody [ Time Frame: 1 months after immunization in each study group ]
    Geometric mean (GMT) of specific antibody against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Spike protein Receptor-binding domain(S-RBD) protein (ELISA)

  2. The incidence of adverse reaction (AR) [ Time Frame: 0 to 7 days after vaccination in each study group ]
    The incidence of adverse reaction (AR)


Secondary Outcome Measures :
  1. The incidence of adverse events (AE) [ Time Frame: 0 to 28 days after vaccination in each study group ]
    The incidence of adverse events (AE)

  2. The incidence of severe adverse events (SAE) [ Time Frame: 0 to 28 days after vaccination in each study group ]
    The incidence of severe adverse events (SAE)

  3. The incidence of serious adverse events [ Time Frame: 6 months after vaccination in each study group ]
    The incidence of serious adverse events

  4. Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies [ Time Frame: 1 months after immunization in each study group ]
    Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies (euvirus and pseudovirus-neutralizing assays)

  5. The positive conversion rate of S-RBD protein-specific antibody [ Time Frame: 14 days, 30 days after immunization in each study group ]
    The positive conversion rate of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2

  6. Geometric mean fold increase (GMI) of S-RBD protein-specific antibody [ Time Frame: 14 days, 30 days after immunization in each study group ]
    Geometric mean fold increase (GMI) of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2

  7. Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies [ Time Frame: 14 days after immunization in each study group ]
    Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies (euvirus and pseudovirus-neutralizing assays)

  8. The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody [ Time Frame: 14 days, 30 days after immunization in each study group ]
    The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization test)

  9. Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies [ Time Frame: 14 days, 30 days after immunization in each study group ]
    Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies (eucivirus and pseudovirus neutralization assays)


Other Outcome Measures:
  1. The consistency analysis of the specific antibody and the specific neutralizing antibody [ Time Frame: 1 months after immunization in each study group ]
    The consistency analysis of the specific antibody (ELISA) and the specific neutralizing antibody (euvirus and pseudovirus neutralization assays) against SARS-CoV-2 S-RBD protein

  2. The geometric mean titer (GMT) ratio of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody [ Time Frame: 1 months after immunization in each study group ]
    The geometric mean titer (GMT) ratio of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody in each study groups

  3. The persistence (GMT，GMI，positive conversion rate) of specific antibodies [ Time Frame: 6 months after vaccination in each study group ]
    The persistence (GMT，GMI，positive conversion rate) of specific antibodies against SARS-CoV-2 S-RBD protein

  4. Subtypes of immunoglobulin G (IgG) antibodies [ Time Frame: 1 months after immunization in each study group ]
    Subtypes of IgG antibodies against the S-RBD protein of SARS-CoV-2 after immunization in each study group


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18 years and above.
  • Able to understand the content of informed consent and willing to sign the informed consent.
  • Able and willing to complete all the secluded study process during the whole study follow-up period (about 7 months).
  • Axillary temperature ≤37.0℃.
  • General good health as established by medical history and physical examination.

Exclusion Criteria:

First dose exclusion criteria:

  • Positive serum immunoglobulin M (IgM) and IgG to the SARS-CoV-2.
  • A Known History of HIV infection
  • Family history of seizure, epilepsy, brain or mental disease.
  • Participant that has an allergic history to any ingredient of vaccines.
  • Woman who is pregnant, breast-feeding or positive in pregnancy test on day of enrollment, or is planning to be pregnant during the next 6 months.
  • Any acute fever disease or infections.
  • Have a medical history of SARS.
  • Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and not well-controlled.
  • Major chronic illness, such as asthma, diabetes, or thyroid disease, and not well-controlled.
  • Hereditary angioneurotic edema or acquired angioneurotic edema.
  • Urticaria in last one year.
  • Asplenia or functional asplenia.
  • Platelet disorder or other bleeding disorder may cause injection contraindication.
  • Faint at the sight of blood or needles.
  • Prior administration of immunodepressant or corticosteroids, antianaphylactics treatment, cytotoxic treatment in last 6 months.
  • Prior administration of blood products in last 4 months.
  • Prior administration of other research medicines in last 1 month.
  • Prior administration of attenuated vaccine in last 1 month.
  • Prior administration of subunit vaccine or inactivated vaccine in last 14 days.
  • Being treated for tuberculosis.
  • Any condition that in the opinion of the investigators may interfere with the evaluation of study objectives.

Exclusion criteria for subsequent doses:

  • Patients with severe allergic reactions after the previous dose of vaccination;
  • Patients with serious adverse events causally related to the previous dose of vaccination.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04640402


Contacts
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Contact: Fanyue Meng, Doctor 18915999245 mfy19780712@163.com

Locations
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China, Jiangsu
Jiangsu Provincial Center for Diseases Control and Prevention Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Siyue Jia, PhD    17826065671    462371198@qq.com   
Principal Investigator: Fengcai Zhu, Doctor         
Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention
West China Hospital
Investigators
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Principal Investigator: Fengcai Zhu, Doctor Jiangsu Provincial Center for Disease Control and Prevention
More Information
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Responsible Party: Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT04640402    
Other Study ID Numbers: JSVCT099
First Posted: November 23, 2020    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu Province Centers for Disease Control and Prevention:
Safety
Immunogenicity
COVID-19 Vaccine
Recombinant vaccine
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs