- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04640402
A Phase Ⅱ Clinical Trial of Recombinant Corona Virus Disease-19 (COVID-19) Vaccine (Sf9 Cells)
May 31, 2022 updated by: Jiangsu Province Centers for Disease Control and Prevention
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
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- 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
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 Type
Interventional
Enrollment (Actual)
960
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210009
- Jiangsu Provincial Center for Diseases Control and Prevention
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 83 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
60-85 years group, three doses of placebo(1.0ml)
at the schedule of day 0, 14, 28.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
1 months after immunization in each study group
|
The incidence of adverse reaction (AR)
Time Frame: 0 to 7 days after vaccination in each study group
|
The incidence of adverse reaction (AR)
|
0 to 7 days after vaccination in each study group
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of adverse events (AE)
Time Frame: 0 to 28 days after vaccination in each study group
|
The incidence of adverse events (AE)
|
0 to 28 days after vaccination in each study group
|
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)
|
0 to 28 days after vaccination in each study group
|
The incidence of serious adverse events
Time Frame: 6 months after vaccination in each study group
|
The incidence of serious adverse events
|
6 months after vaccination in each study group
|
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)
|
1 months after immunization in each study group
|
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
|
14 days, 30 days after immunization in each study group
|
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
|
14 days, 30 days after immunization in each study group
|
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)
|
14 days after immunization in each study group
|
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)
|
14 days, 30 days after immunization in each study group
|
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)
|
14 days, 30 days after immunization in each study group
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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
|
1 months after immunization in each study group
|
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
|
6 months after vaccination in each study group
|
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
|
1 months after immunization in each study group
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 17, 2020
Primary Completion (Actual)
February 18, 2021
Study Completion (Actual)
November 23, 2021
Study Registration Dates
First Submitted
November 19, 2020
First Submitted That Met QC Criteria
November 20, 2020
First Posted (Actual)
November 23, 2020
Study Record Updates
Last Update Posted (Actual)
June 1, 2022
Last Update Submitted That Met QC Criteria
May 31, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JSVCT099
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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