A Phase Ⅱ Clinical Trial of Recombinant Corona Virus Disease-19 (COVID-19) Vaccine (Sf9 Cells)
NCT ID: NCT04640402
Last Updated: 2022-06-01
Study Results
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Basic Information
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COMPLETED
PHASE2
960 participants
INTERVENTIONAL
2020-11-17
2021-11-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Low-dose placebo (18-59 years) & Two dose regimen
two doses of placebo at the schedule of day 0, 21.
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.
Low-dose placebo (18-59 years) & Three dose regimen
three doses of placebo at the schedule of day 0, 14, 28.
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.
High-dose placebo (18-59 years) & Two dose regimen
two doses of placebo at the schedule of day 0, 21.
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.
High-dose placebo (18-59 years) & Three dose regimen
three doses of placebo at the schedule of day 0, 14, 28.
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.
Low-dose placebo (60-85 years) & Two dose regimen
two doses of placebo at the schedule of day 0, 21.
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.
Low-dose placebo (60-85 years) & Three dose regimen
three doses of placebo at the schedule of day 0, 14, 28.
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.
High-dose placebo (60-85 years) & Two dose regimen
two doses of placebo at the schedule of day 0, 21.
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.
High-dose placebo (60-85 years) & Three dose regimen
three doses of placebo at the schedule of day 0, 14, 28.
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.
Interventions
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
* Patients with severe allergic reactions after the previous dose of vaccination;
* Patients with serious adverse events causally related to the previous dose of vaccination.
18 Years
85 Years
ALL
Yes
Sponsors
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West China Hospital
OTHER
Jiangsu Province Centers for Disease Control and Prevention
NETWORK
Responsible Party
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Principal Investigators
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Fengcai Zhu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Provincial Center for Disease Control and Prevention
Locations
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Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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JSVCT099
Identifier Type: -
Identifier Source: org_study_id
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