Phase I Trial of a Recombinant SARS-CoV-2 Vaccine (Sf9 Cell)
NCT ID: NCT04530656
Last Updated: 2022-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
168 participants
INTERVENTIONAL
2020-08-28
2021-11-23
Brief Summary
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Detailed Description
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The study will set up an Independent Data Monitoring Committee (IDMC) to conduct overall supervision. The IDMC is required to review the unblinded data when a significant event or risk occurs in the study that might cause the study to be suspended.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Middle-dose vaccine (18-55 years) & Two dose regimen
Two doses of middle-dose experimental vaccine at the schedule of day 0, 28.
Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28
Two doses of middle-dose (20µg/ 0.5ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28.
Middle-dose vaccine (> 55 years) & Two dose regimen
Two doses of middle-dose experimental vaccine at the schedule of day 0, 28.
Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28
Two doses of middle-dose (20µg/ 0.5ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28.
High-dose vaccine (18-55 years) & Two dose regimen
Two doses of high-dose experimental vaccine at the schedule of day 0, 28.
Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28
Two doses of high-dose (40µg/ 1.0ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28.
High-dose vaccine (> 55 years) & Two dose regimen
Two doses of high-dose experimental vaccine at the schedule of day 0, 28.
Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28
Two doses of high-dose (40µg/ 1.0ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28.
High-dose vaccine (18-55 years) & Three dose regimen
Three doses of high-dose experimental vaccine at the schedule of day 0, 14, 28.
Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28
Three doses of high-dose (40µg/ 1.0ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28
High-dose vaccine (> 55 years) & Three dose regimen
Three doses of high-dose experimental vaccine at the schedule of day 0, 14, 28.
Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28
Three doses of high-dose (40µg/ 1.0ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28
Middle-dose placebo (18-55 years) & Two dose regimen
Two doses of middle-dose placebo at the schedule of day 0, 28.
Two doses of placebo at the schedule of day 0, 28（middle-dose group）
Two doses of placebo (0.5ml) at the schedule of day 0, 28
Middle-dose placebo (> 55 years) & Two dose regimen
Two doses of middle-dose placebo at the schedule of day 0, 28.
Two doses of placebo at the schedule of day 0, 28（middle-dose group）
Two doses of placebo (0.5ml) at the schedule of day 0, 28
High-dose placebo (18-55 years) & Two dose regimen
Two doses of high-dose placebo at the schedule of day 0, 28.
Two doses of placebo at the schedule of day 0, 28（high-dose group）
Two doses of placebo (1.0ml) at the schedule of day 0, 28
High-dose placebo (> 55 years) & Two dose regimen
Two doses of high-dose placebo at the schedule of day 0, 28.
Two doses of placebo at the schedule of day 0, 28（high-dose group）
Two doses of placebo (1.0ml) at the schedule of day 0, 28
High-dose placebo (18-55 years) & Three dose regimen
Three doses of high-dose placebo at the schedule of day 0, 14, 28.
Three doses of placebo at the schedule of day 0, 14, 28（high-dose group）
Three doses of placebo (1.0ml) at the schedule of day 0, 14, 28
High-dose placebo (> 55 years) & Three dose regimen
Three doses of high-dose placebo at the schedule of day 0, 14, 28.
Three doses of placebo at the schedule of day 0, 14, 28（high-dose group）
Three doses of placebo (1.0ml) at the schedule of day 0, 14, 28
Interventions
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Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28
Two doses of middle-dose (20µg/ 0.5ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28.
Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28
Two doses of high-dose (40µg/ 1.0ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28.
Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28
Three doses of high-dose (40µg/ 1.0ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28
Two doses of placebo at the schedule of day 0, 28（middle-dose group）
Two doses of placebo (0.5ml) at the schedule of day 0, 28
Two doses of placebo at the schedule of day 0, 28（high-dose group）
Two doses of placebo (1.0ml) at the schedule of day 0, 28
Three doses of placebo at the schedule of day 0, 14, 28（high-dose group）
Three doses of placebo (1.0ml) at the schedule of day 0, 14, 28
Eligibility Criteria
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Inclusion Criteria
* The subject can provide with informed consent and signs and dates a written informed consent form (ICF) prior to the initiation of any trial procedures.
* They must be able to understand and follow trial-related instructions.
* They must be willing and able to comply with planned visits, treatment schedule, laboratory tests and other requirements of the trial.
* Negative HIV antibody when screening.
* Axillary temperature ≤ 37.0ºC.
* Negative in nucleic acid screening of SARS-CoV-2.
* Negative in antibodies (IgG and IgM) screening of SARS-CoV-2.
* No imaging features of COVID-19 in chest CT.
* There were no significant abnormalities in blood routine, blood biochemistry, coagulation function and urine routine, or no clinical significance was determined by doctors (including white blood cell count, lymphocyte count, neutrophil count, platelet, hemoglobin, glutamic pyruvic transaminase ALT, glutamic oxaloacetic transaminase AST, total bilirubin, fasting blood glucose, creatinine, prothrombin time, partially activated prothrombin time, urine protein, urine red blood cells).
* Healthy subjects who have been examined by medical history, physical examination and clinical examination are in accordance with the immunization of this vaccine.
* Other exclusion reasons determined by the investigators.
Exclusion Criteria
* Allergic to any ingredient in the study vaccine, or used to have a serious vaccine allergic reaction.
* Women who are positive for urine pregnancy test. Women who are pregnant or breastfeeding or planning to be pregnant within 6 months.
* Have acute febrile diseases or infectious diseases.
* History of SARS, SARS-CoV-2 or MERS infection.
* People with serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and can not control using drugs.
* Patients with severe chronic diseases or progressive conditions can not be smoothly controlled, such as asthma, diabetes, and thyroid diseases.
* Have congenital or acquired angioedema/neuroedema.
* Had urticaria 1 year before receiving the study vaccine.
* Asplenium or functional aspleen.
* Have thrombocytopenia or other coagulation disorders (may cause contraindications to intramuscular injection).
* Have acupuncture syncope reaction.
* Have received immunosuppressant therapy, anti-allergic therapy, cytotoxic therapy, inhaled corticosteroids in the past 6 months (excluding corticosteroid spray therapy for allergic rhinitis, and surface corticosteroid therapy for acute non-complicated dermatitis).
* Received blood products within 4 months before receiving the study vaccine.
* Received other study drugs within 1 month before receiving the study vaccine.
* Received a live attenuated vaccine within 1 month before receiving the study vaccine.
* Received a subunit or inactivated vaccine within 14 days before receiving the study vaccine.
* Are receiving anti-tuberculosis treatment.
* According to the judgment of the researchers, due to a variety of medical, psychological, social or other conditions, it is contrary to the trial scheme, or affects the subjects to sign informed consent.
* It is contrary to the trial protocol, or affects the subjects to sign informed consent due to various medical, psychological, social or other conditions, according to the investigator's judgment.
* Have had a severe allergic reaction after the previous dose of vaccination.
* Those with serious adverse events that are causally related to the previous dose of vaccination.
18 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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JSVCT098
Identifier Type: -
Identifier Source: org_study_id
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