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| Name | Class |
|---|---|
| West China Hospital | OTHER |
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This is a phase I, single-center, randomized, placebo-controlled, double-blind study, to evaluate safety, tolerability and immunogenicity of a recombinant SARS-CoV-2 vaccine (Sf9 cell) in Chinese healthy population aged 18 years and older. After randomization, the trial for each subject will last for approximately 13 months. Screening period is 1 week prior to randomization (Day -7 to Day -1), and each dose of either SARS-CoV-2 vaccine (Sf9 Cell) or placebo will be given intramuscularly (IM) on Day 0 and Day 28 for a two-dose regimen, or on Day 0, Day 14, and Day 28 for a three-dose regimen. Subjects who are ≥18 years old and ≤ 55 years old will be enrolled in adult group, and healthy elderly population who are >55 years old will be enrolled in elderly group. After adult group completes the follow-up 7 days after first vaccination, elderly group will be recruited.
This is a phase I, single-center, randomized, placebo-controlled, double-blind study, to evaluate safety, tolerability and immunogenicity of a recombinant SARS-CoV-2 vaccine (Sf9 cell) in Chinese healthy population aged 18 years and older. Healthy adults who are ≥18 years old and ≤55 years old will be enrolled in the adult group and healthy elderly population who are >55 years old will be enrolled in the elderly group. To ensure the enrollment of healthy subjects, screening tests (hematology, biochemistry, and urinalysis) will be performed prior to the vaccination. In each age group, there are three regimen cohort: middle-dose at 0, 28 schedule, high-dose at 0, 28 schedule, and high-dose at 0,14,28 schedule. The subjects in regimen cohort will be randomized to receive vaccines or placebos at a ratio of 3:1.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Middle-dose vaccine (18-55 years) & Two dose regimen | Experimental | Two doses of middle-dose experimental vaccine at the schedule of day 0, 28. |
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| Middle-dose vaccine (> 55 years) & Two dose regimen | Experimental | Two doses of middle-dose experimental vaccine at the schedule of day 0, 28. |
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| High-dose vaccine (18-55 years) & Two dose regimen | Experimental | Two doses of high-dose experimental vaccine at the schedule of day 0, 28. |
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| High-dose vaccine (> 55 years) & Two dose regimen | Experimental | Two doses of high-dose experimental vaccine at the schedule of day 0, 28. |
|
| High-dose vaccine (18-55 years) & Three dose regimen | Experimental | Three doses of high-dose experimental vaccine at the schedule of day 0, 14, 28. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28 | Biological | Two doses of middle-dose (20µg/ 0.5ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse reactions (AR) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo. | Occurrence of solicited AR in the subjects within 7 days after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo. | 7 days after each dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events (AE) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo. | Occurrence of solicited AE in the subjects within 7 days after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo. | 7 days after each dose. |
| Occurrence of AE up to Day 28 after prime and boost vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria of prime dose:
Exclusion criteria of subsequent dose:
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| Name | Affiliation | Role |
|---|---|---|
| Fengcai Zhu, Doctor | Jiangsu Province Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Center for Diseases Control and Prevention | Nanjing | Jiangsu | 210009 | China |
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| High-dose vaccine (> 55 years) & Three dose regimen | Experimental | Three doses of high-dose experimental vaccine at the schedule of day 0, 14, 28. |
|
| Middle-dose placebo (18-55 years) & Two dose regimen | Placebo Comparator | Two doses of middle-dose placebo at the schedule of day 0, 28. |
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| Middle-dose placebo (> 55 years) & Two dose regimen | Placebo Comparator | Two doses of middle-dose placebo at the schedule of day 0, 28. |
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| High-dose placebo (18-55 years) & Two dose regimen | Placebo Comparator | Two doses of high-dose placebo at the schedule of day 0, 28. |
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| High-dose placebo (> 55 years) & Two dose regimen | Placebo Comparator | Two doses of high-dose placebo at the schedule of day 0, 28. |
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| High-dose placebo (18-55 years) & Three dose regimen | Placebo Comparator | Three doses of high-dose placebo at the schedule of day 0, 14, 28. |
|
| High-dose placebo (> 55 years) & Three dose regimen | Placebo Comparator | Three doses of high-dose placebo at the schedule of day 0, 14, 28. |
|
| Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28 | Biological | 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 | Biological | 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) | Biological | 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) | Biological | 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) | Biological | Three doses of placebo (1.0ml) at the schedule of day 0, 14, 28 |
|
Occurrence of subjects experiencing AE associated with recombinant SARS-CoV-2 vaccine (Sf9 cell) up to Day 28. |
| Day 28 after prime and boost vaccination. |
| The proportion of SAEs up to Day 28 after prime and boost vaccination. | The proportion of subjects experiencing SAEs up to Day 28 after prime and boost vaccination. | Day 28 after prime and boost vaccination. |
| The proportion of SAEs up to Month 12 after prime and boost vaccination. | Month 12 after prime and boost vaccination. | The proportion of subjects experiencing SAEs up to Month 12 after prime and boost vaccination. |
| The proportion of abnormal markers of hematology, blood chemistry and urine analysis within 7 days before prime vaccination and at Day 3 after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo. | The proportion of subjects experiencing abnormal markers of hematology, blood chemistry and urine analysis within 7 days before prime vaccination and at Day 3 after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo. | 7 days before prime vaccination and Day 3 after each dose. |
| GMT of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination. | Geometric mean titer (GMT) of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination. | Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination. |
| Four-fold increase in anti-RBD specific antibody titers, at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination. | Four-fold increase in anti-RBD specific antibody titers, as compared to baseline, at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination. | Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination. |
| GMFI of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination. | Geometric mean fold increase (GMFI) of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination. | Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination. |
| GMT of SARS-CoV-2 neutralizing antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination. | Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody (including pseudovirus and live virus-based SARS-CoV-2 neutralizing antibody assay) at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after prime and boost vaccination. | Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination. |
| Four-fold increase in SARS-CoV-2 neutralizing antibody titers, at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination. | Four-fold increase in SARS-CoV-2 neutralizing antibody titers (including pseudovirus and live virus-based SARS-CoV-2 neutralizing antibody assay), as compared to baseline, at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination. | Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination. |
| GMFI of SARS-CoV-2 neutralizing antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after prime and boost vaccination. | Geometric mean fold increase (GMFI) of SARS-CoV-2 neutralizing antibody (including pseudovirus and live virus-based SARS-CoV-2 neutralizing antibody assay) at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination. | Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination. |
| Seroconversion rates of IFN-γ stimulated by the overlapping peptide library of S-RBD protein at Day 14, Day 28 after boost vaccination. | Seroconversion rates of IFN-γ stimulated by the overlapping peptide library of S-RBD protein at Day 14, Day 28 after boost vaccination. | Day 14, Day 28 after boost vaccination. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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