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    Recombinant vaccine

    This report considers only clinical trials that are associated with COVID-19 vaccines.

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (32)


    Name (Synonyms) Correlation
    drug1469 High-dose placebo (18-59 years) & Three dose regimen Wiki 0.58
    drug1889 Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen Wiki 0.58
    drug3408 Three doses of placebo at the schedule of day 0, 14, 28 #High-dose group# Wiki 0.58
    Name (Synonyms) Correlation
    drug1472 High-dose placebo (60-85 years) & Two dose regimen Wiki 0.58
    drug1470 High-dose placebo (18-59 years) & Two dose regimen Wiki 0.58
    drug3510 Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14 Wiki 0.58
    drug1891 Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen Wiki 0.58
    drug3745 avdoralimab Wiki 0.58
    drug3517 Two doses of placebo at the schedule of day 0, 14 #middle-dose group# Wiki 0.58
    drug3409 Three doses of placebo at the schedule of day 0, 14, 28 #middle-dose group# Wiki 0.58
    drug1893 Low-dose placebo (18-59 years) & Two dose regimen Wiki 0.58
    drug1895 Low-dose placebo (60-85 years) & Two dose regimen Wiki 0.58
    drug1466 High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen Wiki 0.58
    drug3519 Two doses of placebo at the schedule of day 0, 28(middle-dose group) Wiki 0.58
    drug3406 Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28 Wiki 0.58
    drug1468 High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen Wiki 0.58
    drug3407 Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28 Wiki 0.58
    drug1888 Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen Wiki 0.58
    drug3518 Two doses of placebo at the schedule of day 0, 28(high-dose group) Wiki 0.58
    drug3410 Three doses of placebo at the schedule of day 0, 14, 28(high-dose group) Wiki 0.58
    drug3504 Two doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14 Wiki 0.58
    drug3511 Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28 Wiki 0.58
    drug1465 High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen Wiki 0.58
    drug1892 Low-dose placebo (18-59 years) & Three dose regimen Wiki 0.58
    drug1890 Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen Wiki 0.58
    drug3405 Three doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28 Wiki 0.58
    drug1894 Low-dose placebo (60-85 years) & Three dose regimen Wiki 0.58
    drug3516 Two doses of placebo at the schedule of day 0, 14 #High-dose group# Wiki 0.58
    drug1471 High-dose placebo (60-85 years) & Three dose regimen Wiki 0.58
    drug3505 Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28 Wiki 0.58
    drug1467 High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen Wiki 0.58
    drug2490 Placebo Wiki 0.07

    Correlated MeSH Terms (1)


    Name (Synonyms) Correlation
    D011014 Pneumonia NIH 0.41

    Correlated HPO Terms (1)


    Name (Synonyms) Correlation
    HP:0002090 Pneumonia HPO 0.41

    Clinical Trials

    Navigate: Correlations   HPO

    There are 3 clinical trials


    1 Safety, Tolerability and Immunogenicity of a Recombinant SARS-CoV-2 Vaccine (Sf9 Cell) in Chinese Healthy Population Aged 18 Years and Older: A Phase I, Single-center, Randomized, Placebo-controlled, Double-blind Study

    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.

    NCT04530656
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28
    2. Biological: Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28
    3. Biological: Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28
    4. Biological: Two doses of placebo at the schedule of day 0, 28(middle-dose group)
    5. Biological: Two doses of placebo at the schedule of day 0, 28(high-dose group)
    6. Biological: Three doses of placebo at the schedule of day 0, 14, 28(high-dose group)

    Primary Outcomes

    Description: Occurrence of solicited AR in the subjects within 7 days after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.

    Measure: Occurrence of adverse reactions (AR) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.

    Time: 7 days after each dose.

    Secondary Outcomes

    Description: Occurrence of solicited AE in the subjects within 7 days after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.

    Measure: Occurrence of adverse events (AE) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.

    Time: 7 days after each dose.

    Description: Occurrence of subjects experiencing AE associated with recombinant SARS-CoV-2 vaccine (Sf9 cell) up to Day 28.

    Measure: Occurrence of AE up to Day 28 after prime and boost vaccination.

    Time: Day 28 after prime and boost vaccination.

    Description: The proportion of subjects experiencing SAEs up to Day 28 after prime and boost vaccination.

    Measure: The proportion of SAEs up to Day 28 after prime and boost vaccination.

    Time: Day 28 after prime and boost vaccination.

    Description: Month 12 after prime and boost vaccination.

    Measure: The proportion of SAEs up to Month 12 after prime and boost vaccination.

    Time: The proportion of subjects experiencing SAEs up to Month 12 after prime and boost vaccination.

    Description: 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.

    Measure: 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.

    Time: 7 days before prime vaccination and Day 3 after each dose.

    Description: 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.

    Measure: GMT of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Time: Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Description: 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.

    Measure: 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.

    Time: Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Description: 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.

    Measure: GMFI of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Time: Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Description: 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.

    Measure: GMT of SARS-CoV-2 neutralizing antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Time: Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Description: 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.

    Measure: 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.

    Time: Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Description: 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.

    Measure: 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.

    Time: Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Description: Seroconversion rates of IFN-γ stimulated by the overlapping peptide library of S-RBD protein at Day 14, Day 28 after boost vaccination.

    Measure: Seroconversion rates of IFN-γ stimulated by the overlapping peptide library of S-RBD protein at Day 14, Day 28 after boost vaccination.

    Time: Day 14, Day 28 after boost vaccination.
    2 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).

    NCT04640402
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen
    2. Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen
    3. Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen
    4. Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen
    5. Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen
    6. Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen
    7. Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen
    8. Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen
    9. Biological: Low-dose placebo (18-59 years) & Two dose regimen
    10. Biological: Low-dose placebo (18-59 years) & Three dose regimen
    11. Biological: High-dose placebo (18-59 years) & Two dose regimen
    12. Biological: High-dose placebo (18-59 years) & Three dose regimen
    13. Biological: Low-dose placebo (60-85 years) & Two dose regimen
    14. Biological: Low-dose placebo (60-85 years) & Three dose regimen
    15. Biological: High-dose placebo (60-85 years) & Two dose regimen
    16. Biological: High-dose placebo (60-85 years) & Three dose regimen

    Primary Outcomes

    Description: 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)

    Measure: Geometric mean (GMT) of specific antibody

    Time: 1 months after immunization in each study group

    Description: The incidence of adverse reaction (AR)

    Measure: The incidence of adverse reaction (AR)

    Time: 0 to 7 days after vaccination in each study group

    Secondary Outcomes

    Description: The incidence of adverse events (AE)

    Measure: The incidence of adverse events (AE)

    Time: 0 to 28 days after vaccination in each study group

    Description: The incidence of severe adverse events (SAE)

    Measure: The incidence of severe adverse events (SAE)

    Time: 0 to 28 days after vaccination in each study group

    Description: The incidence of serious adverse events

    Measure: The incidence of serious adverse events

    Time: 6 months after vaccination in each study group

    Description: Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies (euvirus and pseudovirus-neutralizing assays)

    Measure: Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies

    Time: 1 months after immunization in each study group

    Description: The positive conversion rate of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2

    Measure: The positive conversion rate of S-RBD protein-specific antibody

    Time: 14 days, 30 days after immunization in each study group

    Description: Geometric mean fold increase (GMI) of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2

    Measure: Geometric mean fold increase (GMI) of S-RBD protein-specific antibody

    Time: 14 days, 30 days after immunization in each study group

    Description: Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies (euvirus and pseudovirus-neutralizing assays)

    Measure: Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies

    Time: 14 days after immunization in each study group

    Description: The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization test)

    Measure: The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody

    Time: 14 days, 30 days after immunization in each study group

    Description: Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies (eucivirus and pseudovirus neutralization assays)

    Measure: Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies

    Time: 14 days, 30 days after immunization in each study group

    Other Outcomes

    Description: 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

    Measure: The consistency analysis of the specific antibody and the specific neutralizing antibody

    Time: 1 months after immunization in each study group

    Description: The geometric mean titer (GMT) ratio of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody in each study groups

    Measure: The geometric mean titer (GMT) ratio of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody

    Time: 1 months after immunization in each study group

    Description: The persistence (GMT,GMI,positive conversion rate) of specific antibodies against SARS-CoV-2 S-RBD protein

    Measure: The persistence (GMT,GMI,positive conversion rate) of specific antibodies

    Time: 6 months after vaccination in each study group

    Description: Subtypes of IgG antibodies against the S-RBD protein of SARS-CoV-2 after immunization in each study group

    Measure: Subtypes of immunoglobulin G (IgG) antibodies

    Time: 1 months after immunization in each study group
    3 Safety and Immunogenicity of a Recombinant COVID-19 Vaccine (CHO Cell) in Healthy Population Aged 18 Years and Older: A Phase I Study

    This is a phase I, randomized, placebo-controlled, double-blind study, to evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO 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 (CHO Cell) or placebo will be given intramuscularly (IM) on Day 0 and Day 14 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 ≤ 59 years old will be enrolled in adult group, and healthy elderly population who are >59 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.

    NCT04636333
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14
    2. Biological: Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28
    3. Biological: Two doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14
    4. Biological: Three doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28
    5. Biological: Two doses of placebo at the schedule of day 0, 14 #middle-dose group#
    6. Biological: Three doses of placebo at the schedule of day 0, 14, 28 #middle-dose group#
    7. Biological: Two doses of placebo at the schedule of day 0, 14 #High-dose group#
    8. Biological: Three doses of placebo at the schedule of day 0, 14, 28 #High-dose group#

    Primary Outcomes

    Measure: The proportion of adverse reactions (AR) up to Day 28 after prime and boost vaccination of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.

    Time: 28 days after first dose

    Secondary Outcomes

    Measure: The proportion of adverse events (AE) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.

    Time: 7 days after each dose

    Measure: The proportion of abnormal markers of hematology, blood chemistry and urine analysis within 3 days after each dose of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo

    Time: 3 days after each dose

    Measure: The proportion of serious adverse events up to Month 12 after prime and boost vaccination.

    Time: Month 12 after prime and boost vaccination

    Measure: The proportion of neutralizing antibody positive conversion rate, positive rate, GMT and GMI at Day 14, Day 21, Day 28, Day 42 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 vaccination program#

    Time: Day 14, Day 21, Day 28, Day 42 after prime vaccination

    Measure: The proportion of IgG antibody positive rate at Day 14, Day 21, Day 28, Day 42 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 vaccination program#

    Time: Day 14, Day 21, Day 28, Day 42 after prime vaccination

    Measure: The proportion of neutralizing antibody positive conversion rate, positive rate, GMT and GM at Day 28, Day 35, Day 42, Day 56 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 ,Day 28 vaccination program#

    Time: Day 28, Day 35, Day 42, Day 56 after prime vaccination

    Measure: The proportion of IgG antibody positive rate at Day 28, Day 35, Day 42, Day 56 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 ,Day 28 vaccination program#

    Time: Day 28, Day 35, Day 42, Day 56 after prime vaccination

    Other Outcomes

    Measure: The proportion of IFN-γ secreted by T cells at Day 14 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo using ELISpot detection method

    Time: Day 14 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo

    Description: The units of IL2 and IL6 are both pg/ml

    Measure: Changes in serum cytokine (IL2, IL6) levels from baseline after 3 days of each dose

    Time: 3 days of each dose

    Measure: The proportion of neutralizing antibody and the GMT up to Month 3 after the whole process of vaccination

    Time: Month 3 after the whole process of vaccination

    Measure: The proportion of neutralizing antibody and the GMT up to Month 6 after the whole process of vaccination

    Time: Month 6 after the whole process of vaccination

    Measure: The proportion of neutralizing antibody and the GMT up to Month12 after the whole process of vaccination

    Time: Month 12 after the whole process of vaccination

    No related HPO nodes (Using clinical trials)


    HPO

    Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


    No related HPO nodes (Using clinical trials)


    Reports

    Data processed on January 01, 2021.

    An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

    Drug Reports   MeSH Reports   HPO Reports  

    Interventions

    4,818 reports on interventions/drugs

    MeSH

    706 reports on MeSH terms

    HPO

    306 reports on HPO terms

    All Terms

    Alphabetical index of all Terms

    Google Colab

    Python example via Google Colab Notebook