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    Dose-escalation

    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 (3)


    Name (Synonyms) Correlation
    drug2805 Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Wiki 0.52
    drug3923 mRNA-1273 Wiki 0.33
    drug2490 Placebo Wiki 0.07

    Correlated MeSH Terms (0)


    Name (Synonyms) Correlation

    Correlated HPO Terms (0)


    Name (Synonyms) Correlation

    Clinical Trials

    Navigate: Correlations   HPO

    There are 3 clinical trials


    1 A Single-center,Open-label,Dose-escalating Phase I Clinical Trial to Evaluate Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Healthy Adults Aged 18-60 Years Old

    The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment. This study is a phase I clinical trial. The investigators intent to evaluate the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) .

    NCT04313127
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

    Primary Outcomes

    Description: Occurrence of adverse reactions post-vaccination

    Measure: Safety indexes of adverse reactions

    Time: 0-7 days post-vaccination

    Secondary Outcomes

    Description: Occurrence of adverse events post-vaccination

    Measure: Safety indexes of adverse events

    Time: 0-28 days post-vaccination

    Description: Occurrence of serious adverse events post-vaccination

    Measure: Safety indexes of SAE

    Time: 0-28 days, within 6 mouths post-vaccination

    Description: Occurrence of abnormal changes of laboratory safety examinations

    Measure: Safety indexes of lab measures

    Time: pre-vaccination, day 7 post-vaccination

    Description: Geometric mean titer(GMT)of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum

    Measure: Immunogencity indexes of GMT(ELISA)

    Time: day14,28,month 3,6 post-vaccination

    Description: Geometric mean titer(GMT)of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum

    Measure: Immunogencity indexes of GMT(pseudoviral neutralization test method)

    Time: day14,28,month 6 post-vaccination

    Description: the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum

    Measure: Immunogencity indexes of seropositivity rates(ELISA)

    Time: day14,28,month 3,6 post-vaccination

    Description: the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum

    Measure: Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method)

    Time: day14,28,month 6 post-vaccination

    Description: Geometric mean fold increase(GMI)of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum

    Measure: Immunogencity indexes of GMI(ELISA)

    Time: day14,28,month 3,6 post-vaccination

    Description: Geometric mean fold increase(GMI)of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum

    Measure: Immunogencity indexes of GMI(pseudoviral neutralization test method)

    Time: day14,28,month 6 post-vaccination

    Description: Geometric mean concentration(GMC)of anti-Ad5 vector neutralizing antibody responses

    Measure: Immunogencity indexes of GMC(Ad5 vector)

    Time: day、14,28,month3,6 post-vaccination

    Description: Geometric mean fold increase(GMI)of anti-Ad5 vector neutralizing antibody responses

    Measure: Immunogencity indexes of GMI(Ad5 vector)

    Time: day、14,28,month3,6 post-vaccination

    Description: specific cellular immune responses

    Measure: Immunogencity indexes of cellular immune

    Time: day 14, 28,month 6 post-vaccination

    Other Outcomes

    Description: Consistency analysis of S-specific antibodies against 2019 novel coronavirus tested by ELISA against those tested by pseudoviral neutralization test method

    Measure: Consistency analysis(ELISA and pseudoviral neutralization test method)

    Time: day,14,28, month 6 post-vaccination

    Description: Relationship between Geometric mean titer (GMT) of S protein-specific antibodies against 2019 novel coronavirus and vaccine dose among study groups

    Measure: Dose-response relationship(Humoral immunity)

    Time: day14,28,month 3,6 post-vaccination

    Description: Persistence analysis of anti-S protein antibodies among study groups

    Measure: Persistence analysis of anti-S protein antibodies

    Time: day14,28,month 3,6 post-vaccination

    Description: Relationship between the appearance time of S-specific antibodies against 2019 novel coronavirus and the vaccination dose.

    Measure: Time-dose-response relationship(Humoral immunity)

    Time: day14,28,month 3,6 post-vaccination

    Description: Relationship between cellular immune levels against 2019 novel coronavirus and vaccine dose among study groups

    Measure: Dose-response relationship( cellular immunity)

    Time: day 14, 28,month 6 post-vaccination

    Description: Persistence analysis of specific cellular immune response

    Measure: Persistence analysis of cellular immuse

    Time: day 14, 28,month 6 post-vaccination

    Description: Relationship between the appearance time of cellular immunity against 2019 novel coronavirus and the vaccination dose.

    Measure: Time-dose-response relationship(cellular immunity)

    Time: day 14, 28,month 6 post-vaccination
    2 A Randomized, Observer-Blind, Dose-escalation Phase I/II Clinical Trial of Ad5-nCoV Vaccine in Healthy Adults From 18 to <85 Years of Age in Canada

    This study is a phase I /II adaptive clinical trial to evaluate the safety, tolerability and the Immunogenicity of Ad5-nCoV in healthy adults from 18 to <55 and 65 to <85 years of age,with the randomized, observer-blind, dose-escalation design

    NCT04398147
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
    2. Biological: Placebo

    Primary Outcomes

    Description: The occurrence of Solicited AE in all groups within 0-6 days after each vaccination;

    Measure: Incidence of the Solicited AE in all groups

    Time: 0-6 days after each vaccination

    Description: The occurrence of Unsolicited AE in all groups within 0-28 days after each vaccination.

    Measure: Incidence of Unsolicited AE in all groups

    Time: 0-28 days after each vaccination

    Description: The occurrence of Serious adverse events (SAE) in all groups within 6 months after the final vaccination.

    Measure: Incidence of Serious adverse events (SAE) in all groups

    Time: 6 months after the final vaccination

    Secondary Outcomes

    Description: Geometric mean titer (GMT) of the IgG antibody against SARS-CoV-2 measured on Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group (ELISA method);

    Measure: Geometric mean titer (GMT) of the IgG antibody against SARS-CoV-2 (ELISA method);

    Time: Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group

    Description: Seroconversion rate (%of subjects with 4-fold or greater increase in antibody level) of the IgG antibody against SARS-CoV-2 measured on Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group (ELISA method );

    Measure: Seroconversion rate of the IgG antibody against SARS-CoV-2(ELISA method )

    Time: Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group

    Description: Geometric Mean Increase Ratio (GMI) of the specific antibody against SARS-CoV-2 measured on Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group (ELISA method);

    Measure: Geometric Mean Increase Ratio (GMI) of the specific antibody against SARS-CoV-2(ELISA method);

    Time: Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group

    Description: Geometric mean titer (GMT) of the neutralizing antibody against SARS-CoV-2 measured on Day 0, Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group (Pseudo-viral neutralization assay)

    Measure: Geometric mean titer (GMT) of the neutralizing antibody against SARS-CoV-2(Pseudo-viral neutralization assay)

    Time: Day 0, Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group

    Description: Seroconversion rate of the neutralizing antibody against SARS-CoV-2 measured on Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group(Pseudo-viral neutralization assay);

    Measure: Seroconversion rate of the neutralizing antibody against SARS-CoV-2(Pseudo-viral neutralization assay)

    Time: Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group

    Description: Geometric mean increase ratio (GMI) of neutralizing antibody against SARS-CoV-2 measured on Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group (Pseudo-viral neutralization assay)

    Measure: Geometric mean increase ratio (GMI) of neutralizing antibody against SARS-CoV-2 (Pseudo-viral neutralization assay)

    Time: Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group

    Description: Geometric Mean Titer (GMT) of the neutralizing antibody against adenovirus type 5 vector measured on Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group;

    Measure: Geometric Mean Titer (GMT) of the neutralizing antibody against adenovirus type 5 vector

    Time: Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group

    Description: Geometric mean increase ratio (GMI) of the neutralizing antibody against adenovirus type 5 vector measured on Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group

    Measure: Geometric mean increase ratio (GMI) of the neutralizing antibody against adenovirus type 5 vector

    Time: Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group

    Description: The positive rate of IFN-γ stimulated by S protein overlapping peptide library detected by ELISpot

    Measure: cellular immune response by ELISpot

    Time: on Day 0, Day 14, Day 28 and Day 168 in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group

    Description: The positive rate of IFN-γ, TNF-α, and IL-2 expressed by CD4+ and CD8+ T lymphocytes stimulated by S protein overlapping peptide library detected by Intracellular Cytokine Staining (ICS);

    Measure: cellular immune response by ICS

    Time: Day 0, Day 14, Day 28 and Day 168 in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group
    3 Phase I, Open-Label, Dose-Ranging Study of the Safety and Immunogenicity of 2019-nCoV Vaccine (mRNA-1273) in Healthy Adults

    This is a phase I, open-label, dose-ranging clinical trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273 manufactured by ModernaTX, Inc. mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized spike (S) protein of SARS-CoV-2. Enrollment will occur at up to 3 domestic clinical research sites. One hundred and fifty-five subjects will be enrolled into one of thirteen cohorts (10 micrograms [mcg], 25 mcg, 50 mcg, 100 mcg, and 250 mcg). Subjects will receive an intramuscular (IM) injection (0.5 milliliters [mL]) of mRNA-1273 on Days 1 and 29 in the deltoid muscle and will be followed through 12 months post second vaccination (Day 394). Follow-up visits will occur 1, 2, and 4 weeks post each vaccination (Days 8, 15, 29, 36, 43, and 57), as well as 3, 6, and 12 months post second vaccination (Days 119, 209, and 394). The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 5 dosages in healthy adults.

    NCT04283461
    Conditions
    1. COVID-19
    2. COVID-19 Immunisation
    Interventions
    1. Biological: mRNA-1273

    Primary Outcomes

    Measure: Frequency of solicited local reactogenicity adverse events (AEs)

    Time: Through 7 days post-vaccination

    Measure: Frequency of any medically-attended adverse events (MAAEs)

    Time: Day 1 to Day 394

    Measure: Frequency of any new-onset chronic medical conditions (NOCMCs)

    Time: Day 1 to Day 394

    Measure: Frequency of any serious adverse events (SAEs)

    Time: Day 1 to Day 394

    Measure: Frequency of any unsolicited adverse events (AEs)

    Time: Through 28 days post-vaccination

    Measure: Frequency of solicited systemic reactogenicity adverse events (AEs)

    Time: Through 7 days post-vaccination

    Measure: Grade of any unsolicited adverse events (AEs)

    Time: Through 28 days post-vaccination

    Measure: Grade of solicited local reactogenicity adverse events (AEs)

    Time: Through 7 days post-vaccination

    Measure: Grade of solicited systemic reactogenicity adverse events (AEs)

    Time: Through 7 days post-vaccination

    Secondary Outcomes

    Measure: Geometric mean fold rise (GMFR) in IgG titer from baseline

    Time: Day 1 to Day 57

    Measure: Geometric mean titer (GMT) of antibody

    Time: Day 57

    Description: Seroconversion is defined as a 4-fold change in antibody titer from baseline

    Measure: Percentage of subjects who seroconverted

    Time: Day 1 to Day 57

    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.

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