|drug941||Covigenix VAX-001 placebo Wiki||1.00|
|drug940||Covigenix VAX-001 Wiki||1.00|
There is one clinical trial.
This is a phase I/II, placebo-controlled, randomized, observer-blind, dose ranging adaptive clinical trial in males and non-pregnant females, 18 to <55 and 65 to <85 years of age, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity, immunogenicity and efficacy of Covigenix VAX-001 manufactured by Entos Pharmaceuticals.
Description: Frequency and Grade (mild, moderate, severe, potentially life-threatening; Gr. 1-4, respectively) of solicited injection site and systemic adverse events and unsolicited systemic adverse eventsMeasure: Safety of a 2-dose regimen of VAX-001 when doses are given 14 days apart Time: Up to Day 42
Description: Adverse hematology /clinical chemistry parameter changes (mild, moderate, severe, or life-threatening; Gr. 1-4, respectively)Measure: Mean change from baseline in safety laboratory measures Time: Days 0-42
Description: Frequency of serious AEsMeasure: Frequency of treatment-emergent Serious Adverse Events (SAE) throughout the study and up to 6 months post-second dose immunization (Day 196). Time: Days 0-196
Description: Percent seroconversion post second dose as measured by ELISAMeasure: Percent seroconversion defined as a 4-fold or greater increase in IgG titers after one or two doses as measured by IgG ELISA Time: Up to Day 196
Description: Geometric mean of antibody titers measured by pseudo-viral neutralization assay.Measure: Geometric mean neutralizing antibody titers against pseudo-virion after one and two doses Time: Up to Day 196
Description: Seroconversion as measured by pseudo-viral neutralizationMeasure: Percent seroconversion defined as a 4-fold or greater increase in IgG titers after one or two doses as measured by pseudo-viral neutralization assay. Time: up to Day 196
Description: Maintenance of antibody titers up to Six months post second doseMeasure: Persistence of IgG antibody titers as measured by ELISA and neutralizing antibody titers measured by pseudo-virion neutralization assay, six months after the second vaccine dose Time: Up to Day 196
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