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AG0301-COVID19Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (0)


Name (Synonyms) Correlation

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D058186 Acute Kidney Injury NIH 0.17
D014947 Wounds and Injuries NIH 0.16

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0001919 Acute kidney injury HPO 0.17

There are 2 clinical trials

Clinical Trials


1 A Non-randomized, Open-label, Non-controlled Phase I/II Study to Assess Safety and Immunogenicity of Two Doses of Intramuscular AG0301-COVID19 (1mg/2mg) in Healthy Adults

This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult volunteers.

NCT04463472 COVID-19 Biological: AG0301-COVID19 Biological: AG0301-COVID19

Primary Outcomes

Description: Frequency and severity of each adverse event, solicited local and systemic AEs 8 weeks after each vaccination

Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])

Time: Week 1 through Week 9

Description: Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 spike glycoprotein-specific antibody

Measure: Immunogenicity

Time: Weeks 3, 5, 7, 9

Secondary Outcomes

Measure: Change in GMT of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody

Time: Weeks 13, 25, 53

Measure: Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein receptor binding domain-specific antibody

Time: Weeks 3, 5, 7, 9, 13, 25, 53

Measure: Change in GMT of anti-SARS-CoV-2 B cell epitope antibody

Time: Weeks 3, 5, 7, 9, 13, 25, 53

Measure: Change in IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody

Time: Weeks 3, 5, 7, 9, 13, 25, 53

Measure: Adverse events

Time: Week 9 through Week 53

2 A Non-randomized, Open-label, Non-controlled Phase I/II Study to Assess Safety and Immunogenicity of Two Doses of Intramuscular AG0301-COVID19 (1mg/2mg) in Healthy Adults

This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult volunteers.

NCT04463472 COVID-19 Biological: AG0301-COVID19 Biological: AG0301-COVID19

Primary Outcomes

Description: Frequency and severity of each adverse event, solicited local and systemic AEs 8 weeks after each vaccination

Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])

Time: Week 1 through Week 9

Description: Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 spike glycoprotein-specific antibody

Measure: Immunogenicity

Time: Weeks 3, 5, 7, 9

Secondary Outcomes

Measure: Change in GMT of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody

Time: Weeks 13, 25, 53

Measure: Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein receptor binding domain-specific antibody

Time: Weeks 3, 5, 7, 9, 13, 25, 53

Measure: Change in GMT of anti-SARS-CoV-2 B cell epitope antibody

Time: Weeks 3, 5, 7, 9, 13, 25, 53

Measure: Change in IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody

Time: Weeks 3, 5, 7, 9, 13, 25, 53

Measure: Adverse events

Time: Week 9 through Week 53


No related HPO nodes (Using clinical trials)