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V591Wiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug3348 molecular testing for virus RNA using RT-PCR Wiki 1.00
drug2122 Placebo Wiki 0.05

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Phase 1/Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Safety, Tolerability and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Younger and Older Participants

The primary objective of this early Phase 1 study is to identify the V591 dose that achieves the target immune response in humans based on preclinical or early clinical data.

NCT04498247 Coronavirus Disease (COVID-19) Biological: V591 Other: Placebo
MeSH:Coronavirus Infections

Primary Outcomes

Description: An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Measure: Percentage of Participants with at Least 1 Solicited Injection Site Adverse Event

Time: Up to ~5 days after vaccination

Description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Measure: Percentage of Participants with at Least 1 Solicited Systemic Adverse Event

Time: Up to ~14 days after vaccination

Description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Measure: Percentage of Participants with at Least 1 Unsolicited Adverse Event

Time: Up to ~28 days after vaccination

Description: A serious adverse event is "life threatening," requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity and is a congenital anomaly/birth defect.

Measure: Percentage of Participants with at Least 1 Serious Adverse Event

Time: Up to ~365 days (±14 days) after vaccination

Description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Measure: Percentage of Participants who Discontinued Study Treatment due to an Adverse Event

Time: Up to ~365 days (±7 days) after vaccination

Secondary Outcomes

Description: Serum samples will be collected and the presence of serum neutralization antibodies will be assessed using PRNT.

Measure: Geometric Mean Titers for Serum Neutralizing Antibodies (nAb) as Measured by Plaque Reduction Neutralization Test (PRNT): All Panels

Time: Day 29

Description: Serum samples will be collected and the total anti-spike IgG antibodies will be assessed using ELISA.

Measure: Geometric Mean Concentration of Total Anti-Spike Immunoglobulin G (IgG) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA): All Panels

Time: Day 29

Description: Serum samples will be collected and the presence of serum neutralization antibodies will be assessed using PRNT.

Measure: Geometric Mean Titers for Serum Neutralizing Antibodies as Measured by Plaque Reduction Neutralization Test (PRNT): Panels A,B, I and J

Time: Day 85

Description: Serum samples will be collected and the total anti-spike IgG antibodies will be assessed using ELISA.

Measure: Geometric Mean Concentration of Total Anti-Spike Immunoglobulin G (IgG) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA): Panels A,B, I and J

Time: Day 85

Description: Serum samples will be collected and the presence of serum neutralization antibodies will be assessed using PRNT.

Measure: Geometric Mean Titers for Serum Neutralizing Antibodies as Measured by Plaque Reduction Neutralization Test (PRNT): Panels K and L

Time: Day 197

Description: Serum samples will be collected and the total anti-spike IgG antibodies will be assessed using ELISA.

Measure: Geometric Mean Concentration of Total Anti-Spike Immunoglobulin G (IgG) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA): Panels K and L

Time: Day 197

Description: Serum samples will be collected and the presence of serum neutralization antibodies will be assessed using PRNT.

Measure: Geometric Mean Titers for Serum Neutralizing Antibodies (nAb) as Measured by Plaque Reduction Neutralization Test (PRNT)

Time: Panels C-H: Days 1, 15, 29, 57, 85, 115, 211, and 365; Panels A,B, I and J: Days 1, 15, 29, 57, 71, 85, 115, 211, and 422; Panels K and L: Days 1, 15, 29, 85, 169, 197, 365 and 534

Description: Serum samples will be collected and the total anti-spike IgG antibodies will be assessed using ELISA.

Measure: Geometric Mean Concentration of Total Anti-Spike Immunoglobulin G (IgG) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)

Time: Panels C-H: Days 1, 15, 29, 57, 85, 115, 211, and 365; Panels A,B, I and J: Days 1, 15, 29, 57, 71, 85, 115, 211, and 422; Panels K and L: Days 1, 15, 29, 85, 169, 197, 365 and 534

No related HPO nodes (Using clinical trials)