CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


CVnCoV VaccineWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)


Name (Synonyms) Correlation
drug2901 mouthrinse with bêta-cyclodextrin and citrox Wiki 1.00
drug2902 mouthrinse without bêta-cyclodextrin and citrox Wiki 1.00
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 A Phase 1, Partially Blind, Placebo-controlled, Dose-escalation, First-in-human, Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity After 1 and 2 Doses of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV Administered Intramuscularly in Healthy Adults

This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.

NCT04449276 Severe Acute Respiratory Syndrome Coronavirus SARS-CoV-2 COVID-19 Biological: CVnCoV Vaccine Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: This data will be collected for decisions on subsequent vaccination of an additional open-label sentinel group with the same dose level.

Measure: Number of Participants With Grade 3 Adverse Reactions or any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination

Time: Up to 24 hours after vaccination on Day 1

Description: This data will be collected for decisions on dose escalation as well as continuation of enrollment at the same dose level in the observer-blind placebo-controlled part of the trial.

Measure: Number of Participants With Grade 3 Adverse Reactions or any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination

Time: Up to 60 hours after vaccination on Day 1

Measure: Number of Participants with Solicited Local Adverse Events

Time: 7 days after vaccination

Measure: Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale

Time: 7 days after vaccination

Measure: Duration of Solicited Local Adverse Events

Time: 7 days after vaccination

Measure: Number of Participants with Solicited Systemic Adverse Events

Time: 7 days after vaccination

Measure: Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale

Time: 7 days after vaccination

Measure: Duration of Solicited Systemic Adverse Events

Time: 7 days after vaccination

Measure: Number of Participants with Solicited Systemic Adverse Events Considered Related to Trial Vaccine

Time: 7 days after vaccination

Measure: Number of Participants with Unsolicited Adverse Events

Time: 28 days after vaccination

Measure: Intensity of Unsolicited Adverse Events Assessed by the Investigator

Time: 28 days after vaccination

Measure: Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine

Time: 28 days after vaccination

Measure: Number of Participants with One or More Serious Adverse events (SAEs)

Time: Baseline to Day 393

Measure: Number of Participants with One or More Serious Adverse events (SAEs) Considered Related to Trial Vaccine

Time: Baseline to Day 393

Measure: Number of Participants with One or More Adverse Events of Special Interest (AESIs)

Time: Baseline to Day 393

Measure: Number of Participants with One or More Adverse Events of Special Interest (AESIs) Considered Related to Trial Vaccine

Time: Baseline to Day 393

Secondary Outcomes

Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies

Time: Baseline and on Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393

Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

Measure: Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum

Time: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393

Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies

Time: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393

Description: Measured using an activity assay.

Measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies

Time: Baseline and on Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393

Description: Measured using an activity assay.

Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum

Time: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393

Description: Measured using an activity assay.

Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies

Time: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393


No related HPO nodes (Using clinical trials)