CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

One COVID-19 vaccine candidate (TMV-083) administration - High doseWiki

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


Correlated Drug Terms (3)

Name (Synonyms) Correlation
drug2977 Two COVID-19 vaccine candidate (TMV-083) administrations - Low dose Wiki 1.00
drug2976 Two COVID-19 vaccine candidate (TMV-083) administrations - High dose Wiki 1.00
drug2122 Placebo Wiki 0.05

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 Randomized, Placebo-controlled Trial, to Evaluate the Safety and Immunogenicity of the COVID-19 Vaccine, a Measles Vector-based Vaccine Candidate Against COVID-19 in Healthy Volunteers Consisting of an Unblinded Dose Escalation and a Blinded Treatment Phase

This is a randomized, placebo-controlled, two center, Phase I trial in healthy adult volunteer participants consisting of two phases, an unblinded dose escalation and a double blind treatment phase to investigate the safety, tolerability and immunogenicity of a novel measles-vector based vaccine candidate against SARS-CoV-2 infection (TMV-083).

NCT04497298 COVID-19 Biological: Two COVID-19 vaccine candidate (TMV-083) administrations - Low dose Biological: Two COVID-19 vaccine candidate (TMV-083) administrations - High dose Biological: One COVID-19 vaccine candidate (TMV-083) administration - High dose Other: Placebo

Primary Outcomes

Description: Rate of solicited Adverse Event up to 14 days after each injection. Rate of unsolicited AE up to 28 days after the last injection. Rate of serious adverse events (SAEs) and adverse events of special interest (AESI) all along the study period.

Measure: To assess the safety and tolerability of the COVID-19 vaccine following one or two consecutive intramuscular injections in healthy volunteers

Time: Day 390

Secondary Outcomes

Description: SARS-CoV-2 specific antibodies up to study day 390 as measured by spike protein-specific ELISA

Measure: To assess induction of SARS-CoV-2 spike protein-binding antibodies upon one or two administrations of the COVID-19 vaccine by means of ELISA up to study day 390

Time: Day 390

Description: SARS-CoV-2 specific antibodies up to study day 390 for each cohort as measured by neutralization assay

Measure: To assess induction of SARS-CoV-2 neutralizing antibodies upon one or two administrations of the COVID-19 vaccine by means of serum neutralization assay up to study day 390

Time: Day 390

Description: SARS-CoV-2 spike protein-specific cell-mediated immune response up to study day 390 induced by one or two doses as measured by intracellular staining

Measure: To assess SARS-CoV-2 spike protein-specific, cell-mediated immune responses induced by one or two doses of vaccine, by means of intracellular staining

Time: up to Day 390

Description: SARS-CoV-2 spike protein-specific cell-mediated immune response up to study day 390 induced by one or two doses as measured by flow cytometry

Measure: To assess SARS-CoV-2 spike protein-specific, cell-mediated immune responses induced by one or two doses of vaccine, by means of flow cytometry

Time: up to Day 390

Description: Occurrence of measles virus shedding as evidenced by a positive RT-PCR for saliva, nasal swab, urine, or blood sample in sentinel groups.

Measure: To assess potential measles virus shedding by means of RT-qPCR of saliva, nasal swab, urine, or blood samples in sentinel groups on day 0 and up to day 42

Time: up to Day 42

Other Outcomes

Description: Measles virus antibody levels as assessed by standard ELISA assays on day 0 and day 28.

Measure: To assess the anti-measles antibody levels at baseline and on day 28 by ELISA

Time: up to Day 28

Description: SARS-CoV-2 N protein specific antibody up to study day 390 as measured by ELISA to differentiate the response to the COVID-19 vaccine from infection

Measure: To assess the natural exposure of the subjects to SARS-CoV-2 during the duration of the trial by means of N protein-specific ELISA

Time: Day 390

Description: Occurrence of confirmed COVID-19 (i.e. asymptomatic, paucisymptomatic or symptomatic) cases in the study participant all along the study period

Measure: To assess the occurrence of COVID-19 cases in study participants all along the duration of the study

Time: Day 390

No related HPO nodes (Using clinical trials)