Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2312 | One COVID-19 vaccine candidate (TMV-083) administration - High dose Wiki | 0.71 |
| drug2503 | Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%) Wiki | 0.71 |
| drug3494 | Two COVID-19 vaccine candidate (TMV-083) administrations - High dose Wiki | 0.71 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There are 2 clinical trials
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).
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), serious adverse reactions (SARs), suspected unexpected serious adverse reactions (SUSARs) 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 390Description: 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 390Description: SARS-CoV-2 specific antibodies up to study day 390 for each cohort as measured by serum 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 390Description: 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 and flow cytometry
Measure: To assess SARS-CoV-2 spike protein-specific, cell-mediated immune responses up to study day 390, induced by one or two doses of vaccine, by means of intracellular staining and flow cytometry. Time: up to Day 390Description: 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 42Description: 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 28Description: 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 390Description: 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 390The study will enroll up to 60,000 participants in order to evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to placebo, in adult participants.
Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate greater than or equal to (>=) 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) with Seronegative Status Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of their Serostatus Time: 1 Day post-vaccination (Day 2) to end of study (2.1 Years)Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease COVID-19 Regardless of Their Serostatus Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate greater than or equal to (>=) 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) Time: 1 Day post-vaccination (Day 2) to end of study (2.1 Years)Description: Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, intensive care unit (ICU) admission, mechanical ventilation, and extracorporeal membrane oxygenation (ECMO), linked to objective measures such as decreased oxygenation, X-ray or CT findings) or linked to any molecularly confirmed, COVID-19 at least 14 days post vaccination will be reported.
Measure: Number of Participants with First Occurrence of COVID-19 Requiring Medical Intervention Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: The viral load of SARS-CoV-2 will be assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs will be used to detect and/or quantify SARS-CoV-2.
Measure: SARS-CoV-2 Viral Load as Assessed by Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) in Participants with Molecularly Confirmed, Moderate to Severe/Critical COVID-19 Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: Molecularly confirmed mild COVID-19 is defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Mild COVID-19 includes: Fever, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, or chills, without shortness of breath or dyspnea.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Mild COVID-19 Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: Molecularly confirmed moderate and severe/critical COVID-19 defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case Definition at the time of finalization of this protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized case Definition Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: BOD will be evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.
Measure: Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: Serologic conversion between baseline and (Day 1; pre-vaccination), Day 71, 6 Months, 1 year post-vaccination using an ELISA and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 nucleocapsid (N) protein will be reported.
Measure: Serologic Conversion Between Baseline and (Day 1; Pre-vaccination), Day 71, 6 Months and 1- Year Post-vaccination using an Enzyme-linked Immunosorbent Assay (ELISA) Time: Between baseline (Day 1; pre-vaccination) and Day 71, 6 Months, 1-Year post-vaccination (up to 52 Weeks)Description: Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) with onset at least 14 days after vaccination (Day 15) to end of Study (2.1 Years) will be reported.
Measure: Number of Participants with First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Measure: Number of Participants with Serious Adverse Events (SAEs) Time: Up to 104 WeeksDescription: MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.
Measure: Number of Participants with Medically-Attended Adverse Events (MAAEs) Time: Up to 6 MonthsDescription: MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.
Measure: Number of Participants with Medically-Attended Adverse Events (MAAEs) Leading to Study Discontinuation Time: Up to 104 WeeksDescription: Participants will be asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
Measure: Number of Participants with Solicited Local Adverse Events (AEs) During 7 Days Following Vaccination Time: Up to Day 8 (7 Days after first vaccination on Day 1)Description: Participants will be instructed on how to record daily temperature using a thermometer provided for home use. Participants should record the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement is made on any given day, the highest temperature of that day will be recorded in the e-Diary. Fever is defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants will also be instructed on how to note signs and symptoms in the e-Diary on a daily basis for 7 days post-vaccination (day of vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia.
Measure: Number of Participants with Solicited Systemic AEs During 7 Days Following Vaccination Time: Up to Day 8 (7 Days after first vaccination on Day 1)Description: Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Measure: Number of Participants with Unsolicited Local Adverse Events (AEs) During 28 Days Post-vaccination Time: Up to Day 29 (28 Days after first vaccination on Day 1)Description: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) neutralizing antibody titers as assessed by VNA to measure the humoral immune responses will be reported
Measure: SARS-CoV-2 Neutralizing Antibody Titers as Assessed by Virus Neutralization Assay (VNA) Time: Up to 104 WeeksDescription: SARS-CoV-2 binding antibodies as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response will be reported.
Measure: SARS-CoV-2 Binding Antibodies Assessed by ELISA Time: Up to 104 WeeksAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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