CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D015004: Yellow Fever NIH

(Synonyms: Yellow Fever)

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


Correlated Drug Terms (3)


Name (Synonyms) Correlation
drug984 Galidesivir Wiki 0.71
drug2294 Stamaril (live attenuated yellow fever vaccine) Wiki 0.71
drug1822 Placebo Wiki 0.04

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D005334 Fever NIH 0.82

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0001945 Fever HPO 0.82

There are 2 clinical trials

Clinical Trials


1 Using Systems Vaccinology to Elucidate the Effects of Anti-inflammatory Therapy on Immune Response After Vaccination With a Live Attenuated Vaccine

Since the 1st pandemic of the 21st century caused by SARS coronavirus, the world has experienced outbreaks of swine origin H1N1 influenza, Ebola and Zika viruses, which have all resulted in global health crises. Rapid mass vaccination with an effective vaccine such as a live attenuated vaccine, of vulnerable immune-naïve populations to establish herd immunity is an approach to control outbreaks. Such live attenuated vaccine had been used with great success in sporadic yellow fever outbreaks and recently successfully employed in Ebola field trial, both of these diseases have the potential for pandemic spread. Indeed, live attenuated vaccines have proven especially effective in controlling childhood diseases and have even succeeded in eradicating polio and measles from most parts of the world. However, deployment of such vaccines for pandemic control cannot be limited to children but must include adults in order to rapidly elevate herd immunity rates to halt transmission. Vaccinating adults may produce efficacy rates significantly different to those observed in children due to the prevalence of chronic diseases and their associated metabolic complications. Presently, there are 1 billion people who are overweight, many suffer from concurrent metabolic disorders. As activation of the adaptive immunity is reliant on a robust innate immune response to vaccines, metabolic disorders and long-term anti-inflammatory therapy with interventions such as statins may reduce vaccine immunogenicity resulting in suboptimal efficacy in this subpopulation. This study would therefore test the hypothesis that statins reduce live attenuated vaccine immunogenicity. We will combine a clinical trial with systems vaccinology approaches to define the impact statins has on the innate immune, B and T-cell responses to live attenuated vaccination. Our study will thus extend upon another recently completed trial by us and will provide new insights into the determinants of vaccine efficacy in a rapidly growing and aging population globally

NCT03116802 Yellow Fever Vaccine Yellow Fever Drug: Stamaril (live attenuated yellow fever vaccine)
MeSH:Yellow Fever Fever
HPO:Fever

Primary Outcomes

Description: the difference in neutralizing antibody titer to YF17D at Day 28, as measured by plaque reduction neutralization test (PRNT)

Measure: the adaptive immune response to YF vaccination in (A): Adult human volunteers who are on long term statins therapy and (B): Adult human volunteers (controls)

Time: 28 days

Secondary Outcomes

Description: viremia levels response in adult human volunteers on long term statins therapy compared to controls post-YF vaccination

Measure: the difference in innate immune response to YF vaccination in adult human volunteers on long term statins therapy compared to controls post-YF vaccination

Time: 28 days

Description: To examine the Cd4+ and Cd8+ T cell response in adult human volunteers on long term statins therapy compared to controls post-YF vaccination

Measure: the cellular immune response of adult human volunteers on long term statins therapy with controls following YF vaccination.

Time: 28 days

2 A Phase 1b Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Pharmacokinetics, and Anti-viral Effects of Galidesivir Administered Via Intravenous Infusion to Subjects With Yellow Fever or COVID-19

This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics, safety and antiviral activity of galidesivir in subjects with yellow fever (YF) or COVID-19.

NCT03891420 COVID-19 Yellow Fever Drug: Galidesivir Drug: Placebo
MeSH:Yellow Fever Fever
HPO:Fever

Primary Outcomes

Measure: number of subjects with treatment emergent adverse events and serious adverse events

Time: absolute number through the end of the study, approximately 56 days

Measure: number of subjects with change in laboratory parameters

Time: absolute number and change from baseline through the end of the study, approximately 56 days

Measure: exposure of galidesivir as measured by plasma concentrations

Time: 24 hours post dose on Day 1 through 12 hours post dose on Day 7

Secondary Outcomes

Measure: yellow fever virus (YFV) titer (Group A)

Time: change in YFV titer from baseline through Day 21

Measure: antiviral effect on SARS-CoV-2 in the respiratory tract - COVID-19 (Group B)

Time: change in SARS-CoV-2 from baseline through Day 21

Measure: changes in clinical status using 8-point ordinal scale in COVID-19 (Group B)

Time: through Day 21

Measure: changes from baseline and time to improvement using NEWS in COVID-19 (Group B)

Time: through Day21

Measure: mortality

Time: mortality at Day 56


HPO Nodes