Asthma Clinical Trial
Official title:
Vaccination Response in Individual Monozygotic Twins
Respiratory viruses are known to be risk factors for asthma (e.g respiratory syncytial viruses, RSVs, and Human Rhinoviruses, HRVs, may induce bronchiolitis, and wheezing illnesses respectively). The common flu is also known to be a risk factor and the Centers for Disease Control and Prevention (CDC) recommends that asthmatics receive the annual flu vaccine, as a high-risk group for related asthma exacerbations. The investigators will be evaluating the variation in individual responses over time after controlled immune activation following influenza vaccination of monozygotic twins, both discordant for asthma, and concordant non-asthmatic. The transition from initial healthy to immune-system activated physiological states post vaccination will provide unprecedented molecular (omics) data on the molecular dynamics of immune response to vaccination, and novel insight into the flu response. The investigators will infer novel networks and pathways and as well as the dynamics of genes and mechanisms involved in asthma, flu vaccination, and individual responses, and correlate them to evaluated personalized genetic risks in the same study. The investigators will be able to also contrast the vaccination response in asthmatic and non-asthmatic individuals, in a longitudinal approach which has never been performed before using multiple-omics that included an immunization response.
Asthma pathogenesis and exacerbations have been associated to multiple risk factors,
particularly respiratory viruses. In children respiratory syncytial viruses (RSVs) may
induce bronchiolitis, and Human Rhinoviruses (HRVs) also may induce wheezing illnesses. RSVs
and HRVs are age dependent risk factors for asthma, with the influenza virus also considered
a prominent risk factor in adults. The Center for Disease Control recommends influenza
vaccination in asthmatics annually. Both HRV and RSV infections were detected in a pilot
integrative personal omics investigation, and provided a unique temporal expression
signature in the non-asthmatic subject, with the involvement of a common set of antigen and
defense response genes, as well as immune related pathways. These observed patterns in
addition to the results of the vaccination study will be used as a guide, to find
differences in healthy versus asthmatic patients' pathway activations which will provide
insights into the genes and mechanisms involved in asthma pathogenesis and immune response
to influenza vaccination. The twin paradigm will allow us to control for multiple
confounding factors and focus on the individual genetic and possible epigenetic variation.
The investigators will be able to infer novel networks and pathways and get into the genes
and mechanisms involved in asthma, flu vaccination, and individual responses, while
evaluating personalized genetic risks compared to medical history in the same study.
Our primary investigation involves integrative multi-omics monitoring of individual
monozygotic twins, healthy or discordant for asthma, following their flu vaccination, over a
period of two annual vaccination cycles. The investigators will be collecting blood samples
from monozygotic twin volunteers, for multiple time-points post influenza vaccination. The
measurements will be repeated the following year after a second vaccination. Genomic
sequencing will be used to evaluate the volunteer's genomic risks based on variants with
known disease association. Full transcriptome (via RNA-Sequencing), proteome and metabolome
profiling (via mass spectrometry) will be performed per time-point, as well as cytokine
profiling. This will allow the dynamic monitoring of thousands of molecular components and
their responses to vaccination, capturing both the initial innate response reaction in
addition to the adaptive response and return to baseline. The study involves following
responses in blood and saliva components after influenza vaccination. Two annual
vaccinations will be considered, one per year for 2 years, and at 8 time points samples will
be collected.
This study involves a simple blood draw, saliva collection, standard FDA-approved influenza
vaccine administration and Spirometry.
;
Observational Model: Case Control, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04624425 -
Additional Effects of Segmental Breathing In Asthma
|
N/A | |
Terminated |
NCT04410523 -
Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
|
Phase 2 | |
Active, not recruiting |
NCT03927820 -
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT03694158 -
Investigating Dupilumab's Effect in Asthma by Genotype
|
Phase 4 | |
Terminated |
NCT04946318 -
Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma
|
Phase 2 | |
Completed |
NCT04450108 -
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
|
N/A | |
Completed |
NCT03086460 -
A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)
|
Phase 2 | |
Completed |
NCT01160224 -
Oral GW766944 (Oral CCR3 Antagonist)
|
Phase 2 | |
Completed |
NCT03186209 -
Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)
|
Phase 3 | |
Completed |
NCT02502734 -
Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma
|
Phase 3 | |
Completed |
NCT01715844 -
L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics
|
Phase 1 | |
Terminated |
NCT04993443 -
First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036
|
Phase 1 | |
Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
Recruiting |
NCT06033833 -
Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
|
Phase 2 | |
Completed |
NCT03257995 -
Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.
|
Phase 2 | |
Completed |
NCT02212483 -
Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients
|
N/A | |
Recruiting |
NCT04872309 -
MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
|
||
Withdrawn |
NCT01468805 -
Childhood Asthma Reduction Study
|
N/A | |
Recruiting |
NCT05145894 -
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
|