Vaccination Response in Individual Monozygotic Twins
| Status: | Terminated |
|---|---|
| Conditions: | Asthma, Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | October 2014 |
| End Date: | August 2015 |
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.
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.
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.
Inclusion Criteria:
Volunteers are eligible to participate in this study if both they and their twin sibling
have agreed to participate. If after their enrollment in the study, one of the twin
siblings decides to withdraw, then:
1. If one sibling withdraws during Year 1, the other sibling will be allowed to continue
their participation in the study and to complete the current study Year. However they
will not be included in the randomly selected applicants that will continue
participation in Year 2 of the study.
2. If one sibling withdraws duringYear2, the other sibling will be able to conclude
Year2 study activities. -
Exclusion Criteria:
1. Volunteer is under18.
2. Presence of any medical conditions that the study investigators believe will affect
participation in the study or its results.
3. Presence of a mental incapacity and/or cognitive impairment that would prevent a
subject from adequately understanding, or cooperating with, the study protocol.
4. Volunteers with any severe allergies (life-threatening) or that have ever had a
life-threatening allergic reaction after a dose of flu vaccine, or have a known
severe allergy to any part of this vaccine, will be advised not to participate.
5. If a potential subject has ever had Guillain-Barré Syndrome (a severe paralyzing
illness, also called GBS), they will be advised not to get the influenza vaccine and
be excluded from this study.
- For female participants If they are already enrolled and become pregnant during
this study, the investigators will temporarily withdraw them from the study from
the day they become pregnant. If they would like to stay in the study, the
investigators may continue their participation after their delivery.
- If participants are not feeling well on the scheduled day of vaccination the
investigators will suggest that they postpone the vaccination until they feel
better. If they agree, the vaccination will be re-scheduled for a later date.
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