IndividualityNCT02296359
Vaccination Response in Individual Monozygotic Twins
An observational study of Individuality and Asthma, run by Michigan State University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Individuality, Asthma, Immune System and Related Disorders
- What is being tested?
- Influenza Vaccination
- Type of treatment
- Vaccines
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Monozygotic Twins over 18 years of age with and without asthma, without gender or ethnicity restrictions.
Who may be able to join
- 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:
- 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.
- If one sibling withdraws duringYear2, the other sibling will be able to conclude Year2 study activities. -
Who cannot join
- Volunteer is under18.
- Presence of any medical conditions that the study investigators believe will affect participation in the study or its results.
- Presence of a mental incapacity and/or cognitive impairment that would prevent a subject from adequately understanding, or cooperating with, the study protocol.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical and Translational Science Institute
East Lansing, Michigan, 48824
About this study
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.
Read the detailed description
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.
- Conditions
- Individuality, Asthma, Immune System and Related Disorders
- Being tested
- Influenza Vaccination
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza VaccinationBiological
The individuals will be followed to observe their immune system activation, following their vaccination with the standard influenza vaccine approved for the year by the FDA.
| Study group | Role | What they receive |
|---|---|---|
| Asthma Discordant Monozygotic Twins | This is a group where one of the monozygotic twins has asthma and the other is non-asthmatic. Influenza Vaccination will be performed for both cohorts. Receives: Biological: Influenza Vaccination | |
| Non-Asthma Concordant Monozygotic Twins | This is a group where both of the monozygotic twins are non-asthmatic. Influenza Vaccination will be performed for both cohorts. Receives: Biological: Influenza Vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrated Omics profile
The study will construct RNA-expression, protein profiles and small molecule profiles on immune cells as these change over time prior to and following immune activation by the vaccine. The collective temporal patterns will be used to classify immune response
Measured: all time points (8 per year for 2 years per subject)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IndividualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Mias, Michigan State University
- Investigators
- George Mias, PhD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296359
- Sponsor's protocol ID
- 14-848FM
- Status last verified
- Aug 2015
- First submitted
- 18 Nov 2014
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination Response in Individual Monozygotic Twins
- ClinicalTrials.gov ID
- NCT02296359
- Acronym / sponsor ID
- 14-848FM
- Conditions
- Individuality, Asthma, Immune System and Related Disorders
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma Discordant Monozygotic Twins | – | Biological: Influenza VaccinationThis is a group where one of the monozygotic twins has asthma and the other is non-asthmatic. Influenza Vaccination will be performed for both cohorts. |
| Non-Asthma Concordant Monozygotic Twins | – | Biological: Influenza VaccinationThis is a group where both of the monozygotic twins are non-asthmatic. Influenza Vaccination will be performed for both cohorts. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Monozygotic Twins over 18 years of age with and without asthma, without gender or ethnicity restrictions.
Key inclusion criteria (3 listed)
- 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:
- 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.
- If one sibling withdraws duringYear2, the other sibling will be able to conclude Year2 study activities. -
Key exclusion criteria (7 listed)
- Volunteer is under18.
- Presence of any medical conditions that the study investigators believe will affect participation in the study or its results.
- Presence of a mental incapacity and/or cognitive impairment that would prevent a subject from adequately understanding, or cooperating with, the study protocol.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza VaccinationThe individuals will be followed to observe their immune system activation, following their vaccination with the standard influenza vaccine approved for the year by the FDA. | Biological | Asthma Discordant Monozygotic Twins, Non-Asthma Concordant Monozygotic Twins |
Primary outcome
Integrated Omics profile
Time frame: all time points (8 per year for 2 years per subject)
The study will construct RNA-expression, protein profiles and small molecule profiles on immune cells as these change over time prior to and following immune activation by the vaccine. The collective temporal patterns will be used to classify immune response
Results and safety
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Mias, PhD principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Individuality and Asthma, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Integrated Omics profile (time frame: all time points (8 per year for 2 years per subject)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2015.