Vaccination Response in Individual Monozygotic Twins

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Assess the Safety and Immunogenicity of One or Two Doses of Sing2016 M2SR H3N2 Influenza Vaccine

NCT04960397

H3N2 Influenza

TERMINATED PHASE1

Safety and Immunogenicity of a Monovalent Inactivated Influenza H3N2 Variant (H3N2v) Vaccine in Pediatric Populations

NCT02100436

Influenza

COMPLETED PHASE2

Safety and Efficacy of an H1N1 Influenza Vaccine in People With Asthma

NCT00978120

H1N1 Influenza Virus

COMPLETED PHASE2

Safety and Immunogenicity Study of H3N2 M2SR Monovalent Influenza Vaccine in Healthy Volunteers

NCT02822105

Flu

COMPLETED PHASE1

The Effects of Attenuated Versus Inactivated Flu Vaccine in Twin Sets

NCT03898986

Influenza

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Individuality Asthma Immune System and Related Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Influenza Vaccination

Intervention Type BIOLOGICAL

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.

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.

Influenza Vaccination

Intervention Type BIOLOGICAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Influenza Vaccination

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes