Vaccination Response in Individual Monozygotic Twins

NCT02296359 | Terminated

• 1 other identifier: 14-848FM
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Individuality; Asthma; Immune System and Related Disorders

Outcome Measures

Primary Outcomes (1)

• 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

  all time points (8 per year for 2 years per subject)

Study Arms (2)

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.

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.

Biological: Influenza Vaccination

Interventions

Influenza Vaccination 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.

Asthma Discordant Monozygotic Twins; Non-Asthma Concordant Monozygotic Twins

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Monozygotic Twins over 18 years of age with and without asthma, without gender or ethnicity restrictions.

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michigan State University: lead

Study Sites (1)

Clinical and Translational Science Institute

East Lansing, Michigan, 48824, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

If the volunteers agree,tissue is stored for usage in future research without identifiers. This includes cells from blood and saliva and extracted DNA, RNA and protein. The cells may be used to grow a new cell line that may be maintained in the laboratory.

MeSH Terms

Conditions

Asthma

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• George Mias, PhD

  Michigan State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: November 20, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 14, 2015

Record last verified: 2015-08

Locations

US (1)