Vaccination Responses in Young and Older Adults

NCT02654704 | Terminated

• 1 other identifier: 15-1029F
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

To follow longitudinally healthy and immune-compromised responses to pneumococcal vaccination, in 60+ individuals towards the development of personalized medicine implementation (minimum enrollments in 2 age categories: young adults\[18-25\], older adults \[55+\], within each category: 10+ healthy, 10+ asthma, 10+ immune-compromised \[e.g. leukemia or autoimmune disorders\]). The approach will profile thousands of molecular components utilizing high-throughput technologies and integrate these data to obtain personalized immune response to vaccination. The study will provide insights into immune response mechanisms specific to asthmatics, immune compromised and healthy individuals, as well as in response to vaccination. Additionally the differences in dynamic response across the two age groups will be investigated.

Conditions

Individuality; Healthy; Asthma; Immune System and Related Disorders

Keywords

Personalized Medicine; Precision Medicine

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. The outcome measured is an updated integrative Personal Omics Profile as reported at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3341616/ . This is observational in nature to assess personalized medicine methodology for following immune response.

  Through study completion, an average of 2 years

Study Arms (6)

Healthy Young Adults

Healthy young adults aged 18-25. Vaccination in all cohorts/groups.

Biological: Pneumococcal Vaccination

Asthma Young Adults

Young adults aged 18-25 with asthma. Vaccination in all cohorts/groups.

Biological: Pneumococcal Vaccination

Immunocompromised Young Adults

Young adults aged 18-25 that are immunocompromised (e.g. following treatment for leukemia). Vaccination in all cohorts/groups.

Biological: Pneumococcal Vaccination

Healthy Older Adults

Healthy older adults aged 55+ Vaccination in all cohorts/groups.

Biological: Pneumococcal Vaccination

Asthma Older Adults

Older adults 55+ with asthma. Vaccination in all cohorts/groups.

Biological: Pneumococcal Vaccination

Immunocompromised Older Adults

Older adults aged 55+ that are immunocompromised (e.g. following treatment for leukemia). Vaccination in all cohorts/groups.

Biological: Pneumococcal Vaccination

Interventions

Pneumococcal Vaccination BIOLOGICAL

The individuals will be followed to observe their immune system activation, following their vaccination with the standard Pneumococcal Polysaccharide Vaccine (PPSV23) as approved by the FDA.

Asthma Older Adults; Asthma Young Adults; Healthy Older Adults; Healthy Young Adults; Immunocompromised Older Adults; Immunocompromised Young Adults

Eligibility Criteria

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

Study Population

The initial target enrollment is 60+ individuals in three group classifications \[healthy, asthmatic, immune-compromised (e.g. Leukemia patients)\], with each group further subdivided into two age groups \[Young adults (aged 18-25) or Older adults (aged 55+)\], without gender or ethnicity restrictions.

You may qualify if:

• Participants ages 18 to 25 years old, or 55 and older, who have been diagnosed with asthma, other immune-compromising condition (e.g. Leukemia treated, Pulmonary disorders) or are healthy.

You may not qualify if:

• Subjects may not participate in this study if any of the following applies:
• The potential subjects have already been vaccinated with PPSV23. Subjects have special risks attendant to venipuncture. Existence of any medical conditions that study investigators believe will interfere with the study participation or evaluation of results. This includes subjects on immunosuppressive medications and/or glucocorticoids.
• Mental incapacity and/or cognitive impairment that would preclude adequate understanding of, or cooperation with, the study protocol.
• For female participants: subjects will be excluded if pregnant. There are no known risks to pregnant women from the PPSV23 vaccine (also indicated in the Vaccine Information Statement (VIS) attachment provided to participants), and there is no additional risk associated with becoming pregnant during the study. However, as pregnancy affects immune system responses, this may affect the molecular readout in this study and introduce confounding factors in the analysis by the investigators. If a participant is already enrolled and becomes pregnant during this study, the investigators will temporarily withdraw them from the study from the day the participants become pregnant. If the participants would like to stay in the study, the investigators may continue their participation after their delivery.
• If a participant has any severe allergies (life-threatening) or a participant has ever had a life-threatening allergic reaction after a dose of pneumococcal vaccine, or have a known severe allergy to any part of this vaccine, the participants will be advised not participate.
• If a participant is not feeling well on the scheduled day of vaccination, the study coordinators will suggest waiting until the participants feel better. If the participant agrees, the vaccination will be rescheduled 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

Related Publications (2)

• Chen R, Mias GI, Li-Pook-Than J, Jiang L, Lam HY, Chen R, Miriami E, Karczewski KJ, Hariharan M, Dewey FE, Cheng Y, Clark MJ, Im H, Habegger L, Balasubramanian S, O'Huallachain M, Dudley JT, Hillenmeyer S, Haraksingh R, Sharon D, Euskirchen G, Lacroute P, Bettinger K, Boyle AP, Kasowski M, Grubert F, Seki S, Garcia M, Whirl-Carrillo M, Gallardo M, Blasco MA, Greenberg PL, Snyder P, Klein TE, Altman RB, Butte AJ, Ashley EA, Gerstein M, Nadeau KC, Tang H, Snyder M. Personal omics profiling reveals dynamic molecular and medical phenotypes. Cell. 2012 Mar 16;148(6):1293-307. doi: 10.1016/j.cell.2012.02.009.

  PMID: 22424236 BACKGROUND

• Mias GI, Snyder M. Personal genomes, quantitative dynamic omics and personalized medicine. Quant Biol. 2013 Mar;1(1):71-90. doi: 10.1007/s40484-013-0005-3.

  PMID: 25798291 BACKGROUND

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

Condition Hierarchy (Ancestors)

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

Study Officials

• George I. Mias, PhD

  Michigan State University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 10, 2016
• First Posted: January 13, 2016
• Study Start: November 1, 2015
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

US (1)