Vaccination Responses in Young and Older Adults

NCT ID: NCT02654704

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2020-07-31

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.

Detailed Description

The primary investigation involves integrative multi-omics monitoring of individuals following their pneumonia vaccination over twelve time points. 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. 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. This study involves a simple blood draw, saliva collection, standard FDA-approved pneumococcal vaccine administration and Spirometry.

Conditions

Individuality; Healthy; Asthma; Immune System and Related Disorders

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Young Adults

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

Pneumococcal Vaccination

Intervention Type: 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 Young Adults

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

Pneumococcal Vaccination

Intervention Type: 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.

Immunocompromised Young Adults

Young adults aged 18-25 that are immunocompromised (e.g. following treatment for leukemia).

Vaccination in all cohorts/groups.

Pneumococcal Vaccination

Intervention Type: 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.

Healthy Older Adults

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

Pneumococcal Vaccination

Intervention Type: 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

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

Pneumococcal Vaccination

Intervention Type: 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.

Immunocompromised Older Adults

Older adults aged 55+ that are immunocompromised (e.g. following treatment for leukemia).

Vaccination in all cohorts/groups.

Pneumococcal Vaccination

Intervention Type: 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.

Interventions

Pneumococcal Vaccination

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Michigan State University

OTHER

Sponsor Role: lead

Responsible Party

George Mias

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George I. Mias, PhD

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Locations

Clinical and Translational Science Institute

East Lansing, Michigan, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22424236 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25798291 (View on PubMed)

Other Identifiers

15-1029F

Identifier Type: -

Identifier Source: org_study_id