Vaccination Responses in Young and Older Adults

Terminated

• Conditions: Individuality; Asthma; Immune System and Related Disorders; Healthy
• Interventions: Biological: Pneumococcal Vaccination

• Registration Number: NCT02654704
• Lead Sponsor: Michigan State University

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-01-10
• Study First Submitted QC: 2016-01-12
• Study First Posted: 2016-01-13
• Status Verified: 2020-07
• Primary Completion: 2020-07
• Study Completion: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Immunocompromised Young Adults	Pneumococcal Vaccination	Young adults aged 18-25 that are immunocompromised (e.g. following treatment for leukemia). Vaccination in all cohorts/groups.
Healthy Young Adults	Pneumococcal Vaccination	Healthy young adults aged 18-25. Vaccination in all cohorts/groups.
Asthma Young Adults	Pneumococcal Vaccination	Young adults aged 18-25 with asthma. Vaccination in all cohorts/groups.
Healthy Older Adults	Pneumococcal Vaccination	Healthy older adults aged 55+ Vaccination in all cohorts/groups.
Asthma Older Adults	Pneumococcal Vaccination	Older adults 55+ with asthma. Vaccination in all cohorts/groups.
Immunocompromised Older Adults	Pneumococcal Vaccination	Older adults aged 55+ that are immunocompromised (e.g. following treatment for leukemia). Vaccination in all cohorts/groups.

Primary Outcome Measures

Name	Time	Method
Integrated Omics profile	Through study completion, an average of 2 years	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.

Trial Locations

Locations (1)

Clinical and Translational Science Institute; 🇺🇸 East Lansing, Michigan, United States