NCT02654704

Vaccination Responses in Young and Older Adults

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 61 (actual)
• Sponsor: Michigan State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	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.

Timeline

• Start date: 2015-11-01
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2016-01-13
• Last updated: 2020-07-29

Locations

1 site across 1 country: United States