Vaccination Responses in Young and Older Adults
| Status: | Recruiting |
|---|---|
| Conditions: | Asthma, Asthma, Healthy Studies |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/23/2018 |
| Start Date: | November 2015 |
| End Date: | September 2020 |
| Contact: | George Mias, PhD |
| Email: | gmias@msu.edu |
| Phone: | 517-353-0855 |
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.
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.
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
