Vaccination Responses in Young and Older Adults

Stopped early

Conditions studied: Individuality, Healthy, Asthma, Immune System and Related Disorders

In brief

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.

Key facts

Study ID

NCT02654704

Run by

Michigan State University

People needed

61

Starts

2015-11-01

Expected to finish

2020-07-01

Last updated by the study team

2020-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Clinical and Translational Science Institute — East Lansing, Michigan, United States

Full record on ClinicalTrials.gov

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