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IndividualityNCT02654704

Vaccination Responses in Young and Older Adults

An observational study of Individuality and Healthy, run by Michigan State University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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+… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Individuality, Healthy, Asthma
What is being tested?
Pneumococcal Vaccination
Type of treatment
Vaccines
How many people
61 participants
Where
1 siteUnited States
Study dates
Nov 2015to Jul 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The initial target enrollment is 60+ individuals in three group classifications [healthy, asthmatic, immune-compromised (e.g. Leukemia patients)], with each group further subdivided into two age groups [Young adults (aged 18-25) or Older adults (aged 55+)], without gender or ethnicity restrictions.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Clinical and Translational Science Institute

    East Lansing, Michigan, 48824

Other trials in United States

About this study

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.

Read the 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.

Being tested
Pneumococcal Vaccination
Keywords
Personalized Medicine, Precision Medicine
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pneumococcal VaccinationBiological

    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.

Study groups in NCT02654704
Study groupRoleWhat they receive
Healthy Young AdultsHealthy young adults aged 18-25. Vaccination in all cohorts/groups.
Receives: Biological: Pneumococcal Vaccination
Asthma Young AdultsYoung adults aged 18-25 with asthma. Vaccination in all cohorts/groups.
Receives: Biological: Pneumococcal Vaccination
Immunocompromised Young AdultsYoung adults aged 18-25 that are immunocompromised (e.g. following treatment for leukemia). Vaccination in all cohorts/groups.
Receives: Biological: Pneumococcal Vaccination
Healthy Older AdultsHealthy older adults aged 55+ Vaccination in all cohorts/groups.
Receives: Biological: Pneumococcal Vaccination
Asthma Older AdultsOlder adults 55+ with asthma. Vaccination in all cohorts/groups.
Receives: Biological: Pneumococcal Vaccination
Immunocompromised Older AdultsOlder adults aged 55+ that are immunocompromised (e.g. following treatment for leukemia). Vaccination in all cohorts/groups.
Receives: Biological: Pneumococcal Vaccination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Integrated Omics profile

    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.

    Measured: Through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2016 (estimated)
  2. Study startNov 2015
  3. Primary completionJul 2020
  4. Study completionJul 2020

Why it stopped: There was insufficient enrollment of subjects.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02654704
Sponsor's protocol ID
15-1029F
Status last verified
Jul 2020
First submitted
10 Jan 2016
Last updated
29 Jul 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22424236

  • 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.

    PubMed 25798291

Questions about this trial

What is this clinical trial studying?

An observational study of Individuality and Healthy, run by Michigan State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: There was insufficient enrollment of subjects.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Integrated Omics profile (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02654704, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.

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