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Vaccination Responses in Young and Older Adults

27. juli 2020 oppdatert av: George Mias, Michigan State University
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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

61

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Michigan
      • East Lansing, Michigan, Forente stater, 48824
        • Clinical and Translational Science Institute

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Annen
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Healthy Young Adults
Healthy young adults aged 18-25. Vaccination in all cohorts/groups.
Biologisk: 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.
Asthma Young Adults
Young adults aged 18-25 with asthma. Vaccination in all cohorts/groups.
Biologisk: 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.
Immunocompromised Young Adults

Young adults aged 18-25 that are immunocompromised (e.g. following treatment for leukemia).

Vaccination in all cohorts/groups.
Biologisk: 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.
Healthy Older Adults
Healthy older adults aged 55+ Vaccination in all cohorts/groups.
Biologisk: 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.
Asthma Older Adults
Older adults 55+ with asthma. Vaccination in all cohorts/groups.
Biologisk: 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.
Immunocompromised Older Adults

Older adults aged 55+ that are immunocompromised (e.g. following treatment for leukemia).

Vaccination in all cohorts/groups.
Biologisk: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Integrated Omics profile
Tidsramme: 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.
Through study completion, an average of 2 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Michigan State University

Etterforskere

  • Hovedetterforsker: George I. Mias, PhD, Michigan State University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2015

Primær fullføring (Faktiske)

1. juli 2020

Studiet fullført (Faktiske)

1. juli 2020

Datoer for studieregistrering

Først innsendt

10. januar 2016

Først innsendt som oppfylte QC-kriteriene

12. januar 2016

Først lagt ut (Anslag)

13. januar 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. juli 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. juli 2020

Sist bekreftet

1. juli 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 15-1029F

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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