The Immunologic Basis for an Attenuated Immune Response to the Influenza Vaccine After Repeated Annual Vaccination (FLU1)
11 december 2018 uppdaterad av: Mark Mulligan, Emory University
This is a prospective pilot study designed to suggest differences in the immunologic response to the seasonal influenza vaccine in people with regular vaccination history compared to those vaccinated less regularly.
Participants will receive one dose of the Food and Drug Administration (FDA) approved 2016-2017 seasonal influenza vaccine.
Immune system data will be collected at standard time points.
The duration of the study for each participant will be approximately 1 month.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This is a prospective pilot study in 20 males and non-pregnant females, 20 to 30 years old, inclusive, who are in good health and meet all eligibility criteria. The study is designed to evaluate differences in the immunologic response to the seasonal influenza vaccine in people with regular vaccination history compared to those vaccinated less regularly.
Participants will be sorted to either Arm A (Naïve) or Arm B (Experienced) based on their vaccination history. Those vaccinated no more than 2 out of the past 5 years will be in Arm A. Those vaccinated 3 or more out of the past 5 years will be in Arm B. Participants will receive one dose of the Food and Drug Administration (FDA) approved 2016-2017 seasonal influenza vaccine. The duration of the study for each participant will be approximately 1 month. Subjects will return for clinic visits on Days 3, 8, 15, and 29 during the month follow-up period following vaccination.
The study has two primary objectives; to evaluate the antibody response to the influenza vaccine in people who are vaccinated regularly and those vaccinated less regularly; the second is to evaluate circulating follicular helper T cells (TFH) in people who are vaccinated regularly and those vaccinated less regularly.
Studietyp
Interventionell
Inskrivning (Faktisk)
20
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Georgia
-
Atlanta, Georgia, Förenta staterna, 30322
- The Hope Clinic of the Emory Vaccine Center
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år till 30 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Capable of informed consent and provision of written informed consent before any study procedures.
- Capable of attending all study visits according to the study schedule.
- Are in good health, as determined by medical history and targeted physical exam related to this history.
- Oral temperature is less than 38 degrees Celsius.
- Resting pulse rate is between 50 and 115 beats per minute.
- Female subjects of childbearing age must have a negative urine pregnancy test within 24 hours before study vaccination.
- Have received the influenza vaccine at least 3 of the past 5 years or have received the influenza vaccine in 2 or less of the past 5 years.
Exclusion Criteria:
- Have an acute illness within 72 hours before vaccination.
- Have any condition that, in the opinion of the principal investigator, would place the subject at an unacceptable risk of injury or confound the interpretation of the study results.
- Have any acute or chronic medical condition that, in the opinion of the principal investigator, would make vaccination unsafe or interfere with the evaluation of immune response to study vaccination.
- Have a suppressed immune system as a result of illness, immunosuppressive medication, chemotherapy, or radiation therapy within 3 years prior to study vaccination.
- Have known HIV, hepatitis B, or hepatitis C infection.
- Have a known history of autoimmune disease.
- Have taken oral or parenteral corticosteroids of any dose within 30 days before study vaccination.
- Have taken high-dose inhaled corticosteroids within 30 days before study vaccination.
- Have received any licensed live vaccine within 30 days or any licensed inactivated vaccine within 14 days prior to study vaccination.
- Have planned vaccination with any vaccine during the 29-day duration of subject study participation.
- Have received immunoglobulin or other blood products, with the exception of Rho D immunoglobulin, within 90 days prior to study vaccination.
- Have donated blood or blood products within 30 days before study vaccination, plan to donate blood at any time during the 29-day duration of subject study participation, or plan to donate blood within 30 days after the last blood draw.
- Have known hypersensitivity or allergy to eggs, egg protein, chicken protein, or other compounds of the study vaccine.
- Have a history of severe reactions following vaccination with influenza virus vaccines
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Vaccination Naïve
Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.
|
Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1), A/Influenza A virus subtype (A/H3N2) H3N2,and B virus vaccine for Intramuscular (IM) use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
|
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Experimentell: Vaccination Experienced
Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.
|
Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1), A/Influenza A virus subtype (A/H3N2) H3N2,and B virus vaccine for Intramuscular (IM) use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Geometric Mean Serum Hemagglutination Inhibition (HAI) Antibody Titer
Tidsram: Baseline (Day 1), Day 29
|
Geometric mean serum HAI antibody titers serum HAI titer will be collected via blood draw.
Titer for serum HAI antibodies will be calculated using the geometric mean.
Change is defined as the difference in means from Day 1 to Day 29.
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Baseline (Day 1), Day 29
|
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Change in Mean Level of Circulating Follicular Helper T (TFH) Cells
Tidsram: Up to 15 Days
|
TFH cells will be collected via blood draw.
Change is defined as the difference in the mean levels of cells from baseline, day 8, and day 15.
|
Up to 15 Days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Mean Levels of Plasmablasts
Tidsram: Up to 29 Days
|
Plasmablasts will be collected via blood draw.
Change is defined as the difference in mean levels from baseline to Day 29.
|
Up to 29 Days
|
|
Change in Mean Levels of Memory B Cells From Baseline (Day 1) to Day 29
Tidsram: Baseline (Day 1) and Day 29
|
Memory B cells will be collected via blood draw.
Change is defined as the difference in mean levels from baseline to Day 29.
|
Baseline (Day 1) and Day 29
|
|
Change in Mean Levels of Antigen-specific IL-2 Producing CD4+ T Cells
Tidsram: Up to 29 Days
|
Antigen-specific Interleukin 2 (IL-2) producing cluster of differentiation 4 (CD4)+ T cells will be collected via blood draw.
Change is defined as the difference in mean levels from baseline to Day 29.
|
Up to 29 Days
|
|
Change in Mean Levels of Antigen-specific Cluster of Differentiation 8 (CD8) + T Cells
Tidsram: Up to 29 Days
|
CD8+T cells will be collected via blood draw.
Change is defined as the difference in mean levels from baseline to Day 29.
|
Up to 29 Days
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Mark Mulligan, MD, Emory University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juli 2016
Primärt slutförande (Faktisk)
18 oktober 2016
Avslutad studie (Faktisk)
1 december 2016
Studieregistreringsdatum
Först inskickad
4 augusti 2016
Först inskickad som uppfyllde QC-kriterierna
18 augusti 2016
Första postat (Uppskatta)
23 augusti 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 december 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 december 2018
Senast verifierad
1 december 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB00090196
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .