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Heterologous Effect of Diptheria, Tetanus, Acellular Pertussis Vaccination on Influenza Challenge in the Elderly

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ClinicalTrials.gov Identifier: NCT02765126
Recruitment Status : Unknown
Verified July 2017 by Clifford Craig Medical Research Trust.
Recruitment status was:  Recruiting
First Posted : May 6, 2016
Last Update Posted : July 27, 2017
Sponsor:
Collaborators:
Monash University
The Peter Doherty Institute for Infection and Immunity
University of Sao Paulo
Johns Hopkins Bloomberg School of Public Health
Information provided by (Responsible Party):
Clifford Craig Medical Research Trust

Brief Summary:
Vaccines can have non-targeted or heterologous (also called non-specific) immunological effects on the immune system i.e. effects other than inducing an immune response against the disease targeted by the vaccine. This trial aims to evaluate the non-specific immunological effects of two vaccines - diphtheria-tetanus-acellular pertussis (DTP) vaccine and seasonal influenza vaccine - in a cohort of elderly humans (>65 years of age) and healthy adult control subjects (30-50 years).

Condition or disease Intervention/treatment Phase
Heterologous Effects of Vaccines Biological: Seasonal influenza vaccine Biological: Diphtheria-tetanus-acellular pertussis vaccine Not Applicable

Detailed Description:

This prospective randomised study aims to investigate the heterologous immunological effects of DTP and seasonal influenza (Flu) vaccination in an elderly Tasmanian population and healthy adults. The study will assess whether prior or concurrent administration of DTP with seasonal Flu vaccination affects generalised inflammation / immune homeostasis and gene expression, with a particular focus of inflammation reactive cells. It will also analyse for effects of DTP on the induction of vaccine-specific immunity to seasonal influenza vaccination (antibodies and cellular). Volunteers will be randomised to one of three vaccine groups and serial blood samples taken for immunological assays for up to 30 weeks.

The study is exploratory and will investigate vaccine effects on multiple immune parameters.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Clifford Craig Vaccine Trial Centre: Heterologous Effect of Diptheria, Tetanus, Acellular Pertussis Vaccination on Influenza Vaccine Challenge in the Elderly
Study Start Date : May 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Active Comparator: Group 1
Diphtheria-tetanus-acellular pertussis vaccine administered day 0, followed by seasonal influenza vaccination four weeks later. Blood testing to occur day 0 (prior to vaccine administration), 24 hours, 1 week, 4 weeks, 4 weeks + 24 hours, 5 weeks, 8 weeks and 30 weeks. Stool samples to be taken at day 0 and 1 week post-vaccination.
Biological: Seasonal influenza vaccine
Intramuscular standard seasonal influenza vaccine
Other Name: Quadrivalent Influenza Vaccine

Biological: Diphtheria-tetanus-acellular pertussis vaccine
Intramuscular DTaP vaccine
Other Name: Boostrix vaccine

Active Comparator: Group 2
Seasonal influenza vaccine administered on day 0, to be offered DTP vaccine at week 26. Blood testing to occur day 0 (prior to vaccine administration), 24 hours, 1 week 1, 4 weeks and 26 weeks. Stool samples to be taken at day 0 and 1 week post-vaccination.
Biological: Seasonal influenza vaccine
Intramuscular standard seasonal influenza vaccine
Other Name: Quadrivalent Influenza Vaccine

Biological: Diphtheria-tetanus-acellular pertussis vaccine
Intramuscular DTaP vaccine
Other Name: Boostrix vaccine

Active Comparator: Group 3
Seasonal influenza vaccine and DTP vaccine administered together on day 0. Blood testing to occur day 0 (prior to vaccine administration), 24 hours, 1 week 1, 4 weeks and 26 weeks. Stool samples to be taken at day 0 and 1 week post-vaccination.
Biological: Seasonal influenza vaccine
Intramuscular standard seasonal influenza vaccine
Other Name: Quadrivalent Influenza Vaccine

Biological: Diphtheria-tetanus-acellular pertussis vaccine
Intramuscular DTaP vaccine
Other Name: Boostrix vaccine




Primary Outcome Measures :
  1. Number of inflammation reactive TNFR2+ regulatory T cells per mL of blood [ Time Frame: 24 hours, 1 week, 4 weeks and 26 weeks ]
    Change over time in different vaccine groups of Tregs measured by flow cytometry.


Secondary Outcome Measures :
  1. Whole human genome transcription profile by next generation sequencing in log2 expression levels [ Time Frame: 24 hours ]
    Differential gene expression 24 hours after vaccination compared to baseline, and vaccine groups compared to see which genes / pathways are affected. Differential transcription determined for each gene, then analysed using modular analysis tools to determine vaccine effects.

  2. Influenza-specific antibody titres to seasonal influenza vaccination [ Time Frame: 4 weeks and 26 weeks ]
    Change over time in the different vaccine groups of titres measured by haemagglutination inhibition assay.

  3. Pro-inflammatory (TNF) to anti-inflammatory (IL-10) cytokine ratio in stimulated blood in pg/mL [ Time Frame: 24 hours, 1 week, 4 weeks and 26 weeks ]
    Change in TNF:IL-10 ratio post-vaccination over time as measured by cytokine multiplex assay of anti-CD3 stimulated PBMC.

  4. Influenza-specific IFN-g CD4 T cell responses to seasonal influenza vaccination in pg/mL [ Time Frame: 4 weeks and 26 weeks ]
    Change over time in the different vaccine groups of IFN-g levels in supernatants from CD4 T cells cultured with live influenza virus



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Two study groups 30-50 years old >65 years old

Exclusion Criteria:

  • Unwell on day of vaccination
  • Temperature >38°C
  • Active cancer
  • Active autoimmune disease
  • Diabetes mellitus
  • Taking immunosuppressive drugs including steroids
  • Any vaccination in last 3 months
  • DT or DTaP vaccination in the last year
  • Known allergy or contraindication to influenza or DTaP vaccination
  • Pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02765126


Contacts
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Contact: Kathryn Ogden, MPH FRACGP +61 3 6777 8790 kathryn.ogden@utas.edu.au
Contact: Jane Niekamp research@cliffordcraig.org.au

Locations
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Australia, Tasmania
Clifford Craig Foundation Recruiting
Launceston, Tasmania, Australia, 7250
Contact: Kathryn Ogden, MBBS, MPH    03 6777 6010    kathryn.ogden@utas.edu.au   
Contact: Jane Niekamp    03 6777 6010      
Principal Investigator: Katie Flanagan         
Sponsors and Collaborators
Clifford Craig Medical Research Trust
Monash University
The Peter Doherty Institute for Infection and Immunity
University of Sao Paulo
Johns Hopkins Bloomberg School of Public Health
Investigators
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Principal Investigator: Katie Flanagan, PhD FRACP Clifford Craig Medical Research Trust

Publications:

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Responsible Party: Clifford Craig Medical Research Trust
ClinicalTrials.gov Identifier: NCT02765126    
Other Study ID Numbers: H0015460
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The transcriptome data will be de-identified and deposited in a pubic database. The de-identified microbiome data may well also be made publically available.
Additional relevant MeSH terms:
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Diphtheria
Bacterial Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs