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

July 25, 2017 updated by: Clifford Craig Medical Research Trust

Clifford Craig Vaccine Trial Centre: Heterologous Effect of Diptheria, Tetanus, Acellular Pertussis Vaccination on Influenza Vaccine Challenge in the Elderly

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
        • Recruiting
        • Clifford Craig Foundation
        • Contact:
        • Contact:
          • Jane Niekamp
          • Phone Number: 03 6777 6010
        • Principal Investigator:
          • Katie Flanagan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Quadrivalent Influenza Vaccine
Biological: Diphtheria-tetanus-acellular pertussis vaccine
Intramuscular DTaP vaccine
Other Names:
  • 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 Names:
  • Quadrivalent Influenza Vaccine
Biological: Diphtheria-tetanus-acellular pertussis vaccine
Intramuscular DTaP vaccine
Other Names:
  • 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 Names:
  • Quadrivalent Influenza Vaccine
Biological: Diphtheria-tetanus-acellular pertussis vaccine
Intramuscular DTaP vaccine
Other Names:
  • Boostrix vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours, 1 week, 4 weeks and 26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours
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.
4 weeks and 26 weeks
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.
24 hours, 1 week, 4 weeks and 26 weeks
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
4 weeks and 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clifford Craig Medical Research Trust

Collaborators

Johns Hopkins Bloomberg School of Public Health
Monash University
University of Sao Paulo
The Peter Doherty Institute for Infection and Immunity

Investigators

  • Principal Investigator: Katie Flanagan, PhD FRACP, Clifford Craig Medical Research Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 5, 2016

First Posted (Estimate)

May 6, 2016

Study Record Updates

Last Update Posted (Actual)

July 27, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H0015460

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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