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

NCT02765126 | Unknown

• 1 other identifier: H0015460
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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).

Conditions

Heterologous Effects of Vaccines

Outcome Measures

Primary Outcomes (1)

• Number of inflammation reactive TNFR2+ regulatory T cells per mL of blood

  Change over time in different vaccine groups of Tregs measured by flow cytometry.

  24 hours, 1 week, 4 weeks and 26 weeks

Secondary Outcomes (4)

• Whole human genome transcription profile by next generation sequencing in log2 expression levels

  24 hours

• Influenza-specific antibody titres to seasonal influenza vaccination

  4 weeks and 26 weeks

• Pro-inflammatory (TNF) to anti-inflammatory (IL-10) cytokine ratio in stimulated blood in pg/mL

  24 hours, 1 week, 4 weeks and 26 weeks

• Influenza-specific IFN-g CD4 T cell responses to seasonal influenza vaccination in pg/mL

  4 weeks and 26 weeks

Study Arms (3)

Group 1

ACTIVE COMPARATOR

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; Biological: Diphtheria-tetanus-acellular pertussis vaccine

Group 2

ACTIVE COMPARATOR

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; Biological: Diphtheria-tetanus-acellular pertussis vaccine

Group 3

ACTIVE COMPARATOR

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; Biological: Diphtheria-tetanus-acellular pertussis vaccine

Interventions

Seasonal influenza vaccine BIOLOGICAL

Intramuscular standard seasonal influenza vaccine

Also known as: Quadrivalent Influenza Vaccine

Group 1; Group 2; Group 3

Diphtheria-tetanus-acellular pertussis vaccine BIOLOGICAL

Intramuscular DTaP vaccine

Also known as: Boostrix vaccine

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clifford Craig Medical Research Trust: lead
• Monash University: collaborator
• The Peter Doherty Institute for Infection and Immunity: collaborator
• University of Sao Paulo: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator

Study Sites (1)

Clifford Craig Foundation

Launceston, Tasmania, 7250, Australia

RECRUITING

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MeSH Terms

Interventions

Influenza Vaccines; Diphtheria-Tetanus-acellular Pertussis Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Pertussis Vaccine; Bacterial Vaccines; Diphtheria Toxoid; Toxoids; Tetanus Toxoid; Vaccines, Combined; Vaccines, Acellular; Vaccines, Subunit

Study Officials

• Katie Flanagan, PhD FRACP

  Clifford Craig Medical Research Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Ogden, MPH FRACGP

CONTACT

+61 3 6777 8790; kathryn.ogden@utas.edu.au

Jane Niekamp

CONTACT

research@cliffordcraig.org.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 6, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 27, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)