Trial | NCT02765126  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    450
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).
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 Started
May 31
2016
Primary Completion
Dec 31
2019
Anticipated
Study Completion
Dec 31
2019
Anticipated
Last Update
Jul 27
2017

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

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.

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.

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.

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
No Results Posted