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

Clifford Craig Medical Research Trust

Status: Unknown

Conditions: Heterologous Effects of Vaccines

Treatments: Biological: Seasonal influenza vaccine; Biological: Diphtheria-tetanus-acellular pertussis vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT02765126

H0015460

Details and patient eligibility

About

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).

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 30 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 3 patient groups

Group 1

Active Comparator group

Description:

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.

Treatment:

Biological: Diphtheria-tetanus-acellular pertussis vaccine

Biological: Seasonal influenza vaccine

Group 2

Active Comparator group

Description:

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.

Treatment:

Biological: Diphtheria-tetanus-acellular pertussis vaccine

Biological: Seasonal influenza vaccine

Group 3

Active Comparator group

Description:

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.

Treatment:

Biological: Diphtheria-tetanus-acellular pertussis vaccine

Biological: Seasonal influenza vaccine