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

C

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)

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

Trial contacts and locations

1

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Central trial contact

Kathryn Ogden, MPH FRACGP; Jane Niekamp

Data sourced from clinicaltrials.gov

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