Heterologous Effects of Vaccines Clinical Trial
Official title:
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).
| Status | Recruiting |
| Enrollment | 450 |
| Est. completion date | December 2019 |
| Est. primary completion date | December 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 30 Years to 100 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Clifford Craig Foundation | Launceston | Tasmania |
| Lead Sponsor | Collaborator |
|---|---|
| Clifford Craig Medical Research Trust | Johns Hopkins Bloomberg School of Public Health, Monash University, The Peter Doherty Institute for Infection and Immunity, University of Sao Paulo |
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* Note: There are 28 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Whole human genome transcription profile by next generation sequencing in log2 expression levels | 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 | |
| Secondary | Influenza-specific antibody titres to seasonal influenza vaccination | Change over time in the different vaccine groups of titres measured by haemagglutination inhibition assay. | 4 weeks and 26 weeks | |
| Secondary | Pro-inflammatory (TNF) to anti-inflammatory (IL-10) cytokine ratio in stimulated blood in pg/mL | 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 | |
| Secondary | Influenza-specific IFN-g CD4 T cell responses to seasonal influenza vaccination in pg/mL | 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 |