Prevention of Influenza Clinical Trial
Official title:
A Clinical Study of Biomarkers of Innate and Adaptive Immune Activation Associated With Symptoms and Immune Responses After Administration of a Single Dose of a Quadrivalent Inactivated Split Virus Influenza Vaccine to Healthy Young Adults.
This clinical fase IV study, using the administration of a single dose of a quadrivalent, inactivated, split influenza virus vaccine as biological intervention will mirror a study conducted at Imperial College, London, UK that will use a challenge with live virus as intervention. Comparison of the clinical observations and laboratory measurements generated in both studies will inform us about the similarities and differences in innate and adaptive immune responses elicited by both types of exposure to influenza virus antigen(s).
The study is a monocentric, open label study. All subjects will receive a single dose of alfa-Rix Tetra 2016-2017. The following will be measured - clinical events (recorded adverse events), physiological responses (heart rate, blood pressure, temperature, injection site), innate immune responses (cytokine levels and whole blood gene expression) and adaptive immune responses (serum antibody and antigen-specific cellular responses) at various time points after immunisation. At each study visit, full physiological parameters (including body temperature, heart rate, blood pressure) will be obtained and the injection site will be examined for the presence of any redness or swelling that will be measured and recorded. Standardized diary cards will be used to collect solicited and unsolicited clinical event data. At each visit the diary cards will be examined and any relevant clinical event will be entered into the clinical event form. Participants will be asked to monitor oral temperature from day 0 until day 7 when they wake up and when going to bed. The results of these measurements will be reported in a diary card. Any skin reactions at the site of injection will be evaluated; largest diameter of redness and swelling will be measured with a ruler and data reported on the diary card. Samples of blood (PAXgene tubes, plasma, serum and PBMCs (peripheral blood mononuclear cells)) will be collected for analysis and processing using protocols already in place. Subjects will also have blood obtained for standard safety markers (haematology, biochemistry) as well as acute phase proteins. The purpose of this protocol is to generate a set of data that will be analysed by integrated systems biology approach, for validation in subsequent clinical trials or in animal models. The dataset will broadly characterise: 1. Physiological responses at various time points after immunisation by measuring: 1. Local and systemic vaccine-related clinical events. 2. Physiological assessments: heart rate, body temperature, blood pressure. 3. Haematology (Complete Blood Count (CBC), Erythrocyte Sedimentation Rate (ESR) , phenotyping of White Blood Cells (WBC)), biochemistry parameters. 2. Innate and adaptive immune responses including: 1. Innate immune activation detected by global gene expression in whole blood 2. Adaptive immunity determined by: i. Humoral immune response via serum anti-influenza HAI (Haemagglutination Inhibition) titre ii. Cellular immune response c. Immune activation detected by concentration of selected inflammatory soluble mediators in serum including: i. chemokines and cytokines ii. acute phase proteins 3. Genetic testing of subjects when deemed necessary (genetic testing analysis may be SNIP (Single Nucleotide Polymorphism) analysis or full genome analysis). 4. Correlations in changes in innate and adaptive immune activation with adverse events, haematology and biochemistry panels, genotype and physiological assessments The study team will biobank all samples for the duration of the BIOVACSAFE programme so that different samples and different time points depending on the results generated can selectively be analysed, principally from the gene expression analysis of whole blood. ;
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