Evaluation of the psychoneuroimmunological state of healthy humans following intramuscular injection of the influenza (FluQuadriTM) vaccine, a two-way crossover double-blinded placebo-controlled trial
Australian Government, Department of Defence (Defence Science and Technology Group, DMTC)
40 participants
Aug 22, 2023
Interventional
Conditions
Summary
We want to answer the question, "How do we know we are sick?" by examining a range of functional measures that will capture indications of the body's early response (15 mins - 8 hours) to an immune challenge. We call this response the psychoneuroimmunological (PNI) state and it encompasses emotional, cognitive, immunological, physcial and physiological parameters. We have selected the following methods to monitor the PNI state of each individual in the proposed study: • Physical function (6-minute walk test, Timed Up and Go, and sit-to-stand tasks) • Speech and voice analytics • Executive functioning, spatial learning and memory (eye tracking, error awareness) • Physiological measures of stress and vital signs The measurement of the dynamic time course of these responses and the modelling of the PNI state has not yet been achieved by a research team. Our project will enable new methods for understanding the cognitive and socio-emotional impacts of the response using the influenza vaccination as the key trigger to the immune system. We will use a variety of methods to monitor the innate immune response of each individual involving a battery of cognitive and speech tests that will include: • The brief Psychomotor Vigilance Test (PVT), Attentional Network Task (ANT), and Emotion Processing Task (EPT), • Reading a brief paragraph aloud, • Short vowel sounds, • Speech agility, and • Reading a monologue. The cognitive battery testing will be conducted while participants are monitored with high frame video cameras and and Electroencephalograph system.
Eligibility
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Interventions
Arm 1: Influenza (FluQuadriTM) vaccine; single dose (0.5ml) once only via intramuscular route. Each 0.5 ml contains 15 micrograms from each of the following types of influenza virus: A/Victoria/2570/2019 (H1N1)pdm09-like strain A/Darwin/9/2021 (H3N2)-like strain B/Austria/1359417/2021-like strain B/Phuket/3073/2013-like strain. We have employed several registered pharmacists who are experienced in clinical trials (lead pharmacist is Dr Peter McCarthy, and co-lead is Louise Jarman) who will give the injections and remain on standby for a minimum of 15 mins to administer adrenaline or use an EpiPen, should the need arise. All pharmacists' will be giving participants their own consent form which they will take Medicare details to update the Australian Immunisation Registry at the end of the trial. We are not accessing electronic medical records but have captured medical history of participant in our pre-screening questionnaire, which will be maintained following university guidelines. The wash out period is 4-8 weeks, being that the second study day for each participant will be at a minimum 4 weeks and up to 8 weeks following the first visit.
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ACTRN12623000650695