RecruitingACTRN12623000650695

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


Sponsor

Australian Government, Department of Defence (Defence Science and Technology Group, DMTC)

Enrollment

40 participants

Start Date

Aug 22, 2023

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

When we get sick, our body goes through a series of changes — in how we feel, think, move, and communicate — that are the early warning signs of illness. This study is trying to map these changes precisely by tracking a range of measures in the hours after the immune system is triggered by a flu vaccine. By understanding what normal immune activation looks like across physical, cognitive, and emotional dimensions, researchers hope to develop better tools for detecting illness early. Healthy volunteers will receive a standard flu vaccine (or a placebo injection at a separate visit) and be monitored intensively for up to 8 hours afterward, undergoing tests of physical performance (walking, sit-to-stand), cognitive tasks, eye tracking, speech and voice analysis, and brain activity measurements using EEG — all while vital signs are recorded. You may be eligible if you are a healthy adult aged 18 to 40, are a non-smoker (or have not smoked for 3 months), have a BMI between 18.5 and 29.9, are willing to receive the flu vaccine, and do not have any neurological or mental health conditions. People with a history of severe allergic reactions to vaccines, egg allergy, or who are pregnant or trying to conceive are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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/257

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.


Locations(1)

SA, Australia

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ACTRN12623000650695