None listed
Conditions
Brief 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.
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 giv
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.
Sponsors
Australian Government, Department of Defence (Defence Science and Technology Group, DMTC)
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
- Healthy participants aged between 18 and 40 years. - No history of seizures, head injury or head physiognomy (head shape) that would preclude EEG cap placement. - Able to provide written and informed consent in English. - Are willing to receive the influenza vaccination during the trial. - Body weight greater than 50 kg (minimum blood donation weight set by the Red Cross Blood Bank); BMI index between 18.5-29.9. - Must be non-smokers or have ceased smoking for more than 3 months.
Exclusion criteria
- Have been diagnosed with neurological conditions or neurodegenerative diseases, such as depressive, anxiety or post-traumatic stress disorder, sleep conditions, or Attention Deficit Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder. - 2 week exclusion for vaccination of any type, if infected with Covid or influenza during the testing period, adjustments will be made to the testing protocol to allow for recovery from infection. - Have received an immunisation for the influenza strains contained within the current year’s influenza vaccine formulation. - Participants have had a positive test response for active influenza infection during the same season. - Have medical conditions which preclude them from having an influenza vaccination. - Have a history of anaphylaxis to eggs or past vaccinations. - Have had a ever had a severe allergic reaction to any of the ingredients listed in the FluQuadriTM vaccine as indicated on the Consumer Medicine Information summary (Sodium chloride, dibasic sodium phosphate, monobasic sodium phosphate, water for injection, and traces of ovalbumin (egg protein), octoxinol-9 and formaldehyde). - Be pregnant or actively trying to conceive. - Have an ongoing chronic inflammatory condition. - Have a phobia with needles. - Have used any prescription, or over-the-counter medication (other than paracetamol and oral contraceptives) in the 24 hours leading up to the study days, including the use of illicit drugs and/or alcohol. - Are a regular user of marijuana. Must be able to withstand using for duration of trial. - Have had any caffeine in the 12 hours leading up to the study days.
Outcome results
None listed