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

Not Applicable

Recruiting

• Conditions: Cognitive impairment; Psychomotor impairment; Immune responses; Inflammatory and Immune System - Normal development and function of the immune system; Neurological - Studies of the normal brain and nervous system

• Registration Number: ACTRN12623000650695
• Lead Sponsor: Australian Government, Department of Defence (Defence Science and Technology Group, DMTC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-15
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified