Feasibility study looking at the effects of Gut microbiota on adult immune response to the seasonal influenza vaccine

Not Applicable

Completed

• Conditions: Immune response to trivalent influenza vaccine; Inflammatory and Immune System - Normal development and function of the immune system

• Registration Number: ACTRN12615001365550
• Lead Sponsor: The Malaghan Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Participant is willing and able to give informed consent for participation in the trial.
Male or Female, aged 18-64 years
In the investigators' opinion, is able and willing to comply with all trial requirements

Exclusion Criteria

They have had a known severe reaction or allergy to any components of the influenza vaccine.
They have any contra-indications to vaccination per recommendations of vaccine manufacturer.
They have a history of Guillain-Barre Syndrome within 6 weeks of receiving a previous influenza vaccine.
They have an impaired immune system that may confound immune response testing; i.e. any condition that impairs participant immune response through either the condition itself or through the treatment of the condition.
They have already received the 2016 seasonal influenza vaccine.
They have any other clinical condition which the investigator deems relevant for exclusion from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of participants (95% CI) who fail to complete the feasibility study to Day 28. This is defined by failure to attend the Day 28 visit.[28 days after Day Zero.];The proportion of participants (95% CI) who fail to complete the feasibility study in its entirety.<br>This is defined by failure to attend the Week 26 visit.[26 weeks after Day Zero.];The number needed to participate in the proposed RCT to see a 10% increase in responsiveness to the Medsafe approved annual influenza vaccine in the treated group versus the control group with 90% power and an alpha of 5%. This outcome will be assessed using regression analysis of the immune response rates (which will be analysed using Hemagglutination assays and ELISA testing) and compared to stool community type along with the withdrawal rate calculated at 28 days after Day Zero.[28 days after Day Zero.]