None listed
Conditions
Brief summary
This is a feasibility study that is looking at the effect of gut bacteria on immune response. Participants will be categorised into one of 4 "stool community types" based on their gut bacteria populations. Participants will be given a Medsafe approved influenza vaccine which is being used as a proxy for a respiratory tract infection. During the study participants will need to attend 6 visits spread out over 6 months. Participants will attend an information seminar which will explain the study and answer any questions. They will then attend Visit 1. During this visit they will be given a stool sample collection kit, a lifestyle questionnaire and a 7-day food diary. These must be completed and returned to the study investigators for Visit 2. The lifestyle questionnaire can be done online instead of on paper. Visit 2 will occur 7-14 days after Visit 1. Visit 2 will consist of a blood test, a temperature and general health check and vaccination with the influenza vaccine. Visit 3 will occur 3 days after vaccination. Visit 3 will just consist of a blood test. Visit 4 will occur 7 days after vaccination and will be the same format as Visit 3. At the end of Visit 4 participants will be given another stool sample collection kit and another 7-day food diary. These need to be completed and returned during Visit 5. Visit 5 will occur 28 days after vaccination. Visit 5 will be the same as Visit 3 and 4 with the added step of collecting the stool sample and food diary. The final visit (Visit 6) will occur 6 months after vaccination and will just consist of a blood test. Participants will also have the option to sign an optional consent form for future unspecified research, If they choose to sign this form the samples that remain after testing will be stored for future research at the Malaghan Institute of Medical research.
Interventions
Participants will be vaccinated with a Medsafe approved trivalent influenza vaccine. Participants will be given one dose of the vaccine by intramuscular or deep subcutaneous injection by trained study investigators. The mode of administration will be determined at the discretion of the trained study investigators.
Sponsors
The Malaghan Institute of Medical Research
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Healthy volunteers
Yes
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.
Outcome results
None listed