This metadata record and it's attached files make statements about the kinds of data collected as part of this research, and set out policies for governance of that data, now and in the future.
Description: The purpose of this study is to investigate the effect a blackcurrant powder formulation on immune responses to the influenza vaccine. This is multi-centre randomised double blind placebo controlled parallel intervention study which aims to recruit 120 healthy older adults (50+ years). This means the recruited participants will consume either the blackcurrant based formulation or a placebo for 12 weeks and the participants and trial co-ordinators will not know what treatment is being given. There will be five trial days, including the 4 week visit to receive the influenza vaccine. Fasted blood samples with be collected at 0, 6, 8 and 12 weeks for assays, which will test the participants immune responses towards the influenza antigen. The primary aim of the study is to determine whether the blackcurrant formulation enhances immune responses toward influenza antigens.
Publisher
University of AucklandTemporal coverage: start
2021-01-01Temporal coverage: end
2024-01-01HVN Project / Programme Name
HVN1921Data access requirements
No individual participant data for this trial will be made available. Means and standard errors of combined participant data will be published only.Principal investigator organisation
New Zealand Institute for Plant and Food ResearchCollaborating researchers and affiliations
Principal Investigator:
Dr Kerry Bentley-Hewitt, The New Zealand Institute for Plant & Food Research, Palmerston North
Investigators:
Dr Odette Shaw (Plant and Food Research),
Dr Pramod Gopal (Plant and Food Research),
Dr Dominic Lomiwes (Plant and Food Research),
Professor Carol Cheatham (University of North Carolina),
Dr Janine Cooney (Plant and Food Research),
Dr Heike Schwendel (Plant and Food Research),
Dr Edward Walker (Plant and Food Research)Data description
Outcomes of the Study and associated data
Primary outcomes
- Specific T-cell subset proliferation of ex-vivo stimulated peripheral immune cells isolated from participants peripheral blood with influenza antigens
- Cytokine production of ex-vivo stimulated peripheral immune cells isolated from participants peripheral blood with influenza antigens
Associated data: T-cell proliferation, cytokine production
Secondary outcomes
- Antigen specific immune response to the influenza vaccination as assessed by vaccine antigen-specific plasma IgG1 concentration
- Antigen specific immune response to the influenza vaccination assessed by vaccine antigen-specific haemagglutination inhibition (HAI) in blood
- Incidence of upper respiratory tract infection (URTI) to measure common illness and/or symptoms (e.g. coughs and colds) using the validated Wisconsin Upper Respiratory Symptom Survey – (WURSS-24)
- Innate immune cell populations in participants peripheral blood such as plasma cells expressing IgM and IgG1, natural killer (NK) cells, monocytes, dendritic cells, macrophages, T cells including subsets cytotoxic T cells, T helper cells, NKT cells and regulatory T cells . In addition, the expression of activation markers relevant to each population will be calculated.
- Plasma vitamin C concentrations
- Plasma primary and secondary metabolites
- Antigen specific immune response to the influenza vaccination as assessed by vaccine antigen-specific plasma IgG3 concentration
Associated data: vaccine antigen-specific plasma IgG1, vaccine antigen-specific haemagglutination inhibition (HAI) in blood, WURSS-24, innate immune cell populations in blood, plasma vitamin C concentrations, plasma primary and secondary metabolites, vaccine antigen-specific plasma IgG3 concentration.Principal investigator contact email
kerry.bentley-hewitt@plantandfood.co.nz
