Pilot study: Can a dairy based protein (IDP) enhance immune responses after influenza vaccination?
Not Applicable
Terminated
- Conditions
- Immune response to Influenza vaccineInfection - Other infectious diseasesInflammatory and Immune System - Normal development and function of the immune system
- Registration Number
- ACTRN12622000462785
- Lead Sponsor
- Quantec Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 53
Inclusion Criteria
Age: 25-62 years of age
Sex: Female and male
Health: Healthy as gauged by self-assessment and not having any chronic inflammatory conditions
Agreement: Participants have given written informed consent to the study.
Able to speak and read English
Exclusion Criteria
Lactose intolerance; known or suspected allergy to dairy products, starch, gluten or artificial sweeteners;
Participation in another clinical trial;
Pregnancy or currently lactating; have had flu vaccination recently;
Had anaphylaxis reaction to influenza vaccination;
Had already received the influenza vaccination in 2022;
Had a recent cold (three weeks prior to the first visit);
Have any chronic inflammatory conditions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Antigen-specific immune responses to the influenza vaccination assessed by vaccine antigen-specific plasma IgG concentration via enzyme linked immunosorbent assay (ELISA).[ Six visits (Day 0 is the initiation of intervention) <br>1. First visit in one-week run-in period (one day of Day -7 to Day 0), <br>2. Second visit in week 1 post-intervention (Day 07), <br>3. Third visit in week 2 post-intervention (Day 14)<br>4. Fourth visit in week 4 post-intervention (Day 28)<br>5. Fifth visit in week 6 post-intervention (Day 42)<br>6. Sixth visit in week 8 post-intervention (Day 56)]
- Secondary Outcome Measures
Name Time Method