CompletedPhase 2

Age Differences in Influenza and Herpes Zoster Vaccine Responses (INFLUENZA-SHINGRIX)

Netherlands148 participantsStarted 2021-09-20

Plain-language summary

Vaccines are used to prevent infectious diseases worldwide. Unfortunately, many vaccines, like the flu vaccine, are less effective in older adults. This single-centre open label partially randomised, partially placebo-controlled trial evaluates the differences in immune response between young and older adults after vaccination with a quadrivalent inactivated influenza vaccine and an adjuvanted herpes zoster vaccination. Exploring the underlying mechanisms between the differences in immunogenicity can provide important information for future vaccine development.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 18-35 years old OR age ≥60 years old * Written informed consent Exclusion Criteria: * Known allergy to (components of) the influenza or herpes zoster vaccine * Immunocompromised subjects and subjects with active malignancy within the last two years * Previous herpes zoster vaccination in the last year * Receipt of any vaccination 4 weeks prior to the start of the study or plans to receive any other vaccination in the first 2 months after inclusion * Use of systemic immunomodulatory drugs:steroids, anti-inflammatory biological treatments (e.g. anti-cytokine monoclonal antibodies) * Acute or active illness within two weeks prior to the start of the study * Pregnant, breastfeeding or planning to become pregnant during the study period

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in cytokine productions of PBMCs upon incubation with viral, bacterial, and fungal antigens

Timeframe: 2 months after influenza vaccination

Changes in cytokine productions of PBMCs upon incubation with viral, bacterial, and fungal antigens

Timeframe: 6 months after influenza vaccination

Changes in cytokine productions of PBMCs upon incubation with viral, bacterial, and fungal antigens

Timeframe: 2 months after the first dose of herpes zoster vaccination

Changes in cytokine productions of PBMCs upon incubation with viral, bacterial, and fungal antigens

Timeframe: 2 months after the second dose of herpes zoster vaccination

Changes in cytokine productions of PBMCs upon incubation with viral, bacterial, and fungal antigens

Timeframe: 6 months after the second dose of herpes zoster vaccination

Change in transcriptional profile of individual cells from PBMC population

Timeframe: 2 months after influenza vaccination

Trial details

NCT IDNCT05082688

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-17

View on ClinicalTrials.gov More Influenza trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Changes in cytokine productions of PBMCs upon incubation with viral, bacterial, and fungal antigens

Timeframe: 2 months after influenza vaccination

Changes in cytokine productions of PBMCs upon incubation with viral, bacterial, and fungal antigens

Timeframe: 6 months after influenza vaccination

Changes in cytokine productions of PBMCs upon incubation with viral, bacterial, and fungal antigens

Timeframe: 2 months after the first dose of herpes zoster vaccination

Changes in cytokine productions of PBMCs upon incubation with viral, bacterial, and fungal antigens

Timeframe: 2 months after the second dose of herpes zoster vaccination

Changes in cytokine productions of PBMCs upon incubation with viral, bacterial, and fungal antigens

Timeframe: 6 months after the second dose of herpes zoster vaccination

Change in transcriptional profile of individual cells from PBMC population

Timeframe: 2 months after influenza vaccination