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 range18 Years

SexALL

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

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

Change in transcriptional profile of individual cells from PBMC population

Timeframe: 6 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 range18 Years

SexALL

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

Change in transcriptional profile of individual cells from PBMC population

Timeframe: 6 months after influenza vaccination