NCT05082688

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

September 20, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2023

Completed
Last Updated

June 29, 2023

Status Verified

June 1, 2023

Enrollment Period

1.7 years

First QC Date

January 22, 2021

Last Update Submit

June 28, 2023

Conditions

InfluenzaHerpes Zoster

Keywords

VaccinationTrained immunityImmunosenescenceInflammaging

Outcome Measures

Primary Outcomes (10)

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

    IL-6, TNF, IL-1b, IFNg cytokine concentrations will be measured.

    2 months after influenza vaccination

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

    IL-6, TNF, IL-1b, IFNg cytokine concentrations will be measured.

    6 months after influenza vaccination

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

    IL-6, TNF, IL-1b, IFNg cytokine concentrations will be measured.

    2 months after the first dose of herpes zoster vaccination

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

    IL-6, TNF, IL-1b, IFNg cytokine concentrations will be measured.

    2 months after the second dose of herpes zoster vaccination

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

    IL-6, TNF, IL-1b, IFNg cytokine concentrations will be measured.

    6 months after the second dose of herpes zoster vaccination

  • Change in transcriptional profile of individual cells from PBMC population

    Gene expression profile of PBMCs will be measured by single cell-RNA sequencing.

    2 months after influenza vaccination

  • Change in transcriptional profile of individual cells from PBMC population

    Gene expression profile of PBMCs will be measured by single cell-RNA sequencing.

    6 months after influenza vaccination

  • Transcriptional profile of individual cells from PBMC population

    Gene expression profile of PBMCs will be measured by single cell-RNA sequencing.

    2 months after the first dose of herpes zoster vaccination

  • Transcriptional profile of individual cells from PBMC population

    Gene expression profile of PBMCs will be measured by single cell-RNA sequencing.

    2 months after the second dose of herpes zoster vaccination

  • Transcriptional profile of individual cells from PBMC population

    Gene expression profile of PBMCs will be measured by single cell-RNA sequencing.

    6 months after the second dose of herpes zoster vaccination

Secondary Outcomes (23)

  • Changes in the adaptive immune cell populations in blood

    2 months after influenza vaccination

  • Changes in the adaptive immune cell populations in blood

    6 months after influenza vaccination

  • Changes in the adaptive immune cell populations in blood

    2 months after the first dose of herpes zoster vaccination

  • Changes in the adaptive immune cell populations in blood

    2 months after the second dose of herpes zoster vaccination

  • Changes in the adaptive immune cell populations in blood

    6 months after the second dose of herpes zoster vaccination

  • +18 more secondary outcomes

Study Arms (6)

1: Young adults herpes zoster vaccination

EXPERIMENTAL

Young adults between 18 and 35 years old will receive the herpes zoster vaccine (Shingrix). 60 days later, they will receive a booster dose.

Biological: Herpes zoster vaccination (Shingrix, GSK)

2: Older adults herpes zoster vaccination

EXPERIMENTAL

Adults older than 60 years of age will receive the herpes zoster vaccine (Shingrix). 60 days later, they will receive a booster dose.

Biological: Herpes zoster vaccination (Shingrix, GSK)

3: Young adults influenza vaccination

EXPERIMENTAL

Young adults between 18 and 35 years old will receive the influenza vaccine (Fluarix Tetra).

Biological: Influenza Vaccine (Fluarix Tetra Northern Hemisphere 2021 or 2022, GSK)

4: Older adults influenza vaccination

EXPERIMENTAL

Adults older than 60 years of age will receive the influenza vaccine (Fluarix Tetra).

Biological: Influenza Vaccine (Fluarix Tetra Northern Hemisphere 2021 or 2022, GSK)

5: Young adults herpes zoster vaccination related placebo

PLACEBO COMPARATOR

Young adults between 18 and 35 years old will receive the placebo injection (0.9% NaCl). 60 days later, they will receive another placebo.

Biological: Placebo

6: Young adults influenza vaccination related placebo

PLACEBO COMPARATOR

Young adults between 18 and 35 years old will receive the placebo injection (0.9% NaCl).

Biological: Placebo

Interventions

Herpes zoster vaccination (Shingrix, GSK)BIOLOGICAL

Shingrix is an ASO1-adjuvanted herpes zoster vaccination used to prevent shingles and its associated complications in at-risk populations

1: Young adults herpes zoster vaccination2: Older adults herpes zoster vaccination
Influenza Vaccine (Fluarix Tetra Northern Hemisphere 2021 or 2022, GSK)BIOLOGICAL

Fluarix Tetra is a quadrivalent inactivated influenza vaccine

3: Young adults influenza vaccination4: Older adults influenza vaccination
PlaceboBIOLOGICAL

0.9% NaCl

5: Young adults herpes zoster vaccination related placebo6: Young adults influenza vaccination related placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18-35 years old OR age ≥60 years old
  • Written informed consent

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University

Nijmegen, Gelderland, 6525GA, Netherlands

Location

MeSH Terms

Conditions

Influenza, HumanHerpes Zoster

Interventions

halofantrineInfluenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesVaricella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus Infections

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Jaap ten Oever, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2021

First Posted

October 19, 2021

Study Start

September 20, 2021

Primary Completion

May 17, 2023

Study Completion

May 17, 2023

Last Updated

June 29, 2023

Record last verified: 2023-06

Locations

NL(1)