InfluenzaPhase 2NCT05082688
Age Differences in Influenza and Herpes Zoster Vaccine Responses (INFLUENZA-SHINGRIX)
A Phase 2 study testing Herpes zoster vaccination (Shingrix, GSK) and Influenza Vaccine (Fluarix Tetra Northern Hemisphere 2021 or 2022, GSK) in people with Influenza and Herpes Zoster, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Herpes Zoster
- What is being tested?
- Herpes zoster vaccination (Shingrix, GSK) and Influenza Vaccine (Fluarix Tetra Northern Hemisphere 2021 or 2022, GSK)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Sep 2021to 17 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18-35 years old OR age ≥60 years old
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study Into Age-related Immunological Differences Related to Immunogenicity in Influenza Vaccination and Herpes Zoster Vaccination
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.
Read the detailed description
Rationale: Vaccination of the older adults is often advised as they are a high-risk population; however, vaccine efficacy generally decreases with age. This is mainly due to a decrease in adaptive immune responses known as immunosenescence, which is a factor influencing the response to influenza vaccination. On the other hand, there are vaccines that show high efficacy (more than 95%) in older adults, one of the most effective being the AS01 adjuvanted herpes zoster vaccine, Shingrix. The differential immune pathways associated with vaccine responsiveness as well as the immune mechanisms by which adjuvants overcome immunosenescence remain poorly understood. Targeting key immune pathways could be a way to improve vaccine efficacy in older adults.
Objective: To explore immunological features between young and older adults after administration of an adjuvanted herpes zoster (Shingrix) or influenza unadjuvanted (Fluarix) vaccine that could explain differences in vaccine immunogenicity.
Study design: A single centre open label, randomised, and partially placebo-controlled trial Study population: Approximately 140 healthy adults, 80 of which are between 18-35 years old, the other 60 are 60+ years old.
Intervention: Two groups of young and elderly volunteers receive recombinant zoster vaccine (Shingrix), while two other groups will receive a quadrivalent influenza vaccine (Fluarix). Two groups of young volunteers will receive a placebo.
Main study parameter: To identify immune senescence-related differences contributing to vaccine immunogenicity
- Conditions
- Influenza, Herpes Zoster
- Being tested
- Herpes zoster vaccination (Shingrix, GSK), Influenza Vaccine (Fluarix Tetra Northern Hemisphere 2021 or 2022, GSK), Placebo
- Keywords
- Vaccination, Trained immunity, Immunosenescence, Inflammaging
- Medical subject headings
- Influenza, Human, Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Influenza Vaccine (Fluarix Tetra Northern Hemisphere 2021 or 2022, GSK)Biological
Fluarix Tetra is a quadrivalent inactivated influenza vaccine
PlaceboBiological
0.9% NaCl
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: 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). Receives: 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. Receives: 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). Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
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.
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.
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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after the second dose of herpes zoster vaccination
Secondary outcomes (23)
Changes in the adaptive immune cell populations in blood
Ratio of adaptive immune cells (T and B cells) and their subtypes will be measured by FACS.
Measured: 2 months after influenza vaccination
Changes in the adaptive immune cell populations in blood
Ratio of adaptive immune cells (T and B cells) and their subtypes will be measured by FACS.
Measured: 6 months after influenza vaccination
Changes in the adaptive immune cell populations in blood
Ratio of adaptive immune cells (T and B cells) and their subtypes will be measured by FACS.
Measured: 2 months after the first dose of herpes zoster vaccination
Changes in the adaptive immune cell populations in blood
Ratio of adaptive immune cells (T and B cells) and their subtypes will be measured by FACS.
Measured: 2 months after the second dose of herpes zoster vaccination
Changes in the adaptive immune cell populations in blood
Ratio of adaptive immune cells (T and B cells) and their subtypes will be measured by FACS.
Measured: 6 months after the second dose of herpes zoster vaccination
Baseline DNA methylation
CpG methylation profile of PBMCs
Measured: Baseline (before vaccination)
Changes in B and T cell receptor repertoires
B and T cell receptors will be sequenced.
Measured: 2 months after influenza vaccination
Changes in B and T cell receptor repertoires
B and T cell receptors will be sequenced.
Measured: 2 months after the first dose of herpes zoster vaccination
Changes in B and T cell receptor repertoires
B and T cell receptors will be sequenced.
Measured: 2 months after the second dose of herpes zoster vaccination
Changes in circulating protein concentrations
Concentrations of circulating inflammatory proteins, including TNF, IL-6, IL-8, CCL3, CCL4, CXCL9, CXCL10, CXCL11, will be measured by Olink.
Measured: 2 months after influenza vaccination
Changes in circulating protein concentrations
Concentrations of circulating inflammatory proteins, including TNF, IL-6, IL-8, CCL3, CCL4, CXCL9, CXCL10, CXCL11, will be measured by Olink.
Measured: 2 months after the first dose of herpes zoster vaccination
Changes in circulating protein concentrations
Concentrations of circulating inflammatory proteins, including TNF, IL-6, IL-8, CCL3, CCL4, CXCL9, CXCL10, CXCL11, will be measured by Olink.
Measured: 2 months after the second dose of herpes zoster vaccination
Influenza vaccine-specific antibodies in the serum
HAI titers will be measured.
Measured: 2 months after influenza vaccination
Shingles vaccine-specific antibody production in the serum
Anti-gE titers will be measured.
Measured: 2 months after the first herpes zoster vaccination
Shingles vaccine-specific antibody production in serum
Anti-gE titers will be measured.
Measured: 2 months after the second herpes zoster vaccination
Percentage of participants reporting local reactions
Pain at the injection site, redness, and swelling
Measured: 7 days after influenza and herpes zoster vaccination
Percentage of participants reporting systemic events
Fever, fatigue, headache, chills, vomiting, diarrhea
Measured: 7 days after influenza and herpes zoster vaccination
Changes in epigenetic markers in PBMCs
ATAC-sequencing will be performed to measure post transcriptional modifications (methylation, acetylation, etc) on histones.
Measured: 2 months after influenza vaccination
Changes in epigenetic markers in PBMCs
ATAC-sequencing will be performed to measure post transcriptional modifications (methylation, acetylation, etc) on histones.
Measured: 6 months after influenza vaccination
Changes in epigenetic markers in PBMCs
ATAC-sequencing will be performed to measure post transcriptional modifications (methylation, acetylation, etc) on histones.
Measured: 2 months after the first herpes zoster vaccination
Changes in epigenetic markers in PBMCs
ATAC-sequencing will be performed to measure post transcriptional modifications (methylation, acetylation, etc) on histones.
Measured: 2 months after the second herpes zoster vaccination
Changes in epigenetic markers in PBMCs
ATAC-sequencing will be performed to measure post transcriptional modifications (methylation, acetylation, etc) on histones.
Measured: 6 months after the second herpes zoster vaccination
C-reactive protein in the serum
Soluble C-reactive protein (CRP) concentrations will be measured.
Measured: Baseline (before vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start20 Sep 2021
- Primary completion17 May 2023
- Study completion17 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Jaap ten Oever, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082688
- Sponsor's protocol ID
- NL76061.091.20
- Other IDs
- 2020-005682-13
- Status last verified
- Jun 2023
- First submitted
- 22 Jan 2021
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study Into Age-related Immunological Differences Related to Immunogenicity in Influenza Vaccination and Herpes Zoster Vaccination
- ClinicalTrials.gov ID
- NCT05082688
- Acronym / sponsor ID
- NL76061.091.20
- Conditions
- Influenza, Herpes Zoster
- Keywords
- Vaccination, Trained immunity, Immunosenescence, Inflammaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 17 May 2023 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: Vaccination of the older adults is often advised as they are a high-risk population; however, vaccine efficacy generally decreases with age. This is mainly due to a decrease in adaptive immune responses known as immunosenescence, which is a factor influencing the response to influenza vaccination. On the other hand, there are vaccines that show high efficacy (more than 95%) in older adults, one of the most effective being the AS01 adjuvanted herpes zoster vaccine, Shingrix. The differential immune pathways associated with vaccine responsiveness as well as the immune mechanisms by which adjuvants overcome immunosenescence remain poorly understood. Targeting key immune pathways could be a way to improve vaccine efficacy in older adults.
Objective: To explore immunological features between young and older adults after administration of an adjuvanted herpes zoster (Shingrix) or influenza unadjuvanted (Fluarix) vaccine that could explain differences in vaccine immunogenicity.
Study design: A single centre open label, randomised, and partially placebo-controlled trial Study population: Approximately 140 healthy adults, 80 of which are between 18-35 years old, the other 60 are 60+ years old.
Intervention: Two groups of young and elderly volunteers receive recombinant zoster vaccine (Shingrix), while two other groups will receive a quadrivalent influenza vaccine (Fluarix). Two groups of young volunteers will receive a placebo.
Main study parameter: To identify immune senescence-related differences contributing to vaccine immunogenicity
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1: Young adults herpes zoster vaccination | Experimental | Biological: Herpes zoster vaccination (Shingrix, GSK)Young adults between 18 and 35 years old will receive the herpes zoster vaccine (Shingrix). 60 days later, they will receive a booster dose. |
| 2: Older adults herpes zoster vaccination | Experimental | Biological: Herpes zoster vaccination (Shingrix, GSK)Adults older than 60 years of age will receive the herpes zoster vaccine (Shingrix). 60 days later, they will receive a booster dose. |
| 3: Young adults influenza vaccination | Experimental | Biological: Influenza Vaccine (Fluarix Tetra Northern Hemisphere 2021 or 2022, GSK)Young adults between 18 and 35 years old will receive the influenza vaccine (Fluarix Tetra). |
| 4: Older adults influenza vaccination | Experimental | Biological: Influenza Vaccine (Fluarix Tetra Northern Hemisphere 2021 or 2022, GSK)Adults older than 60 years of age will receive the influenza vaccine (Fluarix Tetra). |
| 5: Young adults herpes zoster vaccination related placebo | Placebo comparator | Biological: PlaceboYoung adults between 18 and 35 years old will receive the placebo injection (0.9% NaCl). 60 days later, they will receive another placebo. |
| 6: Young adults influenza vaccination related placebo | Placebo comparator | Biological: PlaceboYoung adults between 18 and 35 years old will receive the placebo injection (0.9% NaCl). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18-35 years old OR age ≥60 years old
- Written informed consent
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herpes zoster vaccination (Shingrix, GSK)Shingrix is an ASO1-adjuvanted herpes zoster vaccination used to prevent shingles and its associated complications in at-risk populations | Biological | 1: Young adults herpes zoster vaccination, 2: Older adults herpes zoster vaccination |
| Influenza Vaccine (Fluarix Tetra Northern Hemisphere 2021 or 2022, GSK)Fluarix Tetra is a quadrivalent inactivated influenza vaccine | Biological | 3: Young adults influenza vaccination, 4: Older adults influenza vaccination |
| Placebo0.9% NaCl | Biological | 5: Young adults herpes zoster vaccination related placebo, 6: Young adults influenza vaccination related placebo |
Primary outcome
Changes in cytokine productions of PBMCs upon incubation with viral, bacterial, and fungal antigens
Time frame: 2 months after influenza vaccination
IL-6, TNF, IL-1b, IFNg cytokine concentrations will be measured.
Changes in cytokine productions of PBMCs upon incubation with viral, bacterial, and fungal antigens
Time frame: 6 months after influenza vaccination
IL-6, TNF, IL-1b, IFNg cytokine concentrations will be measured.
Changes in cytokine productions of PBMCs upon incubation with viral, bacterial, and fungal antigens
Time frame: 2 months after the first dose of herpes zoster vaccination
IL-6, TNF, IL-1b, IFNg cytokine concentrations will be measured.
Changes in cytokine productions of PBMCs upon incubation with viral, bacterial, and fungal antigens
Time frame: 2 months after the second dose of herpes zoster vaccination
IL-6, TNF, IL-1b, IFNg cytokine concentrations will be measured.
Changes in cytokine productions of PBMCs upon incubation with viral, bacterial, and fungal antigens
Time frame: 6 months after the second dose of herpes zoster vaccination
IL-6, TNF, IL-1b, IFNg cytokine concentrations will be measured.
Change in transcriptional profile of individual cells from PBMC population
Time frame: 2 months after influenza vaccination
Gene expression profile of PBMCs will be measured by single cell-RNA sequencing.
Change in transcriptional profile of individual cells from PBMC population
Time frame: 6 months after influenza vaccination
Gene expression profile of PBMCs will be measured by single cell-RNA sequencing.
Transcriptional profile of individual cells from PBMC population
Time frame: 2 months after the first dose of herpes zoster vaccination
Gene expression profile of PBMCs will be measured by single cell-RNA sequencing.
Transcriptional profile of individual cells from PBMC population
Time frame: 2 months after the second dose of herpes zoster vaccination
Gene expression profile of PBMCs will be measured by single cell-RNA sequencing.
Transcriptional profile of individual cells from PBMC population
Time frame: 6 months after the second dose of herpes zoster vaccination
Gene expression profile of PBMCs will be measured by single cell-RNA sequencing.
23 secondary outcomes
Changes in the adaptive immune cell populations in blood
Time frame: 2 months after influenza vaccination
Changes in the adaptive immune cell populations in blood
Time frame: 6 months after influenza vaccination
Changes in the adaptive immune cell populations in blood
Time frame: 2 months after the first dose of herpes zoster vaccination
Changes in the adaptive immune cell populations in blood
Time frame: 2 months after the second dose of herpes zoster vaccination
Changes in the adaptive immune cell populations in blood
Time frame: 6 months after the second dose of herpes zoster vaccination
Baseline DNA methylation
Time frame: Baseline (before vaccination)
Changes in B and T cell receptor repertoires
Time frame: 2 months after influenza vaccination
Changes in B and T cell receptor repertoires
Time frame: 2 months after the first dose of herpes zoster vaccination
Changes in B and T cell receptor repertoires
Time frame: 2 months after the second dose of herpes zoster vaccination
Changes in circulating protein concentrations
Time frame: 2 months after influenza vaccination
Changes in circulating protein concentrations
Time frame: 2 months after the first dose of herpes zoster vaccination
Changes in circulating protein concentrations
Time frame: 2 months after the second dose of herpes zoster vaccination
Influenza vaccine-specific antibodies in the serum
Time frame: 2 months after influenza vaccination
Shingles vaccine-specific antibody production in the serum
Time frame: 2 months after the first herpes zoster vaccination
Shingles vaccine-specific antibody production in serum
Time frame: 2 months after the second herpes zoster vaccination
Percentage of participants reporting local reactions
Time frame: 7 days after influenza and herpes zoster vaccination
Percentage of participants reporting systemic events
Time frame: 7 days after influenza and herpes zoster vaccination
Changes in epigenetic markers in PBMCs
Time frame: 2 months after influenza vaccination
Changes in epigenetic markers in PBMCs
Time frame: 6 months after influenza vaccination
Changes in epigenetic markers in PBMCs
Time frame: 2 months after the first herpes zoster vaccination
Changes in epigenetic markers in PBMCs
Time frame: 2 months after the second herpes zoster vaccination
Changes in epigenetic markers in PBMCs
Time frame: 6 months after the second herpes zoster vaccination
C-reactive protein in the serum
Time frame: Baseline (before vaccination)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaap ten Oever, MD, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Herpes zoster vaccination (Shingrix, GSK) and Influenza Vaccine (Fluarix Tetra Northern Hemisphere 2021 or 2022, GSK) in people with Influenza and Herpes Zoster, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cytokine productions of PBMCs upon incubation with viral, bacterial, and fungal antigens (time frame: 2 months after influenza vaccination). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.