Shingles vaccine put to the test in frail patients
NCT ID NCT07321808
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study looks at how well the shingles vaccine works in people with weakened immune systems, such as those with cancer or autoimmune diseases. Researchers will measure immune responses and track side effects in 300 adults. The goal is to see if the vaccine can effectively prevent shingles in these vulnerable patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- recombinant zoster vaccine (RZV)
- What this could lead to
- If successful, this could show that the vaccine effectively prevents shingles in frail patients, leading to better vaccination guidelines for this group.
- What could go wrong
- This is an observational study, not a treatment trial. It may find that the vaccine works less well in some patients due to their weakened immune systems, and results may not apply to all frail populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
See eligibility criteria
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
3.1.1. Adult population (longitudinal study) General inclusion criteria Age ≥ 18 years Eligibility for RZV vaccination Written informed consent Inclusion criteria for specific sub-groups: Rheumatologic patients: * rheumatoid arthritis diagnosis according to classification criteria of 1987 and/or 2018 * eligibility or in therapy with JAKis o CTLA4-Ig (monotherapy or DMARD combination) Oncologic patients: * confirmed histological diagnosis of solid tumour (any type) * life expectancy ≥ 6 months * Patients with cancer who have to start immunotherapy with or without chemotherapy/targeted therapy Hematologic patients: * Patients with haematological malignancy treated with drugs (chemotherapy, new drugs, target therapies) other than antibodies. * Patients treated with anti-CD19 or CD20 or CD22 or CD30 or anti-PD1 antibodies with or without chemotherapy * Patients receiving autologous or allogeneic transplantation or CAR-T cells Neurologic patients: * Multiple sclerosis (MS) diagnosis according to McDonald criteria 2017 * Eligibility or in therapy with first- or second-line immunosuppressive treatments General Exclusion criteria No informed consent Previous HZ vaccination Documented reactions or allergies against vaccines Severe infections during the previous 3 months 3.1.2. Pediatric population (cross-sectional study) Inclusion criteria Written informed consent from parents legal tutor and child assent (depending on age) Serology for VZV positive Hematologic patients: * Patients with haematological malignancies treated with chemotherapy including experimental drugs and target therapies; * Patients with haematological malignancies undergoing B-cell depleting treatments, e.g. CAR-T cell therapy or anti-CD20, antiCD22, anti-CD30, anti-CD19 monoclonal or bispecific antibodies * Patients with haematological malignancies receiving allogeneic transplantation due to malignant or non-malignant diseases, including primary immunodeficiencies, hemoglobinopathies and acquired or inherited bone marrow failure syndrome. Rheumatologic patients: 1. patients with connective tissue diseases (including systemic lupus erythematosus, SLE, juvenile dermathomyositis, JDM, and scleroderma) treated with B cell depleting therapies (anti-CD20); 2. patients with juvenile idiopathic arthritis (JIA) treated with TNF inhibitors. The corresponding disease control populations will be patients with the same diseases listed above, who are not receiving anti-CD20 or TNF inhibitors, respectively.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fondazione IRCCS Policlinico San Matteo, SC Microbiologia e Virologia
RECRUITINGPavia, Pavia, 27100, Italy
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