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Shingles vaccine put to the test in frail patients

NCT ID NCT07321808

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Show 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Fondazione IRCCS Policlinico San Matteo, SC Microbiologia e Virologia

    RECRUITING

    Pavia, Pavia, 27100, Italy

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