Recombinant shingles vaccine for frail and immunocompromised adults
Immunogenicity, Efficacy and Safety of Recombinant Herpes Zoster Vaccine (RZV) in Frail Patients: Multicentric Prospective Study
This project will test whether a recombinant shingles (herpes zoster) vaccine produces protective immune responses and is safe in frail adults with weakened immune systems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Drugs / interventions | CAR-T, chemotherapy, immunotherapy, Rituximab, CAR T |
| Locations | 1 site (Pavia, Pavia) |
| Trial ID | NCT07321808 on ClinicalTrials.gov |
What this trial studies
This observational longitudinal study follows adults eligible for the recombinant zoster vaccine to measure immune responses, clinical protection, and safety over time. It enrolls frail and immunocompromised subgroups including rheumatologic patients (including those on JAK inhibitors or CTLA4-Ig), people with solid tumors, hematologic malignancies or post-transplant/CAR-T recipients, and neurologic conditions such as multiple sclerosis. Immunogenicity assessments include VZV-specific T-cell and antibody measurements, while clinical endpoints include occurrence of herpes zoster and adverse events after vaccination. Participants are followed at scheduled clinic visits and blood draws at the coordinating center in Pavia, Italy.
Who should consider this trial
Good fit: Adults (age ≥18) who are frail or immunocompromised and eligible for recombinant zoster vaccination, including patients with autoimmune rheumatic disease on JAK inhibitors or CTLA4-Ig, people with solid or hematologic cancers (including transplant/CAR‑T recipients), and patients with multiple sclerosis.
Not a fit: People without immune compromise, children, or anyone not eligible for RZV vaccination or with contraindications are unlikely to gain benefit from participating.
Why it matters
Potential benefit: If successful, results could clarify who benefits most from the vaccine and help reduce shingles risk and complications in frail, immunocompromised adults.
How similar studies have performed: Recombinant zoster vaccine has shown strong immune responses and clinical protection in older adults and some immunocompromised groups, although evidence in several frail subpopulations remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pavia, Pavia
- Fondazione IRCCS Policlinico San Matteo, SC Microbiologia e Virologia — Pavia, Pavia, Italy (Recruiting)
Study contacts
- Study coordinator: Fausto Baldanti, MD
- Email: f.baldanti@smatteo.pv.it
- Phone: +390382501039
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.