Clinical trial · Observational
Assesment of the Immune Response to RSV Vaccine in Patients With Myeloma, Lymphoma and Hematological Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A prospective study in which hematological oncology patients who were vaccinated against RSV will undergo a blood test to assess their immune response to the vaccine. As part of the study, hematological oncology patients with CLL, lymphoma, acute leukemia, myelodysplastic syndrome, and multiple myeloma, who are being monitored at the Hematology Institute at Ichilov, will be offered a blood test to evaluate their immune response to the RSV vaccine (serology, neutralizing antibodies, and cellular response). In the study, a blood sample of up to 10 ml will be taken in a chemistry tube and blood bank on the day of vaccination and about one month after that. The serological test will be conducted in the hospital's virology laboratory. The test result and its significance will be communicated to the patient by the treating hematologist in TASMC clinic. In this group of patients, a follow-up will be conducted over a 12-month period (during routine clinic visits) to document the incidence of RSV infection and complications related to the vaccine.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CLL | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Leukemia Acute Myeloid - AML | Plasma Cell Neoplasm | PROBABILISTIC | 0.70 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess the immune response to the RSV vaccine in patients with CLL, multiple myeloma, lymphoma, myelodysplastic syndrome, and acute leukemia, by measuring antibody levels in the blood up to 6 weeks after receiving the vaccine
- timeFrame
- Up to 45 days post-vaccination
- description
- The response rate Is expected to be 60-70%
Secondary outcomes (3)
- measure
- To evaluate the safety of the vaccine by measuring the incidence of Treatment-Emergent Adverse Events
- timeFrame
- Up to 45 days post-vaccination
- description
- The safety of the vaccine will be evaluated in hemato-oncological patients through the collection of adverse events (AEs) and serious adverse events (SAEs) up to 45 days post-vaccination.
- measure
- To identify factors predicting success/failure in achieving an antibody response to the vaccine.
- timeFrame
- Up to 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 60 years and older * Patients diagnosed with multiple myeloma(MM) or lymphoma or CLL or myelodysplastic syndrome (MDS) or acute leukemia Exclusion Criteria: * Patients who have been previously vaccinated against RSV * Patients who have experienced a severe reaction to any vaccine in the past
References
Publications (0)
Data not yet available