Clinical trial NCT06944119: Assesment of the Immune Response to RSV Vaccine in Patients With Myeloma, Lymphoma and Hematological Leukemia
Official title: Assesment of the Immune Response to RSV Vaccine in Patients With Myeloma, Lymphoma and Hematological Leukemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myeloma
Lymphoma
CLL
Myelodysplastic Syndrome
Leukemia Acute Myeloid - AML
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2025-04-25
Enrollment: 250
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 60 years and older diagnosed with multiple myeloma, lymphoma, CLL, myelodysplastic syndrome, and acute leukemia who are scheduled to receive the RSV vaccine.

Brief summary: 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 our 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.

Detailed description: participants 250 Single-center Research hypothesis approximately 60%-70% of the 250 hematological oncology patients who will participate in the study will achieve a positive serological response. This estimate is based on a study published in the NEJM which included participants aged 60 and above, without hematological oncological diseases or other conditions causing immunosuppression, where a response was observed in 83.7% of participants. We estimate that the response rate in hematological oncology patients will be lower, ranging from 60-70%, reflecting the degree of immune suppression associated with their disease and the treatment they received.

The study will include patients with chronic lymphocytic leukemia (CLL), lymphoma, myelodysplastic syndrome, leukemia, and myeloma. We expect that approximately 60 patients will belong to each of these subgroups, so the sample size will allow an assessment of the immune response within these subpopulations.

Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
measure: To evaluate the safety of the vaccine by measuring the incidence of Treatment-Emergent Adverse Events
timeFrame: 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
measure: To assess the incidence rate of RSV infection in individuals vaccinated against RSV over a 12-month period following vaccination.
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Irit Avivi, MD
role: PRINCIPAL_INVESTIGATOR
References: