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NCT Number: NCT06944119

Assesment of the Immune Response to RSV Vaccine in Patients With Myeloma, Lymphoma and Hematological Leukemia

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Myeloma Bone Marrow Diseases CLL Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Acute Myeloid - AML Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Myelodysplastic Syndrome Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

About this study

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. the investigators 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. The investigatorsexpect 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: Up to 45 days post-vaccination

    The response rate Is expected to be 60-70%

Secondary outcomes

  1. To evaluate the safety of the vaccine by measuring the incidence of Treatment-Emergent Adverse Events

    Time frame: Up to 45 days post-vaccination

    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.

  2. To identify factors predicting success/failure in achieving an antibody response to the vaccine.

    Time frame: Up to 1 year

    • All adverse events occurring within 30 days following vaccination.
    • Grade≥3 adverse events occurring within 30 days following vaccination.

  3. To assess the incidence rate of RSV infection in individuals vaccinated against RSV over a 12-month period following vaccination.

    Time frame: Up to 1 year

    We will assess the incidence rate of RSV infection in individuals vaccinated against RSV over a 12-month period by collecting data on RSV infections during the year following vaccination.

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 25, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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