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Study on the Effectiveness of Pneumococcal Vaccines PCV13 and PPV23 in Adults with Acute Leukemia or Lymphoma Undergoing Chemotherapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness of a combined vaccination strategy against *pneumococcal infections* in adults who have been treated for *acute myeloblastic leukemia* or *lymphoma*. The study involves two vaccines: *Prevenar 13*, which is a pneumococcal polysaccharide conjugate vaccine, and *Pneumovax*, a pneumococcal polysaccharide vaccine. The purpose of the study is to evaluate how well the immune system responds to this vaccination strategy.

Participants in the study will receive an injection of *Prevenar 13*, followed by an injection of *Pneumovax* two months later. The study will monitor the immune response one month after the complete vaccination regimen. The goal is to determine if the combined vaccination strategy effectively boosts the immune system's ability to fight pneumococcal infections, which are caused by bacteria that can lead to serious illnesses like pneumonia.

The study will track the participants' immune responses over time, checking for specific markers in the blood that indicate a strong defense against pneumococcal bacteria. This includes measuring levels of antibodies, which are proteins the body makes to fight infections. The study will also look at any side effects from the vaccines and assess how well the vaccines work in preventing infections. The results will help understand the best way to protect patients with *acute myeloblastic leukemia* or *lymphoma* from pneumococcal infections.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, ensure that all eligibility criteria are met. This includes being 18 years or older, having a medical follow-up in a hematology unit, and having received a first course of chemotherapy for acute myeloblastic leukemia or lymphoma. A negative pregnancy test is required, and a consent form must be signed.

  2. Step 2

    First vaccination

    Receive the first injection of the PCV13 vaccine. This is a pneumococcal polysaccharide conjugate vaccine administered as a suspension for injection. The injection is given intramuscularly, which means it is injected into a muscle.

  3. Step 3

    Waiting period

    Wait for a period of 2 months after the first vaccination. During this time, continue with regular medical follow-ups as advised by healthcare providers.

  4. Step 4

    Second vaccination

    Receive the second injection of the PPV23 vaccine. This is a pneumococcal polysaccharide vaccine administered as a solution for injection. Like the first vaccine, it is given intramuscularly.

  5. Step 5

    Follow-up and monitoring

    One month after completing the vaccination regimen, attend a follow-up appointment to evaluate the response to the combined vaccination strategy. This involves measuring specific antibody levels in the blood to determine the effectiveness of the vaccines.

    Additional follow-up appointments will occur between 3-6 months and 9-12 months after the second vaccination to assess the sustainability of the immune response.

  6. Step 6

    Final assessment

    At the end of the study period, a final assessment will be conducted to evaluate the overall response to the vaccination strategy. This includes checking for any local or general reactions to the vaccines and documenting any pneumococcal infections that may have occurred.

Who can join the trial?

10 criteria

  • Patient must be 18 years or older.
  • Must have regular medical follow-up in a hematology unit (a specialized medical department for blood-related conditions).
  • Must have received a first course of chemotherapy for:
    • Acute myeloblastic leukemia (a type of blood cancer) without a specific genetic marker (PML-RARa) and no planned stem cell transplant (anti-IDH treatment is allowed).
    • Diffuse large B cell lymphoma (a type of lymphatic system cancer).
    • Follicular lymphoma (another type of lymphatic system cancer).
    • Must have a life expectancy of more than 6 months.
    • Must have a negative pregnancy test if applicable.
    • Must have signed the consent form to participate in the study.
    • Must have health insurance.
    • Must be a free individual, meaning not under guardianship, tutorship, or any form of legal supervision.

Who cannot join the trial?

4 criteria

  • Patients who are not diagnosed with acute myeloblastic leukemia or lymphoma cannot participate.
  • Patients who are not receiving cytotoxic chemotherapy for their condition cannot participate. Cytotoxic chemotherapy is a type of cancer treatment that uses drugs to kill cancer cells.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study but is not specified here.
  • Patients who are part of a vulnerable population, such as those who may not be able to give informed consent, cannot participate.
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Investigated drugs

  • PCV13

    is a vaccine that helps protect against infections caused by 13 types of pneumococcal bacteria. These bacteria can cause serious illnesses like pneumonia, meningitis, and bloodstream infections. In this trial, PCV13 is given as the first step in a vaccination strategy to help boost the immune system of adults who are undergoing treatment for acute leukemia or lymphoma.

  • PPV23

    is another vaccine that targets pneumococcal bacteria, but it covers 23 different types. It is used in this trial as the second step in the vaccination process, given two months after the PCV13 vaccine. The goal is to provide broader protection against pneumococcal infections for patients who have weakened immune systems due to their cancer treatment.

What is already known about the treatment

PCV13 and PPV23 – These medications are vaccines administered through injections to help protect against pneumococcal infections. They are currently being studied for their effectiveness in people with acute leukemia or lymphoma who are receiving chemotherapy. The main purpose of these vaccines is to boost the immune system's ability to fight off pneumococcal bacteria, which can cause serious infections. PCV13 and PPV23 work by introducing small, harmless pieces of the bacteria to the body, prompting the immune system to recognize and combat the real bacteria if encountered in the future. These vaccines are classified as immunological agents, specifically as pneumococcal vaccines.

Investigated diseases

  • Acute Myeloblastic Leukemia

    Acute myeloblastic leukemia is a type of cancer that affects the blood and bone marrow. It is characterized by the rapid growth of abnormal white blood cells, which accumulate in the bone marrow and interfere with the production of normal blood cells. The disease progresses quickly and can lead to symptoms such as fatigue, fever, frequent infections, and easy bruising or bleeding. As the abnormal cells multiply, they can spread to other parts of the body, including the liver, spleen, and lymph nodes. The progression of the disease can vary, but it typically involves a rapid increase in the number of immature white blood cells, known as myeloblasts, in the blood and bone marrow. This can lead to a decrease in the number of healthy red blood cells, white blood cells, and platelets, causing anemia, increased risk of infection, and bleeding problems.

  • Lymphoma

    Lymphoma is a type of cancer that begins in the lymphatic system, which is part of the body's immune system. It occurs when lymphocytes, a type of white blood cell, grow uncontrollably and form tumors in the lymph nodes, spleen, bone marrow, or other organs. The disease can progress at different rates, with some types growing slowly and others more aggressively. Symptoms may include swollen lymph nodes, fever, night sweats, weight loss, and fatigue. As the disease advances, it can spread to other parts of the body, affecting the function of various organs. The progression of lymphoma depends on the specific type and stage of the disease, as well as the individual's overall health.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517288-22-01Protocol codeHEMATOVACEstimated enrolment160 patientsSponsorCentre Hospitalier Universitaire De Poitiers

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