Study Comparing High-Dose and Standard-Dose Inactivated Influenza Vaccines in Adults with Blood Cancer

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What is this study about?

This clinical trial is focused on studying the effects of different doses of the flu vaccine in adults who are being treated for hematological cancer, which includes cancers like multiple myeloma and other B-cell malignancies. The study will compare a high-dose flu vaccine with a standard-dose flu vaccine to see which is more effective in these patients. The vaccines being tested are called Alpharix-Tetra and EFLUELDA, both of which are designed to protect against the flu by using inactivated virus particles.

The purpose of the study is to determine if the high-dose vaccine leads to a better immune response compared to the standard-dose vaccine. Participants will receive one of the two vaccines, and their immune response will be monitored over time. The study will also include a group of healthy individuals to compare how their immune systems respond to the vaccine. The main goal is to see if the high-dose vaccine can increase the rate of seroconversion, which means developing antibodies against the flu virus, in patients with hematological cancer.

Throughout the study, researchers will also look at how the immune system is activated in response to the vaccines and try to identify any factors that might predict a better response to the vaccine. This information could help improve flu vaccination strategies for patients with hematological cancers in the future. Participants will be monitored for any side effects or adverse events following vaccination to ensure their safety.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either a high-dose or standard-dose influenza vaccine. This process is called randomization and ensures that each participant has an equal chance of receiving either dose.

2 receiving the vaccine

You will receive the assigned influenza vaccine as a suspension for injection. The vaccine is administered as a single injection. The specific strains included in the vaccine are designed to protect against different types of influenza viruses.

3 monitoring and follow-up

After receiving the vaccine, your response to the vaccine will be monitored. This includes checking for seroconversion, which means your body has produced antibodies in response to the vaccine. This will be assessed 28 days after vaccination.

You will also be monitored for any adverse events or side effects that may occur within six months following the vaccination. This is to ensure your safety and to gather information on how the vaccine affects individuals with hematological cancer.

4 completion of the study

The study aims to gather data on the effectiveness of the high-dose versus standard-dose vaccine in patients with hematological cancer. Your participation will help in understanding the immune response and potential side effects in this specific group of patients.

Who Can Join the Study?

Patients must be currently receiving treatment for one of the following conditions:
- Multiple myeloma: A type of blood cancer that affects plasma cells.
- B-cell malignancy: A type of cancer that affects B-cells, which are a type of white blood cell. This includes patients who have received rituximab (a medication used to treat certain types of cancer) in the last 6 months, even if no other treatment was given.
- Myeloid malignancy: A type of cancer that affects myeloid cells, which are another type of blood cell. Note that certain medications like hydroxyurea or tyrosine kinase inhibitors are not considered treatments for this study, unlike JAK inhibitors or azacitidine.
- Standard chemotherapy
Patients must be aged 18 years or older at the time of joining the study.
Patients must provide written informed consent, which means they agree to participate in the study after being fully informed about it.

Who Cannot Join the Study?

Patients who do not have hematological cancer cannot participate. This means the study is only for those with certain types of blood cancer.
Patients who are not within the specified age range cannot participate. The study is for adults only.
Patients who are not willing to be randomly assigned to receive one of the two vaccines cannot participate. This means you must agree to receive either vaccine without knowing which one you will get.
Patients who are not able to give informed consent cannot participate. This means you must understand the study and agree to take part.
Patients who are part of a vulnerable population cannot participate. This refers to groups of people who might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre hospitalier universitaire de Liege	Liege	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.09.2023

Trial locations

Investigated drugs:

QIIV-HD is a type of flu vaccine that is being tested in this study. It is designed to help protect people with blood cancers from getting the flu. This vaccine is made from inactivated, or killed, flu viruses, which means it cannot cause the flu. The goal of using this vaccine is to see if it can help the body build a stronger defense against the flu compared to the standard flu vaccine.

QIIV-SD is another type of flu vaccine used in the study. Like QIIV-HD, it is also made from inactivated flu viruses. This vaccine is the standard version that is commonly used to protect against the flu. The study is comparing this standard vaccine to the high-dose version to see which one is more effective in helping patients with blood cancers develop immunity to the flu.

Investigated diseases:

Haematological malignancy

Multiple Myeloma – Multiple myeloma is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. As the disease progresses, abnormal plasma cells multiply and accumulate in the bone marrow, leading to bone damage and affecting the production of normal blood cells. This can result in symptoms such as bone pain, fatigue, and increased susceptibility to infections. Over time, the disease can cause complications like kidney problems and anemia due to the overproduction of abnormal proteins. The progression of multiple myeloma can vary, with periods of stability followed by active disease phases.

B-cell Malignancy – B-cell malignancy refers to a group of cancers that originate in B lymphocytes, a type of white blood cell responsible for producing antibodies. These malignancies can include conditions such as non-Hodgkin lymphoma and chronic lymphocytic leukemia. As the disease progresses, the abnormal B cells can accumulate in lymph nodes, blood, and other tissues, disrupting normal immune function. This can lead to symptoms like swollen lymph nodes, fatigue, and increased risk of infections. The progression of B-cell malignancies can vary widely depending on the specific type and individual patient factors.

Myeloid Malignancy – Myeloid malignancy encompasses a group of cancers that arise from myeloid cells, which are responsible for producing various types of blood cells, including red blood cells, white blood cells, and platelets. These malignancies include conditions such as acute myeloid leukemia and myelodysplastic syndromes. As the disease progresses, the abnormal myeloid cells can crowd out normal cells in the bone marrow, leading to symptoms like anemia, bleeding, and increased risk of infections. The progression of myeloid malignancies can be rapid or slow, depending on the specific type and other factors.

Trial ID:

2023-505357-40-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing High-Dose and Standard-Dose Inactivated Influenza Vaccines in Adults with Blood Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?