RecruitingRare disease

Study on Immunity to Measles and Chickenpox in Children with Cancer Using Measles, Mumps, Rubella, and Varicella Vaccines

Verified siteRegistered drugNo placebo

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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 children and adolescents aged 0-18 years who have been treated for pediatric cancer. The study aims to understand how well these young patients can develop immunity, which is the body's ability to fight off infections, against two diseases: measles and chickenpox. The treatment being studied involves revaccination with vaccines that are designed to protect against these diseases. The vaccines used in this study are a combination vaccine for measles, mumps, and rubella and a separate vaccine for varicella, which is another name for chickenpox.

The purpose of the study is to examine how the immune system responds to these vaccines after cancer treatment. Participants will receive the vaccines through an injection into the muscle. The study will measure the levels of specific antibodies, which are proteins made by the immune system to fight infections, before and after the vaccination. This will help determine if the vaccines are effective in providing protection against measles and chickenpox in children who have undergone cancer treatment.

Throughout the study, researchers will compare the immune responses of the participants to those of a healthy control group. They will also look at differences in immune responses based on factors such as the type of cancer, the intensity of the cancer treatment, and whether the participants had immunity to these diseases before their cancer treatment. The study is expected to continue until 2028, providing valuable insights into the effectiveness of revaccination in young cancer survivors.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, participants will receive both oral and written information about the study. Consent must be signed to confirm understanding and agreement to participate.
Female participants of reproductive age who are sexually active must agree to use effective contraception and have a negative pregnancy test at the time of all vaccinations.
Step 2
Initial assessment
Participants will undergo an initial assessment to determine their current immunity levels against measles and chickenpox. This involves measuring the levels of specific antibodies, known as IgG, in the blood.
Step 3
Vaccination
Participants will receive a revaccination with a vaccine against varicella (chickenpox) and a vaccine against measles. These vaccines are administered through an intramuscular injection, which means the vaccine is injected into a muscle.
The vaccines used are live, attenuated forms, meaning they contain a weakened version of the virus that cannot cause disease.
Step 4
Post-vaccination assessment
After the vaccination, participants will have follow-up assessments to measure the levels of IgG antibodies again. This will help determine the effectiveness of the vaccination in boosting immunity against measles and chickenpox.
The difference in antibody levels before and after vaccination will be analyzed to assess the immune response.
Step 5
Monitoring and follow-up
Participants will be monitored for any changes in their immunity over time. This includes checking for any side effects from the vaccination and ensuring the safety of all participants.
The study will also compare the immune responses of participants with different types of cancer, age groups, and treatment intensities.

Who can join the trial?

10 criteria

Participants must be children or adolescents aged 0 to 18 years who are starting cancer treatment.
Their vaccination status for measles and chickenpox before cancer treatment must be known.
Participants and their guardians must receive oral and written information about the trial and provide signed consent to participate.
Female participants who have started menstruating and are sexually active must agree to use effective birth control and have a negative pregnancy test at the time of all vaccinations. Effective birth control methods include:
- Combined pills with estrogen and progesterone taken orally.
- Intravaginal ring, known as the p-ring.
- Transdermal methods, such as the contraceptive patch.
- Progesterone-only pills, injections, or implants like the contraceptive implant.
- Intrauterine devices (IUDs) that release hormones or are made of copper.
- Completed sterilization with blockage of both fallopian tubes.
- Choosing not to have sexual intercourse (abstinence).

Who cannot join the trial?

7 criteria

Patients who have not completed their treatment for pediatric cancer.
Patients who have not reached a stable health condition after their cancer treatment.
Patients who have a known allergy to the varicella (chickenpox) or measles vaccines.
Patients who have a weakened immune system, which means their body has a harder time fighting infections.
Patients who are currently taking medications that suppress the immune system, such as steroids.
Patients who have received a blood transfusion or blood products recently, as this can affect the vaccine's effectiveness.
Patients who have any other serious health conditions that the study doctors believe would make it unsafe for them to participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Verified
Gothenburg, Sweden
Region Halland
Verified
Varberg, Sweden
Region Joenkoepings Laen
Verified
Jönköping, Sweden

Trial locations

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Investigated drugs

Varicella Vaccine
is a medication used to protect against chickenpox, a common childhood disease. In this clinical trial, the vaccine is given to children and adolescents who have undergone treatment for childhood cancer. The goal is to help their immune system build a defense against chickenpox by measuring the level of specific antibodies in their blood before and after receiving the vaccine. This helps determine if the vaccine successfully boosts their immunity to chickenpox.
Measles Vaccine
is a medication used to protect against measles, a highly contagious viral disease. In this trial, the vaccine is administered to children and adolescents who have been treated for childhood cancer. The purpose is to evaluate their immune response to the vaccine by checking the levels of antibodies against measles in their blood before and after vaccination. This helps assess whether the vaccine effectively enhances their immunity to measles.

What is already known about the treatment

Varicella Vaccine
The varicella vaccine is administered as an injection to help protect against chickenpox, especially in children and adolescents who have undergone cancer treatment. Currently, this vaccine is well-established in medical practice and literature as a preventive measure against chickenpox. Its main use is to boost immunity in individuals who may have weakened immune systems due to previous cancer treatments. The vaccine works by stimulating the body's immune system to produce antibodies against the varicella-zoster virus, which causes chickenpox. It is classified as a live attenuated vaccine, meaning it contains a weakened form of the virus that cannot cause the disease but can still prompt an immune response.
Measles Vaccine
The measles vaccine is given as an injection to protect against measles, particularly in children and adolescents recovering from cancer. It is a well-recognized vaccine in the medical community, used to prevent measles infections. The primary therapeutic indication is to enhance immunity in those whose immune systems may be compromised due to cancer treatments. The vaccine functions by encouraging the immune system to generate antibodies against the measles virus. It is categorized as a live attenuated vaccine, which includes a weakened virus that is safe and effective in triggering an immune response without causing the disease.

Investigated diseases

Leukemia
Leukemia is a type of cancer that affects the blood and bone marrow, where blood cells are produced. It begins with the rapid production of abnormal white blood cells, which crowd out normal cells. This can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding. As the disease progresses, it can affect the production of red blood cells and platelets. The abnormal cells can also spread to other parts of the body, including the lymph nodes, liver, and spleen. Leukemia is classified into different types based on the speed of progression and the type of blood cell affected.
Solid Tumors
Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in any part of the body and are classified based on the type of cells they originate from. As they grow, solid tumors can press on nearby organs and tissues, causing pain and other symptoms. They can be benign, meaning they do not spread to other parts of the body, or malignant, meaning they can invade nearby tissues and spread to distant sites. The progression of solid tumors depends on their location, size, and whether they are benign or malignant. Malignant solid tumors can metastasize, spreading cancer cells to other parts of the body through the bloodstream or lymphatic system.