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Study on HPV Vaccine Timing for Patients After Stem Cell Transplantation Using Gardasil 9

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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 effects of the vaccine Gardasil 9 in individuals who have undergone allogeneic stem cell transplantation. This type of transplantation involves receiving stem cells from a donor, which can help treat various blood-related diseases. The vaccine, Gardasil 9, is designed to protect against nine types of the Human Papillomavirus (HPV), a virus that can lead to certain cancers and other health issues.

The purpose of the study is to compare the body's response to the Gardasil 9 vaccine when given at two different times after the stem cell transplant: either starting at 9 months or at 15 months post-transplant. Participants will receive the vaccine as a series of injections, and the study will monitor how well their immune system responds to the vaccine over time.

Throughout the study, participants will receive three doses of the vaccine, and their antibody levels, which are proteins the body makes to fight infections, will be measured at different intervals. This will help researchers understand how effective the vaccine is when given at different times after the transplant. The study aims to provide valuable information on the best timing for vaccination to ensure optimal protection against HPV for those who have had an allogeneic stem cell transplantation.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after receiving an allogeneic stem cell transplant. Eligibility includes being an adult aged 18 to 45 years, regardless of previous HPV vaccination.
Step 2
Randomization
Participants are randomly assigned to one of two groups: early vaccination starting at 9 months post-transplant or late vaccination starting at 15 months post-transplant.
Step 3
Vaccination schedule
The vaccine used is Gardasil 9, a suspension for injection administered intramuscularly. The schedule includes three doses.
Step 4
First vaccine dose
The first dose is administered according to the assigned group: either at 9 months or 15 months after the transplant.
Step 5
Second vaccine dose
The second dose is given two months after the first dose.
Step 6
Third vaccine dose
The third dose is administered six months after the first dose.
Step 7
Antibody level measurement
Antibody levels against HPV 16 and other serotypes are measured one month after the third dose to assess the immune response.
Step 8
Follow-up
Further antibody level measurements occur at 12 months after the third dose to evaluate long-term immunity.

Who can join the trial?

3 criteria

Must have received an allogeneic stem cell transplant, which means a stem cell transplant from a donor, either related or unrelated.
Must be an adult, both men and women, aged 18 to 45 years old, to receive the vaccination.
Can participate regardless of whether they have had the HPV vaccine before their transplant.

Who cannot join the trial?

1 criterion

Patients who have received an allogeneic stem cell transplantation. This means they have had a procedure where they received stem cells from a donor to replace their own stem cells.

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Verified sites

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Verified
Karolinska University Hospital
Solna, Sweden
Verified
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Gothenburg, Sweden
Responsive
Region Oestergoetland
Linkoping, Sweden

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Investigated drugs

Gardasil 9 is a vaccine used to protect against infections caused by certain types of human papillomavirus (HPV). In this clinical trial, the vaccine is being studied to see how well it works when given at different times after a patient has undergone an allogeneic stem cell transplant. The goal is to determine whether starting the vaccination earlier or later after the transplant provides better protection against HPV.

Human Papillomavirus Type 6 L1 Protein

What is already known about the treatment

Gardasil 9 – This vaccine is administered via injection and is used to protect against infections caused by the human papillomavirus (HPV). It is currently well-established in medical practice and literature as a preventive measure against certain types of cancers and genital warts associated with HPV. The main therapeutic indication for Gardasil 9 is to prevent HPV-related diseases, particularly in individuals who have undergone allogeneic stem cell transplantation. At the molecular level, the vaccine works by stimulating the immune system to produce antibodies that target and neutralize the virus, preventing it from causing infection. Gardasil 9 is classified as a vaccine in pharmacology.

Investigated diseases

Recipients of allogeneic stem cell transplantation – This condition involves individuals who have received stem cells from a donor to replace their own damaged or diseased bone marrow. The process is used to treat various blood disorders and cancers. After the transplant, the recipient's immune system is weakened, making them more susceptible to infections and complications. Over time, the new stem cells can help rebuild the immune system, but the recovery process can be lengthy. The body may also react against the new cells, leading to a condition known as graft-versus-host disease. Monitoring and managing the immune response is crucial during the recovery period.