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

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What is this study about?

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.

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.

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.

3 vaccination schedule

The vaccine used is Gardasil 9, a suspension for injection administered intramuscularly. The schedule includes three doses.

4 first vaccine dose

The first dose is administered according to the assigned group: either at 9 months or 15 months after the transplant.

5 second vaccine dose

The second dose is given two months after the first dose.

6 third vaccine dose

The third dose is administered six months after the first dose.

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.

8 follow-up

Further antibody level measurements occur at 12 months after the third dose to evaluate long-term immunity.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Region Oestergoetland	Linkoping	Sweden
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Karolinska University Hospital	Solna	Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Uiyobzv Uvvolzqpct Hzpwpmbx	Uppsala	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Recruiting	01.10.2024

Trial locations

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.

Investigated diseases:

Allogenic stem cell transplantation

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.

Trial ID:

2022-502912-35-00

Protocol code:

ALLO-HPV

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?