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Study on the Effectiveness of the 9-Valent HPV Vaccine in Children and Adolescents with Weakened Immune Systems

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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 9-valent HPV vaccine, known as Gardasil 9, in children and adolescents who have weakened immune systems. The vaccine is designed to protect against nine types of the Human Papillomavirus (HPV), which can lead to various health issues, including certain types of cancer. The study involves participants who are immunocompromised, meaning their immune systems are not as strong as usual. This includes children and adolescents who are living with HIV, have undergone organ transplants, or have received chemotherapy.

The purpose of the study is to evaluate how well the 9-valent HPV vaccine works in these immunocompromised individuals. Participants will receive three doses of the vaccine over a period of several months. The study will monitor the participants' immune response to the vaccine, specifically looking at how their bodies produce antibodies against the virus. This will be compared to the immune response of healthy individuals who also receive the vaccine.

Throughout the study, participants will have their blood tested at different times to measure the levels of antibodies and other immune markers. The study aims to provide valuable information on the effectiveness of the 9-valent HPV vaccine in protecting immunocompromised children and adolescents from HPV-related diseases. This research could help improve vaccination strategies for those with weakened immune systems, ensuring they receive the best possible protection against HPV.

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 study
Upon joining the study, consent or assent is required. This involves signing a form to confirm understanding and agreement to participate.
Eligibility criteria include being between 9 and 18 years old. If HIV positive, the participant must be on antiretroviral therapy with an undetectable viral load and a CD4 cell count greater than 200/mm3 for at least six months.
Step 2
First vaccination
The first dose of the Gardasil 9 vaccine is administered. This is a suspension for injection given through a pre-filled syringe.
The vaccine is designed to protect against nine types of the human papillomavirus (HPV).
Step 3
Second vaccination
The second dose of the Gardasil 9 vaccine is administered. This occurs according to the schedule recommended for children and adolescents over 9 years of age.
Step 4
Third vaccination
The third and final dose of the Gardasil 9 vaccine is administered. This completes the vaccination schedule.
Step 5
Monitoring and follow-up
Participants are monitored for seroconversion, which is the development of detectable antibodies in the blood, from baseline to month 7 and month 12.
Additional assessments may include age, category of immunosuppression, CD4/CD8 ratio, specific T cell response, and TTV viral load.

Who can join the trial?

4 criteria

Children or adolescents aged 9 to under 18 years.
Willing to sign a consent or assent form, which is a document that explains the study and confirms your agreement to participate.
If HIV positive (a virus that affects the immune system), you must be on ART (antiretroviral therapy, which is medication to control HIV) and have an undetectable viral load (the amount of HIV in the blood is so low that it can't be measured) and a CD4 cell count (a type of white blood cell that fights infection) greater than 200/mm³ for at least 6 months.
If you have received chemotherapy (treatment for cancer) or are a SOT/HSCT recipient (someone who has had an organ transplant or stem cell transplant), you must be referred for immunizations after your immune system has recovered enough, according to routine clinical practice.

Who cannot join the trial?

1 criterion

Patients who are immunosuppressed cannot participate. This means their immune system, which helps fight infections, is not working properly.

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Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain

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Investigated drugs

9-valent HPV vaccine is a vaccine designed to protect against nine different types of the human papillomavirus (HPV). This virus can cause various health issues, including certain types of cancer. The vaccine works by helping the body's immune system recognize and fight the virus if exposed in the future. In this clinical trial, the vaccine is being tested to see how well it works in children and adolescents who have weakened immune systems due to conditions like HIV, organ transplants, or cancer treatments. The goal is to see if these individuals can develop immunity to HPV after receiving the vaccine, similar to healthy individuals.

Human Papillomavirus Type 6 L1 Protein - Adsorbed - In The Form Of Virus-Like Particles Produced In Yeast Cells (Saccharomyces Cerevisiae Canade 3C-5 (Strain 1895)) By Rdna

What is already known about the treatment

9-valent HPV vaccine – This vaccine is administered through an injection, typically given in the upper arm. It is currently being studied for its effectiveness in children and adolescents with weakened immune systems, such as those with HIV, organ transplants, or who have undergone chemotherapy. The main purpose of this vaccine is to protect against nine types of human papillomavirus (HPV), which can lead to certain cancers and diseases. At the molecular level, the vaccine works by stimulating the body's immune system to produce antibodies that can recognize and fight off the virus if exposed in the future. It is classified as a vaccine, which is a type of biological preparation that provides active acquired immunity to a particular infectious disease.

Investigated diseases

Human Immunodeficiency Virus (HIV) Infection – HIV infection is a condition caused by the human immunodeficiency virus, which attacks the body's immune system, specifically the CD4 cells (T cells). Over time, HIV can destroy so many of these cells that the body can't fight off infections and disease. The virus is transmitted through contact with certain body fluids of an infected person, most commonly during unprotected sex or through sharing needles. In the early stages, individuals may experience flu-like symptoms, but as the infection progresses, it can lead to more severe immune system damage. Without intervention, HIV can advance to acquired immunodeficiency syndrome (AIDS), where the immune system is severely compromised. The progression of the disease varies among individuals, and some may remain asymptomatic for years.