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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 study about?

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.

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.

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).

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.

4 third vaccination

The third and final dose of the Gardasil 9 vaccine is administered. This completes the vaccination schedule.

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 Study?

  • 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 Study?

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

Where you can join this trial?

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Site Name City Country Status
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
01.09.2022

Trial locations

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 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.

Trial ID:
2022-501413-31-00
Protocol code:
19042021/22
Trial Phase:
Human Pharmacology (Phase I) – Other

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