Evaluating the 9-valent HPV vaccine in immunocompromised children and adolescents
Immunogenicity of 9-valent HPV Vaccine in Immunocompromised Children and Adolescents
This study is testing how well the 9-valent HPV vaccine works in children and teens aged 9 to 17 who have weakened immune systems, like those with HIV or who have had organ transplants.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 9 Years to 18 Years |
| Sex | All |
| Sponsor | Instituto de Investigación Hospital Universitario La Paz Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Madrid) |
| Trial ID | NCT05439083 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the immunogenicity of the 9-valent HPV vaccine in children and adolescents aged 9 to 17 who are immunocompromised, including those with HIV or those who have undergone organ transplantation. The study aims to assess how effective the vaccine is in generating an immune response in this vulnerable population, which has been less studied compared to healthy individuals. Participants will be monitored for their immune response after vaccination, with a focus on those who have undergone immunosuppressive therapies. The findings could provide crucial insights into the vaccine's effectiveness in preventing HPV-related diseases in immunocompromised youth.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents aged 9 to 17 who are immunocompromised due to conditions like HIV or after receiving organ transplants.
Not a fit: Patients who have previously received any HPV vaccine or have a history of warts or anal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance vaccination strategies and improve protection against HPV-related cancers in immunocompromised children and adolescents.
How similar studies have performed: While studies have shown the effectiveness of the 9-valent HPV vaccine in healthy populations, this specific focus on immunocompromised children and adolescents is relatively novel and less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children or adolescents 9 to \<18 years of age * Willing to sign consent/assent form * If HIV positive, under ART and undetectable viral load and CD4 cell count \>200/mm3 (at least 6 months) * If the patient has received chemotherapy or is a SOT/HSCT recipient, referred for immunizations after adequate immune reconstitution according to routine clinical practice Exclusion Criteria: * Previous history of warts and/or anal cancer. * Previous immunization with any HPV vaccine. * Age below 9. * Patients who for any reason should not be included in the study according to the evaluation of the research team.
Where this trial is running
Madrid
- Hospital Universitario La paz — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Talia Saínz Costa
- Email: talia.sainz@salud.madrid.org
- Phone: + 34 91 727 74 43
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.