NCT05439083

Immunogenicity of 9-valent HPV Vaccine

Immunogenicity of 9-valent HPV Vaccine in Immunocompromised Children and Adolescents

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Talia Sainz Costa · Academic / Other
• Sex: All
• Age: 9 Years – 18 Years
• Healthy volunteers: Accepted

Summary

Human papillomavirus (HPV) causes the most prevalent sexually transmitted infections in the world. The nonavalent HPV vaccine (9vHPV) provides protection against 9 high-risk HPV serotypes, responsible for causing approximately 90% of cervical and other HPV-related anogenital cancers, as well as 90% of genital warts. The risk of cancer is substantially increased among immunocompromised patients. Although studies have demonstrated seroprotection among children and adolescents, boys and girls, with the 9vHPV vaccine, the immunogenicity of this vaccine has been poorly explored in immunocompromised children and adolescents (including transplant patients, and those infected with human immunodeficiency virus (HIV)). Several factors, including the immunological consequences of vertically acquired infection, immunosuppressive therapies and age, could lead to an increased risk of infection in children and adolescents who are immunocompromised. Lower immunogenicity in these populations. These children may have a poor response to vaccines and therefore require additional doses. Markers such as CD4/CD8 or torque teno virus (TTV) replication could be linked to immunogenicity and thus serve as predictors of efficacy for routine clinical practice.

Conditions

• Human Papilloma Virus Infection

Interventions

Type	Name	Description
BIOLOGICAL	9-valent HPV vaccine	All participants will receive the immunization schedule according to guidelines: immunosuppressed patients will receive a three-dose schedule: 0.5 mL intramuscular injection of 9vHPV at entry plus an additional dose at month 2 and month 6. Healthy controls aged 9-14 years will receive a two-dose schedule: 0 and 6 months.

Timeline

• Start date: 2023-03-07
• Primary completion: 2024-09-01
• Completion: 2025-03-01
• First posted: 2022-06-30
• Last updated: 2024-03-08

Locations

1 site across 1 country: Spain