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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 9
Maximum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Spain
Hospital Universitario La paz
RECRUITING
Madrid
Contact Information
Primary
Talia Saínz Costa
talia.sainz@salud.madrid.org
+ 34 91 727 74 43
Time Frame
Start Date: 2023-03-07
Estimated Completion Date: 2025-03-01
Participants
Target number of participants: 120
Treatments
Experimental: Immunosuppressed Group
N=90 Immunosuppressed patients, consisting of HIV-infected children and adolescents, hematopoietic stem cell transplant (HSCT) recipients, solid organ transplant (SOT) recipients and post-chemotherapy patients (PCT) under follow up at Hospital La Paz in Madrid Spain.~9-valent HPV vaccine: three-dose schedule: Months 0-2-6.
Other: Control Group
N=30 Healthy controls aged 9-14 9-valent HPV vaccine: two-dose schedule: Months 0-6.
Sponsors
Leads: Talia Sainz Costa

This content was sourced from clinicaltrials.gov