Clinical trial NCT05439083: Immunogenicity of 9-valent HPV Vaccine
Official title: Immunogenicity of 9-valent HPV Vaccine in Immunocompromised Children and Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Human Papilloma Virus Infection
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 120
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of patients:

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.

Control Group: N=30 Healthy controls aged 9-14. Both groups receive the 9-valent HPV vaccine.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.

Primary outcomes:
measure: Seroconversion of subjects from baseline to month 7 (determined by serum anti-HPV antibody titers)
timeFrame: From baseline to month 7
measure: Seroconversion of subjects from baseline to month 12 (determined by serum anti-HPV antibody titers)
timeFrame: From baseline to month 12
measure: Seroconversion of subjects from baseline to month 18 (determined by serum anti-HPV antibody titers)
timeFrame: From baseline to month 18
Secondary outcomes:
measure: Ratio of geometric mean serum antibody titers (GMTs)
timeFrame: From baseline to month 7
measure: Delta of geometric mean serum antibody titers
timeFrame: From 1 to 12 months
measure: Percentage of subjects seroconverting from baseline to month 7
timeFrame: From baseline to month 7
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La paz
Study officials:
References: