Immunogenicity of 9-valent HPV vaccine in immunocompromised children and adolescents

Phase 1

Recruiting

• Conditions: Immunosuppressed patients; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: CTIS2022-501413-31-00
• Lead Sponsor: Hospital Universitario La Paz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-18
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the immunogenicity of 9vHPV vaccine in immunocompromised children and adolescents. Seroconversion from baseline to month 7 following the three doses schedule recommended for children and adolescents (over 9 years of age) will be evaluated among vertically HIV-infected children and adolescents, SOT/HSCT recipients and post-chemotherapy patients (PCT) and compared to healthy controls;Secondary Objective: To identify markers of immune response (including age, CD4/CD8 ratio, TTV viral load), potential predictors to 9vHPV vaccine-immunogenicity., To generate a cohort of immunized immunosuppressed children and adolescents, candidates for future follow-up (extension phase) addressing duration of vaccine protection in this unique population.;Primary end point(s): Seroconversion of subjects from baseline to month 7 and 12 (anti HPV titers at baseline, month 7 and month 12).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Age, immunosuppression category (HIV, SOT, HSCT, PCT), CD4/CD8 ratio, specific T cell response, TTV viral load