Immunogenicity of 9-valent HPV Vaccine
- Conditions
- Human Papilloma Virus Infection
- Interventions
- Biological: 9-valent HPV vaccine
- Registration Number
- NCT05439083
- Lead Sponsor
- Talia Sainz Costa
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immunosuppressed Group 9-valent HPV vaccine 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. Control Group 9-valent HPV vaccine N=30 Healthy controls aged 9-14 9-valent HPV vaccine: two-dose schedule: Months 0-6.
- Primary Outcome Measures
Name Time Method Seroconversion of subjects from baseline to month 18 (determined by serum anti-HPV antibody titers) From baseline to month 18 Percentage of subjects maintaining antibody titers 18 months after immunization.
Seroconversion of subjects from baseline to month 7 (determined by serum anti-HPV antibody titers) From baseline to month 7 Percentage of subjects seroconverting from baseline to month 7
Seroconversion of subjects from baseline to month 12 (determined by serum anti-HPV antibody titers) From baseline to month 12 Percentage of subjects maintaining antibody titers 12 months after immunization.
- Secondary Outcome Measures
Name Time Method Ratio of geometric mean serum antibody titers (GMTs) From baseline to month 7 GMTs from baseline to month 7
Delta of geometric mean serum antibody titers From 1 to 12 months Delta of geometric mean serum antibody titers from 1 to 12 months after immunization.
Percentage of subjects seroconverting from baseline to month 7 From baseline to month 7 Percentage of subjects seroconverting from baseline to month 7 in each of the study populations.
Trial Locations
- Locations (1)
Hospital Universitario La paz
🇪🇸Madrid, Spain