Immunogenicity of 9-valent HPV Vaccine

NCT ID: NCT05439083

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-07
• Study Completion Date: 2025-03-01

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.

Conditions

Human Papilloma Virus Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

9-valent HPV vaccine

Intervention Type: BIOLOGICAL

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.

Control Group

N=30 Healthy controls aged 9-14 9-valent HPV vaccine: two-dose schedule: Months 0-6.

Group Type: OTHER

9-valent HPV vaccine

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Talia Sainz Costa

OTHER

Sponsor Role: lead

Responsible Party

Talia Sainz Costa

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hospital Universitario La paz

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Talia Saínz Costa

Role: CONTACT

talia.sainz@salud.madrid.org

+ 34 91 727 74 43

Facility Contacts

Talía Sainz Acosta, MD

Role: primary

Other Identifiers

19042021/22

Identifier Type: -

Identifier Source: org_study_id