Immunogenicity of 9-valent HPV Vaccine

NCT05439083 | Recruiting Phase 4

• 1 other identifier: 19042021/22
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Seroconversion of subjects from baseline to month 7 (determined by serum anti-HPV antibody titers)

  Percentage of subjects seroconverting from baseline to month 7

  From baseline to month 7

• Seroconversion of subjects from baseline to month 12 (determined by serum anti-HPV antibody titers)

  Percentage of subjects maintaining antibody titers 12 months after immunization.

  From baseline to month 12

• Seroconversion of subjects from baseline to month 18 (determined by serum anti-HPV antibody titers)

  Percentage of subjects maintaining antibody titers 18 months after immunization.

  From baseline to month 18

Secondary Outcomes (3)

• Ratio of geometric mean serum antibody titers (GMTs)

  From baseline to month 7

• Delta of geometric mean serum antibody titers

  From 1 to 12 months

• Percentage of subjects seroconverting from baseline to month 7

  From baseline to month 7

Study Arms (2)

Immunosuppressed Group

EXPERIMENTAL

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.

Biological: 9-valent HPV vaccine

Control Group

OTHER

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

Biological: 9-valent HPV vaccine

Interventions

9-valent HPV vaccine 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; Immunosuppressed Group

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Talia Sainz Costa: lead

Study Sites (1)

Hospital Universitario La paz

Madrid, 28046, Spain

RECRUITING

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Talia Saínz Costa

CONTACT

+ 34 91 727 74 43; talia.sainz@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 30, 2022
• Study Start: March 7, 2023
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

ES (1)