Immunogenicity of 9-valent HPV Vaccine

Human Papilloma Virus Infection Clinical Trial

Official title:

Immunogenicity of 9-valent HPV Vaccine in Immunocompromised Children and Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05439083
• Other study ID #: 19042021/22
• Status: Recruiting
• Phase: Phase 4
• Start date: March 7, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2024
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: Talia Saínz Costa
• Phone: + 34 91 727 74 43
• Email: talia.sainz[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Human Papilloma Virus Infection
• Papilloma
• Papillomavirus Infections

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario La paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Talia Sainz Costa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Ratio of geometric mean serum antibody titers (GMTs)	GMTs from baseline to month 7	From baseline to month 7
Secondary	Delta of geometric mean serum antibody titers	Delta of geometric mean serum antibody titers from 1 to 12 months after immunization.	From 1 to 12 months
Secondary	Percentage of subjects seroconverting from baseline to month 7	Percentage of subjects seroconverting from baseline to month 7 in each of the study populations.	From baseline to month 7