Immunogenicity of 9-valent HPV Vaccine

March 6, 2024 updated by: Talia Sainz Costa

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
          • Talía Sainz Acosta, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other: Control Group
N=30 Healthy controls aged 9-14 9-valent HPV vaccine: two-dose schedule: Months 0-6.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroconversion of subjects from baseline to month 7 (determined by serum anti-HPV antibody titers)
Time Frame: From baseline to month 7
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)
Time Frame: From baseline to month 12
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)
Time Frame: From baseline to month 18
Percentage of subjects maintaining antibody titers 18 months after immunization.
From baseline to month 18

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio of geometric mean serum antibody titers (GMTs)
Time Frame: From baseline to month 7
GMTs from baseline to month 7
From baseline to month 7
Delta of geometric mean serum antibody titers
Time Frame: From 1 to 12 months
Delta of geometric mean serum antibody titers from 1 to 12 months after immunization.
From 1 to 12 months
Percentage of subjects seroconverting from baseline to month 7
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Talia Sainz Costa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

June 27, 2022

First Submitted That Met QC Criteria

June 27, 2022

First Posted (Actual)

June 30, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19042021/22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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