Immunogenicity of 9-valent HPV Vaccine
Primary Purpose
Human Papilloma Virus Infection
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
9-valent HPV vaccine
Sponsored by
About this trial
This is an interventional health services research trial for Human Papilloma Virus Infection
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Immunosuppressed Group
Control Group
Arm Description
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.
N=30 Healthy controls aged 9-14 9-valent HPV vaccine: two-dose schedule: Months 0-6.
Outcomes
Primary Outcome Measures
Seroconversion of subjects from baseline to month 7 (determined by serum anti-HPV antibody titers)
Percentage of subjects seroconverting 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.
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.
Secondary Outcome Measures
Ratio of geometric mean serum antibody titers (GMTs)
GMTs from baseline to month 7
Delta of geometric mean serum antibody titers
Delta of geometric mean serum antibody titers from 1 to 12 months after immunization.
Percentage of subjects seroconverting from baseline to month 7
Percentage of subjects seroconverting from baseline to month 7 in each of the study populations.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05439083
Brief Title
Immunogenicity of 9-valent HPV Vaccine
Official Title
Immunogenicity of 9-valent HPV Vaccine in Immunocompromised Children and Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Talia Sainz Costa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus Infection
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immunosuppressed Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Other
Arm Description
N=30 Healthy controls aged 9-14 9-valent HPV vaccine: two-dose schedule: Months 0-6.
Intervention Type
Biological
Intervention Name(s)
9-valent HPV vaccine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Seroconversion of subjects from baseline to month 7 (determined by serum anti-HPV antibody titers)
Description
Percentage of subjects seroconverting from baseline to month 7
Time Frame
From baseline to month 7
Title
Seroconversion of subjects from baseline to month 12 (determined by serum anti-HPV antibody titers)
Description
Percentage of subjects maintaining antibody titers 12 months after immunization.
Time Frame
From baseline to month 12
Title
Seroconversion of subjects from baseline to month 18 (determined by serum anti-HPV antibody titers)
Description
Percentage of subjects maintaining antibody titers 18 months after immunization.
Time Frame
From baseline to month 18
Secondary Outcome Measure Information:
Title
Ratio of geometric mean serum antibody titers (GMTs)
Description
GMTs from baseline to month 7
Time Frame
From baseline to month 7
Title
Delta of geometric mean serum antibody titers
Description
Delta of geometric mean serum antibody titers from 1 to 12 months after immunization.
Time Frame
From 1 to 12 months
Title
Percentage of subjects seroconverting from baseline to month 7
Description
Percentage of subjects seroconverting from baseline to month 7 in each of the study populations.
Time Frame
From baseline to month 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Talia Saínz Costa
Phone
+ 34 91 727 74 43
Email
talia.sainz@salud.madrid.org
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity of 9-valent HPV Vaccine
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