Immunogenicity of 9-valent HPV Vaccine

T

Talia Sainz Costa

Status and phase

Enrolling
Phase 4

Conditions

Human Papilloma Virus Infection

Treatments

Biological: 9-valent HPV vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT05439083
19042021/22

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

9 to 18 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Immunosuppressed Group
Experimental group
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.
Treatment:
Biological: 9-valent HPV vaccine
Control Group
Other group
Description:
N=30 Healthy controls aged 9-14 9-valent HPV vaccine: two-dose schedule: Months 0-6.
Treatment:
Biological: 9-valent HPV vaccine

Trial contacts and locations

1

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Central trial contact

Talia Saínz Costa

Data sourced from clinicaltrials.gov

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