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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Group | Other | N=30 Healthy controls aged 9-14 9-valent HPV vaccine: two-dose schedule: Months 0-6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of geometric mean serum antibody titers (GMTs) | GMTs from baseline to month 7 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Talia SaĂnz Costa | Contact | + 34 91 727 74 43 | talia.sainz@salud.madrid.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La paz | Recruiting | Madrid | 28046 | Spain |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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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.
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|
| From 1 to 12 months |
| 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 |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |