Clinical trial · Interventional
Long Term Immunogenicity of Quadrivalent Human Papillomavirus Vaccine (Gardasil®)in HIV-infected Adolescents and Young Adults
Long Term Immunogenicity of Quadrivalent Human Papillomavirus Vaccine (Gardasil®)in HIV-infected Adolescents and Young Adults vs. Healthy Adolescents and Young Adults: Non-randomized Controlled Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Infection with human immunodeficiency virus (HIV) is an important risk factor for HPV infection and the development of HPV-associated lesions in female and male anogenital tract. Data on safety and immunogenicity of quadrivalent human papillomavirus vaccine in HIV-infected population are few. The present study is a non-randomized controlled clinical trial with the primary objective to determine safety ad immunogenicity of quadrivalent human papillomavirus vaccine (Gardasil®) in HIV-infected female and male adolescents and young adults.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIV | — | UNRESOLVED | — |
| HPV | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HIV-infected adolescents and young adults
- description
- female and male HIV-infected subjects aged from 13-27 years old
- interventionNames
- Biological: Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)
- type
- ACTIVE_COMPARATOR
- label
- healthy adolescents and young adults
- description
- female and male healthy adolescents and young adults aged 13-27 years
- interventionNames
- Biological: Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)
Primary outcomes (1)
- measure
- type specific antibody titers for HPV types 6, 11, 16 and 18 at one month after completion of HPV vaccine series (T3) in HIV infected subjects vs. healthy subjects
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
- Maximum age
- 27 Years
Show eligibility criteria text
Inclusion Criteria: * For both HIV-infected and healthy subjects: * Subjects aged 13-27 years, females and males * Written informed consent from parent or guardian if applicable (age\<18 years) * For HIV-infected subjects: * HIV-positive * Asymptomatic subjects (generalized lymphadenopathy is accepted) * Lymphocyte CD4+ count \> or equal to 350 cells/mm3 * For subjects receiving HAART: * Good compliance to therapy * At least two suppressed viral loads HIV-RNA (\<37copies/ml9 during 6 months prior to enrollment. Exclusion Criteria: * For female subjects (both HIV-infected and healthy) * Pregnancy or breastfeeding * Total hysterectomy. Participants who have undergone partial hysterectomy and have a cervix are not excluded. * For both females and males (HIV-infected and healthy): * Prior vaccination with quadrivalent HPV vaccine Gardasil before study entry. * History of severe allergic reaction after previous vaccination or hypersensitivity to any vaccine component. * Any serious chronic or progressive disease (other than HIV) according to the judgment of the investigator: * Acute infection requiring therapy or fever at time of enrollment * Chronic autoimmune or oncologic disease receiving chemotherapy * Concomitant therapies (other than HAART): * Chronic therapy (for more than 14 days consecutively) with immunosuppressive or immunomodulating agents or chemotherapy during the 6 months prior to study entry. * Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation prior to study entry. * Use of investigational agents within 4 weeks prior to study enrollment. * Current drug or alcohol use or dependence. * Documented history of non-adherence to antiretroviral treatment regimen within 12 months prior to study entry.
References
Publications (0)
Data not yet available