Clinical trial · Observational
HPV Vaccination in Special Risk Groups: 5 Year Follow-up
HPV Immunisation Protecting Special Risk Group Patients From Cervical Cancer: 5 Year Follow-up Post-vaccination
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): recruitment problems
Summary
Brief summary (as posted)
In 2007-2009 the investigators conducted a study to determine the immunogenicity response to HPV vaccine in special risk patients known to be at increased risk of abnormal cervical cytology. The serological response to the vaccine was measured 1 month post the third and final dose (n=70) finding a robust response overall. The aim of this follow-on study is to provide data on the long-term protection offered by the HPV vaccination. The persistence of antibody 5 years post immunisation is unknown and the impact on cervical cytology abnormalities in these special risk groups is important. The study results will help inform national immunisation program recommendations re- booster HPV vaccine doses.
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 |
|---|---|---|---|
| IBD (Inflammatory Bowel Disease) | — | UNRESOLVED | — |
| PRD (Paediatric Rheumatological Disease) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- PRD patrients
- description
- Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus) Subgroups: 1. receiving immunosuppressant therapy 2. not on immunosuppressant therapy
- label
- IBD patients
- description
- Children/adolescent females 12-26 years diagnosed with IBD. Subgroups: 3\. receiving immunosuppressant therapy 4. not on immunosuppressant therapy
Primary outcomes (1)
- measure
- Immunogenicity to HPV Vaccine Gardasil
- timeFrame
- 12 months
- description
- To evaluate the long term immunogenicity of the quadrivalent 4/6/11/18 HPV vaccine Gardasil® by following up a cohort of adolescent females aged 16-30 years with PRD or IBD, 5 years post HPV vaccination at the Royal Children's Hospital (RCH) Melbourne .
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 12 Years
- Maximum age
- 26 Years
Show eligibility criteria text
Inclusion Criteria: * Females who participated in the initial HPV vaccine immunogenicity study in 2007. Exclusion Criteria: * Inability to provide informed consent
References
Publications (0)
Data not yet available