Protecting Young Special Risk Females From Cervical Cancer Through Human Papilloma Virus (HPV) Vaccination

Prospective Non Controlled Study of Immunogenicity of Human Papilloma Virus (HPV) Vaccine in Groups at Special Risk of Poor Vaccine Result

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00964210

Acronym

HPV

Enrollment

240

Registered

2009-08-24

Start date

2008-03-31

Completion date

2011-04-30

Last updated

2011-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

Juvenile Idiopathic Arthritis, Inflammatory Bowel Disease, Acute Lymphoblastic Leukemia, Chronic Renal Disease, Solid Organ Transplant

Brief summary

A research project is currently being undertaken looking at Human Papilloma Virus (HPV) vaccination in special risk groups. It aims to see if young women with a chronic illness respond well to the HPV vaccine or whether they may require additional doses to ensure protective immunity. The four valent HPV vaccine protects against HPV types 16 & 18, cervical cancer and HPV types 6 & 11, anogenital warts. The six special risk groups include: Paediatric Rheumatological Disease Inflammatory Bowel Disease Acute Lymphoblastic Leukaemia Solid Organ Transplant Recipients (kidney and liver) Chronic Renal Disease Bone Marrow Transplants This immunity is measured by antibody levels of the HPV types, which requires a single blood test one month after the final dose of HPV vaccine. This is compared to healthy controls using antibody response to HPV vaccine. This will assess directly whether these special risk groups respond as well to the HPV vaccine.

Interventions

DRUGLicensed quadrivalent HPV vaccine, Gardasil

The dose of the four valent (4v) HPV vaccine is 0.5ml administered by intramuscular (IM)injection. The recommended schedule is 0, 2 and 6 months.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

12 Years to 26 Years

Healthy volunteers

Inclusion criteria

* Females aged 12-26 years * Have been diagnosed by a specialist with one of the six chronic medical conditions described: 1. Paediatric Rheumatological Disease 2. Inflammatory Bowel Disease 3. Acute Lymphoblastic Leukaemia 4. Solid Organ Transplant Recipients (kidney and liver) 5. Chronic Renal Disease 6. Bone Marrow Transplant

Exclusion criteria

* Previous immunisation with HPV vaccine Recognised contraindication to the receipt of the vaccine e.g. anaphylaxis

Design outcomes

Primary

Measure	Time frame
Determine the HPV vaccine immunogenicity in females 12-26 years with six special risk groups at one month post the third and final HPV vaccination. Blood analysis taken at one month post third and final HPV vaccine to assess immunogenicity.	One Month post HPV vaccination

Secondary

Measure	Time frame
Describe the safety of the HPV vaccine in the six study groups using self reports and liaison with treating sub specialist team.	One month post third HPV vaccination

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026