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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Licensed 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.

Intervention Type DRUG

Eligibility Criteria

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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