Clinical trial

Immunogenicity and Duration of Immunity in Immunosuppressed Children Vaccinated With Quadrivalent HPV Vaccine

Name

2007/028

Description

Genital HPV is the necessary cause for cervical cancer, as well as a major contributing cause of several other cancers and conditions. There are now effective vaccines against the main oncogenic HPV types, HPV16 and 18. Most research and discussion has focused on targeting the vaccine to young women and older adolescents. Based on this, a national free HPV vaccination program for adolescent girls commenced in 2007, in Australia. However, at the time of commencement, there had been no research on the use of this vaccine in immunosuppressed. Therefore, information on the immunogenicity, safety and duration of efficacy of HPV vaccine when administered to immunosuppressed children is needed. This trial looked at a 3 dose schedule of quadrivalent HPV vaccine in a range of immunosuppressed children, with the endpoint being immunogenicity, followed for 5 years for duration of immunity.

Trial arms

Trial start

2007-05-01

Estimated PCD

2016-02-01

Trial end

2016-12-01

Status

Completed

Phase

Early phase I

Treatment

Quadrivalent HPV vaccine

Three 0.5 mL doses will be given at time 0, 2 months after the 1st dose and then 6 months after the initial dose. For kidney transplant recipients the first dose will be at least 6 months post-transplant.

Arms:

HPV vaccine

Size

Primary endpoint

Immunogenicity

2 years

Eligibility criteria

Inclusion Criteria: - Immunosuppressed patients with following diseases; Bone marrow transplant recipients, liver transplant patients, renal transplant, Children with inflammatory bowel disease, juvenile Idiopathic arthritis and autoimmune conditions. Exclusion Criteria: * A platelet count of \<50 * Immunoglobulin therapy within 3 months. * Yeast allergy * Any other known allergies to one of the vaccine component

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 55, 'type': 'ACTUAL'}}

Updated at

2024-05-08

1 organization

1 product

6 indications

Organization

The University of New South Wales

Product

Quadrivalent HPV vaccine

Indication

autoimmune disease

Indication