Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunogenicity of HPV Vaccine in Immunosuppressed Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02263703
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : May 4, 2017
Sponsor:
Collaborators:
Sydney Children's Hospitals Network
Women's and Children's Hospital, Australia
Information provided by (Responsible Party):
Prof Raina MacIntyre, The University of New South Wales

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Autoimmune Disease Juvenile Idiopathic Arthritis Inflammatory Bowel Disease Evidence of Liver Transplantation Kidney Transplant Infection Bone Marrow Transplant Infection Biological: Quadrivalent HPV vaccine Phase 3

Detailed Description:

To determine the immunogenicity, safety and persistence of immunity following human papillomavirus (HPV) vaccination in three groups of immunosuppressed children: recipients of allogenic bone marrow transplant, recipients of renal and liver transplants, and patients with juvenile chronic arthritis, inflammatory bowel disease and other autoimmune conditions who are on longterm immunosuppressive therapy.

Significance: Immunosuppressed populations are diverse in terms of degree, type and duration of immunosuppression. The study compares several groups in order to address the heterogeneity of immunosuppression and how this affects vaccine response. BMT patients have extreme, severe immunosuppression in the short term, but recover immune function with time. In contrast, solid organ transplant recipients have ongoing, chronic immunosuppression. Although successful cessation of immunosuppressives in liver transplant patients has been reported, most patients require ongoing treatment. The inflammatory bowel disease group of patients represents a non-transplant group who require ongoing, often low level immunosuppression, often with corticosteroids. Our study will compare these three groups, followed up for five years for duration of immunity. Time of vaccines, time of serological measures of immune response are as follows.

Serum collections:

0 - Baseline (before HPV vaccine dose 1); 2 months - At the time of receipt of HPV vaccine dose 2 (to measure response to dose 1); 6 months - At the time of receipt of HPV vaccine dose 3 (to measure response to dose 2); 7 months - 1 month after HPV vaccine dose 3; 12 months - after HPV vaccine dose 1; 2 years after HPV vaccine dose 1; 3 years after HPV vaccine dose 1; 4 years after HPV vaccine dose 1; 5 years after HPV vaccine dose 1.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Duration of Immunity in Immunosuppressed Children Vaccinated With Quadrivalent HPV Vaccine
Actual Study Start Date : May 2007
Actual Primary Completion Date : February 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: HPV vaccine
Quadrivalent HPV vaccine
Biological: 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.




Primary Outcome Measures :
  1. Immunogenicity [ Time Frame: 2 years ]

    Indicator:

    1. Geometric mean four fold rises (with 95% confidence intervals) of the vaccine serotype specific IgG antibody in all participants.
    2. Proportion of subjects achieving a 4 fold rise in antibody titre for each serotype. Serum antibody levels will be measured using a Luminex immunoassay.

    Analysis: For each individual, the change in log-22FA levels for each serotype pre-post vaccination will be calculated. The average change will then be compared over time for each group and also between healthy and immunosuppressed groups using t-tests. Geometric mean titres of antibody for each serotype will be measured and compared at each follow up interval.



Secondary Outcome Measures :
  1. Duration of immunity [ Time Frame: 5 years ]
    Interpretation of Results: Persistance of immunity will be measured over 5 years, as well as the comparison of immunogenicity by immune status.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02263703


Locations
Layout table for location information
Australia, New South Wales
School of Public Health and Community Medicine
Sydney, New South Wales, Australia, 2052
Sponsors and Collaborators
The University of New South Wales
Sydney Children's Hospitals Network
Women's and Children's Hospital, Australia
Investigators
Layout table for investigator information
Principal Investigator: Raina MacIntyre The University of New South Wales
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Prof Raina MacIntyre, Head of School and Professor of Infectious Diseases Epidemiology, The University of New South Wales
ClinicalTrials.gov Identifier: NCT02263703    
Other Study ID Numbers: 2007/028
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We would like to share publication(s) that may arise from the study when applicable.
Keywords provided by Prof Raina MacIntyre, The University of New South Wales:
HPV vaccine, children, immunocompromised
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Arthritis, Juvenile
Inflammatory Bowel Diseases
Autoimmune Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Immune System Diseases
Rheumatic Diseases
Connective Tissue Diseases