Immunogenicity of HPV Vaccine in Immunosuppressed Children

Inflammatory Bowel Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02263703
• Other study ID #: 2007/028
• Status: Completed
• Phase: Phase 3
• Start date: May 2007
• Est. completion date: December 2016

Study information

• Verified date: May 2024
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Juvenile
• Autoimmune Disease
• Autoimmune Diseases
• Bone Marrow Transplant Infection
• Communicable Diseases
• Evidence of Liver Transplantation
• Infections
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Juvenile Idiopathic Arthritis
• Kidney Transplant Infection

Intervention

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.

Locations

Country	Name	City	State
Australia	School of Public Health and Community Medicine	Sydney	New South Wales

Sponsors (3)

Lead Sponsor	Collaborator
The University of New South Wales	Sydney Children's Hospitals Network, Women's and Children's Hospital, Australia

Country where clinical trial is conducted

Australia, 

References & Publications (1)

MacIntyre CR, Shaw P, Mackie FE, Boros C, Marshall H, Barnes M, Seale H, Kennedy SE, Moa A, Hayen A, Chughtai AA, O'Loughlin EV, Stormon M. Immunogenicity and persistence of immunity of a quadrivalent Human Papillomavirus (HPV) vaccine in immunocompromise — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity	Indicator: Geometric mean four fold rises (with 95% confidence intervals) of the vaccine serotype specific IgG antibody in all participants.; 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.	2 years
Secondary	Duration of immunity	Interpretation of Results: Persistance of immunity will be measured over 5 years, as well as the comparison of immunogenicity by immune status.	5 years