Immunogenicity of HPV Vaccine in Immunosuppressed Children

NCT ID: NCT02263703

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2016-12-31

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.

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.

Conditions

Autoimmune Disease; Juvenile Idiopathic Arthritis; Inflammatory Bowel Disease; Evidence of Liver Transplantation; Kidney Transplant Infection; Bone Marrow Transplant Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HPV vaccine

Quadrivalent HPV vaccine

Group Type: EXPERIMENTAL

Quadrivalent HPV vaccine

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sydney Children's Hospitals Network

OTHER

Sponsor Role: collaborator

Women's and Children's Hospital, Australia

OTHER_GOV

Sponsor Role: collaborator

The University of New South Wales

OTHER

Sponsor Role: lead

Responsible Party

Prof Raina MacIntyre

Head of School and Professor of Infectious Diseases Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raina MacIntyre

Role: PRINCIPAL_INVESTIGATOR

The University of New South Wales

Locations

School of Public Health and Community Medicine

Sydney, New South Wales, Australia

Countries

Australia

References

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 immunocompromised children. Vaccine. 2016 Aug 5;34(36):4343-50. doi: 10.1016/j.vaccine.2016.06.049. Epub 2016 Jul 9.

Reference Type: RESULT

PMID: 27406936 (View on PubMed)

MacIntyre CR, Shaw PJ, Mackie FE, Boros C, Marshall H, Seale H, Kennedy SE, Moa A, Chughtai AA, Trent M, O'Loughlin EV, Stormon M. Long term follow up of persistence of immunity following quadrivalent Human Papillomavirus (HPV) vaccine in immunocompromised children. Vaccine. 2019 Sep 3;37(37):5630-5636. doi: 10.1016/j.vaccine.2019.07.072. Epub 2019 Aug 8.

Reference Type: DERIVED

PMID: 31402238 (View on PubMed)

Other Identifiers

2007/028

Identifier Type: -

Identifier Source: org_study_id