Immunogenicity of HPV Vaccine in Immunosuppressed Children

NCT02263703 | Completed Phase 3

• 1 other identifier: 2007/028
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

HPV vaccine, children, immunocompromised

Outcome Measures

Primary Outcomes (1)

• Immunogenicity

  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.

  2 years

Secondary Outcomes (1)

• Duration of immunity

  5 years

Study Arms (1)

HPV vaccine

EXPERIMENTAL

Quadrivalent HPV vaccine

Biological: Quadrivalent HPV vaccine

Interventions

Quadrivalent HPV vaccine 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.

HPV vaccine

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• A platelet count of \<50
• Immunoglobulin therapy within 3 months.
• Yeast allergy
• Any other known allergies to one of the vaccine component

Sponsors & Collaborators

• The University of New South Wales: lead
• Sydney Children's Hospitals Network: collaborator
• Women's and Children's Hospital, Australia: collaborator

Study Sites (1)

School of Public Health and Community Medicine

Sydney, New South Wales, 2052, Australia

Location

Related Publications (2)

• 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.

  PMID: 27406936 RESULT

• 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.

  PMID: 31402238 DERIVED

MeSH Terms

Conditions

Autoimmune Diseases; Arthritis, Juvenile; Inflammatory Bowel Diseases

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Immune System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Study Officials

• Raina MacIntyre

  The University of New South Wales

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of School and Professor of Infectious Diseases Epidemiology

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 13, 2014
• Study Start: May 1, 2007
• Primary Completion: February 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)