HPV Vaccination in Special Risk Groups: 5 Year Follow-up

NCT01896986 | Terminated Results

• 1 other identifier: HPV girls 5year followup
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

In 2007-2009 the investigators conducted a study to determine the immunogenicity response to HPV vaccine in special risk patients known to be at increased risk of abnormal cervical cytology. The serological response to the vaccine was measured 1 month post the third and final dose (n=70) finding a robust response overall. The aim of this follow-on study is to provide data on the long-term protection offered by the HPV vaccination. The persistence of antibody 5 years post immunisation is unknown and the impact on cervical cytology abnormalities in these special risk groups is important. The study results will help inform national immunisation program recommendations re- booster HPV vaccine doses.

Conditions

PRD (Paediatric Rheumatological Disease); IBD (Inflammatory Bowel Disease)

Keywords

Special risk patients; Immunosuppressive biologic treatments; PRD (Paediatric Rheumatological Disease); IBD (Inflammatory Bowel Disease)

Outcome Measures

Primary Outcomes (1)

• Immunogenicity to HPV Vaccine Gardasil

  To evaluate the long term immunogenicity of the quadrivalent 4/6/11/18 HPV vaccine Gardasil® by following up a cohort of adolescent females aged 16-30 years with PRD or IBD, 5 years post HPV vaccination at the Royal Children's Hospital (RCH) Melbourne .

  12 months

Study Arms (2)

PRD patrients

Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus) Subgroups: 1. receiving immunosuppressant therapy 2. not on immunosuppressant therapy

IBD patients

Children/adolescent females 12-26 years diagnosed with IBD. Subgroups: 3\. receiving immunosuppressant therapy 4. not on immunosuppressant therapy

Eligibility Criteria

• Age: 12 Years - 26 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

In 2007 we began a clinical audit of the 'special risk patients' within two subgroups (PRD\&IBD). From April 2007- March 2010 there were 64 special risk female participants including 38 PRD patients of which 28 had juvenile idiopathic arthritis (JIA). The other subgroups included: 14 IBD; 10 paediatric cancer; 1 SOTR (solid organ transplant recipient) and 1 CRD (Chronic Renal Disease). The median age at the first dose of 4vHPV vaccine administration was 14.7 years \[range 11.8 to 24.7\]. The overall results were good with all participants showing at least some level of antibody protection against HPV. Long-term follow-up will help determine the requirement for booster vaccine doses, including those patients treated with combination immunosuppressive therapies.

You may qualify if:

• Females who participated in the initial HPV vaccine immunogenicity study in 2007.

You may not qualify if:

• Inability to provide informed consent

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead
• Monash Medical Centre: collaborator

Study Sites (1)

Royal Childrens Hospital

Melbourne, Victoria, 2106, Australia

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Limitations and Caveats

Study serum samples being misplaced so sample testing could not be done. As such we had no choice but to close this study. This was communicated to the enrolled participants and the RCH ethics department.

Results Point of Contact

• Title: Dr. Nigel Crawford
• Organization: MCRI

nigel.crawford@rch.org.au

9345 4772

Study Officials

• Nigel Crawford, PhDMPHMBBS

  Royal Childrens Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Head Immunisation, General Paediatrician

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: July 11, 2013
• Study Start: March 1, 2012
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: June 15, 2017
• Results First Posted: June 15, 2017

Record last verified: 2017-03

Locations

AU (1)