Human Papilloma Virus (HPV) Vaccination in Special Risk Groups

Prospective non controlled study of immunogenicity of Human Papilloma Virus (HPV) Vaccine in groups at special risk of poor vaccine result

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000571279

Enrollment

Registered

2009-07-13

Start date

2008-03-12

Completion date

2011-04-07

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A research project is currently being undertaken looking at Human Papilloma Virus (HPV) vaccination in special risk groups. It aims to see if young women with a chronic illness respond well to the HPV vaccine or whether they may require additional doses to ensure protective immunity. The four valent HPV vaccine protects against HPV types 16 & 18, cervical cancer and HPV types 6 & 11, anogenital warts. The six special risk groups include: Paediatric Rheumatalogical Disease Inflammatory Bowel Disease Acute Lymphoblastic Leukaemia Solid Organ Transplant Recipients (kidney and liver) Chronic Renal Disease Bone Marrow Transplants This immunity is measured by antibody levels of the HPV types, which requires a single blood test one month after the final dose of HPV vaccine. This is compared to healthy controls using antibody response to HPV vaccine. This will assess directly whether these special risk groups respond as well to the HPV vaccine.

Interventions

Licensed quadrivalent HPV vaccine. The dose of the four valent (4v) HPV vaccine is 0.5ml administered by intramuscular (IM)injection. The recommended schedule is 0, 2 and 6 months.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

12 Years to 26 Years

Healthy volunteers

Inclusion criteria

Females aged 12-26 years Have been diagnosed by a specialist with one of the six chronic medical conditions described. Special Risk Groups 1. Paediatric Rheumatalogical Disease 2. Inflammatory Bowel Disease 3. Acute Lymphoblastic Leukaemia 4. Solid Organ Transplant Recipients (kidney and liver) 5. Chronic Renal Disease 6. Bone Marrow Transsplant

Exclusion criteria

Previous immunisation with HPV vaccine Recognised contraindication to the receipt of the vaccine e.g. anaphylaxis

Outcome results