Published 2 December 2008, doi:10.1136/bmj.a2642
Cite this as: BMJ 2008;337:a2642

Research

Hypersensitivity reactions to human papillomavirus vaccine in Australian schoolgirls: retrospective cohort study

Liew Woei Kang, clinical fellow and associate consultant1,2, Nigel Crawford, consultant paediatrician3,4, Mimi L K Tang, associate professor and director1,5, Jim Buttery, infectious disease physician3,4, Jenny Royle, consultant paediatrician3, Michael Gold, senior lecturer and head6, Christine Ziegler, consultant allergist and immunologist6, Patrick Quinn, consultant allergist and immunologist6, Sonja Elia, immunisation nurse consultant3, Sharon Choo, consultant allergist and immunologist1

1 Department of Allergy and Immunology, Royal Children’s Hospital, Flemington Road, Parkville, Victoria 3052, Australia, 2 Paediatric Allergy, Immunology and Rheumatology, Department of Paediatric Medicine, KK Women’s and Children’s Hospital, Singapore, 3 Department of General Medicine, Royal Children’s Hospital, Melbourne, Australia, 4 NHMRC Centre for Clinical Research Excellence in Child and Adolescent Immunisation, Surveillance of Adverse Events Following Vaccination in the Community, Murdoch Children’s Research Institute, Department of Paediatrics, University of Melbourne, Melbourne, Australia, 5 Murdoch Children’s Research Institute, Royal Children’s Hospital, Melbourne, and Department of Paediatrics, University of Melbourne, Australia, 6 Department of Allergy and Immunology, Women’s and Children’s Hospital, Adelaide, Australia

Correspondence to: S Choo sharon.choo{at}rch.org.au

Objective To describe the outcomes of clinical evaluation, skin testing, and vaccine challenge in adolescent schoolgirls with suspected hypersensitivity to the quadrivalent human papillomavirus vaccine introduced in Australian schools in 2007.

Design Retrospective cohort study.

Setting Two tertiary paediatric allergy centres in Victoria and South Australia, Australia.

Participants 35 schoolgirls aged 12 to 18.9 years with suspected hypersensitivity reactions to the quadrivalent human papillomavirus vaccine.

Main outcome measures Clinical review and skin prick and intradermal testing with the quadrivalent vaccine and subsequent challenge with the vaccine.

Results 35 schoolgirls with suspected hypersensitivity to the quadrivalent human papillomavirus vaccine were notified to the specialised immunisation services in 2007, after more than 380 000 doses had been administered in schools. Of these 35 schoolgirls, 25 agreed to further evaluation. Twenty three (92%) experienced reactions after the first dose. Thirteen (52%) experienced urticaria or angio-oedema, and of these, two experienced anaphylaxis. Thirteen had generalised rash, one with angio-oedema. The median time to reaction was 90 minutes. Nineteen (76%) underwent skin testing with the quadrivalent vaccine: all were skin prick test negative and one was intradermal test positive. Eighteen (72%) were subsequently challenged with the quadrivalent vaccine and three (12%) elected to receive the bivalent vaccine. Seventeen tolerated the challenge and one reported limited urticaria four hours after the vaccine had been administered. Only three of the 25 schoolgirls were found to have probable hypersensitivity to the quadrivalent vaccine.

Conclusion True hypersensitivity to the quadrivalent human papillomavirus vaccine in Australian schoolgirls was uncommon and most tolerated subsequent doses.


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