OAKLAND, Calif. — A study of almost 200,000 young females who received the quadrivalent human papilloma virus (HPV4) vaccine found that immunization was associated only with same-day syncope (fainting) and skin infections in the two weeks after vaccination. These findings support the general safety of routine vaccination with HPV4 in a clinical care setting to prevent cervical and other genital and reproductive cancers.
The association between HPV4 and syncope was not unexpected, the researchers noted, because injections in general are known to have a correlation to fainting, particularly in the study's age group. The review of skin-infection diagnoses suggested that some may have been local injection-site reactions, although there was insufficient detail to exclude acute infections.
The study appears in the current online issue of Archives of Pediatrics & Adolescent Medicine.
"Taking into account all the analyses, subanalyses and relevant medical record reviews, an independent safety committee noted that there may be an association between HPV4 vaccination and same-day syncope, as well as skin infections during the two weeks after immunization," said lead author Nicola Klein, MD, PhD, co-director and research scientist at the Kaiser Permanente Vaccine Study Center in Oakland, Calif.
Dr. Klein outlined the study's strengths — a large, ethnically diverse population who received a total of nearly 350,000 HPV4 doses; an integrated health care delivery system that assured complete or near-complete medical information; and a pre-specified, validated, clinically meaningful system to categorize all outcomes. However, she noted that ongoing monitoring of spontaneous reports and other sources such as the Vaccine Safety Datalink will further contribute to HPV4's safety profile.
Human papillomavirus (HPV) is a family of small DNA viruses that are associated with the most commonly detected sexually transmitted infection in women. While most HPV infections cause no symptoms and are self-limited, persistent genital HPV infection can lead to cervical cancer. HPV is estimated to cause over half a million new cancers every year, most of which affect women in developing countries.
The Food and Drug Administration approved the quadrivalent HPV vaccine in 2006 for females between the ages of 9 to 26 for prevention of a range of diseases attributed to HPV. More recently, HPV4 was approved for the same age group for the prevention of vaginal and vulvar cancer, for males between the ages of 9 to 26 years for the prevention of genital warts, and in both males and females for the prevention of anal intraepithelial neoplasia and cancer.
The study was conducted within the integrated health care delivery systems of Northern and Southern California Kaiser Permanente, which each have more than 3 million members representative of the regions' populations, and included 189,629 females who received one or more doses of HPV4 between August 2006 and March 2008.
The design of the study compared the risk of emergency department visits and hospitalizations during post-vaccination intervals of 1-60 days, 1-14 days and day 0 (day of vaccination) with control intervals ranging from 60 days for those who received one dose of HPV4 to 180 days for those who received three doses.
"That this study detected two potentially expected outcomes provides reasonable reassurance that it was a valid approach to uncovering HPV4-associated safety signals," Dr. Klein said. "The findings substantiate the overall safety of the HPV4 vaccine in women and girls following routine administration."
The study, funded by Merck & Co., manufacturer of the HPV4 vaccine GARDASIL™, was a post-licensure commitment to the FDA and the European Medicines Agency.
Additional authors on the study included John Hansen, MPH, Michael Emery, MS, Ned Lewis, MPH, and Kamala Deosaransingh, MS, of the Kaiser Permanente Vaccine Study Center; Chun Chao, PhD, Jeff Slezak, Lina Sy, MPH, Harpreet Takhar, MPH, and Steven Jacobsen, MD, PhD, of the Department of Research & Evaluation, Kaiser Permanente Southern California; Christine Velicer, PhD, and Kai-Li Liaw, PhD, of the Department of Epidemiology, Merck Sharp and Dohme; Bradley Ackerson, MD, of the Department of Pediatrics, South Bay Medical Center, Kaiser Permanente Southern California; and T. Craig Cheetham, PharmD, MS, of Pharmacy Analytical Service, Kaiser Permanente Southern California.
About the Kaiser Permanente Vaccine Study Center
Founded in 1985, the Kaiser Permanente Vaccine Study Center began as a way of responding to numerous requests to use Kaiser Permanente's large population for vaccine efficacy studies. Key studies have focused on Haemophilus influenza, type B (Hib), chickenpox, pneumococcus, rotavirus, and flu vaccines. The center operates 31 sites in Northern California and collaborates with Kaiser Permanente's Northwest, Hawaii, and Colorado regions as well as participates in several Centers for Disease Control and Prevention and National Institutes of Health studies. For more information, visit www.dor.kaiser.org/external/research/topics/Vaccine_Epidemiology/.
About the Kaiser Permanente Division of Research
The Kaiser Permanente Division of Research conducts, publishes, and disseminates epidemiologic and health services research to improve the health and medical care of Kaiser Permanente members and the society at large. It seeks to understand the determinants of illness and well-being and to improve the quality and cost-effectiveness of health care. Currently, DOR's 500-plus staff is working on more than 250 epidemiological and health services research projects. For more information, visit www.dor.kaiser.org/.
About Kaiser Permanente
Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America's leading health care providers and not-for-profit health plans. Founded in 1945, our mission is to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve more than 9 million members in nine states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the-art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to: kp.org/newscenter.
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