(Press-News.org) 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.
Study affirms safety of HPV4 vaccine for adolescents and young women in routine clinical care
2012-10-02
ELSE PRESS RELEASES FROM THIS DATE:
Restricting nuclear power has little effect on the cost of climate policies
2012-10-02
"Questions have been raised if restricting nuclear energy – an option considered by some countries after the accident in Fukushima, Japan – combined with climate policies might get extremely expensive. Our study is a first assessment of the consequences of a broad range of combinations of climate and nuclear policies," lead author Nico Bauer says. Restrictions on nuclear power could be political decisions, but also regulations imposed by safety authorities. Power generation capacities would have to be replaced, but fossil fuels would become costly due to a price on CO2 ...
The Great Barrier Reef has lost half of its coral in the last 27 years
2012-10-02
The Great Barrier Reef has lost half its coral cover in the last 27 years. The loss was due to storm damage (48%), crown of thorns starfish (42%), and bleaching (10%) according to a new study published in the Proceedings of the National Academy of Sciences today by researchers from the Australian Institute of Marine Science (AIMS) in Townsville.
"We can't stop the storms but, perhaps we can stop the starfish. If we can, then the Reef will have more opportunity to adapt to the challenges of rising sea temperatures and ocean acidification, says John Gunn, CEO of AIMS.
...
Tree rings go with the flow of the Amazon
2012-10-02
University of Leeds-led research has used tree rings from eight cedar trees in Bolivia to unlock a 100-year history of rainfall across the Amazon basin, which contains the world's largest river system.
The new study shows that the rings in lowland tropical cedar trees provide a natural archive of data closely related to historic rainfall.
Researchers measured the amounts of two different oxygen isotopes trapped in the wood's rings: oxygen-16 and the heavier oxygen-18. By looking at the varying amounts of the two isotopes, they could see how the pattern of rainfall ...
Sexually abused women much less likely to be screened for cervical cancer
2012-10-02
[Barriers to cervical screening in women who have experienced sexual abuse: an exploratory study 2012; 38: 214-20 (Research)
The effect of childhood sexual abuse on women's lives and their attitudes to cervical screening 2012; 38:1-2 (Editorial)]
Women who have been sexually abused as children or young adults are much less likely to get screened for cervical cancer than other women, indicates exploratory research published in the Journal of Family Planning and Reproductive Health Care.
Figures published last year by the national NHS Cervical Cancer Screening Programme ...
Misconduct, not error, accounts for most scientific paper retractions
2012-10-02
October 1, 2012 — (Bronx, NY) — In sharp contrast to previous studies suggesting that errors account for the majority of retracted scientific papers, a new analysis—the most comprehensive of its kind—has found that misconduct is responsible for two-thirds of all retractions. In the paper, misconduct included fraud or suspected fraud, duplicate publication and plagiarism. The paper's findings show as a percentage of all scientific articles published, retractions for fraud or suspected fraud have increased 10-fold since 1975. The study, from a collaboration between three ...
Potential new class of drugs blocks nerve cell death
2012-10-02
Diseases that progressively destroy nerve cells in the brain or spinal cord, such as Parkinson's disease (PD) and amyotrophic lateral sclerosis (ALS), are devastating conditions with no cures.
Now, a team that includes a University of Iowa researcher has identified a new class of small molecules, called the P7C3 series, which block cell death in animal models of these forms of neurodegenerative disease. The P7C3 series could be a starting point for developing drugs that might help treat patients with these diseases. These findings are reported in two new studies published ...
Homolog of mammalian neocortex found in bird brain
2012-10-02
A seemingly unique part of the human and mammalian brain is the neocortex, a layered structure on the outer surface of the organ where most higher-order processing is thought to occur. But new research at the University of Chicago has found the cells similar to those of the mammalian neocortex in the brains of birds, sitting in a vastly different anatomical structure.
The work, published in Proceedings of the National Academy of Sciences, confirms a 50-year-old hypothesis about the identity of a mysterious structure in the bird brain that has provoked decades of scientific ...
Penn researchers connect baboon personalities to social success and health benefits
2012-10-02
PHILADELPHIA — Whether human or baboon, it helps to have friends. For both species, studies have shown that robust social networks lead to better health and longer lives. Now, a team of University of Pennsylvania researchers has helped show that baboon personality plays a role in these outcomes, and, like people, some baboons' personalities are better suited to making and keeping friends than others.
The research was conducted by psychology professor Robert Seyfarth and biology professor Dorothy Cheney, both of Penn's School of Arts and Sciences. They collaborated with ...
A simple blood test could be used to detect breast cancer
2012-10-02
A SIMPLE blood test could one day be a more accurate way to test for the early signs of breast cancer than using mammograms to spot a lump say researchers today (Tuesday), as Breast Cancer Awareness Month gets underway.
They also hope the blood test could improve treatment by detecting whether breast cancer patients are likely to relapse and what drugs their particular type of tumour will respond to.
This pioneering new clinical study – funded by Cancer Research UK in collaboration with the University of Leicester and Imperial College London – is about to start in the ...
Breakthrough in understanding lung cancer vulnerabilities points the way to new targeted therapy
2012-10-02
More effective treatments for one of the deadliest forms of cancer are one step closer thanks to groundbreaking research from an international collaborative study.
Scientists from the Universities of Sheffield and Cologne have identified the dependencies of multiple Small Cell Lung Cancer (SCLC) types – paving the way for clinical trials of new targeted treatments which could revolutionise the current approach.
Around 40,000 people are diagnosed annually with lung cancer in the UK, and SCLC accounts for nearly one in five of all these cases.
Unfortunately, the prognosis ...