Gardasil(R) Is The First Cervical Cancer Vaccine To Demonstrate Protectionagainst Genital Disease Associated With Human Papillomavirus (HPV)
"Women remain at significant risk for developing human papillomavirus-related genital diseases, including cervical cancer, throughout their lifetime," comments Patrick Poirot, vice president for Medical and Scientific Affairs at Sanofi Pasteur MSD. "These new results suggest that Gardasil® has comparable efficacy in older women to that shown in girls and young women and that older women could also benefit from this vaccine".
This is the first time that a cervical cancer vaccine has been shown to prevent human papillomavirus-related gynaecological diseases in older women.
"The results build on the development programme for Gardasil®, the objective of which is the proof of efficacy against clinical diseases in each age group that could benefit from vaccination," says Patrick Poirot.
"The measurement of antibody levels induced by vaccination or the prevention of persistent infection alone cannot replace the demonstration of efficacy against clinical disease as the best measure of the effectiveness of a human papillomavirus vaccine in adults," adds Professor Margaret Stanley from the University of Cambridge, United Kingdom.
The current indications for the two currently approved cervical cancer vaccines do not include data on the efficacy against clinical diseases in women older than their mid-20s2,3. "Based on these encouraging new results, the competent regulatory bodies and experts will now have to define how to approach the possible vaccination of older women in the future," concludes Patrick Poirot. "Until this is done, the focus of public health authorities will certainly remain on vaccinating girls and young women prior to exposure to the human papillomavirus."
Gardasil® is generally well tolerated and provides wide-ranging and early benefits in addition to the prevention of cervical cancer due to human papillomavirus types 16 and 18. Wide-ranging benefits because it also helps prevent pre-cancerous and early cervical lesions, vulvar precancerous lesions and genital warts due to types 6, 11, 16 and 18; early benefits because early cervical lesions and genital warts occur much faster than cervical cancer, often within a few months after exposure to the virus.
Gardasil® is the only cervical cancer vaccine that directly targets the four human papillomavirus types 6, 11, 16 and 18 which cause the vast majority of cervical cancer and other human papillomavirus-related genital diseases.
It is estimated that human papillomavirus types 6, 11,16 and 18 together cause 75% of cervical cancer 4,5,6,2,7,870% of pre-cancerous (CIN‡ 2/3)2,6,9 and 50% of potentially pre-cancerous cervical lesions (CIN‡ 1)2,10, a significant proportion of vulvar and vaginal cancers2,11,12 and their associated pre-cancerous lesions 2,13,14,15, and 90% of genital warts in Europe.2,16,17,18,19 Despite screening for early detection, cervical cancer remains the second most common cause of death from cancer (after breast cancer) among young women (15-44 yrs) in Europe.
Around 33,500 women are diagnosed with, and 15,000 women die from cervical cancer each year.
In addition, hundreds of thousands of women are diagnosed with other genital human papillomavirus diseases that start before the occurrence of cervical cancer and can touch other genital organs than the cervix. These diseases include pre-cancerous and early cervical lesions, vulvar and vaginal cancer, pre-cancerous vulvar and vaginal lesions, and genital warts.
i Gardasil® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed))
ii 95% CI [50,100]
About the study
3,819 women aged 24 to 45, from the Americas, Europe and Asia, were enrolled in a 1:1 ratio randomised, double-blind study. They had no history of LEEP (loop electrosurgical excision procedure) or hysterectomy; no history of biopsy-diagnosed cervical human papillomavirus disease in the past five years and no history of genital warts. Pap testing and cervico-vaginal sampling is performed at about six-month intervals for a total of 48 months. Analyses were conducted among subjects PCR- and seronegative to the relevant papillomavirus type (6, 11, 16, 18).
Subjects received three doses of either Gardasil® or placebo at day 1, month 2 and month 6. Analysis was done in a per-protocol efficacy population through a mean follow up of 1.65 year after start of vaccination. The first co-primary endpoint was combined incidence of persistent infection (same virus type found at six months interval), early or pre-cancerous cervical lesions (all grades of CIN), as well as external genital lesions (EGLs: vulvar and vaginal precancerous lesions, genital warts) caused by human papillomavirus types 6, 11, 16, 18. Efficacy was 91% (95% CI [74, 98]). In order to evaluate the efficacy against clinical disease alone (early or pre-cancerous cervical lesions (all grades of CIN), as well as EGLs), persistent infection was extracted from the first co-primary endpoint. Efficacy against clinical disease alone was 92% (95% CI [50,100]) as reported above.
Current UK indication of Gardasil®
Gardasil®, Human Papillomavirus Vaccine [types 6,11,16,18] (recombinant, adsorbed), can be given to children and adolescents 9 to15 years and adult females 16 to 26 years of age and is indicated for the prevention of cervical carcinoma (cervical cancer), high grade cervical dysplasia CIN2/3 (precancerous cervical lesions), high grade vulvar dysplastic lesions VIN 2/3 (precancerous vulvar lesions) and external genital warts (condyloma acuminata) caused by human papillomavirus types 6, 11, 16 and 18.
About Sanofi Pasteur MSD
Sanofi Pasteur MSD is a joint venture between sanofi pasteur, the vaccine division of sanofi-aventis, and Merck & Co., Inc. Combining innovation and expertise, Sanofi Pasteur MSD is the only company in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of sanofi pasteur and Merck & Co., Inc., together with their teams throughout the world, to focus on the development of new vaccines for Europe, which aim to extend protection to other diseases and perfect existing vaccines in order to improve the acceptability, efficacy and tolerability of vaccination.
http://www.sanofipasteur.com/
References
1 Luna J, The safety, efficacy and immunogenicity of quadrivalent HPV (types 6/11/16/18) L1 virus-like-particle (VLP) vaccine in women aged 24 to 45, oral presentation of abstract, plenary session (PA1-04), 24th International Papillomavirus Conference and Clinical Workshop, (3-10 November 2007), Beijing, China.
2 Gardasil®, Summary of Product Characteristics
3 Cervarix™, Summary of Product Characteristics
4 Calculation based on 1998 US data and population data obtained from http://www.PopulationData.net. Calculation of HPV-related lesions is determined as follows: annual incidence of lesions multiplied by EU female population and prevalence of virus types.
5 Calculation based on 2002 UK data and population data obtained from http://www.PopulationData.net. Number of cases of genital warts in EU females is determined as follows: genital warts cases in UK female population multiplied by the EU female population divided by the UK female population.
6 Smith JS et al. Human papillomavirus type distribution in invasive cervical cancer and high-grade cervical lesions: A metaanalysis update. Int J Cancer 2007; 121:621-632.
7 Daling JR et al. A population-based study of squamous cell vaginal cancer: HPV and cofactors. Gynecol Oncol 2002;84:263- 270.
8 Madeleine MM et al. Cofactors with Human Papillomavirus in a population-based study of vulvar cancer. J Natl Cancer Inst 1997;89:1516-1523.
9 Sotlar K et al. Detection and typing of Human Papillomavirus by E6 nested multiplex PCR. J Clin Microbiol 2004;42:3176-3184.
10 Clifford GM et al. Human papillomavirus genotype distribution in low-grade cervical lesions: Comparison by geographic region and with cervical cancer. Cancer Epidemiol Biomarkers Prev 2005;14:1157-1164.
11 Daling JR et al. A population-based study of squamous cell vaginal cancer: HPV and cofactors. Gynecol Oncol 2002;84:263- 270.
12 Madeleine MM et al. Cofactors with Human Papillomavirus in a population-based study of vulvar cancer. J Natl Cancer Inst 1997;89:1516-1523.
13 Dodge JA et al. Clinical features and risk of recurrence among patients with vaginal intraepithelial neoplasia. Gynecol Oncol 2001;83:363-369.
14 van Beurden M et al. Multifocal intraepithelial neoplasia grade III and multicentric lower genital tract neoplasia is associated with transcriptionally active human papillomavirus. Cancer 1995;75:2879-2884.
15 Hording U et al. Vulvar intraepithelial neoplasia III: A viral disease of undetermined progressive potential. Gynecol Oncol 1995;56:276-279.
16 Jones RW. Vulval intraepithelial neoplasia: Current perspectives. Eur J Gynaecol Oncol 2001;22:393-402.
17 Wieland U and Pfister H. papillomaviruses in human pathology: Epidemiology, pathogenesis and oncologic role. In: Gross, Barasso Eds.Human Papilloma Virus Infection: A clinical atlas. Ullstein Mosby 1997; p1-18.
18 von Krogh G. Management of anogenital warts (condylomata acuminata). Eur J Dermatol 2001;11:598-603.
19 UK Health Protection Agency. CDR Weekly 2003;3(44)
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Gardasil (R) este primul cancerului de col uterin Vaccin pentru a demonstra Protectionagainst Genital bolilor asociate cu Human Papillomavirus (HPV) - Gardasil(R) Is The First Cervical Cancer Vaccine To Demonstrate Protectionagainst Genital Disease Associated With Human Papillomavirus (HPV) - articole medicale engleza - startsanatate