Monday, December 13, 2010

Quadrivalent Anti-HPV Vaccine to Prevent Cervical as well as Vaginal and Vulvar HPV-related Malignancies

Quadrivalent Anti-HPV Vaccine to Prevent Cervical as well as Vaginal and Vulvar HPV-related Malignancies
Date: 2/23/2008

TUMS / Public Relations English News Service: In the one-day seminar of “The New Methods in Screening Cervical Cancer and the Use of HPV Vaccine” held at the TUMS Imam Khomeini Hospital’s Conference Hall on February 20, 2008, Dr. Ezzedin, the Head of Gynecology & Obstetrics Department of the American University of Beirut comprehensively explained the …


Dr. Ezzedin, the Head of Gynecology & Obstetrics Department of the American University of Beirut comprehensively explained the aim of administration of quadrivalent anti-HPV vaccine, containing VLPs of HPV 16,18,6 and 11 is to prevent cervical cancer development, as well as to protect against vaginal and vulvar malignant HPV-­related lesions and genital warts formation.



The clinical studies demonstrated 98% efficacy of quadrivalent vaccine in prevention of HPV 16-18 containing cervical cancer necessary precursors (intraepithelial neoplasia of 2 and 3 grade and in situ glandular cancer) in the population of women not infected with these HPV types before and during the period of 3 doses of vaccine administration. Analysis of data concerning vaginal and vulvar cancer precursors related to HPV 16 and 18 revealed 100% protection with the per-­protocol application of quadrivalent vaccine. The same consistent data is showing 100% of protection against HPV 6 and 11 related genital warts, which were the part of composite end-point in per-protocol efficacy analysis.

The pivot element to achieve total protection against HPV 16, 18, 6 and 11 anogenital lesions with the use of quadrivalent vaccine, is to administer it to HPV naive subjects, as demonstrated by the trials. Inclusion of subjects already infected with HPV 16 and / or 18 deflate the efficacy to 44% in respect of cervical cancer protection (FUTURE II study).

The recommendations for quadrivalent vaccine administration formed on the basis of its efficacy trials and on trials concerning its immunogenicity in preadolescent population (bridging studies) strongly suggest vaccination of girls before the onset of sexual activity (the point of potential exposure to HPV). Although the exact age of sexual debut is variable across the countries, it is believed it is not lower than 12 years of age. So it is widely recommended to administer the vaccine around this age, though the immunogenicity trials showed very strong antibody response even in subjects as young as 9 year old, therefore this is the lower age limit of vaccination. The upper age limit of the subjects recruited to the clinical trials, and for whom the extremely high efficacy was demonstrated, was set at 26 years. Therefore, the quadrivalent vaccine can be administered to women up to 26 year of age, though the detailed recommendations may locally vary in this respect. We can expect the vaccine would appear to be highly effective in women much older (up to 45 years) too, but the clinical observations aiming to assess this are in progress now. The analysis of published recommendations will be provided.

http://publicrelations.tums.ac.ir/english/news/detail.asp?newsID=6415

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