Difference between revisions of "Cervarix"

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:The pre-licensing programme for Cervarix comprised two major clinical trials (a ‘proof-ofconcept’ Phase IIb study and a larger Phase III trial) encompassing some 19,788 women aged
 
:The pre-licensing programme for Cervarix comprised two major clinical trials (a ‘proof-ofconcept’ Phase IIb study and a larger Phase III trial) encompassing some 19,788 women aged
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15–25 years.7,9,11,12 The key features of these studies are summarised in Table 1. A further Phase III, community-based, randomised clinicaltrial is currently underway in Costa Rica, which
+
15–25 years. A further Phase III, community-based, randomised clinicaltrial is currently underway in Costa Rica, which
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is sponsored by the National Cancer Institute. An
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is sponsored by the National Cancer Institute.
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interim analysis of this study has reported on the
+
 
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effects of Cervarix in women with pre-existing
 
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HPV infections (see below).13 In total, completed
 
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and ongoing clinical trials of Cervarix will
 
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involve nearly 30,000 women and girls aged
 
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between 10 and 55 years.8
 
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In the initial Phase IIb study, vaccine efficacy
 
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was evaluated by examining the impact of
 
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Cervarix on incident and persistent HPV 16/18
 
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infections in women naïve to 14 different high-risk
 
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oncogenic HPV types, including HPV 16 and 18,
 
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and who also had normal cervical cytology (Table
 
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1). This study also included an extension phase,
 
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which evaluated these same parameters with
 
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longer-term follow-up (mean follow-up 47.7
 
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months). Although it is only a surrogate marker
 
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for vaccine efficacy against clinical disease,
 
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persistent HPV infection can be readily
 
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monitored using standard molecular biology
 
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techniques thereby providing substantial
 
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reproducibility between testing centres, in contrast
 
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to the subjective nature of cytological and
 
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histological assessments. However, licensing
 
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authorities now demand that clinical trials of
 
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cervical cancer vaccine also evaluate the incidence
 
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of histological lesions of the cervix including the
 
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incidence of CIN2+, which is now widely
 
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considered to be the most direct correlate of
 
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vaccine efficacy in preventing cervical cancer.14
 
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Although the Phase II study evaluated the effect of
 
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Cervarix on cytological and histological cervical
 
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abnormalities, with extended follow-up of up to
 
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4.5 years, the trial was insufficiently powered to
 
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provide firm evidence of vaccine efficacy.<ref>Scott Chambers CSF Medical Communications, Cheltenham, UK [http://www.drugsincontext.com/downloads/Cervarix.pdf Cervarix – preventing cervical cancer and other diseases related to HPV]  ''Drugs in Context'' 2008; 4: 59–70</ref>
 
  
 
==Biographical Information==
 
==Biographical Information==

Revision as of 11:16, 5 April 2009

Background

Introduction

Cervarix is a vaccine intended to protect females against the diseases caused by infection with Human Papillomavirus (HPV) types 16 and 18. These diseases include: - cervical cancer(cancer of the cervix i.e. lower part of the uterus or womb), - precancerous cervical lesions(changes in cells of the cervix that have a risk of turning into cancer).

Cervarix will not protect against all types of Human Papillomavirus.HPV types 16 and 18 are responsible for approximately 70% ofcervical cancer cases. When a female is vaccinated with Cervarix, the immune system(the body’s natural defence system) will make antibodies against HPV types 16 and 18.

The Cervarix clinical trial programme

The pre-licensing programme for Cervarix comprised two major clinical trials (a ‘proof-ofconcept’ Phase IIb study and a larger Phase III trial) encompassing some 19,788 women aged

15–25 years. A further Phase III, community-based, randomised clinicaltrial is currently underway in Costa Rica, which is sponsored by the National Cancer Institute.


Biographical Information

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