A Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years.
Summary
Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will evaluate the immune response induced by the HPV-16/18 L1 VLP AS04 vaccine and the safety of the vaccine.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Description
The protocol was primarily amended for the following reason:
Merck's tetravalent HPV vaccine, Gardasil®, has been licensed and is now becoming commercially available in an increasing number of countries. Therefore, the study procedures were revised to include questions at every visit to determine if subjects have received an HPV vaccine outside of the study.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Conditions
Human Papillomavirus (HPV) Infection
Intervention
HPV-16/18 L1 VLP AS04
Location
GSK Investigational Site
Hong Kong
Hong Kong
Status
Completed
Source
GlaxoSmithKline
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00306241
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Human Papillomavirus 18
A type of human papillomavirus especially associated with malignant tumors of the genital and RESPIRATORY MUCOSA.
Papillomavirus Vaccines
Vaccines or candidate vaccines used to prevent PAPILLOMAVIRUS INFECTIONS. Human vaccines are intended to reduce the incidence of UTERINE CERVICAL NEOPLASMS, so they are sometimes considered a type of CANCER VACCINES. They are often composed of CAPSID PROTEINS, especially L1 protein, from various types of ALPHAPAPILLOMAVIRUS.
Papillomavirus E7 Proteins
ONCOGENE PROTEINS from papillomavirus that deregulate the CELL CYCLE of infected cells and lead to NEOPLASTIC CELL TRANSFORMATION. Papillomavirus E7 proteins have been shown to interact with various regulators of the cell cycle including RETINOBLASTOMA PROTEIN and certain cyclin-dependent kinase inhibitors.
Human Papillomavirus 6
A type of ALPHAPAPILLOMAVIRUS usually associated with GENITAL WARTS; and LARYNGEAL NEOPLASMS.
Human Papillomavirus 31
A type of ALPHAPAPILLOMAVIRUS associated with high risk for anogenital neoplasms.
Clinical Trials
Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to cervi...
A phase I, open label, single-centre study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' HPV -16/18 L1 VLP AS04 vaccine (GSK 580299, Cervarix TM), administered...
Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection
RATIONALE: Vaccines made from human papillomavirus may help the body build an effective immune response to kill HIV cells. PURPOSE: This phase II trial is studying the side effects and ho...
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and...
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the ut...
PubMed Articles
The human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine has been demonstrated to be highly efficacious and immunogenic with a favorable safety profile. This study assessed the imm...
Role of AS04 in human papillomavirus vaccine: mode of action and clinical profile.
Introduction: Understanding the mode of action of adjuvants is important for the interpretation of clinical studies. Areas covered: This paper discusses how the results of GSK's clinical studies with...
It is well established that the prevalence of human papillomavirus (HPV) infection is increased among human immunodeficiency virus (HIV)-positive individuals, but the temporal relationships between th...
HPV typing and its relation with apoptosis in cervical carcinoma from Indian population.
Definite progress in understanding the etiology of cervical cancer has been achieved, and some types of human papillomavirus have been established as the central cause of cervical cancer worldwide. Th...
Determining the rate at which men develop genital warts after infection with alpha genus human papillomavirus (HPV) types will provide important information for the design of prevention strategies. We...
