Study to Evaluate the Safety and Immunogenicity of MEDI-517P in Healthy Adult Female Volunteers Who Are HPV-16 or HPV-18 DNA Positive
Summary
The primary objective of this study is to describe the safety of 40 mg MEDI-517, with a control of aluminum hydroxide, when given to healthy adult women who have evidence of HPV-16 and/or HPV-18 DNA detected in cervical brushings.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Conditions
Healthy
Intervention
MEDI 517, Aluminum hydroxide
Status
Completed
Source
MedImmune LLC
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00263744
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Aluminum Hydroxide
A compound with many biomedical applications: as a gastric antacid, an antiperspirant, in dentifrices, as an emulsifier, as an adjuvant in bacterins and vaccines, in water purification, etc.
Aluminum Compounds
Inorganic compounds that contain aluminum as an integral part of the molecule.
Aluminum Oxide
An oxide of aluminum, occurring in nature as various minerals such as bauxite, corundum, etc. It is used as an adsorbent, desiccating agent, and catalyst, and in the manufacture of dental cements and refractories.
Lye
Generally speaking, it is the alkaline substance obtained from wood ashes by percolation. Preparations of lye can be solutions of either potassium or sodium hydroxide. The term lye, is also used to refer to the household product which is a mixture of sodium hydroxide and sodium carbonate.
Aluminum Silicates
Any of the numerous types of clay which contain varying proportions of Al2O3 and SiO2. They are made synthetically by heating aluminum fluoride at 1000-2000 degrees C with silica and water vapor. (From Hawley's Condensed Chemical Dictionary, 11th ed)
Clinical Trials
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PubMed Articles
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Hydrolysis of aluminum dross material to achieve zero hazardous waste.
A simple method with high efficiency for generating high pure hydrogen by hydrolysis in tap water of highly activated aluminum dross is established. Aluminum dross is activated by mechanically milling...
Updated aluminum pharmacokinetics following infant exposures through diet and vaccination.
Aluminum is a ubiquitous element that is released naturally into the environment via volcanic activity and the breakdown of rocks on the earth's surface. Exposure of the general population to aluminum...
A novel molecular probe sensing polynuclear hydrolyzed aluminum by chelation-enhanced fluorescence.
A novel molecular probe (P2) sensing polynuclear hydrolyzed aluminum by chelation-enhanced fluorescence was described, which was prepared from 1,1'-(1,4-phenylene)bis(7-methyl-1,3,5-octanetrione) and...
Potential benefits of adherence to the Mediterranean diet on cognitive health.
The purpose of this review was to update available knowledge on the relationship between adherence to the Mediterranean diet (MeDi) and cognitive decline, risk of dementia or Alzheimer's Disease (AD),...