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Sponsors and Collaborators: |
MedImmune LLC GSK Biologicals |
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Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00263744 |
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.
Condition | Intervention | Phase |
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Healthy |
Biological: MEDI 517 Other: Aluminum hydroxide |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety Study |
Official Title: | A Phase I/II Study to Evaluate the Safety and Immunogenicity of MEDI-517, a Virus-Like Particle Vaccine Against Human Papillomavirus (HPV) Types 16 and 18, in Healthy Adult Female Volunteers Who Are HPV-16 or HPV-18 DNA Positive |
Enrollment: | 60 |
Study Start Date: | November 1999 |
Study Completion Date: | June 2001 |
Primary Completion Date: | April 2001 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
MEDI517
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Biological: MEDI 517
Vaccine is supplied in single use vials containing 0.75 mL of MEDI-517 at a concentration of 40 mg/0.5 mL formulated with SBAS4 adjuvant.
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2: Active Comparator
Aluminum hydroxide
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Other: Aluminum hydroxide
Aluminum hydroxide supplied in single use vials containing 0.75 mL of aluminum hydroxide at a concentration of 0.5 mg of aluminum in the form of aluminum hydroxide per 0.5 mL.
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Ages Eligible for Study: | 18 Years to 30 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Those volunteers with ASCUS or AGCUS must have had a clinical evaluation by colposcopy within the previous month which showed no evidence of CIN or SIL.
Exclusion Criteria:
Responsible Party: | MedImmune Inc. ( Genevieve Lonosky, M.D. ) |
Study ID Numbers: | MI-CP058 |
Study First Received: | December 8, 2005 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00263744 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Immunologic Factors Adjuvants, Immunologic |
Antacids Healthy Aluminum Hydroxide |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adjuvants, Immunologic |
Antacids Pharmacologic Actions Aluminum Hydroxide |