NCT00263744

Study to Evaluate the Safety and Immunogenicity of MEDI-517P in Healthy Adult Female Volunteers Who Are HPV-16 or HPV-18 DNA Positive

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: Female
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 1999-11-01
• Primary completion: 2001-04-01
• Completion: 2001-06-01
• First posted: 2005-12-09
• Last updated: 2009-01-08