NCT00693615

Safety and Immunogenicity Study of MEDI-517 (GSK 580299) With or Without Adjuvant in Healthy Adult Females

Study to Evaluate the Safety and Immunogenicity of MEDI-517, a Virus-Like Particle Vaccine Against Human Papillomavirus Types 16 and 18, When Formulated With Aluminum Hydroxide, AS04, or Without Adjuvant, in Healthy Adult Female Volunteers

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

Summary

The goals of this study are to describe the safety, reactogenicity and immunogenicity of MEDI-517 with and without adjuvant in HPV-naïve humans. Long-term immune data is collected. This study was originally performed by MedImmune. However, GSK is now responsible for the clinical development of the HPV vaccine.

Detailed description

This is a Phase II, double-blind, randomized, comparative trial of three formulations of MEDI-517 given at 0, 30, and 180 days by intramuscular injection. The volunteers in this study will be healthy females 18 through 30 years of age. The study collects safety, reactogenicity and immunogenicity data of MEDI-517 with and without adjuvant. Extended follow-up will provide long-term immune response data.

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	MEDI-517 HPV-16/18 VLP AS04 vaccine	IM injection
BIOLOGICAL	MEDI-517 HPV-16/18 VLP vaccine with Al(OH)3	IM injection
BIOLOGICAL	MEDI-517 HPV-16/18 VLP vaccine without adjuvant	IM injection

Timeline

• Start date: 2000-10-01
• Primary completion: 2005-01-01
• Completion: 2005-01-01
• First posted: 2008-06-09
• Last updated: 2016-09-16