NCT02787109

Safety of Chlamydia Vaccine CTH522 in Healthy Women Aged 18 to 45 Years

A Phase I First in Human, Double-blind, Parallel, Randomised and Placebo Controlled Clinical Trial of the Safety of SSI's Adjuvanted Chlamydia Vaccine CTH522 in Healthy Women Aged 18 to 45 Years

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Statens Serum Institut · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The present trial is a phase I first in human, double blind, parallel and placebo controlled trial of SSI's adjuvanted chlamydia vaccine CTH522: CTH522-CAF01 (CAF01 is an adjuvant system) and CTH522-Al(OH)3. The trial will be conducted at Imperial College Research site in the United Kingdom. Subjects are randomly assigned to one of the following three treatment groups in a ratio of 3:3:1. This trial consisted of 10 visits and 5 telephonic interviews

Conditions

• Chlamydia Trachomatis

Interventions

Type	Name	Description
BIOLOGICAL	CTH522-CAF01	CTH522 chlamydia antigen adjuvanted with CAF01 for IM administration
BIOLOGICAL	CTH522-Al(OH)3	CTH522 chlamydia antigen adjuvanted with aluminium hydroxide, Al(OH)3 , for IM administration
BIOLOGICAL	Placebo	Saline

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-07-31
• Completion: 2017-07-31
• First posted: 2016-06-01
• Last updated: 2017-08-10

Locations

1 site across 1 country: United Kingdom