Clinical Trial: Safety of Chlamydia Vaccine CTH522 in Healthy Women Aged 18 to 45 Years
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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
Brief 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
Detailed Summary:
Sponsor: Statens Serum Institut
Current Primary Outcome: Evaluation of adverse events/reactions and laboratory safety of adjuvanted chlamydia vaccine [ Time Frame: Through study completion (Day 0 to Day 168) ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Serum immunoglobulin G antibody responses after vaccination with CTH522 [ Time Frame: At Days 0, 28, 112, 126, 140, 154 and 168 ]
Original Secondary Outcome: Same as current
Information By: Statens Serum Institut
Dates:
Date Received: May 23, 2016
Date Started: July 2016
Date Completion:
Last Updated: October 3, 2016
Last Verified: October 2016