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) ]

Solicited local injection site reactions (recorded at any visit) after intramuscular (IM) administration (pain, erythema, tenderness, pruritus, warmth, stiffness and swelling) Solicited local reactions (recorded at any visit) after IN administration (discharge, including bleeding, congestion, discomfort, sneezing and cough) Solicited systemic reactions (recorded at any visit) after IM and IN administration (abnormally raised temperature, chills, myalgia, malaise, fatigue, rash, headache, nausea and vomiting, and clinically significant abnormal values among full blood count, liver function test and renal profile results)


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 ]

Percentage of subjects achieving seroconversion for anti-CTH522 immunoglobulin G antibody at any time points after IM vaccination(s)


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