A Phase 1 interventional study of CTH522-CAF01 and CTH522-Al(OH)3 in Chlamydia Trachomatis, sponsored by Statens Serum Institut. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-10.
Sponsored by Statens Serum Institut · Phase 1, Interventional, and Prevention
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
121 studies on the registry are indexed under Chlamydia Infections; 21 are open to participants now.
This study's enrollment of 35 is below the median of 600 across 85 interventional studies indexed under Chlamydia Infections.
Browse Chlamydia Infections studies →Statens Serum Institut is the lead sponsor of 28 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Willing to use acceptable contraceptive measures* during the trial (2 weeks before and 2 weeks after the trial)
Exclusion Criteria:
CTH522-CAF01: CTH522 chlamydia antigen adjuvanted with CAF01 for IM administration (preferably the non-dominant arm) CTH522 chlamydia antigen diluted with Tris buffer for IN administration
Biological: CTH522-CAF01
CTH522-Al(OH)3: CTH522 chlamydia antigen adjuvanted with aluminium hydroxide, Al(OH)3 , for IM administration (preferably the non-dominant arm) CTH522 chlamydia antigen diluted with Tris buffer for IN administration
Biological: CTH522-Al(OH)3
Saline for IM and In administrations
Biological: Placebo
CTH522 chlamydia antigen adjuvanted with CAF01 for IM administration
CTH522 chlamydia antigen adjuvanted with aluminium hydroxide, Al(OH)3 , for IM administration
Saline
Evaluation of adverse events/reactions and laboratory safety of adjuvanted chlamydia vaccine
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)
Time frame: Through study completion (Day 0 to Day 168)
Serum immunoglobulin G antibody responses after vaccination with CTH522
Percentage of subjects achieving seroconversion for anti-CTH522 immunoglobulin G antibody at any time points after IM vaccination(s)
Time frame: At Days 0, 28, 112, 126, 140, 154 and 168
Plan to share: No
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Statens Serum Institut