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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
35
CTH522 chlamydia antigen adjuvanted with CAF01 for IM administration
CTH522 chlamydia antigen adjuvanted with aluminium hydroxide, Al(OH)3 , for IM administration
Saline
NIHR/Wellcome Trust Imperial Clinical Research Facility, Hammersmith Hospital
London, United Kingdom
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
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