CHLM-02 was a phase I, double-blind, randomized, placebo-controlled trial of the chlamydia vaccine CTH522. 65 trial participants were randomized into 12 groups and six cohorts (A1 to F2). Cohorts A to E received three intramuscular (IM) injections of CTH522 (Day 0, 28, and 112). Cohorts A to D received CTH522 adjuvanted with Cationic Adjuvant Formulation (CAF®) 01 IM in two doses (85µg \[A to C\] or 15µg \[D\]). Cohort E received 85µg CTH522 adjuvanted with CAF®09b. Cohorts B and C received unadjuvanted CTH522 boost via the topic ocular (TO) or intradermal (ID) route, respectively, jointly with the second and third IM vaccinations. Cohort F received placebo. The effect of mucosal recall on eye immunity with TO CTH522 or placebo was assessed Day 140.
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Solicited Local Injection Site Reactions
Timeframe: Visit 2 (Day 0) plus 14 Days
Solicited Local Injection Site Reactions
Timeframe: Visit 4 (Day 28) plus 14 Days
Solicited Local Injection Site Reactions
Timeframe: Visit 7 (Day 112) plus 14 Days
Solicited Local Ocular Reactions
Timeframe: Visit 4 (Day 28) plus 14 Days
Solicited Local Ocular Reactions
Timeframe: Visit 7 (Day 112) plus 14 Days
Solicited Local Ocular Reactions
Timeframe: Visit 9 (Day 140) plus 14 Days
Solicited Systemic Reactions
Timeframe: Visit 2 (Day 0) plus 14 Days
Solicited Systemic Reactions
Timeframe: Visit 4 (Day 28) plus 14 Days
Solicited Systemic Reactions
Timeframe: Visit 7 (Day 112) plus 14 Days