Safety and Immunogenicity of a Chlamydia Vaccine CTH522

Summary

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.

Timeline

Start

2020-02-17

Primary completion

2022-02-22

Completion

2022-02-22

Publications

• Pollock KM, Borges AH, Cheeseman HM, Rosenkrands I, Schmidt KL, Sondergaard RE, Day S, Evans A, McFarlane LR, Joypooranachandran J, Amini F, Skallerup P, Dohn RB, Jensen CG, Olsen AW, Bang P, Cole T, Schronce J, Lemm NM, Kristiansen MP, Andersen PL, Dietrich J, Shattock RJ, Follmann F. An investigation of trachoma vaccine regimens by the chlamydia vaccine CTH522 administered with cationic liposomes in healthy adults (CHLM-02): a phase 1, double-blind trial. Lancet Infect Dis. 2024 Aug;24(8):829-844. doi: 10.1016/S1473-3099(24)00147-6. Epub 2024 Apr 11.

Drugs

Indications