Safety and immunogenicity of the chlamydia vaccine candidate CTH522 adjuvanted with CAF01 liposomes or aluminium hydroxide: a first-in-human, randomised, double-blind, placebo-controlled, phase 1 trial

Chlamydia is the most common sexually transmitted bacterial infection worldwide

Sonya Abraham; Helene B Juel; Peter Bang; Hannah M Cheeseman; Rebecca B Dohn; Tom Cole; Max P Kristiansen; Karen S Korsholm; David Lewis; Anja W Olsen; Leon R McFarlane; Suzanne Day; Sara Knudsen; Kjersti Moen; Morten Ruhwald; Ingrid Kromann; Peter Andersen; Robin J Shattock; Frank Follmann


Scholarcy highlights

  • Chlamydia is the most common sexually transmitted bacterial infection worldwide
  • National screening programmes and antibiotic treatment have failed to decrease incidence, and to date no vaccines against genital chlamydia have been tested in clinical trials
  • We aimed to assess the safety and immunogenicity, in humans, of a novel chlamydia vaccine based on a recombinant protein subunit in a prime–boost immunisation schedule
  • Participants were randomly assigned to three groups: CTH522 adjuvanted with CAF01 liposomes, CTH522 adjuvanted with aluminium hydroxide, or placebo
  • No related serious adverse reactions were reported, and the most frequent adverse events were mild local injection-site reactions, which were reported in all participants in the two vaccine groups and in three of five participants in the placebo group
  • Both CTH522:CAF01 and CTH522:AH induced anti-CTH522 IgG seroconversion in 15 of 15 participants after five immunisations, whereas no participants in the placebo group seroconverted
  • Prospective studies have estimated that 10–15% of untreated chlamydia infections lead to symptomatic pelvic inflammatory disease, and 10–15% of women with symptomatic pelvic inflammatory disease, as well as many with subclinical pelvic inflammatory disease, will develop tubal factor infertility

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