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

2019

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

Need more features? Save interactive summary cards to your Scholarcy Library.