Safety of Chlamydia Vaccine CTH522 in Healthy Women Aged 18 to 45 Years

Summary

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

Timeline

Start

2016-07

Primary completion

2017-07-31

Completion

2017-07-31

Publications

• Olsen AW, Rosenkrands I, Jacobsen CS, Cheeseman HM, Kristiansen MP, Dietrich J, Shattock RJ, Follmann F. Immune signature of Chlamydia vaccine CTH522/CAF(R)01 translates from mouse-to-human and induces durable protection in mice. Nat Commun. 2024 Feb 23;15(1):1665. doi: 10.1038/s41467-024-45526-2.
• Abraham S, Juel HB, Bang P, Cheeseman HM, Dohn RB, Cole T, Kristiansen MP, Korsholm KS, Lewis D, Olsen AW, McFarlane LR, Day S, Knudsen S, Moen K, Ruhwald M, Kromann I, Andersen P, Shattock RJ, Follmann F. 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. Lancet Infect Dis. 2019 Oct;19(10):1091-1100. doi: 10.1016/S1473-3099(19)30279-8. Epub 2019 Aug 12.

Drugs

Indications