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First chlamydia vaccine trial in humans

Nature Reviews Urology volume 16, page 566 (2019)Cite this article

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Results of the first-in-human trial of a vaccine against Chlamydia trachomatis infections indicate that the use of the antigen CTH522 with either CAF01 liposomes or aluminium hydroxide (AH) as adjuvant is safe and well tolerated. Both vaccine formulations induced anti-CTH522 IgG seroconversion, but the formulation containing the liposomal adjuvant had an overall better immunogenicity profile than the one containing AH.

Chlamydia is the most common sexually transmitted bacterial disease, but an effective preventive medication is currently lacking. The recombinant antigen CTH522 is a version of the major outer membrane protein of C. trachomatis, which has shown promising results in animal vaccination studies. In this phase I, randomized, parallel, double-blind, placebo-controlled trial, women were randomly assigned to receive CTH522 (with either adjuvant CAF01 (CTH522:CAF01) or AH (CTH522:AH); n = 15, respectively) or saline (n = 5). Intramuscular injections were given at 0, 1 and 4 months, followed by intranasal administrations of CTH22 without adjuvant or placebo at 4.5 and 5 months. Previous studies with CAF01 showed that systemic administration followed by mucosal boosting is highly effective in inducing mucosal immunity and IgA and, although genital mucosa does not have immune inductive sites, intranasal immunization induced mucosal immunity also in the genital tract. The trial primary outcome was safety and the secondary outcome was humoral immunogenicity.

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  1. Nature Reviews Urology http://www.nature.com/nrurol/

    Clemens Thoma

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  1. Clemens Thoma
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Correspondence to Clemens Thoma.

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Thoma, C. First chlamydia vaccine trial in humans. Nat Rev Urol 16, 566 (2019). https://doi.org/10.1038/s41585-019-0232-0

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