Innovative approach for the clinical development of a Chlamydia trachomatis vaccine through a human challenge model in women

Chlamydia trachomatis remains the most common sexually transmitted bacterial infection worldwide. Recent phase I trials of the C. trachomatis vaccine candidate CTH522 in women and men have shown that the adjuvanted and non-adjuvanted formulations are safe and elicit systemic (immunoglobulin G) and m...

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Main Author: Craig R. Cohen
Format: Article
Language:English
Published: Elsevier 2025-05-01
Series:International Journal of Infectious Diseases
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Online Access:http://www.sciencedirect.com/science/article/pii/S1201971225000840
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author Craig R. Cohen
author_facet Craig R. Cohen
author_sort Craig R. Cohen
collection DOAJ
description Chlamydia trachomatis remains the most common sexually transmitted bacterial infection worldwide. Recent phase I trials of the C. trachomatis vaccine candidate CTH522 in women and men have shown that the adjuvanted and non-adjuvanted formulations are safe and elicit systemic (immunoglobulin G) and mucosal (immunoglobulin A) antibodies, as well as vaccine-specific cell-mediated immunity. In advance of a standard phase II randomized controlled trial to determine the vaccine's efficacy, this perspective advocates for a carefully and ethically designed human challenge model as an innovative approach to assess a vaccine's ability to prevent infection and its impact on tubal immunopathogenesis in breakthrough infections. Such models could accelerate vaccine development by providing critical insights, making it essential for stakeholders to consider this approach and expedite the long-awaited chlamydia vaccine.
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spelling doaj-art-3a55fc067b6547d0b9c24a32215caa532025-08-20T03:06:30ZengElsevierInternational Journal of Infectious Diseases1201-97122025-05-0115410786110.1016/j.ijid.2025.107861Innovative approach for the clinical development of a Chlamydia trachomatis vaccine through a human challenge model in womenCraig R. Cohen0Corresponding author. Tel.: +1 415 290 7085.; Department of Obstetrics, Gynecology & Reproductive Sciences, University of California San Francisco, San Francisco, CA, USAChlamydia trachomatis remains the most common sexually transmitted bacterial infection worldwide. Recent phase I trials of the C. trachomatis vaccine candidate CTH522 in women and men have shown that the adjuvanted and non-adjuvanted formulations are safe and elicit systemic (immunoglobulin G) and mucosal (immunoglobulin A) antibodies, as well as vaccine-specific cell-mediated immunity. In advance of a standard phase II randomized controlled trial to determine the vaccine's efficacy, this perspective advocates for a carefully and ethically designed human challenge model as an innovative approach to assess a vaccine's ability to prevent infection and its impact on tubal immunopathogenesis in breakthrough infections. Such models could accelerate vaccine development by providing critical insights, making it essential for stakeholders to consider this approach and expedite the long-awaited chlamydia vaccine.http://www.sciencedirect.com/science/article/pii/S1201971225000840Chlamydia trachomatisVaccineClinical trialHuman challenge model
spellingShingle Craig R. Cohen
Innovative approach for the clinical development of a Chlamydia trachomatis vaccine through a human challenge model in women
International Journal of Infectious Diseases
Chlamydia trachomatis
Vaccine
Clinical trial
Human challenge model
title Innovative approach for the clinical development of a Chlamydia trachomatis vaccine through a human challenge model in women
title_full Innovative approach for the clinical development of a Chlamydia trachomatis vaccine through a human challenge model in women
title_fullStr Innovative approach for the clinical development of a Chlamydia trachomatis vaccine through a human challenge model in women
title_full_unstemmed Innovative approach for the clinical development of a Chlamydia trachomatis vaccine through a human challenge model in women
title_short Innovative approach for the clinical development of a Chlamydia trachomatis vaccine through a human challenge model in women
title_sort innovative approach for the clinical development of a chlamydia trachomatis vaccine through a human challenge model in women
topic Chlamydia trachomatis
Vaccine
Clinical trial
Human challenge model
url http://www.sciencedirect.com/science/article/pii/S1201971225000840
work_keys_str_mv AT craigrcohen innovativeapproachfortheclinicaldevelopmentofachlamydiatrachomatisvaccinethroughahumanchallengemodelinwomen