First-in-human, Phase I clinical trial holds great promise for the development of an effective vaccine against genital chlamydia

Recently, a first-in-human, Phase I clinical trial was successfully completed for a novel chlamydia vaccine. The trial results hold great promise for the development of an effective vaccine against genital chlamydia, says GlobalData, a leading data and analytics company.

The trial aimed to evaluate both the safety and efficiency of the vaccine, with the latter being measured via anti-CTH522 immunoglobulin G (IgG) seroconversion. There were no serious adverse reactions reported, leading the trial authors to conclude that the vaccine was both safe and well-tolerated. Two possible vaccine options were tested; both proved to be effective, with seroconversion reported in 100% of women treated. The trial authors indicated that a Phase II dose optimization study will begin later in 2019.

Alison Casey, PhD, Medical Devices Analyst at GlobalData, comments: “The in vitro diagnostics (IVD) testing market for chlamydia tests is dominated by dual Chlamydia trachomatis (CT)/Neisseria gonorrhoeae (NG) nucleic acid amplification tests (NAATs), which simultaneously screen for both CT and NG. In the vast majority of countries, these dual CT/NG NAATs are used to screen both suspected chlamydia cases and suspected gonorrhea cases.

“In some key markets, pregnant women are also screened for these two diseases. Specifically, universal screening of pregnant women for CT and NG infections is currently standard of care in Canada, Germany, and Japan. In the US, Australia, Norway, and New Zealand, CT and/or NG screening is recommended for pregnant women ages 25 years and under, with some US states performing routine screening of all pregnant women during their first prenatal visit.”

“Long-term development of an effective chlamydia vaccine may negatively impact the IVD market for chlamydia tests. However, these negative repercussions are unlikely to impact sales within the next decade and will be mitigated by the fact that current IVD devices also screen for additional diseases that will not be prevented by the vaccine.”

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