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Controlled Human Hookworm Infection: Accelerating Human Hookworm Vaccine Development
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DOI：10.1093/ofid/ofy083.png)
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Background. Controlled human hookworm infection (CHHI) is a central component of a proposed hookworm vaccination-challenge model (HVCM) to test the efficacy of candidate vaccines. Critical to CH H I is the manufacture of Necator americanus infective larvae (NaL3) according to current Good Manufacturing Practice (cGMP) and the determination of an inoculum of NaL3 that is safe and reliably induces patent infection. Methods. cGMP-grade NaI,3 were produced for a phase 1 trial in 20 healthy, hookworm-naive adults in the United States, who received either 25 or 50 NaL3. Participants were monitored for 12-18 weeks postinfection for safety, tolerability, and patency of N. americanus infection. Results. Both NaL3 doses were well tolerated. Early manifestations of infection included pruritus, pain, and papulovesicular rash at the application site. Gastrointestinal symptoms and eosinophilia appeared after week 4 postinfection. The 50 NaL3 inoculum induced patent N. americanus infection in 90% of this dose group. Conclusions. The inoculum of 50 NaL3 was well tolerated and consistently induced patent N. americanus infection suitable for future HVCM trials.
Keyword:
challenge model
controlled human hookworm infection
current good manufacturing practice
hookworm vaccine
Necator americanus
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分享收藏Characterising the Mucosal and Systemic Immune Responses to Experimental Human Hookworm Infection.png)
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