ANZCTR search results

This is a stage 1b placebo controlled clinical trial investigating the safety and tolerability of an attenuated live hookworm vaccine. The study will be performed in two parts. Stage 1. The degree to which attenuation will impede the larvae’s ability to penetrate the skin in vivo is unknown. This is a dose escalation stage performed to de ne the optimal dose to be used in stage 2. The dose in cohort 1 will be 50 attenuated larvae dermaly applied to the volar aspect of the forearm, approximately 4 inches proximal to the thumb. Dose escalation will occur after safety review following completion of cohort 1. Cohort 2 will consist of 100 attenuated hookworm larvae applied in the same way. The optimal dose is defined as the number of larvae required to produce a grade 2 -3 dermal reaction. Cohorts of two participants will be enrolled and inoculated sequentially with attenuated hookworm. Safety and tolerability data will be collected and used to guide the escalation of dose for use in the next cohort. STAGE 2 Pilot randomised control trial 15 participants will be randomly assigned 1:2 to receive either 2 doses of placebo or attenuated larvae via dermal application 6 weeks apart. Albendazole will be administered 4 weeks following each inoculation. 6 weeks following the second dose all participants will receive a challenge dose of 30 normal hookworm larvae (15 larvae dermaly applied to each forearm). Albendazole 400mg (200mg tablets, Zentel – Glaxo-Smith-Kline) will be administered at the termination of the studyat week 11. Outcomes measured will include adverse events, faecal hookworm egg content and immune response