Paxvax´s cholera vaccine meets its primary outcome in a PIII trial designed to evaluate the safety and ability to induce an immune response of three consecutive lots of the vaccine candidate. In 3,000 subjects in the Australia and the U.S., each of the three lots met a pre-set immunological endpoint for consistency of manufacture .
Interim data from a PIII cholera challenge study reported. In participants challenged at 10 days post vaccination with wild type, fully pathogenic cholera bacteria the rate of diarrhoea was reduced in the vaccine group: 20/33 participants who received placebo experienced moderate-to-severe diarrhoea vs 2/35 of 35 who received PXVX0200. A second, separate group of volunteers will be challenged at 90 days post vaccination to further evaluate duration of vaccine protection. The co-primary endpoint will combine both challenge time points .
PaxVax has raised $22m which will be used to continue to fund the recently initiated PIII clinical trial program for PXVX0200 as a traveler´s vaccine. Approximately 3,000 participants will be enrolled in this pivotal international programme, which comprises cholera challenge, safety, and immunogenicity studies. Studies are being conducted in the US, Australia, and Canada .
NCT01895855 is a PIII randomized, double-blind, placebo-controlled, trial of a single dose of PXVX0200 in preventing cholera following challenge with vibrio cholera O1 El Tor Inaba. The co-primary outcomes are protection afforded at 10 and at 90 days post-vaccination. The study plans to enrol 210 healthy volunteers aged 18-45 from Sep 13. Estimated date of study completion is Jul 14 .