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Methods We designed, expressed, and produced under GMP a trimeric gp140 from a clade C isolate, 96ZM651.8. A phase 1 trial to establish safety and immunogenicity was conducted. 100 μg of ZM96gp140 was mixed with 3 ml of a 0.92% Carbopol® 974P NF polymer gel and delivered intravaginally 9 times during a single menstrual cycle, with a 2:1 randomisation of active to placebo. We measured vaginal, cervical, and systemic IgG and IgA responses and systemic IFN-gamma ELISpot responses, as well as safety parameters, with a three month follow up design.

P14-06. Phase 1 safety and immunogenicity randomised controlled trial of a vaginal gp140 vaccine