Genotypic infection endpoint analysis to understand efficacy and escape potential of the malaria monoclonal antibody CIS43LS

In 330 Malian adults in a phase 2 trial, CIS43LS reduced molecular force of infection by 86.5% (95% CI 80.1–90.8) at 40 mg/kg and 70.7% (61.0–78.0) at 10 mg/kg over six months.

• Why it matters: Time-to-first infection can bias efficacy estimates by censoring participants after their first infection and shrinking the risk set, leaving infection risk after initial infection unmeasured.
• What they did: The study genotyped all Plasmodium falciparum infections detected during full follow-up in the CIS43LS phase 2 trial, estimating molFOI per participant and expressing efficacy as EffmolFOI versus placebo.
• The result: Genotypic endpoints produced similar efficacy to time-to-first analyses but were more precise by trial-month and by enrollment infection-status stratification, and genotyping found no evidence of escape-polymorphisms in the CIS43LS epitope.

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