Observational studyPLoS neglected tropical diseases2026
Safety and operational feasibility of single versus cocktail rabies monoclonal antibodies for post-exposure prophylaxis in a resource-limited setting.
Observational study in PLoS neglected tropical diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundRabies is almost universally fatal once symptoms develop but is preventable through timely post-exposure prophylaxis (PEP). Global shortages of human and equine rabies immunoglobulin (RIG) have led the World Health Organization to recommend human monoclonal antibodies (mAbs) as acceptable alternatives. Comparative real-world data on single-antibody versus two-antibody cocktail mAbs are limited, particularly from endemic, resource-limited settings.
methodsA comparative observational study was conducted in a high-volume rabies PEP clinic in India between October 2021 and December 2022. Consecutive patients with category III animal exposures received either a single human anti-rabies mAb (Rabishield; n = 159) or a two-mAb cocktail (Twinrab; n = 159) in combination with WHO-recommended vaccine. Primary outcomes included safety, ease of administration, and operational feasibility. Data were analysed using independent t-tests and chi-square or Fisher's exact tests, with p < 0.05 considered significant.
resultsMean age was 29.7 ± 19.4 years in the Rabishield group and 32.8 ± 20.4 years in the Twinrab group. Ease of infiltration was rated "easy" in 66.7% versus 62.9% of patients (p = 0.63). Local adverse events were uncommon, with pain reported in 2.5% versus 7.5% (p = 0.07) and erythema in ≤ 1.3% of participants. No serious systemic adverse events occurred. Rabishield required more vials per patient (2.28 ± 0.84 vs 2.00 ± 0.69; p = 0.001) and had a higher mean infiltration volume (4.7 ± 1.9 mL vs 4.0 ± 1.6 mL; p < 0.001), while wastage was similar between groups (1.03 ± 0.72 mL vs 1.03 ± 0.69 mL; p = 0.95).
conclusionsBoth single and cocktail human anti-rabies mAbs were safe, well tolerated, and operationally feasible in a programmatic setting. The slightly higher volume and vial requirement for Rabishield may have cost and logistics implications. These findings support broader mAb adoption to address RIG shortages in rabies-endemic, resource-limited settings.
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