A WHO International Standard for neutralising antibodies to Chikungunya virus: development and evaluation

Sally A Baylis; Constanze Yue; Marcus Panning; Marie-Christin Pauly; Lia Laura Lewis-Ximenez; Helen M Faddy; Graham Simmons; Michael Busch; Barbara S Schnierle; Hanna Roth; Kay-Martin O Hanschmann; Collaborative Study Group

doi:10.1016/j.lanmic.2026.101465

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A WHO International Standard for neutralising antibodies to Chikungunya virus: development and evaluation

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A WHO International Standard for neutralising antibodies to Chikungunya virus: development and evaluation

Sally A Baylis, Constanze Yue, Marcus Panning, Marie-Christin Pauly, Lia Laura Lewis-Ximenez, Helen M Faddy, Graham Simmons, Michael Busch, Barbara S Schnierle, Hanna Roth, …

The Lancet Microbe, Vol.Advanced Access, 101465

17-Aug-2026

DOI: https://doi.org/10.1016/j.lanmic.2026.101465

PMID: 42607694

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Abstract

Background Chikungunya fever is a mosquito-borne disease characterised by severe arthralgia and is caused by chikungunya virus (CHIKV), an alphavirus. The aim of this study was to establish a WHO International Standard for CHIKV-specific neutralising antibodies–a potential correlate of protection. Methods Two candidate International Standards (code numbers 1502/19 and 1504/19) were prepared: 1502/19 using plasma from a CHIKV-convalescent individual and 1504/19 using plasma from blood donors from a CHIKV-endemic region. Potencies of the two candidate International Standards were evaluated alongside samples from recovered individuals and donors previously infected with CHIKV, in an international study (2019–20), using a range of virus-neutralisation assays and immunoassays. Statistical analysis was used to estimate mean and relative potencies of the candidate International Standards. Participants included vaccine developers, arbovirus reference laboratories, and diagnostics manufacturers. Findings 26 laboratories from 12 countries reported detection of anti-CHIKV antibodies and associated potencies. All participants consistently detected both 1502/19 and 1504/19. Overall mean potencies were near-identical for the two candidate International Standards (1502/19, 3·44 log10 and 1504/19, 3·48 log10). Intra-assay variation was considerably lower than inter-assay variation for the candidate International Standards, which varied by more than 100-fold; this variability was seen for all other anti-CHIKV-positive samples. Assay variability was substantially reduced when antibody titres from the panel of samples were expressed relative to 1502/19 or 1504/19. An agreement was reached to establish 1502/19 as the first WHO International Standard for anti-CHIKV neutralising antibodies, with an assigned unitage of 1000 International Unitage/mL. Interpretation The use of the candidate International Standards resulted in harmonisation of anti-CHIKV neutralisation titres, allowing for better comparison of results of neutralisation assays for anti-CHIKV antibodies, either as a consequence of natural infection or produced in response to different vaccines, and will be essential in estimating antibody titres associated with protection against CHIKV.

Details

Title: A WHO International Standard for neutralising antibodies to Chikungunya virus: development and evaluation
Authors: Sally A Baylis (Corresponding Author) - Paul Ehrlich Institut
Constanze Yue - Paul Ehrlich Institut
Marcus Panning - University of Freiburg
Marie-Christin Pauly - University of Freiburg
Lia Laura Lewis-Ximenez - Fundação Oswaldo Cruz
Helen M Faddy - University of the Sunshine Coast
Graham Simmons - Vitalant Research Institute
Michael Busch - Vitalant Research Institute
Barbara S Schnierle - Paul Ehrlich Institut
Hanna Roth - Paul Ehrlich Institut
Kay-Martin O Hanschmann - Paul Ehrlich Institut
Collaborative Study Group
Publication details: The Lancet Microbe, Vol.Advanced Access, 101465
Publisher: The Lancet Publishing Group
DOI: 10.1016/j.lanmic.2026.101465
ISSN: 2666-5247
PMID: 42607694
Data Availability: All data analysed during this study are included in the published article and its supplementary files. Raw data from the participating laboratories have been blinded to maintain anonymity in accordance with the WHO Technical Report Series, number 932. Reasonable requests for access to the original blinded datasets will be considered.
Grant note: This work was funded by the German Ministry of Health (Bundesministerium für Gesundheit; grant number ZMV I1-2517 FSB 413).
Organisation Unit: School of Health - Biomedicine
Language: English
Record Identifier: 991253598702621
Output Type: Journal article

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