Imperial College London
Alternate

Dr Lionel Tan

Faculty of Medicine, Department of Infectious Disease

Honorary Clinical Senior Lecturer
 
 
 
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Contact

 

+44 (0)20 3313 2065lionel.tan

 
 
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Location

 

Commonwealth BuildingHammersmith Campus

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Summary

 

Publications

Citation

BibTex format

@article{Skoura:2020:10.1016/S1473-3099(20)30069-4,
author = {Skoura, N and Wang-Jairaj, J and Della, Pasqua O and Chandrasekaran, V and Billiard, J and Yeakey, A and Smith, W and Steel, H and Tan, LK},
doi = {10.1016/S1473-3099(20)30069-4},
journal = {Lancet Infect Dis},
pages = {983--991},
title = {Effect of raxibacumab on immunogenicity of Anthrax Vaccine Adsorbed: a phase 4, open-label, parallel-group, randomised non-inferiority study.},
url = {http://dx.doi.org/10.1016/S1473-3099(20)30069-4},
volume = {20},
year = {2020}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - BACKGROUND: Raxibacumab is a monoclonal antibody against protective antigen, which is the cell-binding part of Bacillus anthracis toxin, and is approved for treatment and postexposure prophylaxis of inhalational anthrax. Anthrax Vaccine Adsorbed (AVA), for anthrax prophylaxis, consists primarily of adsorbed protective antigen. We did a postapproval study to assess the effect of raxibacumab on immunogenicity of AVA. METHODS: We did an open-label, parallel-group, randomised non-inferiority study at three centres in the USA. We enrolled healthy volunteers (aged 18-65 years) with no evidence of exposure to protective antigen. Participants were randomly allocated (1:1) according to a pregenerated balanced independent randomisation schedule to either subcutaneous 0·5 mL AVA on days 1, 15, and 29 or raxibacumab intravenous infusion (40 mg/kg) immediately before AVA on day 1, followed by AVA only on days 15 and 29. It was an open-label study to investigators and participants; however, the sponsor remained blinded during the study. The primary outcome was the ratio of geometric mean concentrations (GMCs) of anti-protective antigen antibodies (attributable to the immune response to AVA) between AVA and AVA plus raxibacumab 4 weeks after the first AVA dose in the per-protocol population. The per-protocol population comprised all individuals who received the allocated treatment within the protocol-specified visit window and completed the primary study outcome assessment, without a protocol deviation requiring exclusion. The non-inferiority margin for the ratio of GMCs was predefined (upper limit of 90% CI <1·5). This trial is registered with ClinicalTrials.gov, NCT02339155. FINDINGS: Between Feb 24, 2015, and June 6, 2017, 873 participants were screened for eligibility, of whom 300 were excluded. 573 were randomly allocated either AVA (n=287) or AVA plus raxibacumab (n=286). The per-protocol population comprised 276 individuals assigned AVA and 269 allocated AV
AU  - Skoura,N
AU  - Wang-Jairaj,J
AU  - Della,Pasqua O
AU  - Chandrasekaran,V
AU  - Billiard,J
AU  - Yeakey,A
AU  - Smith,W
AU  - Steel,H
AU  - Tan,LK
DO  - 10.1016/S1473-3099(20)30069-4
EP  - 991
PY  - 2020///
SP  - 983
TI  - Effect of raxibacumab on immunogenicity of Anthrax Vaccine Adsorbed: a phase 4, open-label, parallel-group, randomised non-inferiority study.
T2  - Lancet Infect Dis
UR  - http://dx.doi.org/10.1016/S1473-3099(20)30069-4
UR  - https://www.ncbi.nlm.nih.gov/pubmed/32333847
VL  - 20
ER  -
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