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dc.contributor.authorGogtay, Nithya J.
dc.contributor.authorCheslock, Peter
dc.contributor.authorMolrine, Deborah C.
dc.contributor.authorKulkarni, Prasad S.
dc.date2022-08-11T08:10:13.000
dc.date.accessioned2022-08-23T16:59:34Z
dc.date.available2022-08-23T16:59:34Z
dc.date.issued2017-09-15
dc.date.submitted2017-11-27
dc.identifier.citationClin Infect Dis. 2017 Sep 15. doi: 10.1093/cid/cix791. <a href="https://doi.org/10.1093/cid/cix791">Link to article on publisher's site</a>
dc.identifier.issn1058-4838 (Linking)
dc.identifier.doi10.1093/cid/cix791
dc.identifier.pmid29020321
dc.identifier.urihttp://hdl.handle.net/20.500.14038/43617
dc.description<p>Full list of authors omitted for brevity. For full list see article.</p>
dc.description.abstractBackground: Lack of access to rabies immunoglobulin (RIG) contributes to the high rabies mortality. A recombinant human monoclonal antibody (SII RMAb) was tested in a post-exposure prophylaxis (PEP) regimen in comparison to a human RIG (HRIG)-containing PEP regimen. Methods: This was a Phase 2/3 randomized, single blind, non-inferiority study conducted in 200 participants with WHO category III suspected rabies exposures. On Day 0, participants received either SII RMAb or HRIG (1:1 ratio) into wounds and if required, intramuscularly (IM) along with five doses of rabies vaccine IM on Days 0, 3, 7, 14 and 28. The primary endpoint was the ratio of Day 14 geometric mean concentration (GMC) of RVNA activity as measured by RFFIT for SII RMAb recipients relative to HRIG recipients. Results: 199 participants received SII RMAb (101) or HRIG (98) and at least one dose of vaccine. The Day 14 GMC ratio of SII RMAb group to HRIG group was 4.23 (96.9018% CI 2.59 - 6.94) with the GMC for SII RMAb recipients of 24.90 IU/mL (95% CI 18.94 - 32.74) and 5.88 IU/mL (95% CI 4.11 - 8.41) for HRIG recipients. Majority of local injection site and systemic adverse reactions reported from bothgroups were mild to moderate in severity. Conclusions: A PEP regimen containing SII RMAb was safe and demonstrated non-inferiority to HRIG PEP in RVNA production. The novel monoclonal potentially offers a safe and potent alternative for the passive component of PEP and could significantly improve the management of bites from suspected rabid animals. Trial registration number: CTRI/2012/05/002709.
dc.language.isoen_US
dc.relation<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=29020321&dopt=Abstract">Link to Article in PubMed</a>
dc.relation.urlhttps://doi.org/10.1093/cid/cix791
dc.subjectmonoclonal antibody
dc.subjectpost-exposure prophylaxis
dc.subjectrabies
dc.subjectrabies immunoglobulin
dc.subjectImmunoprophylaxis and Therapy
dc.subjectInfectious Disease
dc.subjectPublic Health
dc.subjectVirus Diseases
dc.titleComparison of a novel human rabies monoclonal antibody to human rabies immunoglobulin for post-exposure prophylaxis: A phase 2/3 randomized, single blind, non-inferiority, controlled study
dc.typeArticle
dc.source.journaltitleClinical infectious diseases : an official publication of the Infectious Diseases Society of America
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/peds_pp/189
dc.identifier.contextkey11154106
html.description.abstract<p>Background: Lack of access to rabies immunoglobulin (RIG) contributes to the high rabies mortality. A recombinant human monoclonal antibody (SII RMAb) was tested in a post-exposure prophylaxis (PEP) regimen in comparison to a human RIG (HRIG)-containing PEP regimen.</p> <p>Methods: This was a Phase 2/3 randomized, single blind, non-inferiority study conducted in 200 participants with WHO category III suspected rabies exposures. On Day 0, participants received either SII RMAb or HRIG (1:1 ratio) into wounds and if required, intramuscularly (IM) along with five doses of rabies vaccine IM on Days 0, 3, 7, 14 and 28. The primary endpoint was the ratio of Day 14 geometric mean concentration (GMC) of RVNA activity as measured by RFFIT for SII RMAb recipients relative to HRIG recipients.</p> <p>Results: 199 participants received SII RMAb (101) or HRIG (98) and at least one dose of vaccine. The Day 14 GMC ratio of SII RMAb group to HRIG group was 4.23 (96.9018% CI 2.59 - 6.94) with the GMC for SII RMAb recipients of 24.90 IU/mL (95% CI 18.94 - 32.74) and 5.88 IU/mL (95% CI 4.11 - 8.41) for HRIG recipients. Majority of local injection site and systemic adverse reactions reported from bothgroups were mild to moderate in severity.</p> <p>Conclusions: A PEP regimen containing SII RMAb was safe and demonstrated non-inferiority to HRIG PEP in RVNA production. The novel monoclonal potentially offers a safe and potent alternative for the passive component of PEP and could significantly improve the management of bites from suspected rabid animals. Trial registration number: CTRI/2012/05/002709.</p>
dc.identifier.submissionpathpeds_pp/189
dc.contributor.departmentDepartment of Pediatrics, Division of Immunology and Infectious Disease
dc.contributor.departmentMassBiologics


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