Safety Evaluation of the Novel Cocktail of Monoclonal Antibodies for Postexposure Prophylaxis in Category III Animal Exposures
Introduction: Rabies monoclonal antibody (mAb) is a life-saving immune-biological for postexposure prophylaxis (PEP) in all Category III animal exposures. A novel cocktail of mAbs derived using recombinant DNA technology is presently available for usage. The WHO recommends monitoring the clinical us...
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2024-12-01
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| Series: | Journal of Global Infectious Diseases |
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| Online Access: | https://journals.lww.com/10.4103/jgid.jgid_71_24 |
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| author | Ravish Haradanahalli Shankaraiah N. R. Ramesh Masthi M. K. Poornima Vinitha Kiruffi S. Sowmyashree Trayambak Dutta Manish Mahajan Samir Desai |
| author_facet | Ravish Haradanahalli Shankaraiah N. R. Ramesh Masthi M. K. Poornima Vinitha Kiruffi S. Sowmyashree Trayambak Dutta Manish Mahajan Samir Desai |
| author_sort | Ravish Haradanahalli Shankaraiah |
| collection | DOAJ |
| description | Introduction:
Rabies monoclonal antibody (mAb) is a life-saving immune-biological for postexposure prophylaxis (PEP) in all Category III animal exposures. A novel cocktail of mAbs derived using recombinant DNA technology is presently available for usage. The WHO recommends monitoring the clinical use and outcomes of mAb products.
Methods:
An open-label, postmarketing study was conducted at the anti-rabies clinic in the southern part of India. PEP was provided to all the study participants per the national guidelines. All the subjects were assessed for any adverse events (AEs) following PEP up to 35 days; if any, were treated free of cost at the study center.
Results:
The present study included 309 subjects across all age groups, 59.2% were adults, 33.3% of children, and 7.5% elderly. Majority of the patients were exposed to dogs (89.6%) and most of them had lacerations (86.3%) in different parts of their body. A total of 19 (6.2%) AEs were reported. All the AEs were local reactions, namely pain (2.6%), erythema (1.4%), tenderness (1%), induration (0.6%), and swelling (0.6%). All reported AEs were mild (Grade 1 severity) and resolved completely with symptomatic treatment.
Conclusion:
The novel cocktail of mAbs was safe for PEP in Category III animal exposures across all the age groups and supports its continued and improved usage for Universal Health Coverage to prevent rabies. |
| format | Article |
| id | doaj-art-c9e3d1e6f01647b1a002a6a0e0d82b02 |
| institution | Kabale University |
| issn | 0974-777X 0974-8245 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Journal of Global Infectious Diseases |
| spelling | doaj-art-c9e3d1e6f01647b1a002a6a0e0d82b022025-01-07T07:10:17ZengWolters Kluwer Medknow PublicationsJournal of Global Infectious Diseases0974-777X0974-82452024-12-0116414014410.4103/jgid.jgid_71_24Safety Evaluation of the Novel Cocktail of Monoclonal Antibodies for Postexposure Prophylaxis in Category III Animal ExposuresRavish Haradanahalli ShankaraiahN. R. Ramesh MasthiM. K. PoornimaVinitha KiruffiS. SowmyashreeTrayambak DuttaManish MahajanSamir DesaiIntroduction: Rabies monoclonal antibody (mAb) is a life-saving immune-biological for postexposure prophylaxis (PEP) in all Category III animal exposures. A novel cocktail of mAbs derived using recombinant DNA technology is presently available for usage. The WHO recommends monitoring the clinical use and outcomes of mAb products. Methods: An open-label, postmarketing study was conducted at the anti-rabies clinic in the southern part of India. PEP was provided to all the study participants per the national guidelines. All the subjects were assessed for any adverse events (AEs) following PEP up to 35 days; if any, were treated free of cost at the study center. Results: The present study included 309 subjects across all age groups, 59.2% were adults, 33.3% of children, and 7.5% elderly. Majority of the patients were exposed to dogs (89.6%) and most of them had lacerations (86.3%) in different parts of their body. A total of 19 (6.2%) AEs were reported. All the AEs were local reactions, namely pain (2.6%), erythema (1.4%), tenderness (1%), induration (0.6%), and swelling (0.6%). All reported AEs were mild (Grade 1 severity) and resolved completely with symptomatic treatment. Conclusion: The novel cocktail of mAbs was safe for PEP in Category III animal exposures across all the age groups and supports its continued and improved usage for Universal Health Coverage to prevent rabies.https://journals.lww.com/10.4103/jgid.jgid_71_24adverse eventspostexposure prophylaxisrabiessafety assessmenttwinrab™ |
| spellingShingle | Ravish Haradanahalli Shankaraiah N. R. Ramesh Masthi M. K. Poornima Vinitha Kiruffi S. Sowmyashree Trayambak Dutta Manish Mahajan Samir Desai Safety Evaluation of the Novel Cocktail of Monoclonal Antibodies for Postexposure Prophylaxis in Category III Animal Exposures Journal of Global Infectious Diseases adverse events postexposure prophylaxis rabies safety assessment twinrab™ |
| title | Safety Evaluation of the Novel Cocktail of Monoclonal Antibodies for Postexposure Prophylaxis in Category III Animal Exposures |
| title_full | Safety Evaluation of the Novel Cocktail of Monoclonal Antibodies for Postexposure Prophylaxis in Category III Animal Exposures |
| title_fullStr | Safety Evaluation of the Novel Cocktail of Monoclonal Antibodies for Postexposure Prophylaxis in Category III Animal Exposures |
| title_full_unstemmed | Safety Evaluation of the Novel Cocktail of Monoclonal Antibodies for Postexposure Prophylaxis in Category III Animal Exposures |
| title_short | Safety Evaluation of the Novel Cocktail of Monoclonal Antibodies for Postexposure Prophylaxis in Category III Animal Exposures |
| title_sort | safety evaluation of the novel cocktail of monoclonal antibodies for postexposure prophylaxis in category iii animal exposures |
| topic | adverse events postexposure prophylaxis rabies safety assessment twinrab™ |
| url | https://journals.lww.com/10.4103/jgid.jgid_71_24 |
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