A Phase 3, Randomized, Open-label, Noninferiority Trial Evaluating Anti-Rabies Monoclonal Antibody Cocktail (TwinrabTM) Against Human Rabies Immunoglobulin (HRIG)
| Autor: | Deven Parmar, Sanjeev Kumar Mendiratta, RajendraKumar Verma, Anurag Parihar, Abhishek Gupta, Renuka Munshi, HiraLal Bhalla, Jatin Patel, Ruchir Shah, Prakash Kurmi, Dinesh C. Agarwal, Nitin Sharma, Shuchi Joshi, Shrikant Sharma, Swapnil Bhoge, Avinash Gawande, Pankaj Kalita, Gaurav Chhaya, Kevinkumar Kansagra, Harish Bekkalele, Harilal Patel |
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| Rok vydání: | 2020 |
| Předmět: |
Microbiology (medical)
medicine.medical_specialty Rabies medicine.medical_treatment Population Antibodies Viral medicine.disease_cause Internal medicine Clinical endpoint Animals Humans Medicine Post-exposure prophylaxis education Adverse effect education.field_of_study business.industry Rabies virus Antibodies Monoclonal medicine.disease Antibodies Neutralizing Clinical trial Regimen Infectious Diseases Rabies Vaccines Post-Exposure Prophylaxis business |
| Zdroj: | Clinical Infectious Diseases. 73:e2722-e2728 |
| ISSN: | 1537-6591 1058-4838 |
| DOI: | 10.1093/cid/ciaa779 |
| Popis: | BackgroundLimited supply, cost and potential for severe adverse effects observed with the blood derived rabies immunoglobulin products has led to search for alternative therapies. This issue has been addressed by developing an anti-rabies monoclonal antibody cocktail.MethodsThis is a phase 3, randomized, open-label, noninferiority trial conducted in patients with World Health Organization (WHO) category III exposure with suspected rabid animal. Eligible patients were assigned to either the test arm, TwinrabTM (docaravimab and miromavimab) or the reference arm, human rabies immunoglobulin (HRIG; Imogam® Rabies-HT), in a ratio of 1:1. The primary endpoint was the comparison of responder rates between the 2 arms assessed as percentage of those with rabies virus neutralizing antibodies titers ≥0.5 IU/mL on day 14.ResultsA total of 308 patients were equally randomized into the 2 arms. In the per-protocol (PP) population, there were 90.21% responders in the TwinrabTM arm and 94.37% in the HRIG arm. The geometric mean of rapid fluorescent foci inhibition test titers in the PP on day 14 were 4.38 and 4.85 IU/mL, for the TwinrabTM and HRIG arms, respectively. There were no deaths or serious adverse events reported.ConclusionsThis study confirmed that TwinrabTM is noninferior to HRIG in terms of providing an unbroken window of protection up to day 84. This trial in healthy adults with WHO category III exposure from suspected rabid animal also establishes the safety of TwinrabTM in patients with 1 WHO approved vaccine regimen (Essen).Clinical Trials RegistrationCTRI/2017/07/009038. |
| Databáze: | OpenAIRE |
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