Comparison of a Novel Human Rabies Monoclonal Antibody to Human Rabies Immunoglobulin for Postexposure Prophylaxis: A Phase 2/3, Randomized, Single-Blind, Noninferiority, Controlled Study

Gogtay, Nithya J; Munshi, Renuka; Narayana, Doddabele Hanumanthaiah Ashwath; Mahendra, B J; Kshirsagar, Vikas D; Gunale, Bhagwat; Moore, Susan M.; Cheslock, Peter S.; Thaker, Saket; Deshpande, Siddharth; Karande, Sunil; Kumbhar, Dipti; Ravish, H; Harish, B R; Pisal, Sambhaji S.; Dhere, Rajeev; Parulekar, Varsha; Blackwelder, William C.; Molrine, Deborah C.; Kulkarni, Prasad S.

doi:10.1093/cid/cix791

Cited by 68 publications

(42 citation statements)

References 20 publications

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“…patients infected with the Ebola virus highlight the superiority of mAb treatment over convalescent plasma treatment (7,8). Moreover, mAb therapy has been proven safe and effective against influenza virus, rabies virus, and respiratory syncytial virus (RSV) (9)(10)(11).…”

mentioning

confidence: 99%

Potent neutralizing antibodies from COVID-19 patients define multiple targets of vulnerability

Brouwer

Caniels

Straten

et al. 2020

Preprint

350

563

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The rapid spread of SARS-CoV-2 has a significant impact on global health, travel and economy. Therefore, preventative and therapeutic measures are urgently needed. Here, we isolated neutralizing antibodies from convalescent COVID-19 patients using a SARS-CoV-2 stabilized prefusion spike protein. Several of these antibodies were able to potently inhibit live SARS-CoV-2 infection at concentrations as low as 0.007 µg/mL, making them the most potent human SARS-CoV-2 antibodies described to date. Mapping studies revealed that the SARS-CoV-2 spike protein contained multiple distinct antigenic sites, including several receptorbinding domain (RBD) epitopes as well as previously undefined non-RBD epitopes. In addition to providing guidance for vaccine design, these mAbs are promising candidates for treatment and prevention of COVID-19.

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mentioning

confidence: 99%

Potent neutralizing antibodies from COVID-19 patients define multiple targets of vulnerability

Brouwer

Caniels

Straten

et al. 2020

Preprint

350

563

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“…Este tem a capacidade de se ligar a um epítopo da glicoproteína rábica. 41 Este estudo demonstrou que uma dose de 10 UI/kg de Rabishield TM produz imunidade equiparável a 20 UI/kg de IGR. 42 Sendo este o único anticorpo monoclonal licenciado e dadas as limitações de acesso à IGR, o seu uso está autorizado em zonas geográficas seleccionadas.…”

Section: Perspectivas Futuras A) Prevençãounclassified

Raiva Humana: Optimização da Prevenção e Caminhos Para a Cura

Conceição¹,

Abreu

2021

Acta Med Port

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Introduction: Rabies is one of the oldest and deadliest infectious diseases known by human beings and is commonly transmitted by animal bites. Dogs have a major role in the transmission of the virus. Rabies has no approved curative therapy, and its prevention, even though it is highly effective, it is complex, expensive and challenging in terms of accessibility, particularly regarding immunoglobulin. This review aims to provide a practical approach to cost-effective prevention as well as the future perspectives regarding the development of an effective and secure cure.Material and Methods: This review article was based on a search in PubMed using the following MeSH terms: rabies, preexposure and postexposure prophylaxis, rabies immune globulin, treatment, Milwaukee Protocol.Results: Concerning rabies infection, it’s important to apply the prevention protocols effectively as early as possible due the unpredictable time window between infection and the appearance of symptoms. The literature shows that is possible to reduce the vaccination dosage and maintain the efficiency of the immunization, and booster vaccination is only required in specific risk groups/populations.Discussion: The current philosophy of cost-effective prevention which consists of canine vaccination, restriction of vaccine overdosage used in humans and the appropriate use of rabies immunoglobulin – could make the prevention of the disease accessible for those countries that need it the most. There are several therapies in development but they’re all in early stages of development.Conclusion: The development of new and more effective therapeutic and prophylactic approaches is a goal not yet achieved and relies on a better understanding of the disease pathophysiology.

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“…So far, though, activities have been most advanced in respect to rabies, for which at least two different products are considered [19]. For one of these, a single human monoclonal antibody (SII-RMAb), a recently completed noninferiority controlled trial concluded it as a potential safe and potent alternative to human rabies immunoglobulin-containing postexposure prophylaxis regimen [57].…”

Section: Replacement Of Polyclonal Antibodiesmentioning

confidence: 99%

Monoclonal antibodies as anti-infective products: a promising future?

Pelfrene¹,

Mura²,

Sanches³

et al. 2019

Clinical Microbiology and Infection

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mAbs may represent important tools in treating or preventing infections occurring with reasonably sufficient prevalence to justify demand and for which existing alternatives are not deemed fully adequate. Future initiatives need to address the prohibitive costs encountered in the development process. The feasibility of more large-scale administration of alternative modalities merits further exploration. In order to ensure optimal prospect of regulatory success, an early dialogue with competent authorities is encouraged.

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Comparison of a Novel Human Rabies Monoclonal Antibody to Human Rabies Immunoglobulin for Postexposure Prophylaxis: A Phase 2/3, Randomized, Single-Blind, Noninferiority, Controlled Study

Abstract: CTRI/2012/05/002709.

Cited by 68 publications

References 20 publications

Potent neutralizing antibodies from COVID-19 patients define multiple targets of vulnerability

Potent neutralizing antibodies from COVID-19 patients define multiple targets of vulnerability

Raiva Humana: Optimização da Prevenção e Caminhos Para a Cura

Monoclonal antibodies as anti-infective products: a promising future?

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