Safety and tolerability of a novel, polyclonal human anti-MERS coronavirus antibody produced from transchromosomic cattle: a phase 1 randomised, double-blind, single-dose-escalation study

Beigel, John H.; Voell, Jocelyn; Kumar, Parag; Raviprakash, Kanakatte; Wu, Hua; Jiao, Jin; Sullivan, Eddie; Luke, Thomas; Davey, Richard T.

doi:10.1016/s1473-3099(18)30002-1

Cited by 108 publications

(101 citation statements)

References 13 publications

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“…The trial was registered with ClinicalTrials.gov, number NCT02788188. SAB-301 was well tolerated and the most reported adverse events were headache, elevated creatinine kinase, and albuminuria [68].…”

Section: Human Studiesmentioning

confidence: 97%

See 1 more Smart Citation

A Systematic Review of therapeutic agents for the treatment of the Middle East Respiratory Syndrome Coronavirus (MERS-CoV)

Momattin

Al-Ali

Al‐Tawfiq

2019

Travel Medicine and Infectious Disease

114

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Direct. Based on the inclusions and exclusions criteria, 30 articles were included in the final review and comprised: 22 in vitro studies, 8 studies utilizing animal models, 13 studies in humans, and one study included both in vitro and animal model. There are a few promising therapeutic agents on the horizon. The combination of lopinavir/ritonavir and interferon-beta-1b showed excellent results in common marmosets and currently is in a randomized control trial. Ribavirin and interferon were the most widely used combination and experience comes from a number of observational studies. Although, the data are heterogenous, this combination might be of potential benefit and deserve further investigation. There were no randomized clinical trials to recommend specific therapy for the treatment of MERS-CoV infection. Only one such study is planned for randomization and is pending completion. The study is based on a combination of lopinavir/ritonavir and interferon-beta-1b. A fully human polyclonal IgG antibody (SAB-301) was safe and well tolerated in healthy individuals and this agent may deserve further testing for efficacy. Conclusion: Despite multiple studies in humans there is no consensus on the optimal therapy for MERS-CoV. Randomized clinical trials are needed and potential therapies should be evaluated only in such clinical trials. In order to further enhance the therapeutic aroma for MERS-CoV infection, repurposing old drugs against MERS-CoV is an interesting strategy and deserves further consideration and use in clinical settings.

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Section: Human Studiesmentioning

confidence: 97%

“…A phase 1 randomized placebo-controlled study utilized a fully human polyclonal IgG antibody (SAB-301) and evaluated the safety and tolerability of this agent in 28 adults compared with 10 adults who received placebo [68]. The trial was registered with ClinicalTrials.gov, number NCT02788188.…”

Section: Human Studiesmentioning

confidence: 99%

A Systematic Review of therapeutic agents for the treatment of the Middle East Respiratory Syndrome Coronavirus (MERS-CoV)

Momattin

Al-Ali

Al‐Tawfiq

2019

Travel Medicine and Infectious Disease

114

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“…The three most frequent symptoms are: fever (77% [IQR: 59-82]), cough (90% [52][53][54][55][56][57][58][59][60][61][62][63][64][65][66][67][68][69]), and dyspnea (68% ).…”

Section: Clinical Symptomsmentioning

confidence: 99%

“…No clinical trials are currently underway. Recently, a phase I placebo-controlled, dose escalation study evaluated the efficacy of polyclonal IgGs produced by transchromosomal cattle with human immunoglobulin genes immunized with the MERS-CoV spike (S) protein [65]. The primary outcome of tolerance to a single dose was reached.…”

Section: Intravenous Immunoglobulins (Iggs)mentioning

confidence: 99%

Focus on Middle East respiratory syndrome coronavirus (MERS-CoV)

Bleibtreu

Bertine

Bertin

et al. 2020

Médecine et Maladies Infectieuses

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a b s t r a c tSince the first case of human infection by the Middle East respiratory syndrome coronavirus (MERS-CoV) in Saudi Arabia in June 2012, more than 2260 cases of confirmed MERS-CoV infection and 803 related deaths have been reported since the 16th of October 2018. The vast majority of these cases (71%) were reported in Saudi Arabia but the epidemic has now spread to 27 countries and has not ceased 6 years later, unlike SARS-CoV that disappeared a little less than 2 years after emerging. Due to the high fatality rate observed in MERS-CoV infected patients (36%), much effort has been put into understanding the origin and pathophysiology of this novel coronavirus to prevent it from becoming endemic in humans. This review focuses in particular on the origin, epidemiology and clinical manifestations of MERS-CoV, as well as the diagnosis and treatment of infected patients. The experience gained over recent years on how to manage the different risks related to this kind of epidemic will be key to being prepared for future outbreaks of communicable disease. Mots clés : Maladies émergentes MERS-CoV Coronavirus Pneumonie r é s u m é Depuis le premier cas d'infection liée au Middle East Respiratory Syndrome -Coronavirus (MERS-CoV), détecté en Arabie Saoudite en juin 2012, le MERS-CoV a donné lieu, au 16 octobre 2018, à plus de 2260 cas d'infections confirmées et à 803 décès. La grande majorité des cas (71 %) ont été déclarés en ArabieSaoudite mais l'épidémie a depuis touché 27 pays et n'est toujours pas enrayée 6 ans après son émergence, contrairement au SRAS-CoV qui a disparu un peu moins de deux ans après sa première détection. En raison du taux important de décès observé parmi les patients infectés par le MERS-CoV (36 %), beaucoup d'efforts ont été déployés pour comprendre l'origine et la physiopathologie de ce nouveau coronavirus ainsi que pour lutter contre une éventuelle installation endémique de ce virus au sein de la population humaine. Cette revue s'attache plus particulièrement à retracer l'origine et l'épidémiologie du MERS-CoV à décrire la clinique observée chez les patients ainsi que la prise en charge diagnostique et thérapeutique des patients infectés. L'expérience acquise au cours des dernières années dans la gestion des différents risques liés à ce type d'épidémie est importante pour pouvoir faire face à la prochaine émergence d'infection transmissible.

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“…* where peer reviewed results are available the reference has been included, otherwise the ClinicalTrials.gov identifier has been listed. rV = Recombinant virus vaccine, iV = Inactivated virus vaccine, iB = inactivated Bacterial vaccine, VLP = Virus like particle vaccine, Sub = Subunit vaccine, N = Nanoparticle, IgG = Therapeutic antibody, DNA = DNA vaccine, VSV = Vesicular stomatitis virus, Ad5, Ad26 = replication defective Human Adenovirus type 5 strictly vaccines, the development of therapeutic antibodies that can be used post exposure during an outbreak, such as those developed against MERS coronavirus, may be particularly useful for outbreak type diseases provided that they are effective in the field [41].…”

Section: Progress Towards Disease Controlmentioning

confidence: 99%

UK vaccines network: Mapping priority pathogens of epidemic potential and vaccine pipeline developments

Noad¹,

Simpson²,

Fooks³

et al. 2019

Vaccine

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a b s t r a c tDuring the 2013-2016 Ebola outbreak in West Africa an expert panel was established on the instructions of the UK Prime Minister to identify priority pathogens for outbreak diseases that had the potential to cause future epidemics. A total of 13 priority pathogens were identified, which led to the prioritisation of spending in emerging diseases vaccine research and development from the UK. This meeting report summarises the process used to develop the UK pathogen priority list, compares it to lists generated by other organisations (World Health Organisation, National Institutes of Allergy and Infectious Diseases) and summarises clinical progress towards the development of vaccines against priority diseases. There is clear technical progress towards the development of vaccines. However, the availability of these vaccines will be dependent on sustained funding for clinical trials and the preparation of clinically acceptable manufactured material during inter-epidemic periods.

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Safety and tolerability of a novel, polyclonal human anti-MERS coronavirus antibody produced from transchromosomic cattle: a phase 1 randomised, double-blind, single-dose-escalation study

Abstract: National Institute of Allergy and Infectious Diseases, National Institutes of Health, and Biomedical Advanced Research and Development Authority.

Cited by 108 publications

References 13 publications

A Systematic Review of therapeutic agents for the treatment of the Middle East Respiratory Syndrome Coronavirus (MERS-CoV)

A Systematic Review of therapeutic agents for the treatment of the Middle East Respiratory Syndrome Coronavirus (MERS-CoV)

Focus on Middle East respiratory syndrome coronavirus (MERS-CoV)

UK vaccines network: Mapping priority pathogens of epidemic potential and vaccine pipeline developments

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