Questionable efficacy of the rVSV-ZEBOV Ebola vaccine – Authors' reply

Longini, Ira M.; Røttingen, John-Arne; Kiény, Marie Paule; Edmunds, W. John; Henao-Restrepo, Ana María

doi:10.1016/s0140-6736(18)30559-2

Cited by 9 publications

(4 citation statements)

References 2 publications

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“…Only adults older than 18 could be vaccinated. In addition to showing high efficacy among the vaccinated, the study revealed that unvaccinated people were indirectly protected against the Ebola virus through the vaccination method indicated [10][11][12][13][14][15][16][17].…”

Section: Measures To Takementioning

confidence: 99%

Emerging viral diseases: Ebola hemmorrhagic fever

Hernández¹,

Rodríguez²,

Rodríguez³

et al. 2018

Dis Disord

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Ebola hemorrhagic fever disease affects humans and primates; and is produced by five ebola virus of the Filoviridae family: Zaire virus, Sudan, Bundibugyo, Ivory Coast (Taï forest virus) and Reston. The disease has a high mortality rate, ranging from 25% to 90% of those infected with the virus. During 2014, more than 10,000 suspected cases and numerous deaths have been reported.The virus can be acquired by coming into contact with blood or other body fluids of an infected human or other animal. The symptoms begin 2 to 21 days after contracting the virus, with fever, sore throat, muscle pain and headaches. They are followed by vomiting, diarrhea, rashes, impaired liver and kidney function and subsequently, bleeding.Outbreak control requires community participation, case management, surveillance and follow-up of contacts, appropriate laboratory services and adequate treatment of remains through cremation or burial. There is no specific treatment for the disease. In laboratories where, diagnostic tests are carried out, level 4 containment biosecurity is required. Forced isolation (or quarantine) and contact tracking are considered important to contain an outbreak.

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Section: Measures To Takementioning

confidence: 99%

Emerging viral diseases: Ebola hemmorrhagic fever

Hernández¹,

Rodríguez²,

Rodríguez³

et al. 2018

Dis Disord

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“…However, the efficacy of vaccination was questioned by claiming of a bias of the medical study team not staying in the communities of the delayed vaccination group, which could be considered as important for disease transmission, even suggesting that EVD was averted due to behavioral changes and the effect of the vaccine was 0% [ 139 ]. In response, the team behind the study confirmed that both the immediate and the delayed vaccination communities had similar exposure to health workers during the period after detection and no bias existed [ 140 ]. Moreover, at 10 days or more after randomization, eight unvaccinated contacts developed confirmed symptoms of EVD.…”

Section: Clinical Trialsmentioning

confidence: 99%

Self-Amplifying RNA Viruses as RNA Vaccines

Lundström¹

2020

IJMS

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Single-stranded RNA viruses such as alphaviruses, flaviviruses, measles viruses and rhabdoviruses are characterized by their capacity of highly efficient self-amplification of RNA in host cells, which make them attractive vehicles for vaccine development. Particularly, alphaviruses and flaviviruses can be administered as recombinant particles, layered DNA/RNA plasmid vectors carrying the RNA replicon and even RNA replicon molecules. Self-amplifying RNA viral vectors have been used for high level expression of viral and tumor antigens, which in immunization studies have elicited strong cellular and humoral immune responses in animal models. Vaccination has provided protection against challenges with lethal doses of viral pathogens and tumor cells. Moreover, clinical trials have demonstrated safe application of RNA viral vectors and even promising results in rhabdovirus-based phase III trials on an Ebola virus vaccine. Preclinical and clinical applications of self-amplifying RNA viral vectors have proven efficient for vaccine development and due to the presence of RNA replicons, amplification of RNA in host cells will generate superior immune responses with significantly reduced amounts of RNA delivered. The need for novel and efficient vaccines has become even more evident due to the global COVID-19 pandemic, which has further highlighted the urgency in challenging emerging diseases.

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“…The vaccine was approved for 'compassionate use' in outbreaks, meaning that it had been proven sufficiently safe and effective to be recommended, although it had not yet been formally approved by a full regulatory process. According to later correspondence in The Lancet, the efficacy estimate of the vaccine remained at 100% despite concerns about bias in the research design (Longini et al 2018;Metzger and Vivas-Martínez 2018). The vaccine eventually contributed to the suppression of the 2013-2016 Ebola virus disease epidemic (Geisbert 2017;Calain 2018).…”

Section: Adaptive Trials In Epidemicsmentioning

confidence: 99%

Adapt to Translate

Jadreškić

2021

EuJAP

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The article presents the advantages and limitations of adaptive clinical trials for assessing the effectiveness of medical interventions and specifies the conditions that contributed to their development and implementation in clinical practice. I advance two arguments by discussing different cases of adaptive trials. The normative argument is that responsible adaptation should be taken seriously as a new way of doing clinical research insofar as a valid justification, sufficient understanding, and adequate operational conditions are provided. The second argument is historical. The development of adaptive trials can be related to lessons learned from research in cases of urgency and to the decades-long efforts to end the productivity crisis of pharmaceutical research, which led to the emergence of translational, personalized, and, recently, precision medicine movements.

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Questionable efficacy of the rVSV-ZEBOV Ebola vaccine – Authors' reply

Abstract: JLB and MRS contributed equally. We declare no competing interests.

Cited by 9 publications

References 2 publications

Emerging viral diseases: Ebola hemmorrhagic fever

Emerging viral diseases: Ebola hemmorrhagic fever

Self-Amplifying RNA Viruses as RNA Vaccines

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