Safety and immunogenicity of a novel recombinant adenovirus type-5 vector-based Ebola vaccine in healthy adults in China: preliminary report of a randomised, double-blind, placebo-controlled, phase 1 trial

Zhu, Fengcai; Hou, Lihua; Li, Jingxin; Wu, Shipo; Liu, Pei; Zhang, Guirong; Hu, Yuemei; Meng, Fanjuan; Xu, Junjie; Tang, Rong; Zhang, Jinlong; Wang, Wen‐Juan; Duan, Lijun; Cui, Kai; Liang, Qi; Hu, Jialei; Luo, Li; Zhu, Tao; Wang, Junzhi; Chen, Wei

doi:10.1016/s0140-6736(15)60553-0

Cited by 158 publications

(144 citation statements)

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“…The safety, tolerability and immunogenicity of the Ad5-EBOV was evaluated in 120 healthy adults in China (ClinicalTrials.gov NCT02326194), receiving either one shot of the Ad5-EBOV at 4 £ 10 10 vp, 1.6 £ 10 11 vp, or placebo. 31 The safety observation for adverse reactions post-vaccination indicated a good safety profile of the Ad5-EBOV, which was in line with the previous reports of other Ad5-based Ebola vaccines. Though higher incidence of injection-site reactions was associated with the higher dosage of Ad5-EBOV, most of the reactions were mild or moderate.…”

Section: Non-replicative Vector-based Ebola Vaccinessupporting

confidence: 89%

“…A single-center, randomized, placebocontrolled, observer-blind, phase I trial adopting prime-boost regimen (prime with Ad26-EBOV or MVA-BN Filo and boost with the alternative vaccine 28 or 56 d later) enrolled 87 participants to evaluate the safety and immunogenicity of the Ad26-EBOV (Table 4). 30 Mild to moderate injection-site pain was the 31 Two outstanding advantages of this Ad5-EBOV was noticed: first, the Ad5-EBOV is the first Ebola vaccine developed according to the 2014 epidemic strain, which was considered to be a new epidemic strain, with 96.7% homology of the nucleotide sequence and 97.6% homology of amino acid sequence 31 compared to the GP gene of the strain in 1976 which was based on by other vaccines; 32,33 Second, the Ad5-EBOV is lyophilized white powder (can be stored at 2-8 C), which may be more suitable for the areas where the cold chain system is incomplete than those liquid formulations. After a preliminary efficacy was observed in the pre-clinical animal studies, the Ad5-EBOV was quickly put into the clinical trials at the end of 2014 ( Table 1).…”

Section: Non-replicative Vector-based Ebola Vaccinesmentioning

confidence: 99%

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Ebola vaccines in clinical trial: The promising candidates

Wang

et al. 2016

Human Vaccines & Immunotherapeutics

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Ebola virus disease (EVD) has become a great threat to humans across the world in recent years. The 2014 Ebola epidemic in West Africa caused numerous deaths and attracted worldwide attentions. Since no specific drugs and treatments against EVD was available, vaccination was considered as the most promising and effective method of controlling this epidemic. So far, 7 vaccine candidates had been developed and evaluated through clinical trials. Among them, the recombinant vesicular stomatitis virusbased vaccine (rVSV-EBOV) is the most promising candidate, which demonstrated a significant protection against EVD in phase III clinical trial. However, several concerns were still associated with the Ebola vaccine candidates, including the safety profile in some particular populations, the immunization schedule for emergency vaccination, and the persistence of the protection. We retrospectively reviewed the current development of Ebola vaccines and discussed issues and challenges remaining to be investigated in the future.

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Section: Non-replicative Vector-based Ebola Vaccinessupporting

confidence: 89%

Section: Non-replicative Vector-based Ebola Vaccinesmentioning

confidence: 99%

Ebola vaccines in clinical trial: The promising candidates

Wang

et al. 2016

Human Vaccines & Immunotherapeutics

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“…Vaccines that were assessed in phase I and/or II studies during the 2013-2016 EBOV epidemic include rVSV-EBOV [268][269][270][271][272] , Ad5-EBOV [273][274][275] , rVSV-EBOV combined with rAd5-EBOV 276 , ChAd3-EBOV with or without MVA-EBOV [277][278][279][280] , Ad26-EBOV combined with MVA-EBOV 281 , and DNA encoding multiple filovirus GPs 282,283 . These EBOV vaccines generally elicited good immunogenicity against EBOV GP, and no serious adverse events were described.…”

Section: Vaccination Of Humansmentioning

confidence: 99%

Post-exposure treatments for Ebola and Marburg virus infections

Cross

Mire

Feldmann

et al. 2018

Nat Rev Drug Discov

105

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| The filoviruses -Ebola virus and Marburg virus -cause lethal haemorrhagic fever in humans and non-human primates (NHPs). Filoviruses present a global health threat both as naturally acquired diseases and as potential agents of bioterrorism. In the recent 2013-2016 outbreak of Ebola virus, the most promising therapies for post-exposure use with demonstrated efficacy in the gold-standard NHP models of filovirus disease were unable to show statistically significant protection in patients infected with Ebola virus. This Review briefly discusses these failures and what has been learned from these experiences, and summarizes the current status of post-exposure medical countermeasures in development, including antibodies, small interfering RNA and small molecules. We outline how our current knowledge could be applied to the identification of novel interventions and ways to use interventions more effectively. R E V I E W SNATURE REVIEWS | DRUG DISCOVERY VOLUME 17 | JUNE 2018 | 413 © 2 0 1 8 M a c m i l l a n P u b l i s h e r s L i m i t e d , p a r t o f S p r i n g e r N a t u r e . A l l r i g h t s r e s e r v e d . AstheniaMuscular weakness. MyalgiaMuscular pain. ArthralgiaJoint pain. LeukopeniaA condition of having a low number of circulating leukocytes, including neutrophils, eosinophils, basophils, lymphocytes and monocytes. LymphocytopeniaA condition of having a low number of circulating leukocytes, including natural killer cells, T cells and B cells. ThrombocytopeniaA condition of having a low number of circulating thrombocytes, also known as platelets.and Ebolavirus. The Marburgvirus genus contains a single species, Marburg marburgvirus, which contains two members, Marburg virus (MARV) and Ravn virus (RAVV). The Ebolavirus genus consists of five distinct species: Bundibugyo ebolavirus (BDBV), Reston ebolavirus (RESTV), Sudan ebolavirus (SUDV), Tai Forest ebolavirus (TAFV; previously termed 'Côte d'Ivoire ebolavirus' but more commonly known as 'Ivory Coast ebolavirus') and Zaire ebolavirus (EBOV). MARV, RAVV, BDBV, SUDV and EBOV are important human pathogens, with case fatality rates often up to 90% for MARV, RAVV and EBOV, and around 55% for SUDV 8,10 . On the basis of two small outbreaks in 2007 and 2012, BDBV seems to be the least pathogenic, with a case fatality rate of about 40-48% 11,12 . In 1994, TAFV was associated with a number of deaths in chimpanzees and a single symptomatic but non-lethal human infection in the Republic of Côte d'Ivoire 13,14 . RESTV is lethal for macaques but is not thought to cause disease in humans 15 . An outbreak of RESTV was reported in pigs in the Philippines in 2008; however, it remains uncertain whether the disease observed in the pigs was caused by RESTV or other agents reported to have co-infected the animals 16 . Clinical manifestationsClinical and laboratory signs of disease caused by filovirus infection are nonspecific and usually associated with an incubation period of 2-21 days (mean 4-10 days) 8,17 . Illness begins with an abrupt onset of fever, astheni...

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“…1 However, at present, no licensed vaccines are available, despite promising results for several candidate vaccines in non-human primate studies and phase 1 trials. [2][3][4][5][6][7][8][9] The recombinant, replication-competent vesicular stomatitis virus-based candidate vaccine expressing the glycoprotein of a Zaire Ebolavirus (rVSV-ZEBOV) causes a transient systemic infection after a single injection, and produces a rapid immune response against the Ebola virus surface protein. 6,7 The Ebola ça Suffi t ("Ebola this is enough") clusterrandomised phase 3 trial is currently underway in Guinea to assess the effi cacy of the rVSV-ZEBOV candidate vaccine for the prevention of Ebola virus disease.…”

Section: Introductionmentioning

confidence: 99%