Vaccines for emerging infectious diseases: Lessons from MERS coronavirus and Zika virus

Maslow, Joel N.

doi:10.1080/21645515.2017.1358325

Cited by 32 publications

(26 citation statements)

References 143 publications

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“…GLS-5300 is the first MERS coronavirus vaccine to advance into human trials. Among vaccine candidates in development, 22 four have started or will soon start phase 1 testing, including measles-vectored, 9,23 chimpanzee adenovirus-vectored, 24 and modified vaccinia Ankaravectored vaccines, all expressing full-length S-glycoprotein. [25][26][27] DNA vaccines and viral-vectored vaccines use recombinant technology that allows for rapid vaccine design in response to emerging infectious diseases.…”

Section: Discussionmentioning

confidence: 99%

Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial

Modjarrad

Roberts

Mills

et al. 2019

The Lancet Infectious Diseases

279

288

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Background Middle East respiratory syndrome (MERS) coronavirus causes a highly fatal lower-respiratory tract infection. There are as yet no licensed MERS vaccines or therapeutics. This study (WRAIR-2274) assessed the safety, tolerability, and immunogenicity of the GLS-5300 MERS coronavirus DNA vaccine in healthy adults. Methods This study was a phase 1, open-label, single-arm, dose-escalation study of GLS-5300 done at the Walter ReedArmy Institute for Research Clinical Trials Center (Silver Spring, MD, USA). We enrolled healthy adults aged 18-50 years; exclusion criteria included previous infection or treatment of MERS. Eligible participants were enrolled sequentially using a dose-escalation protocol to receive 0·67 mg, 2 mg, or 6 mg GLS-5300 administered by trained clinical site staff via a single intramuscular 1 mL injection at each vaccination at baseline, week 4, and week 12 followed immediately by co-localised intramuscular electroporation. Enrolment into the higher dose groups occurred after a safety monitoring committee reviewed the data following vaccination of the first five participants at the previous lower dose in each group. The primary outcome of the study was safety, assessed in all participants who received at least one study treatment and for whom post-dose study data were available, during the vaccination period with follow-up through to 48 weeks after dose 3. Safety was measured by the incidence of adverse events; administration site reactions and pain; and changes in safety laboratory parameters. The secondary outcome was immunogenicity. This trial is registered at ClinicalTrials.gov (number NCT 02670187) and is completed.Findings Between Feb 17 and July 22, 2016, we enrolled 75 individuals and allocated 25 each to 0·67 mg, 2 mg, or 6 mg GLS-5300. No vaccine-associated serious adverse events were reported. The most common adverse events were injection-site reactions, reported in 70 participants (93%) of 75. Overall, 73 participants (97%) of 75 reported at least one solicited adverse event; the most common systemic symptoms were headache (five [20%] with 0·67 mg, 11 [44%] with 2 mg, and seven [28%] with 6 mg), and malaise or fatigue (five [20%] with 0·67 mg, seven [28%] with 2 mg, and two [8%] with 6 mg). The most common local solicited symptoms were administration site pain (23 [92%] with all three doses) and tenderness (21 [84%] with all three doses). Most solicited symptoms were reported as mild (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg) and were self-limiting. Unsolicited symptoms were reported for 56 participants (75%) of 75 and were deemed treatment-related for 26 (35%). The most common unsolicited adverse events were infections, occurring in 27 participants (36%); six (8%) were deemed possibly related to study treatment. There were no laboratory abnormalities of grade 3 or higher that were related to study treatment; laboratory abnormalities were uncommon, except for 15 increases in creatine phosphokinase in 14 participants (three participants in the 0·67 mg grou...

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Section: Discussionmentioning

confidence: 99%

Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial

Modjarrad

Roberts

Mills

et al. 2019

The Lancet Infectious Diseases

279

288

View full text Add to dashboard Cite

show abstract

“…In the setting of the 2012 MERS‐CoV syndrome, despite some similarities with SARS‐CoV, the early mortality rate for the former achieved 60%, 10 remaining higher than 35% during the overall outbreak period, while for SARS‐CoV the mortality rate was about 10% 11 . A meta‐analysis suggested that MERS‐CoV infection was more likely to occur in patients with underlying cardiovascular diseases 12 .…”

Section: Introductionmentioning

confidence: 99%

Cardiac and arrhythmic complications in patients with COVID‐19

Kochi

Tagliari

Forleo

et al. 2020

Cardiovasc electrophysiol

599

517

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In December 2019, the world started to face a new pandemic situation, the severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2). Although coronavirus disease (COVID-19) clinical manifestations are mainly respiratory, major cardiac complications are being reported. Cardiac manifestations etiology seems to be multifactorial, comprising direct viral myocardial damage, hypoxia, hypotension, enhanced inflammatory status, ACE2-receptors downregulation, drug toxicity, endogenous catecholamine adrenergic status, among others. Studies evaluating patients with COVID-19 presenting cardiac injury markers show that it is associated with poorer outcomes, and arrhythmic events are not uncommon. Besides, drugs currently used to treat the COVID-19 are known to prolong the QT interval and can have a proarrhythmic propensity. This review focus on COVID-19 cardiac and arrhythmic manifestations and, in parallel, makes an appraisal of other virus epidemics as SARS-CoV, Middle East respiratory syndrome coronavirus, and H1N1 influenza. K E Y W O R D S arrhythmia, COVID-19, myocardial damage, myocarditis, SARS-CoV-2 | KOCHI ET AL.

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“…Little may be known about the basic virology or immunology of a new pathogen, though the need for developing vaccines and therapeutics is urgent. 9 Some typical methods used as vaccine clinical assays are antibody-binding ELISAs, virus neutralization or bactericidal immunoassays, IFNγ-ELISpot or related cellular immune methodology using the target antigen or antigen-derived peptide pools, and detection of the pathogen through molecular or culture assays. Vaccine clinical assays measuring humoral and cellular immune responses developed early in a program will likely evolve as clinical development progresses or as the scientific knowledge base of the pathogen and relevant immunology broadens.…”

Section: Vaccine Clinical Assays Reference Reagents International Cmentioning

confidence: 99%

“…While the identification of an immune correlate of protection for each new vaccine is highly desirable, it is not always attainable. 3 Here we will use our recent experiences with the Middle East Respiratory Syndrome coronavirus (MERS-CoV) and Zika virus (ZIKV) [4][5][6][7][8][9] outbreaks and ensuing public health countermeasures for containment and vaccine development as examples of challenges faced during emerging infectious disease emergencies.…”

Section: Introductionmentioning

confidence: 99%

Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development

Roberts¹

2019

Human Vaccines & Immunotherapeutics

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Rapid vaccine development in response to an outbreak of a new emerging infectious disease (EID) is a goal targeted by public health agencies worldwide. This goal becomes more complicated when there are no standardized sets of viral and immunological assays, no accepted and well-characterized samples, standards or reagents, and no approved diagnostic tests for the EID pathogen. The diagnosis of infections is of critical importance to public health, but also in vaccine development in order to track incident infections during clinical trials, to differentiate natural infection responses from those that are vaccine-related and, if called for by study design, to exclude subjects with prior exposure from vaccine efficacy trials. Here we review emerging infectious disease biological standards development, vaccine clinical assay development and trial execution with the recent experiences of MERS-CoV and Zika virus as examples. There is great need to establish, in advance, the standardized reagents, sample panels, controls, and assays to support the rapid advancement of vaccine development efforts in response to EID outbreaks.

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Vaccines for emerging infectious diseases: Lessons from MERS coronavirus and Zika virus

Cited by 32 publications

References 143 publications

Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial

Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial

Cardiac and arrhythmic complications in patients with COVID‐19

Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development

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