PREVAIL I Cluster Vaccination Study With rVSVΔG-ZEBOV-GP as Part of a Public Health Response in Liberia

Bolay, Fatorma K.; Grandits, Gregory A; Lane, H. Clifford; Kennedy, Stephen B.; Johnson, Melvin; Fallah, Mosoka; Wilson, Barthalomew; Njoh, Wissedi; McNay, Laura A.; Hensley, Lisa E.; Higgs, Elizabeth

doi:10.1093/infdis/jiy698

Cited by 16 publications

(12 citation statements)

References 9 publications

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“…A second ring-vaccination trial, not yet fully published, has since been conducted in the Democratic Republic of Congo. 16 Results from this trial are largely similar to Henao-Restrapo et al 15 Of those who were vaccinated in the trial (n = 68 279), there were 71 cases of EVD reported with 15 reporting symptom onset more than 10 days after vaccination. There were 9 deaths in those who developed EVD within 10 days of vaccination and no deaths after that duration.…”

Section: Additional Trialssupporting

confidence: 76%

“…It is unknown at what time between 1 week and 1 month that an immune response meets an immunogenic threshold, representing an evidence gap between immunogenicity and efficacy data. [12][13][14][15][16][17] A limitation of PREVAIL I is that antibody responses were measured via FANG testing, with an arbitrary value 4 times the baseline value considered a positive response. There are no established correlates of positive immunity to EVD after vaccination, although there are proposed variables that were not tested during the trials referenced.…”

Section: Safetymentioning

confidence: 99%

See 1 more Smart Citation

Ervebo (Ebola Zaire Vaccine, Live/rVSVΔG-ZEBOV-GP): The First Licensed Vaccine for the Prevention of Ebola Virus Disease

Piszczatoski

Gums

2020

Journal of Pharmacy Technology

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Objective: To review the clinical data regarding the safety and efficacy of the Ervebo (Ebola Zaire vaccine, live/rVSVΔG-ZEBOV-GP) vaccine for the prevention of the Ebola virus disease. Data Sources: A literature search through PubMed, MEDLINE, and Cochrane Library was conducted for clinical trials published between January 2014 and June 2020 in the English language using the keywords Ervebo, rVSVΔG-ZEBOV, rVSVΔG-ZEBOV-GP, Ebola Zaire, and vaccine. Study Selection and Data Extraction: Articles were selected if they were related to the Food and Drug Administration (FDA) approval of Ervebo (Ebola Zaire vaccine, live/rVSVΔG-ZEBOV-GP) or provided novel data regarding this entity. Twelve articles noted in the FDA approval were chosen, along with 2 additional articles identified as providing novel information. Data Synthesis: The findings of the review show that Ervebo (Ebola Zaire vaccine, live/rVSVΔG-ZEBOV-GP) is a safe, immunogenic, and likely effective vaccine for the prevention of Ebola virus disease. Relevance to Patient Care and Clinical Practice: Ebola virus disease is highly infectious and often fatal. There have been multiple large outbreaks in the past 5 years, with no licensed treatments or vaccines. An effective vaccine could largely curtail current outbreaks and prevent further ones. Conclusion: The recent FDA approval of Ervebo (Ebola Zaire vaccine, live/rVSVΔG-ZEBOV-GP) offers the first approved vaccine for the prevention of Ebola virus disease. It has been shown to be safe, immunogenic, and likely effective for use in real-world applications for those at risk of contracting the disease.

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Section: Additional Trialssupporting

confidence: 76%

Section: Safetymentioning

confidence: 99%

Ervebo (Ebola Zaire Vaccine, Live/rVSVΔG-ZEBOV-GP): The First Licensed Vaccine for the Prevention of Ebola Virus Disease

Piszczatoski

Gums

2020

Journal of Pharmacy Technology

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“… 15 In addition, serology data from the Liberian PREVAIL trials with more than 700 rVSV-ZEBOV vaccinated participants, showed that ~20% of vaccinated individuals did not develop positive Ebola IgG binding titers one month following vaccination. 19 , 20 Combined, these findings raise concerns about the true effectiveness of the rVSV-ZEBOV vaccine, which has been estimated to be 100% in the Guinean “Ebola ça suffit!” trial and 97.5% in the preliminary report by the WHO from its use in DRC. 21 , 22 …”

Section: Discussionmentioning

confidence: 99%

Ebola Virus Transmission Initiated by Relapse of Systemic Ebola Virus Disease

et al. 2021

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Summary During the 2018-2020 Nord Kivu Ebola virus disease (EVD) outbreak in the Democratic Republic of the Congo, an individual who had received the Merck rVSV-ZEBOV vaccine was diagnosed with EVD. His treatment included an Ebola virus-specific monoclonal antibody (mAb114), and he recovered within 14 days but re-presented six months later with severe EVD-like illness and Ebola virus viremia and died. We initiated an epidemiological and genomic investigation that showed the patient had a relapse of acute EVD, which led to a transmission chain that resulted in 91 cases spanning six health zones over four-months.

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“…The day 14 anti-GP seroconversion was lower than that found in rhesus macaques [ 4 , 24 , 25 ] and in human participants in pooled North American phase I studies, which showed universal seroconversion by day 14 [ 26 ]. In the phase II PREVAIL trials, 77–83% of 500 individuals seroconverted within 1 month of vaccination [ 8 , 27 ]. We found that the numbers of individuals with positive neutralizing antibody responses were similar to those with anti-GP responses evaluated by ELISA.…”

Section: Discussionmentioning

confidence: 99%

Postexposure Prophylaxis With rVSV-ZEBOV Following Exposure to a Patient With Ebola Virus Disease Relapse in the United Kingdom: An Operational, Safety, and Immunogenicity Report

Davis

Tipton

Sabir

et al. 2019

Clinical Infectious Diseases

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Background In October 2015, 65 people came into direct contact with a healthcare worker presenting with a late reactivation of Ebola virus disease (EVD) in the United Kingdom. Vaccination was offered to 45 individuals with an initial assessment of high exposure risk. Methods Approval for rapid expanded access to the recombinant vesicular stomatitis virus–Zaire Ebola virus (rVSV-ZEBOV) vaccine as an unlicensed emergency medicine was obtained from the relevant authorities. An observational follow-up study was carried out for 1 year following vaccination. Results Twenty-six of 45 individuals elected to receive vaccination between 10 and 11 October 2015 following written informed consent. By day 14, 39% had seroconverted, increasing to 87% by day 28 and 100% by 3 months, although these responses were not always sustained. Neutralizing antibody responses were detectable in 36% by day 14 and 73% at 12 months. Common side effects included fatigue, myalgia, headache, arthralgia, and fever. These were positively associated with glycoprotein-specific T-cell but not immunoglobulin (Ig) M or IgG antibody responses. No severe vaccine-related adverse events were reported. No one exposed to the virus became infected. Conclusions This paper reports the use of the rVSV-ZEBOV vaccine given as an emergency intervention to individuals exposed to a patient presenting with a late reactivation of EVD. The vaccine was relatively well tolerated, but a high percentage developed a fever ≥37.5°C, necessitating urgent screening for Ebola virus, and a small number developed persistent arthralgia.

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PREVAIL I Cluster Vaccination Study With rVSVΔG-ZEBOV-GP as Part of a Public Health Response in Liberia

Cited by 16 publications

References 9 publications

Ervebo (Ebola Zaire Vaccine, Live/rVSVΔG-ZEBOV-GP): The First Licensed Vaccine for the Prevention of Ebola Virus Disease

Ervebo (Ebola Zaire Vaccine, Live/rVSVΔG-ZEBOV-GP): The First Licensed Vaccine for the Prevention of Ebola Virus Disease

Ebola Virus Transmission Initiated by Relapse of Systemic Ebola Virus Disease

Postexposure Prophylaxis With rVSV-ZEBOV Following Exposure to a Patient With Ebola Virus Disease Relapse in the United Kingdom: An Operational, Safety, and Immunogenicity Report

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