Identification

Summary

Ebola Zaire vaccine (live, attenuated) is a vaccine used in the prophylaxis of Ebola virus disease caused by the species of Zaire ebolaviruses.

Generic Name
Ebola Zaire vaccine (live, attenuated)
DrugBank Accession Number
DB15595
Background

Ebola virus vaccine is a vaccine used to prevent Ebola virus disease caused by Zaire ebolavirus in adults, prevent outbreaks, and reduce the extent of the virus spreading in case of outbreaks.6 Ebola virus disease, formerly known as Ebola hemorrhagic fever, is a rare but severe and often deadly disease. It is highly contagious: human to human transmission occurs from contact with body fluids from infected patients.4 It is characterized by fever, headache, myalgia, and gastrointestinal symptoms. These may be accompanied by hypotension and respiratory, kidney and liver failure, as well as internal and external bleeding.1,2 In the Filoviridae family, there are five unique Ebolavirus species that are each named after the geographical region where it was first identified. The mortality rate of the Zaire species is about 80%.2

Confirmed outbreaks of Ebola virus disease have been documented since the 1970s, mostly in Sub-Saharan Africa, where Ebola first appeared in 1976 near the Ebola River in Zaire (presently referred to as the Democratic Republic of the Congo) and Sudan.1 Between 2014 and 2016, Ebola outbreaks occurred in West Africa, leading to more than 11,310 total deaths during this time in Guinea, Liberia, and Sierra Leone.2 In 2016, this epidemic was exhausted after these countries were declared Ebola-free by 2016, and the World Health Organization (WHO) lifted the Public Health Emergency of International Concern (PHEIC) status on the West Africa Ebola outbreak.9

The first live, attenuated Ebola virus vaccine was developed by a team of Canadian researchers at Canada’s National Microbiology Laboratory and was later patented by the Canadian government.8 In non-human primate clinical trials, the vaccine was effective in inducing an immune response against the Ebola viruses.3 This vaccine was later sold to NewLink Genetics, a biotech company that held the license to the vaccine from 2010 to 2014, although the vaccine was not marketed.8 In 2014, Merck Inc. signed a licensing agreement with NewLink for further development and marketing. Ervebo, the marketed Ebola virus vaccine by Merck, was first approved by the European Commission in November 2019 after the European Medicines Agency recommended it be licensed. In December 2019, Ervebo was approved by the FDA in the United States. Ervebo consists of an envelope glycoprotein of the Zaire ebolavirus (Kikwit 1995 strain) fused into a vesicular stomatitis virus (VSV) backbone.6 By introducing the relatively inactive viral protein to the patient, the patient’s immune system learns to recognize and attack the virus if he or she is exposed to it in the future.

Type
Biotech
Groups
Approved
Biologic Classification
Vaccines
Attenuated
Synonyms
  • Ebola Zaire vaccine (live)
  • Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)
  • Recombinant Vesicular Stomatitis Virus (rVSV) strain Indiana with a deletion of the VSV envelope glycoprotein (G) replaced with the Zaire Ebola Virus (ZEBOV) Kikwit 1995 strain surface glycoprotein (GP)

Pharmacology

Indication

Ebola Zaire vaccine is indicated for active immunization of individuals 18 years of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebolavirus.7

Pharmacology
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Associated Conditions
Contraindications & Blackbox Warnings
Contraindications
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Pharmacodynamics

Ebola Zaire vaccine protects against the Ebola virus infection and disease by introducing a protein produced by the Zaire ebolavirus and initiating the body's normal immune responses against the virus. In clinical trials consisting of subjects receiving the Ebola virus vaccine, the vaccine virus RNA was detected in the plasma samples of most subjects within the first week after intramuscular injection.6

Mechanism of action

Ebola virus disease occurs when the virus comes into contact with the host tissue and invades the tissue by breaking in the mucosa or skin. Exposure can occur through animal-to-human or human-to-human transmission from blood and other bodily fluids of the virus-infected animal or human.4 The viral genome then replicates inside the cell, causing gene modulation in host cells - including monocytes, macrophages, and dendritic cells - and promote cell apoptosis, releasing the viral particles to extracellular tissue.2 The virus can further disseminate the infection by migrating to the regional lymph nodes, liver, and spleen to cause lymphadenopathy, hepatocellular necrosis, and lymphopenia.2,4 Ebola virus can cause dysregulation of the host immune system by inducing the host expression and release of pro-inflammatory mediators, including interferons, interleukins (IL-2, IL- 6, IL-8, and IL-10), and tumour necrosis factor α (TNF-α).4 These inflammatory processes promote endothelial activation and reduced vascular integrity. Furthermore, the release of tissue factors and increased nitric oxide levels lead to disseminated intravascular coagulation (DIC) and hypotension seen in the Ebola virus disease, respectively.2,4 The incubation period after the Ebola virus infection is 1-21 days.4

By introducing the attenuated viral protein to the patient, the Ebola Zaire vaccine elicits strong cellular and antibody responses against the virus. The vaccine produces a long-term immunity and protects the patient from Ebola virus infection and disease when he or she is exposed to Zaire ebolavirus in the future.5 However, the relative contributions of innate, humoral and cell-mediated immunity to protection from Zaire ebolavirus is not fully understood.6

Absorption

There is limited pharmacokinetic information on Ebola virus vaccine.

Volume of distribution

There is limited pharmacokinetic information on Ebola virus vaccine.

Protein binding

There is limited pharmacokinetic information on Ebola virus vaccine.

Metabolism

As with other live attenuated vaccines, Ebola virus vaccine is speculated to undergo nonspecific cellular degradation.

Route of elimination

Although there is limited information on the main route of elimination of Ebola virus vaccine, vaccine virus RNA was detected in the in the urine or saliva samples of the subjects in clinical trials who received intramuscular injections.6

Half-life

There is limited pharmacokinetic information on Ebola virus vaccine.

Clearance

There is limited pharmacokinetic information on Ebola virus vaccine.

Adverse Effects
Adverseeffects
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Toxicity

There is limited information on the overdose and LD50 of Ebola Zaire vaccine.

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
AbataceptThe therapeutic efficacy of Ebola Zaire vaccine (live, attenuated) can be decreased when used in combination with Abatacept.
AbciximabThe therapeutic efficacy of Ebola Zaire vaccine (live, attenuated) can be decreased when used in combination with Abciximab.
AdalimumabThe therapeutic efficacy of Ebola Zaire vaccine (live, attenuated) can be decreased when used in combination with Adalimumab.
AducanumabThe therapeutic efficacy of Ebola Zaire vaccine (live, attenuated) can be decreased when used in combination with Aducanumab.
AldesleukinThe therapeutic efficacy of Ebola Zaire vaccine (live, attenuated) can be decreased when used in combination with Aldesleukin.
AlefaceptThe therapeutic efficacy of Ebola Zaire vaccine (live, attenuated) can be decreased when used in combination with Alefacept.
AlemtuzumabThe therapeutic efficacy of Ebola Zaire vaccine (live, attenuated) can be decreased when used in combination with Alemtuzumab.
AlirocumabThe therapeutic efficacy of Ebola Zaire vaccine (live, attenuated) can be decreased when used in combination with Alirocumab.
AltretamineThe therapeutic efficacy of Ebola Zaire vaccine (live, attenuated) can be decreased when used in combination with Altretamine.
AmivantamabThe therapeutic efficacy of Ebola Zaire vaccine (live, attenuated) can be decreased when used in combination with Amivantamab.
Interactions
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Food Interactions
No interactions found.

Products

Products2
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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
ErveboInjection, solution72000000 PFUIntramuscularMerck Sharp & Dohme B.V.2021-03-17Not applicableEU flag
ZabdenoInjection, suspension0.94 Inf.UIntramuscularJanssen Cilag International Nv2021-03-17Not applicableEU flag

Categories

Drug Categories
Classification
Not classified
Affected organisms
Not Available

Chemical Identifiers

UNII
3R8G5WNW24
CAS number
Not Available

References

General References
  1. Laupland KB, Valiquette L: Ebola virus disease. Can J Infect Dis Med Microbiol. 2014 May;25(3):128-9. doi: 10.1155/2014/527378. [Article]
  2. Khalafallah MT, Aboshady OA, Moawed SA, Ramadan MS: Ebola virus disease: Essential clinical knowledge. Avicenna J Med. 2017 Jul-Sep;7(3):96-102. doi: 10.4103/ajm.AJM_150_16. [Article]
  3. Jones SM, Feldmann H, Stroher U, Geisbert JB, Fernando L, Grolla A, Klenk HD, Sullivan NJ, Volchkov VE, Fritz EA, Daddario KM, Hensley LE, Jahrling PB, Geisbert TW: Live attenuated recombinant vaccine protects nonhuman primates against Ebola and Marburg viruses. Nat Med. 2005 Jul;11(7):786-90. doi: 10.1038/nm1258. Epub 2005 Jun 5. [Article]
  4. Beeching NJ, Fenech M, Houlihan CF: Ebola virus disease. BMJ. 2014 Dec 10;349:g7348. doi: 10.1136/bmj.g7348. [Article]
  5. Pulendran B, Ahmed R: Immunological mechanisms of vaccination. Nat Immunol. 2011 Jun;12(6):509-17. doi: 10.1038/ni.2039. [Article]
  6. ERVEBO® (Ebola Zaire Vaccine, Live) - FDA Label [Link]
  7. ERVEBO, INN-Ebola Zaire Vaccine - Summary of Product Characteristics - EMA [Link]
  8. How the new Ebola vaccine was made in Canada - CBC News [Link]
  9. 2014-2016 Ebola Outbreak in West Africa | History | Ebola (Ebola Virus Disease) | CDC [Link]
Not Available
FDA label
Download (254 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
2Not Yet RecruitingPreventionEbolavirus Disease1
2Not Yet RecruitingPreventionEbola / Ebolavirus Disease / Human Immunodeficiency Virus (HIV) Infections1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, solutionIntramuscular72000000 PFU
Injection, suspensionIntramuscular0.5 ML
Injection, suspensionIntramuscular0.94 Inf.U
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Drug created at December 20, 2019 21:28 / Updated at February 13, 2021 10:53