Ebola vaccine
Vaccine description | |
---|---|
Target | Ebola virus |
Vaccine type | Viral vector |
Clinical data | |
Trade names | Ervebo, Zabdeno, Mvabea |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
CAS Number |
Ebola vaccines are
Vaccines include
Approved
rVSV-ZEBOV
VSV-EBOV or
The most common side effects include pain, swelling and redness at the injection site, headache, fever, muscle pain, tiredness and joint pain.[3] In general, these reactions occur within seven days after vaccination, are mild to moderate in intensity and resolved in less than a week.[3]
It was developed by the Public Health Agency of Canada, with development subsequently taken over by Merck Inc.[19] In October 2014, the Wellcome Trust, who was also one of the biggest UK founders,[20] announced the start of multiple trials in healthy volunteers in Europe, Gabon, Kenya, and the US.[21] The vaccine was proven safe at multiple sites in North America, Europe, and Africa, but several volunteers at one trial site in Geneva, Switzerland, developed vaccine-related arthritis after about two weeks, and about 20–30% of volunteers at reporting sites developed low-grade post-vaccine fever, which resolved within a day or two. Other common side-effects were pain at the site of injection, myalgia, and fatigue.[22] The trial was temporarily halted in December 2014 due to possible adverse effects, but subsequently resumed.[23] As of April 2015[update], a Phase III trial with a single dose of VSV-EBOV began in Liberia after a successful Phase II study in the West African country.[24] On 31 July 2015, preliminary results of a Phase III trial in Guinea indicated that the vaccine appeared to be "highly efficacious and safe."[25] The trial used a ring vaccination protocol that first vaccinated all the closest contacts of new cases of Ebola infection either immediately or after 21 days. Because of the demonstrated efficacy of immediate vaccination, all recipients will now be immunized immediately.[26][27] Ring vaccination is the method used in the program to eradicate smallpox in the 1970s. The trial will continue to assess whether the vaccine is effective in creating herd immunity to Ebola virus infection.[28] In December 2016, a study found the VSV-EBOV vaccine to be 95–100% effective against the Ebola virus, making it the first proven vaccine against the disease.[29][30][31]
The approval was supported by a study conducted in Guinea during the 2014–2016 outbreak in individuals 18 years of age and older.[8] The study was a randomized cluster (ring) vaccination study in which 3,537 contacts, and contacts of contacts, of individuals with laboratory-confirmed Ebola virus disease (EVD) received either "immediate" or 21-day "delayed" vaccination.[8] This design was intended to capture a social network of individuals and locations that might include dwellings or workplaces where a patient spent time while symptomatic, or the households of individuals who had contact with the patient during that person's illness or death.[8] In a comparison of cases of EVD among 2,108 individuals in the "immediate" vaccination arm and 1,429 individuals in the "delayed" vaccination arm, Ervebo was determined to be 100% effective in preventing Ebola cases with symptom onset greater than ten days after vaccination.[8] No cases of EVD with symptom onset greater than ten days after vaccination were observed in the "immediate" cluster group, compared with ten cases of EVD in the 21-day "delayed" cluster group.[8]
In additional studies, antibody responses were assessed in 477 individuals in Liberia, some 500 individuals in Sierra Leone, and about 900 individuals in Canada, Spain, and the US.[8] The antibody responses among those in the study conducted in Canada, Spain and the US were similar to those among individuals in the studies conducted in Liberia and Sierra Leone.[8]
The safety was assessed in approximately 15,000 individuals in Africa, Europe, and North America.[8] The most commonly reported side effects were pain, swelling and redness at the injection site, as well as headache, fever, joint and muscle aches and fatigue.[8]
In December 2016, a study found the VSV-EBOV vaccine to be 70–100% effective against the Ebola virus, making it the first proven vaccine against the disease.[29][30][31] However, the design of this study and the high efficacy of the vaccine were questioned.[32] In November 2019, the European Commission granted a conditional marketing authorization to Ervebo (rVSV∆G-ZEBOV-GP, live)[17][33][34] and the WHO prequalified an Ebola vaccine for the first time.[18]
In July 2023, the FDA expanded the indication for Ervebo to cover people aged 12 years of age and older.[35][36]
Zabdeno/Mvabea
The two-dose regimen of Ad26.ZEBOV and MVA-BN-Filo, sold under the brand names Zabdeno and Mvabea,
The regimen consists of two vaccine components (first vaccine as prime, followed by a second vaccine as
In September 2019, the
In May 2020, the EMA CHMP recommended granting a marketing authorization for the combination of Ad26.ZEBOV (Zabdeno) and MVA-BN-Filo (Mvabea) vaccines.[45][46][47] Zabdeno is given first and Mvabea is administered approximately eight weeks later as a booster.[45] This prophylactic two-dose regimen is therefore not suitable for an outbreak response where immediate protection is necessary.[45] As a precautionary measure for individuals at imminent risk of exposure to Ebola virus (for example healthcare professionals and those living in or visiting areas with an ongoing Ebola virus disease outbreak), an extra Zabdeno booster vaccination should be considered for individuals who completed the Zabdeno-Mvabea two-dose vaccination regimen more than four months ago.[45] Efficacy for humans is not yet known as the efficacy has been extrapolated from animal studies.[48]
Ad5-EBOV
In late 2014 and early 2015, a double-blind, randomized Phase I trial was conducted in the
In 2017, the
In development
Articles related to the |
Western African Ebola virus epidemic |
---|
Overview |
Nations with widespread cases |
Other affected nations |
Other outbreaks |
Vaccine | Associated organisations | Status |
---|---|---|
Chimp adenovirus 3 vectored glycoprotein (cAd3-EBO Z) | GSK & NIAID |
Phase III Feb. 2016[14] |
rVSV vectored glycoprotein (VSV-EBOV) | Newlink Genetics & Merck | In use[54][55][17][8] |
Adenovirus 26 vectored glycoprotein / MVA-BN (Ad26.ZEBOV/ |
Johnson & Johnson | In use[39][56] |
HPIV-3 vectored glycoprotein | Ministry of Health (Russia) | Phase I planned[57] |
Rabies vectored glycoprotein | Thomas Jefferson University & NIAID | Non-human primate challenge complete[58] |
Purified glycoprotein | Protein Sciences | NHP challenge initiated[59] |
Ebola ∆VP30 H2O2 treated | University of Wisconsin |
Non-human primate challenge complete[60] |
cAd3-EBO Z
In September 2014, two Phase I clinical trials began for the vaccine
Ebola GP vaccine
At the 8th Vaccine and ISV Conference in Philadelphia on 27−28 October 2014,
Nasal vaccine
On 5 November 2014, the
Vaxart tablet
Vaxart Inc. is developing a vaccine technology in the form of a temperature-stable tablet which may offer advantages such as reduced cold chain requirement, and rapid and scalable manufacturing. In January 2015, Vaxart announced that it had secured funding to develop its Ebola vaccine to Phase I trial.[73]
Attenuated Ebola virus vaccine
A study published in Science during March 2015, demonstrated that vaccination with a weakened form of the Ebola virus provides some measure of protection to non-human primates. This study was conducted in accordance with a protocol approved by an Institutional Animal Care and Use Committee of the National Institutes of Health.[74] The new vaccine relies on a strain of Ebola called EBOVΔVP30, which is unable to replicate.[60]
GamEvac-Combi
A study published in Human Vaccines & Immunotherapeutics in March 2017, analyzing data from a clinical trial of the GamEvac-Combi vaccine in Russia, concluded said vaccine to be safe and effective and recommended proceeding to Phase III trials.[75]
Prospects
In September 2019, a study published in Cell Reports demonstrated the role of the Ebola virus VP35 protein in its immune evasion. A recombinant form of Ebola virus with a mutant VP35 protein (VP35m) was developed, and showed positive results in the activation of the RIG-I-like receptor signaling. Non-human primates were challenged with different doses of VP35. This challenge resulted in the activation of the innate immune system and the production of anti-EBOV antibodies. The primates were then back-challenged with the wild type Ebola virus and survived. This potentially creates a prospect for a future vaccine development.[76]
Clinical trials in West Africa
In January 2015, Marie-Paule Kieny, the World Health Organization's (WHO) assistant director-general of health systems and innovation, announced that the vaccines cAd3-EBO Z and VSV-EBOV had demonstrated acceptable safety profiles during early testing and would soon progress to large-scale trials in Liberia, Sierra Leone, and Guinea. The trials would involve up to 27,000 people and comprise three groups – members of the first two groups would receive the two candidate vaccines, while the third group will receive a placebo.[77] Both vaccines have since successfully completed the Phase 2 studies. The large scale Phase 3 studies have begun as of April 2015[update], in Liberia and Sierra Leone,[24][67] and in Guinea in March 2016.[27]
In addition, a medical anthropologist at Université de Montréal, had been working in Guinea and raised further questions about safety in the ring trial after spending time in April at one of the Ebola treatment units where trial participants are taken if they become ill, the centre in Coyah, about 50 km from the capital of Conakry.[22]
The Russian Foreign Ministry announced in 2016, the intention to conduct field trials of two Russian vaccines involving 2000 people.[78] According to local media reports, the Guinean government authorized the commencement of the trials on 9 August 2017, at the Rusal-built Research and Diagnostic Center of Epidemiology and Microbiology in Kindia. The trials were slated to continue until 2018.[78][79] As of October 2019, Russia licensed the vaccine by local regulatory authorities and was reportedly ready to ship vaccine to Africa.[80]
U.S. national stockpile
In 2014,
See also
- Ebola virus disease
- Ebola virus disease treatment research
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Further reading
- Choi MJ, Cossaboom CM, Whitesell AN, Dyal JW, Joyce A, Morgan RL, et al. (January 2021). "Use of Ebola Vaccine: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020" (PDF). MMWR Recomm Rep. 70 (1): 1–12. (PDF) from the original on 20 March 2021. Retrieved 29 August 2021.
- Farooq F, Beck K, Paolino KM, Phillips R, Waters NC, Regules JA, Bergmann-Leitner ES (June 2016). "Circulating follicular T helper cells and cytokine profile in humans following vaccination with the rVSV-ZEBOV Ebola vaccine". Scientific Reports. 6: 27944. PMID 27323685.
- Sullivan N, Yang ZY, Nabel GJ (September 2003). "Ebola virus pathogenesis: implications for vaccines and therapies". Journal of Virology. 77 (18): 9733–7. PMID 12941881.
- Diakite I, Mooring EQ, Velásquez GE, Murray MB (August 2016). "Novel Ordered Stepped-Wedge Cluster Trial Designs for Detecting Ebola Vaccine Efficacy Using a Spatially Structured Mathematical Model". PLOS Neglected Tropical Diseases. 10 (8): e0004866. PMID 27509037.
- Cazares LH, Ward MD, Brueggemann EE, Kenny T, Demond P, Mahone CR, et al. (September 2016). "Development of a liquid chromatography high resolution mass spectrometry method for the quantitation of viral envelope glycoprotein in Ebola virus-like particle vaccine preparations". Clinical Proteomics. 13 (1): 18. PMID 27597813.
- Konduru K, Shurtleff AC, Bradfute SB, Nakamura S, Bavari S, Kaplan G (September 2016). "Ebolavirus Glycoprotein Fc Fusion Protein Protects Guinea Pigs against Lethal Challenge". PLOS ONE. 11 (9): e0162446. PMID 27622456.
- Cheng F, Murray JL, Zhao J, Sheng J, Zhao Z, Rubin DH (September 2016). "Systems Biology-Based Investigation of Cellular Antiviral Drug Targets Identified by Gene-Trap Insertional Mutagenesis". PLOS Computational Biology. 12 (9): e1005074. PMID 27632082.
- Olowookere SA, Abioye-Kuteyi EA, Adekanle O (November 2016). "Willingness to participate in Ebola viral disease vaccine trials and receive vaccination by health workers in a tertiary hospital in Ile-Ife, Southwest Nigeria". Vaccine. 34 (47): 5758–5761. PMID 27751640.
- Pavot V (December 2016). "Ebola virus vaccines: Where do we stand?". Clinical Immunology. 173: 44–49. PMID 27910805.
- The Wellcome Trust–CIDRAP Ebola Vaccine Team B (January 2017). Completing the development of Ebola vaccines: current status, remaining challenges, and recommendations. Center for Infectious Disease Research and Policy (CIDRAP) and Wellcome Trust. Archived (PDF) from the original on 18 January 2017. Retrieved 18 January 2017.
- Rosales-Mendoza S, Nieto-Gómez R, Angulo C (January 2017). "A Perspective on the Development of Plant-Made Vaccines in the Fight against Ebola Virus". Frontiers in Immunology. 8: 252. PMID 28344580.
External links
- "Ebola Vaccines". Drug Information Portal. U.S. National Library of Medicine.
- "Ebola Vaccine Information Statement". U.S. Centers for Disease Control and Prevention (CDC). June 2022.
- Ebola Vaccines at the U.S. National Library of Medicine Medical Subject Headings (MeSH)