Humoral and cellular immune response induced by rVSVΔG-ZEBOV-GP vaccine among frontline workers during the 2013–2016 West Africa Ebola outbreak in Guinea
•We found rVSVΔG-ZEBOV-GP to be immunogenic at 28- and 180-days post vaccination.•At 28 days post-vaccination, seroresponse rate was higher in the high-risk group.•There is a significant pairwise correlation at 28 days post-vaccination between assays.•One dose of rVSVΔG-ZEBOV-GP induces a cellular r...
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| Vydané v: | Vaccine Ročník 38; číslo 31; s. 4877 - 4884 |
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| Hlavní autori: | , , , , , , , , , , , , , , , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | English |
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Elsevier Ltd
26.06.2020
Elsevier Limited Elsevier Science |
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| ISSN: | 0264-410X, 1873-2518, 1873-2518 |
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| Abstract | •We found rVSVΔG-ZEBOV-GP to be immunogenic at 28- and 180-days post vaccination.•At 28 days post-vaccination, seroresponse rate was higher in the high-risk group.•There is a significant pairwise correlation at 28 days post-vaccination between assays.•One dose of rVSVΔG-ZEBOV-GP induces a cellular response that increased with time.
As part of a Phase III trial with the Ebola vaccine rVSVΔG-ZEBOV-GP in Guinea, we invited frontline workers (FLWs) to participate in a sub-study to provide additional information on the immunogenicity of the vaccine.
We conducted an open‐label, non‐randomized, single-arm immunogenicity evaluation of one dose of rVSVΔG-ZEBOV-GP among healthy FLWs in Guinea. FLWs who refused vaccination were offered to participate as a control group. We followed participants for 84 days with a subset followed-up for 180 days. The primary endpoint was immune response, as measured by ELISA for ZEBOV-glycoprotein–specific antibodies (ELISA-GP) at 28 days. We also conducted neutralization, whole virion ELISA and enzyme-linked immunospot (ELISPOT) assay for cellular response.
A total of 1172 participants received one dose of vaccine and were followed-up for 84 days, among them 114 participants were followed-up for 180 days. Additionally, 99 participants were included in the control group and followed up for 180 days. Overall, 86.4% (95% CI 84.1–88.4) of vaccinated participants seroresponded at 28 days post-vaccination (ELISA- GP) with 65% of these seroresponding at 14 days post-vaccination. Among those who seroresponded at 28 days, 90.7% (95% CI 82.0–95.4) were still seropositive at 180 days. The proportion of seropositivity in the unvaccinated group was 0.0% (95% CI 0.0–3.8) at 28 days and 5.4% (95% CI 2.1–13.1) at 180 days post-vaccination. We found weak correlation between ELISA-GP and neutralization at baseline but significant pairwise correlation at 28 days post-vaccination. Among samples analysed for cellular response, only 1 (2.2%) exhibited responses towards the Zaire Ebola glycoprotein (Ebola GP ≥ 10) at baseline, 10 (13.5%) at day 28 post-vaccination and 27 (48.2%) at Day 180.
We found one dose of rVSVΔG-ZEBOV-GP to be highly immunogenic at 28- and 180-days post vaccination among frontline workers in Guinea. We also found a cellular response that increased with time. |
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| AbstractList | As part of a Phase III trial with the Ebola vaccine rVSVΔG-ZEBOV-GP in Guinea, we invited frontline workers (FLWs) to participate in a sub-study to provide additional information on the immunogenicity of the vaccine.
We conducted an open-label, non-randomized, single-arm immunogenicity evaluation of one dose of rVSVΔG-ZEBOV-GP among healthy FLWs in Guinea. FLWs who refused vaccination were offered to participate as a control group. We followed participants for 84 days with a subset followed-up for 180 days. The primary endpoint was immune response, as measured by ELISA for ZEBOV-glycoprotein-specific antibodies (ELISA-GP) at 28 days. We also conducted neutralization, whole virion ELISA and enzyme-linked immunospot (ELISPOT) assay for cellular response.
A total of 1172 participants received one dose of vaccine and were followed-up for 84 days, among them 114 participants were followed-up for 180 days. Additionally, 99 participants were included in the control group and followed up for 180 days. Overall, 86.4% (95% CI 84.1-88.4) of vaccinated participants seroresponded at 28 days post-vaccination (ELISA- GP) with 65% of these seroresponding at 14 days post-vaccination. Among those who seroresponded at 28 days, 90.7% (95% CI 82.0-95.4) were still seropositive at 180 days. The proportion of seropositivity in the unvaccinated group was 0.0% (95% CI 0.0-3.8) at 28 days and 5.4% (95% CI 2.1-13.1) at 180 days post-vaccination. We found weak correlation between ELISA-GP and neutralization at baseline but significant pairwise correlation at 28 days post-vaccination. Among samples analysed for cellular response, only 1 (2.2%) exhibited responses towards the Zaire Ebola glycoprotein (Ebola GP ≥ 10) at baseline, 10 (13.5%) at day 28 post-vaccination and 27 (48.2%) at Day 180.
We found one dose of rVSVΔG-ZEBOV-GP to be highly immunogenic at 28- and 180-days post vaccination among frontline workers in Guinea. We also found a cellular response that increased with time. • We found rVSVΔG-ZEBOV-GP to be immunogenic at 28- and 180-days post vaccination. • At 28 days post-vaccination, seroresponse rate was higher in the high-risk group. • There is a significant pairwise correlation at 28 days post-vaccination between assays. • One dose of rVSVΔG-ZEBOV-GP induces a cellular response that increased with time. As part of a Phase III trial with the Ebola vaccine rVSVΔG-ZEBOV-GP in Guinea, we invited frontline workers (FLWs) to participate in a sub-study to provide additional information on the immunogenicity of the vaccine.BACKGROUNDAs part of a Phase III trial with the Ebola vaccine rVSVΔG-ZEBOV-GP in Guinea, we invited frontline workers (FLWs) to participate in a sub-study to provide additional information on the immunogenicity of the vaccine.We conducted an open-label, non-randomized, single-arm immunogenicity evaluation of one dose of rVSVΔG-ZEBOV-GP among healthy FLWs in Guinea. FLWs who refused vaccination were offered to participate as a control group. We followed participants for 84 days with a subset followed-up for 180 days. The primary endpoint was immune response, as measured by ELISA for ZEBOV-glycoprotein-specific antibodies (ELISA-GP) at 28 days. We also conducted neutralization, whole virion ELISA and enzyme-linked immunospot (ELISPOT) assay for cellular response.METHODSWe conducted an open-label, non-randomized, single-arm immunogenicity evaluation of one dose of rVSVΔG-ZEBOV-GP among healthy FLWs in Guinea. FLWs who refused vaccination were offered to participate as a control group. We followed participants for 84 days with a subset followed-up for 180 days. The primary endpoint was immune response, as measured by ELISA for ZEBOV-glycoprotein-specific antibodies (ELISA-GP) at 28 days. We also conducted neutralization, whole virion ELISA and enzyme-linked immunospot (ELISPOT) assay for cellular response.A total of 1172 participants received one dose of vaccine and were followed-up for 84 days, among them 114 participants were followed-up for 180 days. Additionally, 99 participants were included in the control group and followed up for 180 days. Overall, 86.4% (95% CI 84.1-88.4) of vaccinated participants seroresponded at 28 days post-vaccination (ELISA- GP) with 65% of these seroresponding at 14 days post-vaccination. Among those who seroresponded at 28 days, 90.7% (95% CI 82.0-95.4) were still seropositive at 180 days. The proportion of seropositivity in the unvaccinated group was 0.0% (95% CI 0.0-3.8) at 28 days and 5.4% (95% CI 2.1-13.1) at 180 days post-vaccination. We found weak correlation between ELISA-GP and neutralization at baseline but significant pairwise correlation at 28 days post-vaccination. Among samples analysed for cellular response, only 1 (2.2%) exhibited responses towards the Zaire Ebola glycoprotein (Ebola GP ≥ 10) at baseline, 10 (13.5%) at day 28 post-vaccination and 27 (48.2%) at Day 180.RESULTSA total of 1172 participants received one dose of vaccine and were followed-up for 84 days, among them 114 participants were followed-up for 180 days. Additionally, 99 participants were included in the control group and followed up for 180 days. Overall, 86.4% (95% CI 84.1-88.4) of vaccinated participants seroresponded at 28 days post-vaccination (ELISA- GP) with 65% of these seroresponding at 14 days post-vaccination. Among those who seroresponded at 28 days, 90.7% (95% CI 82.0-95.4) were still seropositive at 180 days. The proportion of seropositivity in the unvaccinated group was 0.0% (95% CI 0.0-3.8) at 28 days and 5.4% (95% CI 2.1-13.1) at 180 days post-vaccination. We found weak correlation between ELISA-GP and neutralization at baseline but significant pairwise correlation at 28 days post-vaccination. Among samples analysed for cellular response, only 1 (2.2%) exhibited responses towards the Zaire Ebola glycoprotein (Ebola GP ≥ 10) at baseline, 10 (13.5%) at day 28 post-vaccination and 27 (48.2%) at Day 180.We found one dose of rVSVΔG-ZEBOV-GP to be highly immunogenic at 28- and 180-days post vaccination among frontline workers in Guinea. We also found a cellular response that increased with time.CONCLUSIONSWe found one dose of rVSVΔG-ZEBOV-GP to be highly immunogenic at 28- and 180-days post vaccination among frontline workers in Guinea. We also found a cellular response that increased with time. Highlights•We found rVSVΔG-ZEBOV-GP to be immunogenic at 28- and 180-days post vaccination. •At 28 days post-vaccination, seroresponse rate was higher in the high-risk group. •There is a significant pairwise correlation at 28 days post-vaccination between assays. •One dose of rVSVΔG-ZEBOV-GP induces a cellular response that increased with time. •We found rVSVΔG-ZEBOV-GP to be immunogenic at 28- and 180-days post vaccination.•At 28 days post-vaccination, seroresponse rate was higher in the high-risk group.•There is a significant pairwise correlation at 28 days post-vaccination between assays.•One dose of rVSVΔG-ZEBOV-GP induces a cellular response that increased with time. As part of a Phase III trial with the Ebola vaccine rVSVΔG-ZEBOV-GP in Guinea, we invited frontline workers (FLWs) to participate in a sub-study to provide additional information on the immunogenicity of the vaccine. We conducted an open‐label, non‐randomized, single-arm immunogenicity evaluation of one dose of rVSVΔG-ZEBOV-GP among healthy FLWs in Guinea. FLWs who refused vaccination were offered to participate as a control group. We followed participants for 84 days with a subset followed-up for 180 days. The primary endpoint was immune response, as measured by ELISA for ZEBOV-glycoprotein–specific antibodies (ELISA-GP) at 28 days. We also conducted neutralization, whole virion ELISA and enzyme-linked immunospot (ELISPOT) assay for cellular response. A total of 1172 participants received one dose of vaccine and were followed-up for 84 days, among them 114 participants were followed-up for 180 days. Additionally, 99 participants were included in the control group and followed up for 180 days. Overall, 86.4% (95% CI 84.1–88.4) of vaccinated participants seroresponded at 28 days post-vaccination (ELISA- GP) with 65% of these seroresponding at 14 days post-vaccination. Among those who seroresponded at 28 days, 90.7% (95% CI 82.0–95.4) were still seropositive at 180 days. The proportion of seropositivity in the unvaccinated group was 0.0% (95% CI 0.0–3.8) at 28 days and 5.4% (95% CI 2.1–13.1) at 180 days post-vaccination. We found weak correlation between ELISA-GP and neutralization at baseline but significant pairwise correlation at 28 days post-vaccination. Among samples analysed for cellular response, only 1 (2.2%) exhibited responses towards the Zaire Ebola glycoprotein (Ebola GP ≥ 10) at baseline, 10 (13.5%) at day 28 post-vaccination and 27 (48.2%) at Day 180. We found one dose of rVSVΔG-ZEBOV-GP to be highly immunogenic at 28- and 180-days post vaccination among frontline workers in Guinea. We also found a cellular response that increased with time. As part of a Phase III trial with the Ebola vaccine rVSVΔG-ZEBOV-GP in Guinea, we invited frontline workers (FLWs) to participate in a sub-study to provide additional information on the immunogenicity of the vaccine.We conducted an open‐label, non‐randomized, single-arm immunogenicity evaluation of one dose of rVSVΔG-ZEBOV-GP among healthy FLWs in Guinea. FLWs who refused vaccination were offered to participate as a control group. We followed participants for 84 days with a subset followed-up for 180 days. The primary endpoint was immune response, as measured by ELISA for ZEBOV-glycoprotein–specific antibodies (ELISA-GP) at 28 days. We also conducted neutralization, whole virion ELISA and enzyme-linked immunospot (ELISPOT) assay for cellular response.A total of 1172 participants received one dose of vaccine and were followed-up for 84 days, among them 114 participants were followed-up for 180 days. Additionally, 99 participants were included in the control group and followed up for 180 days. Overall, 86.4% (95% CI 84.1–88.4) of vaccinated participants seroresponded at 28 days post-vaccination (ELISA- GP) with 65% of these seroresponding at 14 days post-vaccination. Among those who seroresponded at 28 days, 90.7% (95% CI 82.0–95.4) were still seropositive at 180 days. The proportion of seropositivity in the unvaccinated group was 0.0% (95% CI 0.0–3.8) at 28 days and 5.4% (95% CI 2.1–13.1) at 180 days post-vaccination. We found weak correlation between ELISA-GP and neutralization at baseline but significant pairwise correlation at 28 days post-vaccination. Among samples analysed for cellular response, only 1 (2.2%) exhibited responses towards the Zaire Ebola glycoprotein (Ebola GP ≥ 10) at baseline, 10 (13.5%) at day 28 post-vaccination and 27 (48.2%) at Day 180.We found one dose of rVSVΔG-ZEBOV-GP to be highly immunogenic at 28- and 180-days post vaccination among frontline workers in Guinea. We also found a cellular response that increased with time. BackgroundAs part of a Phase III trial with the Ebola vaccine rVSVΔG-ZEBOV-GP in Guinea, we invited frontline workers (FLWs) to participate in a sub-study to provide additional information on the immunogenicity of the vaccine.MethodsWe conducted an open‐label, non‐randomized, single-arm immunogenicity evaluation of one dose of rVSVΔG-ZEBOV-GP among healthy FLWs in Guinea. FLWs who refused vaccination were offered to participate as a control group. We followed participants for 84 days with a subset followed-up for 180 days. The primary endpoint was immune response, as measured by ELISA for ZEBOV-glycoprotein–specific antibodies (ELISA-GP) at 28 days. We also conducted neutralization, whole virion ELISA and enzyme-linked immunospot (ELISPOT) assay for cellular response.ResultsA total of 1172 participants received one dose of vaccine and were followed-up for 84 days, among them 114 participants were followed-up for 180 days. Additionally, 99 participants were included in the control group and followed up for 180 days. Overall, 86.4% (95% CI 84.1–88.4) of vaccinated participants seroresponded at 28 days post-vaccination (ELISA- GP) with 65% of these seroresponding at 14 days post-vaccination. Among those who seroresponded at 28 days, 90.7% (95% CI 82.0–95.4) were still seropositive at 180 days. The proportion of seropositivity in the unvaccinated group was 0.0% (95% CI 0.0–3.8) at 28 days and 5.4% (95% CI 2.1–13.1) at 180 days post-vaccination. We found weak correlation between ELISA-GP and neutralization at baseline but significant pairwise correlation at 28 days post-vaccination. Among samples analysed for cellular response, only 1 (2.2%) exhibited responses towards the Zaire Ebola glycoprotein (Ebola GP ≥ 10) at baseline, 10 (13.5%) at day 28 post-vaccination and 27 (48.2%) at Day 180.ConclusionsWe found one dose of rVSVΔG-ZEBOV-GP to be highly immunogenic at 28- and 180-days post vaccination among frontline workers in Guinea. We also found a cellular response that increased with time. |
| Author | Strecker, Thomas Becker, Stephan Draguez, Bertrand Boum, Yap Kondé, Mandy Kader Grais, Rebecca F. Faga, Elisabetta Maria Halis, Bassam Kieny, Marie-Paule Cisse, Mohamed Clarck, Carolyn Hitchings, Matt Røttingen, John-Arne Juan-Giner, Aitana Doumbia, Moise Soumah, Aboubacar Tchaton, Marie Jemmy, Jean-Paul Gunnstein, Norheim Carroll, Miles Henao-Restrepo, Ana-Maria Cuthbertson, Hannah King, Deborah Hayes, Peter Sadjo, Mariama |
| Author_xml | – sequence: 1 givenname: Yap surname: Boum fullname: Boum, Yap organization: Epicentre, Yaoundé, Cameroon – sequence: 2 givenname: Aitana surname: Juan-Giner fullname: Juan-Giner, Aitana organization: Epicentre, Paris, France – sequence: 3 givenname: Matt surname: Hitchings fullname: Hitchings, Matt organization: Center for Communicable Disease Dynamics and Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, MA, USA – sequence: 4 givenname: Aboubacar surname: Soumah fullname: Soumah, Aboubacar organization: Epicentre, Paris, France – sequence: 5 givenname: Thomas surname: Strecker fullname: Strecker, Thomas organization: Institute of Virology, Philipps University, Marburg, Germany – sequence: 6 givenname: Mariama surname: Sadjo fullname: Sadjo, Mariama organization: Centre Hospital-Universitaire de Donka, Conakry, Guinea – sequence: 7 givenname: Hannah surname: Cuthbertson fullname: Cuthbertson, Hannah organization: Public Health England, National Infection Service, Porton Down, UK – sequence: 8 givenname: Peter surname: Hayes fullname: Hayes, Peter organization: Division of Medicine, Department of Infectious Diseases, Imperial College London, UK – sequence: 9 givenname: Marie surname: Tchaton fullname: Tchaton, Marie organization: Epicentre, Paris, France – sequence: 10 givenname: Jean-Paul surname: Jemmy fullname: Jemmy, Jean-Paul organization: Médecins Sans Frontières-Operational Center Belgium, Brussels, Belgium – sequence: 11 givenname: Carolyn surname: Clarck fullname: Clarck, Carolyn organization: Division of Infectious Disease Control, Norwegian Institute of Public Health, Oslo, Norway – sequence: 12 givenname: Deborah surname: King fullname: King, Deborah organization: Division of Medicine, Department of Infectious Diseases, Imperial College London, UK – sequence: 13 givenname: Elisabetta Maria surname: Faga fullname: Faga, Elisabetta Maria organization: Médecins Sans Frontières-Operational Center Belgium, Brussels, Belgium – sequence: 14 givenname: Stephan surname: Becker fullname: Becker, Stephan organization: Institute of Virology, Philipps University, Marburg, Germany – sequence: 15 givenname: Bassam surname: Halis fullname: Halis, Bassam organization: Public Health England, National Infection Service, Porton Down, UK – sequence: 16 givenname: Norheim orcidid: 0000-0002-1711-937X surname: Gunnstein fullname: Gunnstein, Norheim organization: Division of Infectious Disease Control, Norwegian Institute of Public Health, Oslo, Norway – sequence: 17 givenname: Miles surname: Carroll fullname: Carroll, Miles organization: Public Health England, National Infection Service, Porton Down, UK – sequence: 18 givenname: John-Arne surname: Røttingen fullname: Røttingen, John-Arne organization: Division of Infectious Disease Control, Norwegian Institute of Public Health, Oslo, Norway – sequence: 19 givenname: Mandy Kader surname: Kondé fullname: Kondé, Mandy Kader organization: Center of Excellence for Training, Research On Malaria & Priority Diseases In Guinea, Conakry, Guinea – sequence: 20 givenname: Moise surname: Doumbia fullname: Doumbia, Moise organization: World Health Organization, Geneva, Switzerland – sequence: 21 givenname: Ana-Maria surname: Henao-Restrepo fullname: Henao-Restrepo, Ana-Maria organization: World Health Organization, Geneva, Switzerland – sequence: 22 givenname: Marie-Paule surname: Kieny fullname: Kieny, Marie-Paule organization: World Health Organization, Geneva, Switzerland – sequence: 23 givenname: Mohamed surname: Cisse fullname: Cisse, Mohamed organization: Centre Hospital-Universitaire de Donka, Conakry, Guinea – sequence: 24 givenname: Bertrand surname: Draguez fullname: Draguez, Bertrand organization: Médecins Sans Frontières-Operational Center Belgium, Brussels, Belgium – sequence: 25 givenname: Rebecca F. orcidid: 0000-0002-5037-8218 surname: Grais fullname: Grais, Rebecca F. email: Rebecca.grais@epicentre.msf.org organization: Epicentre, Paris, France |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/32499066$$D View this record in MEDLINE/PubMed |
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| Copyright | 2020 The Author(s) The Author(s) Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved. 2020. The Author(s) 2020 The Author(s) 2020 |
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| DOI | 10.1016/j.vaccine.2020.04.066 |
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| Keywords | Humoral response Frontline workers Immunogenicity Ebola vaccine Cellular response |
| Language | English |
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Med doi: 10.1056/NEJMoa1414216 – volume: 24 start-page: 1050 issue: 4 year: 2018 ident: 10.1016/j.vaccine.2020.04.066_b0060 article-title: Qualitative profiling of the humoral immune response elicited by rVSV-ΔG-EBOV-GP using a systems serology assay, domain programmable arrays publication-title: Cell Rep doi: 10.1016/j.celrep.2018.06.077 – volume: 10 issue: 3 year: 2019 ident: 10.1016/j.vaccine.2020.04.066_b0100 article-title: Antiviral innate responses induced by VSV-EBOV vaccination contribute to rapid protection publication-title: mBio doi: 10.1128/mBio.00597-19 – volume: 215 start-page: 287 issue: 2 year: 2017 ident: 10.1016/j.vaccine.2020.04.066_b0090 article-title: Comprehensive characterization of cellular immune responses following ebola virus infection publication-title: J Infect Dis – volume: 19 start-page: 107 year: 2017 ident: 10.1016/j.vaccine.2020.04.066_b0035 article-title: Dose-dependent T-cell dynamics and cytokine cascade following rVSV-ZEBOV immunization 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| Snippet | •We found rVSVΔG-ZEBOV-GP to be immunogenic at 28- and 180-days post vaccination.•At 28 days post-vaccination, seroresponse rate was higher in the high-risk... Highlights•We found rVSVΔG-ZEBOV-GP to be immunogenic at 28- and 180-days post vaccination. •At 28 days post-vaccination, seroresponse rate was higher in the... As part of a Phase III trial with the Ebola vaccine rVSVΔG-ZEBOV-GP in Guinea, we invited frontline workers (FLWs) to participate in a sub-study to provide... BackgroundAs part of a Phase III trial with the Ebola vaccine rVSVΔG-ZEBOV-GP in Guinea, we invited frontline workers (FLWs) to participate in a sub-study to... • We found rVSVΔG-ZEBOV-GP to be immunogenic at 28- and 180-days post vaccination. • At 28 days post-vaccination, seroresponse rate was higher in the high-risk... |
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| SubjectTerms | Africa, Western - epidemiology Allergy and Immunology Antibodies Antibodies, Viral Antigens cell-mediated immunity Cellular response Clinical trials Democratic Republic of the Congo Disease Outbreaks Ebola vaccine Ebola Vaccines Ebola virus Ebolavirus Enzyme-linked immunosorbent assay Enzymes Frontline workers Glycoproteins Guinea Guinea - epidemiology Health services Hemorrhagic Fever, Ebola - epidemiology Hemorrhagic Fever, Ebola - prevention & control Humans Humoral response Immune response Immune response (cell-mediated) Immune response (humoral) Immune system Immunity, Cellular Immunogenicity Immunology Laboratories Neutralization Public health seroprevalence Vaccination Vaccines virion Virions Virology Workers |
| Title | Humoral and cellular immune response induced by rVSVΔG-ZEBOV-GP vaccine among frontline workers during the 2013–2016 West Africa Ebola outbreak in Guinea |
| URI | https://www.clinicalkey.com/#!/content/1-s2.0-S0264410X20305831 https://www.clinicalkey.es/playcontent/1-s2.0-S0264410X20305831 https://dx.doi.org/10.1016/j.vaccine.2020.04.066 https://www.ncbi.nlm.nih.gov/pubmed/32499066 https://www.proquest.com/docview/2425699124 https://www.proquest.com/docview/2410350774 https://www.proquest.com/docview/2551999303 https://pubmed.ncbi.nlm.nih.gov/PMC7306162 |
| Volume | 38 |
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