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Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries
INTRODUCTION: The Ebola virus disease (EVD) outbreak in 2014–2016 in West Africa was the largest on record and provided an opportunity for large clinical trials and accelerated efforts to develop an effective and safe preventative vaccine. Multiple questions regarding the safety, immunogenicity, and...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7823170/ https://www.ncbi.nlm.nih.gov/pubmed/33485369 http://dx.doi.org/10.1186/s13063-021-05035-9 |
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author | Badio, Moses Lhomme, Edouard Kieh, Mark Beavogui, Abdoul Habib Kennedy, Stephen B. Doumbia, Seydou Leigh, Bailah Sow, Samba O. Diallo, Alpha Fusco, Daniela Kirchoff, Matthew Termote, Monique Vatrinet, Renaud Wentworth, Deborah Esperou, Helène Lane, H. Clifford Pierson, Jerome Watson-Jones, Deborah Roy, Céline D’Ortenzio, Eric Greenwood, Brian Chêne, Genevieve Richert, Laura Neaton, James D. Yazdanpanah, Yazdan |
author_facet | Badio, Moses Lhomme, Edouard Kieh, Mark Beavogui, Abdoul Habib Kennedy, Stephen B. Doumbia, Seydou Leigh, Bailah Sow, Samba O. Diallo, Alpha Fusco, Daniela Kirchoff, Matthew Termote, Monique Vatrinet, Renaud Wentworth, Deborah Esperou, Helène Lane, H. Clifford Pierson, Jerome Watson-Jones, Deborah Roy, Céline D’Ortenzio, Eric Greenwood, Brian Chêne, Genevieve Richert, Laura Neaton, James D. Yazdanpanah, Yazdan |
author_sort | Badio, Moses |
collection | PubMed |
description | INTRODUCTION: The Ebola virus disease (EVD) outbreak in 2014–2016 in West Africa was the largest on record and provided an opportunity for large clinical trials and accelerated efforts to develop an effective and safe preventative vaccine. Multiple questions regarding the safety, immunogenicity, and efficacy of EVD vaccines remain unanswered. To address these gaps in the evidence base, the Partnership for Research on Ebola Vaccines (PREVAC) trial was designed. This paper describes the design, methods, and baseline results of the PREVAC trial and discusses challenges that led to different protocol amendments. METHODS: This is a randomized, double-blind, placebo-controlled phase 2 clinical trial of three vaccine strategies against the Ebola virus in healthy volunteers 1 year of age and above. The three vaccine strategies being studied are the rVSVΔG-ZEBOV-GP vaccine, with and without a booster dose at 56 days, and the Ad26.ZEBOV,MVA-FN-Filo vaccine regimen with Ad26.ZEBOV given as the first dose and the MVA-FN-Filo vaccination given 56 days later. There have been 4 versions of the protocol with those enrolled in Version 4.0 comprising the primary analysis cohort. The primary endpoint is based on the antibody titer against the Ebola virus surface glycoprotein measured 12 months following the final injection. RESULTS: From April 2017 to December 2018, a total of 5002 volunteers were screened and 4789 enrolled. Participants were enrolled at 6 sites in four countries (Guinea, Liberia, Sierra Leone, and Mali). Of the 4789 participants, 2560 (53%) were adults and 2229 (47%) were children. Those < 18 years of age included 549 (12%) aged 1 to 4 years, 750 (16%) 5 to 11 years, and 930 (19%) aged 12–17 years. At baseline, the median (25th, 75th percentile) antibody titer to Ebola virus glycoprotein for 1090 participants was 72 (50, 116) EU/mL. DISCUSSION: The PREVAC trial is evaluating—placebo-controlled—two promising Ebola candidate vaccines in advanced stages of development. The results will address unanswered questions related to short- and long-term safety and immunogenicity for three vaccine strategies in adults and children. TRIAL REGISTRATION: ClinicalTrials.gov NCT02876328. Registered on 23 August 2016. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05035-9. |
format | Online Article Text |
id | pubmed-7823170 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-78231702021-01-25 Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries Badio, Moses Lhomme, Edouard Kieh, Mark Beavogui, Abdoul Habib Kennedy, Stephen B. Doumbia, Seydou Leigh, Bailah Sow, Samba O. Diallo, Alpha Fusco, Daniela Kirchoff, Matthew Termote, Monique Vatrinet, Renaud Wentworth, Deborah Esperou, Helène Lane, H. Clifford Pierson, Jerome Watson-Jones, Deborah Roy, Céline D’Ortenzio, Eric Greenwood, Brian Chêne, Genevieve Richert, Laura Neaton, James D. Yazdanpanah, Yazdan Trials Study Protocol INTRODUCTION: The Ebola virus disease (EVD) outbreak in 2014–2016 in West Africa was the largest on record and provided an opportunity for large clinical trials and accelerated efforts to develop an effective and safe preventative vaccine. Multiple questions regarding the safety, immunogenicity, and efficacy of EVD vaccines remain unanswered. To address these gaps in the evidence base, the Partnership for Research on Ebola Vaccines (PREVAC) trial was designed. This paper describes the design, methods, and baseline results of the PREVAC trial and discusses challenges that led to different protocol amendments. METHODS: This is a randomized, double-blind, placebo-controlled phase 2 clinical trial of three vaccine strategies against the Ebola virus in healthy volunteers 1 year of age and above. The three vaccine strategies being studied are the rVSVΔG-ZEBOV-GP vaccine, with and without a booster dose at 56 days, and the Ad26.ZEBOV,MVA-FN-Filo vaccine regimen with Ad26.ZEBOV given as the first dose and the MVA-FN-Filo vaccination given 56 days later. There have been 4 versions of the protocol with those enrolled in Version 4.0 comprising the primary analysis cohort. The primary endpoint is based on the antibody titer against the Ebola virus surface glycoprotein measured 12 months following the final injection. RESULTS: From April 2017 to December 2018, a total of 5002 volunteers were screened and 4789 enrolled. Participants were enrolled at 6 sites in four countries (Guinea, Liberia, Sierra Leone, and Mali). Of the 4789 participants, 2560 (53%) were adults and 2229 (47%) were children. Those < 18 years of age included 549 (12%) aged 1 to 4 years, 750 (16%) 5 to 11 years, and 930 (19%) aged 12–17 years. At baseline, the median (25th, 75th percentile) antibody titer to Ebola virus glycoprotein for 1090 participants was 72 (50, 116) EU/mL. DISCUSSION: The PREVAC trial is evaluating—placebo-controlled—two promising Ebola candidate vaccines in advanced stages of development. The results will address unanswered questions related to short- and long-term safety and immunogenicity for three vaccine strategies in adults and children. TRIAL REGISTRATION: ClinicalTrials.gov NCT02876328. Registered on 23 August 2016. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05035-9. BioMed Central 2021-01-23 /pmc/articles/PMC7823170/ /pubmed/33485369 http://dx.doi.org/10.1186/s13063-021-05035-9 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Badio, Moses Lhomme, Edouard Kieh, Mark Beavogui, Abdoul Habib Kennedy, Stephen B. Doumbia, Seydou Leigh, Bailah Sow, Samba O. Diallo, Alpha Fusco, Daniela Kirchoff, Matthew Termote, Monique Vatrinet, Renaud Wentworth, Deborah Esperou, Helène Lane, H. Clifford Pierson, Jerome Watson-Jones, Deborah Roy, Céline D’Ortenzio, Eric Greenwood, Brian Chêne, Genevieve Richert, Laura Neaton, James D. Yazdanpanah, Yazdan Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries |
title | Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries |
title_full | Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries |
title_fullStr | Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries |
title_full_unstemmed | Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries |
title_short | Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries |
title_sort | partnership for research on ebola vaccination (prevac): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against ebola in healthy volunteers in four west african countries |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7823170/ https://www.ncbi.nlm.nih.gov/pubmed/33485369 http://dx.doi.org/10.1186/s13063-021-05035-9 |
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