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 - Archive ouverte HAL Access content directly
Journal Articles Trials Year : 2021

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

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Moses Badio
  • Function : Author
Mark Kieh
  • Function : Author
Stephen Kennedy
  • Function : Author
Daniela Fusco
  • Function : Author
Matthew Kirchoff
  • Function : Author
Renaud Vatrinet
  • Function : Author
H. Clifford Lane
  • Function : Author
Céline Roy
  • Function : Author
Genevieve Chêne
  • Function : Author
Laura Richert
James Neaton
  • Function : Author
Yazdan Yazdanpanah
  • Function : Author
Coulibaly Abdoulaye
  • Function : Author
Jamilia Aboulhab
  • Function : Author
Pauline Akoo
  • Function : Author
Esther Akpa
  • Function : Author
Robert Akpata
  • Function : Author
Sara Albert
  • Function : Author
Boni Maxime Ale
  • Function : Author
Benetta C. Andrews
  • Function : Author
Stephane Anoma
  • Function : Author
Saw-San Assiandi
  • Function : Author
Augustin Augier
  • Function : Author
Ken Awuondo
  • Function : Author
Aminata Bagayoko
  • Function : Author
Nyasha Bakare
  • Function : Author
Abby Balde
  • Function : Author
Lamin Molecule Bangura
  • Function : Author
Kesha Barrington
  • Function : Author
Eric Barte de Saint Fare
  • Function : Author
Beth Baseler
  • Function : Author
Ali Bauder
  • Function : Author
Claire Bauduin
  • Function : Author
Luke Bawo
  • Function : Author
Abdoul Habib Beavogui
  • Function : Author
Michael Belson
  • Function : Author
Marion Bererd
  • Function : Author
Teedoh Beyslow
  • Function : Author
Blandine Binachon
  • Function : Author
Julie Blie
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Viki Bockstal
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Youba Boire
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Patricia Boison
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Fatorma Bolay
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Aliou Boly
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Anne Gael Borg
  • Function : Author
Donna Bowers
  • Function : Author
Sarah Browne
  • Function : Author
Barbara Cagniard
  • Function : Author
Kelly Cahill
  • Function : Author
Aissata Abdoulaye Camara
  • Function : Author
Keira Camara
  • Function : Author
Modet Camara
  • Function : Author
Cécilia Campion
  • Function : Author
Jennifer Cash
  • Function : Author
Siew Pin Chai
  • Function : Author
Francois Chambelin
  • Function : Author
Keita Chieck
  • Function : Author
Séverine Ciancia
  • Function : Author
Papa Ndiaga Cisse
  • Function : Author
Elfrida Clide
  • Function : Author
Céline Colin
  • Function : Author
Beth-Ann Coller
  • Function : Author
Djélikan Siaka Conde
  • Function : Author
Katherine Cone
  • Function : Author
Laurie Connor
  • Function : Author
Nicholas Connor
  • Function : Author
Joseph Boye Cooper
  • Function : Author
Sandrine Couffin-Cardiergues
  • Function : Author
Fatoumata Coulibaly
  • Function : Author
Mariam Coulibaly
  • Function : Author
Sandrine Dabakuyo-Yonli
  • Function : Author
Djeneba Dabitao
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Thierry Damerval
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Bionca Davis
  • Function : Author
Gibrilla Fadlu Deen
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Eline Dekeyster
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Jean-François Delfraissy
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Christelle Delmas
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Rokia Dembele
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Mahamadou Diakite
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Mamadou Saliou Diallo
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Ayouba Diarra
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Oualy Diawara
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Bonnie Dighero-Kemp
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Samba Diop
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Waly Diouf
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Laurie Doepel
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Moussa Moise Doumbia
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Macaya Douoguih
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Alain Duchêne
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Michael Duvenhage
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Risa Eckes Eckes
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Avril Egan
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Luisa Enria
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Cécile Etienne
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Allison Eyler
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Sylvain Faye
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José Fernandez
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Suzanne Fleck
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Vemy Fofana
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Kokulo Franklin
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Auguste Gaddah
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Marylène Gaignet
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Katherine Gallagher
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Julia Garcia Gozalbes
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Greg Grandits
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Maima Gray
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Astrid Greijer
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Louis Grue
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Birgit Grund
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Oumar Guindo
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Swati Gupta
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Fadima Haidara
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Benjamin Hamze
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Emma Hancox
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Gavin Hart
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Jean-Christophe Hébert
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Esther Heijnen
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Patricia Hensley
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Lisa Hensley
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Elisabeth Higgs
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Trudi Hilton
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Preston Holley
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Marie Hoover
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Natasha Howard
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Melissa Hughes
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Dicko Ilo
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Jen Imes
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Skip Irvine
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David Ishola
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Will Jacob
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Yvonne Jato
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Melvin Johnson
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Morrison Jusu
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Aboubacar Sidiki Kaba
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Myriam Kante
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Judith Katoudi
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Sakoba Keita
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Babajide Jide Keshinro
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Brian Khon
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Hassan Kiawu
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Matt Kirchoff
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Mamoudou Kodio
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Lamine Koivogui
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Tania Kombi
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Stacy Kopka
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Dickens Kowuors
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Christine Lacabaratz
Boris Lacarra
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Laurie Lambert
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Cliff Lane
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Shona Lee
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Shelley Lees
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Annabelle Lefevre
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Frederic Lemarcis
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Yves Lévy
Claire Levy-Marchal
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Jemilla Lewally
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Maarten Leyssen
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Ken Liu
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Brett Lowe
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Julia Lysander
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Claire Madelaine
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Ibrah Mahamadou
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Daniela Manno
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Johnathan Marchand
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Siegfried Marynissen
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Moses B.F. Massaquoi
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Laure Masson
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Charly Matard
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Onorato Matthew
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John Mccullough
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Noemie Mercier
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Pauline Michavila
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Tracey Miller
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Alejandra Miranda
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Soumaya Mohamed
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Tom Mooney
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Hans Morsch
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Dally Muamba
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Rita Lukoo Ndamenyaa
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Désiré Neboua
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Micki Nelson
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Kevin Newell
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Vinh-Kim Nguyen
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Leslie Nielsen
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Millimouno Niouma
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Kim Offergeld
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Matthew Onorato
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Uma Onwuchekwa
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Susan Orsega
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Inmaculada Ortega-Perez
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Cynthia Osborne
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Tuda Otieno
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Sushma Patel
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Nathan Peiffer-Smadj
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Robert Phillips
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Peter Piot
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Micheal Piziali
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Stephany Pong
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Calvin Proffitt
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Alexandre Quach
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Corina Ramers-Verhoeven
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Nadeeka Randunu
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Priscille Rivière
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Cynthia Robinson
Griet van Roey
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Amy Falk Russell
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Mohamed Samai, Sibiry Samake
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Ballan Sangare
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Ibrahim Sanogo
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Yeya Sadio Sarro
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Sadio Sarro
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Mélanie Saville
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Serge Sawadogo
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Maxime Schvartz
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Christine Schwimmer
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Fatou Secka
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Jacques Seraphin
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Denise Shelley
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Sophia Siddiqui
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Jakub Simon
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Shelly Simpson
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Billy Muyisa Sivahera
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Irvine Skip
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Karen Slater
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Mary Smolskis
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Elizabeth Smout
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Emily Snowden
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Anne-Aygline Soutthiphong
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Ydrissa Sow
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Daniel Splinter
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Simone Spreng
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Helen Stapleton
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Jeroen Stoop
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Mary Sweeney
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Sienneh Tamba
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Mili Tapia
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Jemee Tegli
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Rodolphe Thiebaut
Greg Thompson
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John Tierney
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Abdoulaye Touré
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Stacey Traina
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Awa Traore
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Moussa Traore
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Tijili Tyee
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David Vallée
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Katrien van Der Donck
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Nadia Verbruggen
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Corine Vincent
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Susan Vogel
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Cedrick Wallet
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Cecelia Wesseh
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Jimmy Whitworth
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Aurelie Wiedemann
Wouter Willems
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Julian Williams
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Barthalomew Wilson
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Njoh Wissedi
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Jayanthi Wolf
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Ian Woods
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Alie Wurie
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Delphine Yamadjako
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Marcel Yaradouno
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Zara Zeggani
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Abstract

Abstract 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.

Dates and versions

hal-03526667 , version 1 (14-01-2022)

Identifiers

Cite

Moses Badio, Edouard Lhomme, Mark Kieh, Abdoul Habib Beavogui, Stephen Kennedy, et al.. 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. Trials, 2021, 22 (1), pp.86. ⟨10.1186/s13063-021-05035-9⟩. ⟨hal-03526667⟩

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