Immune response of a two-dose heterologous Ebola vaccine regimen: summary of three African clinical trials using a single validated Filovirus Animal Nonclinical Group enzyme-linked immunosorbent assay in a single accredited laboratory.

Autor: McLean C; Janssen Vaccines and Prevention BV, Leiden, the Netherlands. Electronic address: cmclean@its.jnj.com., Barry H; Centre MURAZ, Bobo-Dioulasso, Burkina Faso., Kieh M; Partnership for Research on Ebola Virus in Liberia (PREVAIL), Monrovia, Liberia., Anywaine Z; Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda., Tapima Rogers B; University of Sierra Leone, Freetown, Sierra Leone., Doumbia S; University Clinical Research Center, University of Sciences, Technique and Technology of Bamako, Bamako, Mali., Sirima SB; Groupe de Recherche Action en Santé (GRAS), Ouagadougou, Burkina Faso., Serry-Bangura A; University of Sierra Leone, Freetown, Sierra Leone., Habib Beavogui A; Centre National de Formation et de Recherche en Santé Rurale de Mafèrinyah, Mafèrinyah, Guinea., Gaddah A; Janssen Research and Development, Beerse, Belgium., Katwere M; Janssen Vaccines and Prevention BV, Leiden, the Netherlands., Hendriks J; Janssen Vaccines and Prevention BV, Leiden, the Netherlands., Keshinro B; Janssen Vaccines and Prevention BV, Leiden, the Netherlands., Eholie S; Medical School, University Felix Houphouet Boigny, Abidjan, Cote d'Ivoire., Kibuuka H; Makerere University Walter Reed Project, Kampala, Uganda., Kennedy SB; Partnership for Research on Ebola Virus in Liberia (PREVAIL), Monrovia, Liberia., Anzala O; Kenya AIDS Vaccine Initiative (KAVI), University of Nairobi, Nairobi, Kenya., Samai M; University of Sierra Leone, Freetown, Sierra Leone., D'Ortenzio E; ANRS Emerging Infectious Diseases, Institut national de la santé et de la recherche médicale (Inserm), Paris, France., Leigh B; University of Sierra Leone, Freetown, Sierra Leone., Sow S; Centre pour le Développement des Vaccins, Bamako, Mali., Thiébaut R; University of Bordeaux, Inserm, Bordeaux Population Health Research Center, Bordeaux, France., Greenwood B; London School of Hygiene and Tropical Medicine, London, UK., Watson-Jones D; London School of Hygiene and Tropical Medicine, London, UK; Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania., Douoguih M; Janssen Vaccines and Prevention BV, Leiden, the Netherlands., Luhn K; Janssen Vaccines and Prevention BV, Leiden, the Netherlands., Robinson C; Janssen Vaccines and Prevention BV, Leiden, the Netherlands.
Jazyk: angličtina
Zdroj: EBioMedicine [EBioMedicine] 2023 May; Vol. 91, pp. 104562. Date of Electronic Publication: 2023 Apr 24.
DOI: 10.1016/j.ebiom.2023.104562
Abstrakt: Background: This analysis evaluated the immune response to the two-dose, heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola virus vaccine regimen, administered 56-days apart, from multiple African sites based on results from one analytic laboratory.
Methods: Immunogenicity across three trials (EBL2002, EBL2004/PREVAC, EBL3001) conducted in East and West Africa is summarised. Vaccine-induced Ebola glycoprotein-binding antibody concentrations were analysed by Q 2 Solutions laboratory at baseline, 21 days (EBL2002 and EBL3001) or 28 days (EBL2004) post-dose 2 (regimen completion), and 12 months post-dose 1 using the validated Filovirus Animal Nonclinical Group Ebola glycoprotein enzyme-linked immunosorbent assay (ELISA). Responders were defined as those with a >2.5-fold increase from baseline or the lower limit of quantification (LLOQ) if Findings: At 21 or 28 (21/28) days post-dose 2, the geometric mean concentration (GMC) range was 3810-7518 ELISA units (EU)/mL (percent responders: ≥98%) in adults, 9929-13532 EU/mL (≥98%) in adolescents aged 12-17 years, 10,212-17388 EU/mL (≥99%) in older children, and 22,568-25111 EU/mL (≥98%) in younger children. When stratified by country, GMCs at 21/28 days post-dose 2 were generally similar among adults and within paediatric cohorts (percent responders: 95%-100%). At month 12, GMC range was 259-437 EU/mL (percent responders: 49%-88%) in adults and 386-1139 EU/mL (70%-100%) in paediatric participants.
Interpretation: Based on data from a single laboratory using a single validated assay, Ad26.ZEBOV, MVA-BN-Filo induced a strong humoral immune response, with ≥95% of participants across countries classified as responders at 21/28 days post-dose 2 (regimen completion), regardless of age.
Funding: Janssen Vaccines & Prevention BV; Innovative Medicines Initiative.
Competing Interests: Declaration of interests CM, AG, JH, BK, MD, KL, and CR were full-time employees of Janssen Pharmaceuticals at the time of the study and report stock or stock options in Janssen Pharmaceuticals. HB's institution has received funding from the Innovative Medicines Initiative to conduct the EBL2002 study. M Katwere was a full-time employee of Janssen Pharmaceuticals at the time of the study. SE's institution has received funding from Inserm France to conduct the EBL2002 study. BL's institution has received funding from the Innovative Medicines Initiative to conduct the EBL3005 study. DW-J is a consortia partner with Janssen Pharmaceuticals on EBOVAC1 and EBOVAC3 projects, has received Ad26.MVA Ebola vaccines donated by Janssen Pharmaceuticals for clinical trials under EBOVAC1 and EBOVAC3 projects, and her institution has received funding from the Innovative Medicines Initiative to conduct the EBL3005 study. M Kieh, ZA, BTR, SD, SBS, AS-B, AHB, HK, SBK, OA, MS, EDO, SS, RT, and BG declare no competing interests.
(Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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