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.
Ad26.ZEBOV
Africa
Ebola
MVA-BN-Filo
Vaccine
Journal
EBioMedicine
ISSN: 2352-3964
Titre abrégé: EBioMedicine
Pays: Netherlands
ID NLM: 101647039
Informations de publication
Date de publication:
May 2023
May 2023
Historique:
received:
01
09
2022
revised:
24
03
2023
accepted:
28
03
2023
medline:
15
5
2023
pubmed:
27
4
2023
entrez:
26
4
2023
Statut:
ppublish
Résumé
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. 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 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. 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. Janssen Vaccines & Prevention BV; Innovative Medicines Initiative.
Sections du résumé
BACKGROUND
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
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
FINDINGS
RESULTS
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
CONCLUSIONS
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
BACKGROUND
Janssen Vaccines & Prevention BV; Innovative Medicines Initiative.
Identifiants
pubmed: 37099841
pii: S2352-3964(23)00127-5
doi: 10.1016/j.ebiom.2023.104562
pmc: PMC10149382
pii:
doi:
Substances chimiques
Antibodies, Viral
0
Ebola Vaccines
0
Glycoproteins
0
Types de publication
Clinical Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
104562Subventions
Organisme : FIC NIH HHS
ID : D43 TW011818
Pays : United States
Informations de copyright
Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
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.