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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.
McLean, Chelsea; Barry, Houreratou; Kieh, Mark; Anywaine, Zacchaeus; Tapima Rogers, Baimba; Doumbia, Seydou; Sirima, Sodiomon B; Serry-Bangura, Alimamy; Habib Beavogui, Abdoul; Gaddah, Auguste; Katwere, Michael; Hendriks, Jenny; Keshinro, Babajide; Eholie, Serge; Kibuuka, Hannah; Kennedy, Stephen B; Anzala, Omu; Samai, Mohamed; D'Ortenzio, Eric; Leigh, Bailah; Sow, Samba; Thiébaut, Rodolphe; Greenwood, Brian; Watson-Jones, Deborah; Douoguih, Macaya; Luhn, Kerstin; Robinson, Cynthia.
Affiliation
  • 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.
EBioMedicine ; 91: 104562, 2023 May.
Article in En | MEDLINE | ID: mdl-37099841
ABSTRACT

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 Q2 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.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Hemorrhagic Fever, Ebola / Ebola Vaccines / Ebolavirus Limits: Animals Language: En Journal: EBioMedicine Year: 2023 Document type: Article
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Hemorrhagic Fever, Ebola / Ebola Vaccines / Ebolavirus Limits: Animals Language: En Journal: EBioMedicine Year: 2023 Document type: Article