Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in infants: a phase 2, randomised, double-blind, active-controlled trial in Guinea and Sierra Leone - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue The Lancet global health Année : 2023

Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in infants: a phase 2, randomised, double-blind, active-controlled trial in Guinea and Sierra Leone

Edward Man-Lik Choi
  • Fonction : Auteur
Boris Lacarra
  • Fonction : Auteur
Muhammed O Afolabi
  • Fonction : Auteur
Boni Maxime Ale
  • Fonction : Auteur
Frank Baiden
  • Fonction : Auteur
Christine Betard
  • Fonction : Auteur
Julie Foster
  • Fonction : Auteur
Benjamin Hamze
  • Fonction : Auteur
Daniela Manno
  • Fonction : Auteur
Eric d'Ortenzio
  • Fonction : Auteur
David Ishola
  • Fonction : Auteur
Cheick Mohamed Keita
  • Fonction : Auteur
Babajide Keshinro
  • Fonction : Auteur
Yusupha Njie
  • Fonction : Auteur
Wim van Dijck
  • Fonction : Auteur
Auguste Gaddah
  • Fonction : Auteur
Dickson Anumendem
  • Fonction : Auteur
Brett Lowe
  • Fonction : Auteur
Renaud Vatrinet
  • Fonction : Auteur
Bolarinde Joseph Lawal
  • Fonction : Auteur
Godfrey T Otieno
  • Fonction : Auteur
Mohamed Samai
  • Fonction : Auteur
Gibrilla Fadlu Deen
  • Fonction : Auteur
Ibrahim Bob Swaray
  • Fonction : Auteur
Abu Bakarr Kamara
  • Fonction : Auteur
Michael Morlai Kamara
  • Fonction : Auteur
Mame Aminata Diagne
  • Fonction : Auteur
Dickens Kowuor
  • Fonction : Auteur
Chelsea Mclean
  • Fonction : Auteur
Bailah Leigh
  • Fonction : Auteur
Abdoul Habib Beavogui
  • Fonction : Auteur
Maarten Leyssen
  • Fonction : Auteur
Kerstin Luhn
  • Fonction : Auteur
Cynthia Robinson
  • Fonction : Auteur
Macaya Douoguih
  • Fonction : Auteur
Brian Greenwood
  • Fonction : Auteur
Deborah Watson-Jones
  • Fonction : Auteur

Résumé

Background This study assessed the safety and immunogenicity of the Ad26.ZEBOV and MVA-BN-Filo Ebola virus (EBOV) vaccine regimen in infants aged 4-11 months in Guinea and Sierra Leone. Methods In this phase 2, randomised, double-blind, active-controlled trial, we randomly assigned healthy infants (1:1 in a sentinel cohort, 5:2 for the remaining infants via an interactive web response system) to receive Ad26.ZEBOV followed by MVA-BN-Filo (Ebola vaccine group) or two doses of meningococcal quadrivalent conjugate vaccine (control group) administered 56 days apart. Infants were recruited at two sites in west Africa: Conakry, Guinea, and Kambia, Sierra Leone. All infants received the meningococcal vaccine 8 months after being randomly assigned. The primary objective was safety. The secondary objective was immunogenicity, measured as EBOV glycoprotein-binding antibody concentration 21 days post-dose 2, using the Filovirus Animal Non-Clinical Group ELISA. This study is registeredwithClinicalTrials.gov (NCT03929757) and the Pan African Clinical Trials Registry (PACTR201905827924069).Findings From Aug 20 to Nov 29, 2019, 142 infants were screened and 108 were randomly assigned (Ebola vaccine n=75; control n=33). The most common solicited local adverse event was injection-site pain (Ebola vaccine 15 [20%] of 75; control four [12%] of 33). The most common solicited systemic adverse events with the Ebola vaccine were irritability (26 [35%] of 75), decreased appetite (18 [24%] of 75), pyrexia (16 [21%] of 75), and decreased activity (15 [20%] of 75). In the control group, ten (30%) of 33 had irritability, seven (21%) of 33 had decreased appetite, three (9%) of 33 had pyrexia, and five (15%) of 33 had decreased activity. The frequency of unsolicited adverse events was 83% (62 of 75 infants) in the Ebola vaccine group and 85% (28 of 33 infants) in the control group. No serious adverse events were vaccine-related. In the Ebola vaccine group, EBOV glycoprotein-binding antibody geometric mean concentrations (GMCs) at 21 days post -dose 2 were 27 700 ELISA units (EU)/mL (95% CI 20 477-37 470) in infants aged 4-8 months and 20 481 EU/mL (15 325- 27 372) in infants aged 9-11 months. The responder rate was 100% (74 of 74 responded). In the control group, GMCs for both age groups were less than the lower limit of quantification and the responder rate was 3% (one of 33 responded).Interpretation Ad26.ZEBOV and MVA-BN-Filo was well tolerated and induced strong humoral responses in infants younger than 1 year. There were no safety concerns related to vaccination.
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hal-04384862 , version 1 (10-01-2024)

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Edward Man-Lik Choi, Boris Lacarra, Muhammed O Afolabi, Boni Maxime Ale, Frank Baiden, et al.. Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in infants: a phase 2, randomised, double-blind, active-controlled trial in Guinea and Sierra Leone. The Lancet global health, 2023, 11 (11), pp.e1743-e1752. ⟨10.1016/S2214-109X(23)00410-2⟩. ⟨hal-04384862⟩

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