Replication, safety and immunogenicity of the vectored Ebola vaccine rVSV-ΔG-ZEBOV-GP in a sub-Saharan African paediatric population: A randomised controlled, open-label trial in children aged 1-12 years living in Lambaréné, Gabon - 17/09/24
VSV-EBOPLUS Consortium1
Summary |
Background |
Unlike adults, children experienced stronger and longer vector replication in plasma and shedding in saliva following rVSVΔG-ZEBOV-GP vaccination. The resulting risks of immunosuppression or immune hyperactivation leading to increased Adverse Events (AEs) and altered antibody responses are concerns that have been addressed in the present manuscript.
Methods |
Children aged 1–12 years living in Gabon received either rVSVΔG-ZEBOV-GP (ERVEBO®) vaccine or the varicella-zoster virus (VZV) vaccine (VZV). The concentration of rVSVΔG vector in blood and saliva, the occurrence of AEs up to day 28; the anti-rVSVΔG-ZEBOV-GP and anti-VZV IgG antibody titres, neutralising and avidity functions of anti-rVSVΔG-ZEBOV-GP by day 365; were assessed in serum. (PACTR202005733552021)
Findings |
In the rVSVΔG-ZEBOV-GP group, 70% and 7% of children had >0 copies/ml of rVSVΔG respectively in plasma by day 3 and in saliva by day 14 after vaccination, with no detection on day 28. Significantly higher but transient AEs occurred in the rVSVΔG-ZEBOV-GP group. Both vaccines induced seroconversion on day 28 and sustainable IgG antibody titres by day 365. Avidity and neutralisation functions of the anti-rVSVΔG-ZEBOV-GP antibodies peaked at day 28 and were maintained by day 365.
Interpretation |
The replication and shedding do not affect the favourable risk-benefit balance of the rVSVΔG-ZEBOV-GP in children.
Le texte complet de cet article est disponible en PDF.Highlights |
• | Replication and shedding of the rVSVΔG-ZEBOV-GP vaccine not prolonged in children. |
• | Replication-competent rVSVΔG-ZEBOV-GP induced sustainable and functional antibodies. |
• | The rVSVΔG-ZEBOV-GP replication does not induce any unexpected adverse event. |
• | Single dose of rVSVΔG-ZEBOV-GP is safe and immunogenic in Central African children. |
Keywords : RVSVΔG-ZEBOV-GP (ERVEBO®) vaccine, Varicella-zoster virus (VZV) vaccine (VARILIX®), RVSVΔG vector, -rVSVΔG-ZEBOV-GP antibodies, Children aged 1–12 years Lambaréné, Gabon
Plan
Vol 89 - N° 4
Article 106237- octobre 2024 Retour au numéro
Article précédent
- Prevalence, risk factors and characterisation of individuals with long COVID using Electronic Health Records in over 1.5 million COVID cases in England
- Han-I. Wang, Tim Doran, Michael G. Crooks, Kamlesh Khunti, Melissa Heightman, Arturo Gonzalez-Izquierdo, Muhammad Qummer Ul Arfeen, Antony Loveless, Amitava Banerjee, Christina Van Der Feltz-Cornelis
- Favipiravir for COVID-19 in adults in the community in PRINCIPLE, an open-label, randomised, controlled, adaptive platform trial of short- and longer-term outcomes
- FD Richard Hobbs, Oghenekome A. Gbinigie-Thompson, Milensu Shanyinde, Ly-Mee Yu, Victoria Harris, Jienchi Dorward, Gail Hayward, Benjamin R. Saville, Nicholas S. Berry, Philip H. Evans, Nicholas PB Thomas, Mahendra G. Patel, Duncan Richards, Oliver Van Hecke, Michelle A. Detry, Christina T. Saunders, Mark Fitzgerald, Jared Robinson, Charlotte Latimer-Bell, Julie Allen, Emma Ogburn, Jenna Grabey, Simon de Lusignan, Monique Andersson, Paul Little, Christopher C. Butler, PRINCIPLE Trial Collaborative Group
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?