A Study of 2-dose Vaccination Regimen of Ad26.ZEBOV and MVA-BN-Filo in Infants

Summary

The purpose of this study is to assess the safety and reactogenicity of a heterologous 2-dose regimen utilizing Ad26.ZEBOV (first vaccination; Dose 1) and MVA-BN-Filo (second vaccination; Dose 2) administered intramuscularly (IM) on Days 1 and 57, respectively (Main Study) and also to provide the heterologous 2-dose vaccination regimen (Ad26.ZEBOV on Day 1 and MVABN-Filo on Day 57) to participants in the control arm of the main study (Extension Phase).

Timeline

Start

2019-08-19

Primary completion

2022-08-22

Completion

2022-09-28

Publications

• Choi EM, Lacarra B, Afolabi MO, Ale BM, Baiden F, Betard C, Foster J, Hamze B, Schwimmer C, Manno D, D'Ortenzio E, Ishola D, Keita CM, Keshinro B, Njie Y, van Dijck W, Gaddah A, Anumendem D, Lowe B, Vatrinet R, Lawal BJ, Otieno GT, Samai M, Deen GF, Swaray IB, Kamara AB, Kamara MM, Diagne MA, Kowuor D, McLean C, Leigh B, Beavogui AH, Leyssen M, Luhn K, Robinson C, Douoguih M, Greenwood B, Thiebaut R, Watson-Jones D; EBOVAC-3/EBL2005 Study Team. 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. Lancet Glob Health. 2023 Nov;11(11):e1743-e1752. doi: 10.1016/S2214-109X(23)00410-2.

Drugs

Indications