Stability and suitability for storage and distribution of Ad26.ZEBOV/MVA-BN®-Filo heterologous prime-boost Ebola vaccine

    loading  Checking for direct PDF access through Ovid

Abstract

The stability profile of a vaccine has important implications for storage, cold chain management and field deployment. The heterologous prime-boost Janssen Ebola vaccine regimen demonstrated an acceptable safety profile and durability of Ebola-specific immune responses in Phase I studies in healthy adults.

Potency (infectious titre) of both components of the Ad26.ZEBOV/MVA-BN-Filo regimen were assessed using qPCR-based potency assay and flow cytometry during real-time and accelerated stability studies, conducted between −80 °C and 25 °C. Additionally, vaccine potency was assessed following agitation, temperature cycling, freeze-thawing and while in the injection system.

Ad26.ZEBOV remained stable for 24 months when frozen and at 2–8 °C; MVA-BN-Filo remained stable for 24 months frozen and 12 months at 2–8 °C. Potency of both vaccines was maintained during temperature cycling, agitation and freeze-thawing. When exposed to high temperatures (up to 40 °C) in a syringe/needle both vaccines remained stable for at least 6 h. The vaccines are expected to maintain potency for 36 months when frozen (based on extrapolation of observed stability).

The findings of this study indicate that the stability of the Ad26.ZEBOV/MVA-BN-Filo is likely suitable for field deployment in regions at risk of Ebola outbreaks, where cold chain maintenance is challenging owing to infrastructure and resource limitations.

Related Topics

    loading  Loading Related Articles