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Eur J Pharm Biopharm. 2018 Aug;129:215-221. doi: 10.1016/j.ejpb.2018.06.001. Epub 2018 Jun 2.

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

Author information

1
Janssen Vaccines, Leiden, Netherlands. Electronic address: mcapelle@its.jnj.com.
2
Janssen Vaccines, Leiden, Netherlands.
3
Bavarian Nordic, Munich, Germany.
4
Bavarian Nordic, Kvistgaard, Denmark.

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.

KEYWORDS:

Agitation; Ebola; Frozen; In-use; Potency; Stability; Storage; Temperature; Vaccine

PMID:
29870747
DOI:
10.1016/j.ejpb.2018.06.001
[Indexed for MEDLINE]

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