Abstract:
:For the routine manufacture of live virus vaccines, virus is diluted into a formulation buffer to stabilize it for long-term storage, and to facilitate vaccine administration. The characteristics of this buffer are dependent on the storage temperature of the vaccine, as well as the desired characteristics of the product. The formulation buffer for RotaTeq, Merck's live, pentavalent, oral rotavirus vaccine to prevent rotavirus gastroenteritis was developed as a fully liquid solution that requires no pre-feeding prior to administration, and is stable for 24 months at refrigerated temperatures. In studying the effects of the formulation buffer on the live virus contained within RotaTeq, we observed that the formulation buffer also directly impacts the state of rotavirus aggregation. This observation, termed "the matrix effect," was first noted as an approximately 50% increase in measured in vitro infectivity, following dilution of the virus into the buffer. Subsequent experiments confirmed that citrate in the formulation buffer facilitates the disaggregation of viral particles, likely through a carboxylic-acid mediated interaction. For vaccine manufacture, bulk virus is titered and subsequently diluted to a target concentration for dosing. Aggregation of the virus and subsequent inaccurate measurement of the amount of virus contained in either the bulk sample or in the final dosing container could lead to an inability to accurately predict final vaccine concentrations. Thus, discerning the nature and extent of the matrix effect was key principally for providing an accurate prediction of final virus concentration upon dilution, to ensure a robust manufacturing process. In addition, understanding potential contributions of the formulation buffer to clinical efficacy of the vaccine was critical. Clinical data have confirmed that the citrate-mediated disaggregation had no measurable impact on vaccine safety, immunogenicity, or efficacy.
journal_name
Antiviral Resjournal_title
Antiviral researchauthors
Peterson SE,Wang S,Ranheim T,Owen KEdoi
10.1016/j.antiviral.2005.11.001subject
Has Abstractpub_date
2006-02-01 00:00:00pages
107-15issue
2eissn
0166-3542issn
1872-9096pii
S0166-3542(05)00235-4journal_volume
69pub_type
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journal_title:Antiviral research
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journal_title:Antiviral research
pub_type: 杂志文章
doi:10.1016/j.antiviral.2007.09.001
更新日期:2008-02-01 00:00:00
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journal_title:Antiviral research
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journal_title:Antiviral research
pub_type: 杂志文章
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journal_title:Antiviral research
pub_type: 杂志文章,评审
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更新日期:2006-09-01 00:00:00
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journal_title:Antiviral research
pub_type: 杂志文章
doi:10.1016/0166-3542(95)00839-x
更新日期:1996-05-01 00:00:00
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journal_title:Antiviral research
pub_type: 杂志文章
doi:10.1016/s0166-3542(95)00989-2
更新日期:1996-11-01 00:00:00
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pub_type: 杂志文章
doi:10.1016/0166-3542(85)90004-x
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pub_type: 杂志文章
doi:10.1016/j.antiviral.2020.104974
更新日期:2021-01-01 00:00:00
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journal_title:Antiviral research
pub_type: 杂志文章
doi:10.1016/j.antiviral.2005.11.005
更新日期:2006-03-01 00:00:00
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journal_title:Antiviral research
pub_type: 杂志文章
doi:10.1016/j.antiviral.2011.06.013
更新日期:2011-10-01 00:00:00
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journal_title:Antiviral research
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doi:10.1016/j.antiviral.2017.01.022
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journal_title:Antiviral research
pub_type: 杂志文章
doi:10.1016/j.antiviral.2010.08.007
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journal_title:Antiviral research
pub_type: 杂志文章
doi:10.1016/j.antiviral.2004.09.005
更新日期:2005-01-01 00:00:00
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journal_title:Antiviral research
pub_type: 杂志文章
doi:10.1016/j.antiviral.2015.03.009
更新日期:2015-06-01 00:00:00
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journal_title:Antiviral research
pub_type: 杂志文章
doi:10.1016/j.antiviral.2003.11.008
更新日期:2004-04-01 00:00:00
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journal_title:Antiviral research
pub_type: 杂志文章
doi:10.1016/j.antiviral.2015.10.019
更新日期:2016-02-01 00:00:00
abstract::Human papilloma virus (HPV)-16 is the prevalent genotype associated with cervical tumours. Virus-like-particle (VLP)-based vaccines have proven to be effective in limiting new infections of high-risk HPVs, but their high cost has hampered their use, especially in the poor developing countries. Avipox-based recombinant...
journal_title:Antiviral research
pub_type: 杂志文章
doi:10.1016/j.antiviral.2015.01.012
更新日期:2015-04-01 00:00:00
abstract::A recombinant baculovirus (vAc-gC1) was constructed that expresses the glycoprotein C (gC) gene of herpes simplex virus type 1 (HSV-1). When Sf9 cells were infected with this recombinant, a protein that was smaller in size than authentic HSV-1 gC was detected by Western blotting using anti-gC polyclonal antibody. The ...
journal_title:Antiviral research
pub_type: 杂志文章
doi:10.1016/0166-3542(92)90062-a
更新日期:1992-06-01 00:00:00
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journal_title:Antiviral research
pub_type: 杂志文章,评审
doi:
更新日期:1999-02-01 00:00:00
abstract::In the absence of antiviral treatment, chronic hepatitis C virus (HCV) infection is a liver disease characterized by the development of necroinflammatory changes and progressive liver fibrosis, leading to cirrhosis, end-stage liver disease and hepatocellular carcinoma (HCC). The approval of ribavirin in combination th...
journal_title:Antiviral research
pub_type: 杂志文章,评审
doi:10.1016/j.antiviral.2003.08.009
更新日期:2003-10-01 00:00:00
abstract::Viramidine, the 3-carboxamidine derivative of ribavirin, was effective against a spectrum of influenza A (H1N1, H3N2 and H5N1) and B viruses in vitro, with the 50% effective concentration (EC50) ranging from 2 to 32 microg/ml. The mean 50% cytotoxic concentration (CC50) in the MDCK cells used in these experiments was ...
journal_title:Antiviral research
pub_type: 杂志文章
doi:10.1016/j.antiviral.2005.06.003
更新日期:2005-10-01 00:00:00
abstract::Chronic hepatitis B infection remains a major public health problem worldwide. The hepatitis B virus belongs to the family of hepadnaviruses that replicate their DNA genome via a reverse transcription pathway. The chronicity of infection in infected hepatocytes is maintained by the persistence of the viral covalently ...
journal_title:Antiviral research
pub_type: 杂志文章,评审
doi:10.1016/s0166-3542(99)00056-x
更新日期:1999-11-01 00:00:00