Release and stability testing programs for a novel virus-like particle vaccine

BioPharm International

Volumn 23, Issue 10 SUPPL., 2010, Pages 26-34

  Pincus, Steven ^a   Boddapati, Sarathi ^a   Li, Jingning ^a   Sadowski, Travis ^a  

^a NOVAVAX INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HEMAGGLUTININ; MONOCLONAL ANTIBODY; SIALIDASE; UNCLASSIFIED DRUG; VIRUS LIKE PARTICLE VACCINE; VIRUS VACCINE;

ANTIBODY RESPONSE; ARTICLE; CONTROLLED STUDY; DRUG DETERMINATION; DRUG POTENCY; DRUG PURIFICATION; DRUG PURITY; DRUG RELEASE; DRUG SAFETY; DRUG SCREENING; DRUG STABILITY; ENZYME ACTIVITY; IMMUNODIFFUSION; PARTICLE SIZE; VACCINE PRODUCTION;

EID: 78650482581     PISSN: 1542166X     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (8)

1. Clinical trials performed include a) a two part 2009 pandemic H1N1 A/ Calif/04 study in healthy adults (18-64 yrs) with an n=1000; dose ranging study with 5, 15, and 45uμg HA dose injected IM in Stage A followed by an expanded safety Stage B study with an n=3550 and a 15uμg HA dose; b) seasonal trivalent vaccine with more than 1,000 subjects performed in three different trials with 2008-9 seasonal trivalent strains in healthy adults (age: 18-49; A/Bris/59; A/Bris/10; B/ Flor/04), 2009-10 seasonal trivalent in healthy older adults (age: >60; A/ Bris/59; A/Bris/10; B/Bris/60) and 2005-6 seasonal trivalent (age: 18-49; A/NC; A/NY; B/Jiangsu) and c) H5N1 prepandemic A/Indonesia/05 study in healthy adults (18-40) in more than 200 subjects.
2. Pushko R, Tumpey TM, BeF, Knell J, Robinson R, Smith G. Influenza viruslike particles composed of the HA, NA and M1 proteins of H9N2 influenza virus induce protective immune responses in BALB/c mice. Vaccine. 2005:23:5751-9.
3. Williams MS. Single-radialimmunodiffusion as an in vitro potency assay for human inactivated viral vaccines. Vet Microbiol. 1993:37:253-62.
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5. DiNapoli JM, Nayak B, Yang L, Finneyfrock BW, Cook A, Anderson H, T, et al. Newcastle disease virus-vectored vaccines expressing the hemagglutinin or neuraminidase protein of H5N1 highly pathogenic avian influenza virus protect against viral challenge in monkeys. J Virol. 2010:84:1489-1503.
6. Huber VC, Peltola V, Iverson AR, McCullers JA. Contribution of vaccineinduced immunity toward either the HA or NA component of influenza virus limits secondary bacterial complications. J Virol. 2010:84:4105-8.
7. Gillim-Ross L, Subbarao K. Can immunity induced by human influenza virus N1 neuraminidase provide some protection from avian influenza H5N1 virus? PLoS Med. 2007:4:e91:226-8.
8. Stephenson I, Wood JM, Nicholson KG, Charlett A, Zambon MC. Detection of anti-H5 responses in human sera by HI using horse erythrocytes following Mf59-adjuvanted influenza A/Duck/ Singapore/97 vaccine: Virus Res. 2004:103:91-5.