Technology transfer of oil-in-water emulsion adjuvant manufacturing for pandemic influenza vaccine production in Romania

Vaccine

Volumn 31, Issue 12, 2013, Pages 1633-1640

  Fox, Christopher B ^a   Huynh, Chuong ^b   O'Hara, Michael K ^b   Onu, Adrian ^c  

^a INFECTIOUS DISEASE RESEARCH INSTITUTE   (United States)

^b U S DEPARTMENT OF HEALTH AND HUMAN SERVICES   (United States)

^c CANTACUZINO INSTITUTE   (Romania)

Author keywords

Oil in water emulsion; Pandemic influenza; Technology transfer; Vaccine adjuvant

Indexed keywords

ADJUVANT; AS 03; HEMAGGLUTININ; INFLUENZA VACCINE; MIFAMURTIDE; NEUTRALIZING ANTIBODY; PHOSPHATIDYLCHOLINE; PYROGEN; UNCLASSIFIED DRUG; VIRUS ANTIGEN; WATER OIL CREAM;

ARTICLE; DRUG MANUFACTURE; GAS CHROMATOGRAPHY; GOOD MANUFACTURING PRACTICE; HUMAN; HUMIDITY; IMMUNODIFFUSION; INFLUENZA VIRUS A H5N1; LIGHT SCATTERING; NONHUMAN; OSMOLALITY; PANDEMIC INFLUENZA; PARTICLE SIZE; PH; PRIORITY JOURNAL; QUALITY CONTROL; ROMANIA; SCIENTIST; TECHNOLOGY; TEMPERATURE;

ADJUVANTS, IMMUNOLOGIC; DEVELOPING COUNTRIES; EMULSIONS; FACILITY REGULATION AND CONTROL; INFLUENZA VACCINES; INTERNATIONAL COOPERATION; QUALITY CONTROL; ROMANIA; TECHNOLOGY TRANSFER; TECHNOLOGY, PHARMACEUTICAL;

EID: 84875240669     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2012.10.048     Document Type: Article

References (21)

1. Baldwin S.L., Shaverdian N., Goto Y., Duthie M.S., Raman V.S., Evers T., et al. Enhanced humoral and Type 1 cellular immune responses with Fluzone adjuvanted with a synthetic TLR4 agonist formulated in an emulsion. Vaccine 2009, 27:5956-5963.
2. Coler R.N., Baldwin S.L., Shaverdian N., Bertholet S., Reed S.J., Raman V.S., et al. A synthetic adjuvant to enhance and expand immune responses to influenza vaccines. PLoS ONE 2010, 5:e13677.
3. Fox C.B., Baldwin S.L., Duthie M.S., Reed S.G., Vedvick T.S. Immunomodulatory and physical effects of oil composition in vaccine adjuvant emulsions. Vaccine 2011, 29:9563-9572.
4. Keitel W., Groth N., Lattanzi M., Praus M., Hilbert A.K., Borkowski A., et al. Dose ranging of adjuvant and antigen in a cell culture H5N1 influenza vaccine: safety and immunogenicity of a phase 1/2 clinical trial. Vaccine 2010, 28:840-848.
5. Carter N.J., Plosker G.L. Prepandemic influenza vaccine H5N1 (split virion, inactivated, adjuvanted) [Prepandrix™]. BioDrugs 2008, 22:279-292.
6. Anderson R.C., Fox C.B., Dutill T.S., Shaverdian N., Evers T.L., Poshusta G.R., et al. Physicochemical characterization and biological activity of synthetic TLR4 agonist formulations. Coll Surf B: Biointerfaces 2010, 75:123-132.
7. Fox C.B. Squalene emulsions for parenteral vaccine and drug delivery. Molecules 2009, 14:3286-3312.
8. Fox C.B., Anderson R.C., Dutill T.S., Goto Y., Reed S.G., Vedvick T. Monitoring the effects of component structure and source and formulation stability and adjuvant activity of oil-in-water emulsions. Coll Surf B: Biointerfaces 2008, 65:98-105.
9. Fox C.B., Baldwin S.L., Duthie M.S., Reed S.G., Vedvick T.S. Immunomodulatory and physical effects of phospholipid composition in vaccine adjuvant emulsions. AAPS PharmSciTech 2012, 13:498-506.
10. Fox C.B., Lin S., Sivananthan S.J., Dutill T.S., Forseth K.T., Reed S.G., et al. Effects of emulsifier concentration, composition, and order of addition in squalene-phosphatidylcholine oil-in-water emulsions. Pharm Dev Technol 2011, 16:511-519.
11. Tsai T.F., Crucitti A., Nacci P., Nicolay U., Della Cioppa G., Ferguson J., et al. Explorations of clinical trials and pharmacovigilance databases of MF59-adjuvanted influenza vaccines for associated cases of narcolepsy. Scand J Infect Dis 2011, 43:702-706.
12. Schultze V., D'Agosto V., Wack A., Novicki D., Zorn J., Hennig R. Safety of MF59 adjuvant. Vaccine 2008, 26:3209-3222.
13. Nohynek H., Jokinen J., Partinen M., Vaarala O., Kirjavainen T., Sundman J., et al. AS03 adjuvanted H1N1 vaccine associated with an abrupt increase in the incidence of childhood narcolepsy in Finland. PLoS ONE 2012, 7:e33536.
14. Ansaldi F., Zancolli M., Durando P., Montomoli E., Sticchi L., Del Guidice G., et al. Antibody response against heterogeneous circulating influenza virus strains elicited by MF59- and non-adjuvanted vaccines during seasons with good or partial matching between vaccine strain and clinical isolates. Vaccine 2010, 28:4123-4129.
15. Khurana S., Chearwae W., Castellino F., Manischewitz J., King L.R., Honorkiewicz A., et al. Vaccines with MF59 adjuvant expand the antibody repertoire to target protective sites of pandemic avian H5N1 influenza virus. Sci Transl Med 2010, 2:15ra.
16. A-adjuvanted H5 N1 influenza vaccine improves the kinetics, magnitude and durability of the immune response after a heterologous booster vaccination: an open non-randomised extension of a double-blind randomised primary study. Vaccine 2010, 28:849-857.
17. Banzhoff A., Pellegrini M., Del Guidice G., Fragapane E., Groth N., Podda A. MF59-adjuvanted vaccines for seasonal and pandemic influenza prophylaxis. Influenza Other Respi Viruses 2008, 2:243-249.
18. Baldwin S.L., Fox C.B., Pallansch M.A., Coler R.N., Reed S.G., Friede M. Increased potency of an inactivated polio vaccine with oil-in-water emulsions. Vaccine 2011, 29:644-649.
19. Velez I.D., Gilchrist K., Martinez S., Ramirez-Pineda J.R., Ashman J.A., Alves F.P., et al. Safety and immunogenicity of a defined vaccine for the prevention of cutaneous leishmaniasis. Vaccine 2009, 28:329-337.
20. Cox M. 7th WHO meeting on evaluation of pandemic influenza vaccines in clinical trials 2011, http://www.who.int/vaccine_research/diseases/influenza/18_feb_2011_manon_Cox_ws.pdf.
21. US Food and Drug Administration. In: Vaccines and related biological products advisory committee meeting, February 29; 2012. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM296459.pdf.