Technology transfer of oil-in-water emulsion adjuvant manufacturing for pandemic influenza vaccine production in Romania: preclinical evaluation of split virion inactivated H5N1 vaccine with adjuvant

Stavaru, Crina, Onu, Adrian, Lupulescu, Emilia, Tucureanu, Catalin, Rasid, Orhan, Vlase, Ene, Coman, Cristin, Caras, Iuliana, Ghiorghisor, Alina, Berbecila, Laurentiu, Tofan, Vlad, Bowen, Richard A., Marlenee, Nicole, Hartwig, Airn, Bielefeldt-Ohmann, Helle, Baldwin, Susan L., Van Hoeven, Neal, Vedvick, Thomas S., Huynh, Chuong, O'Hara, Michael K., Noah, Diana L. and Fox, Christopher B. (2016) Technology transfer of oil-in-water emulsion adjuvant manufacturing for pandemic influenza vaccine production in Romania: preclinical evaluation of split virion inactivated H5N1 vaccine with adjuvant. Human Vaccines and Immunotherapeutics, 12 4: 1009-1026. doi:10.1080/21645515.2015.1111495


Author Stavaru, Crina
Onu, Adrian
Lupulescu, Emilia
Tucureanu, Catalin
Rasid, Orhan
Vlase, Ene
Coman, Cristin
Caras, Iuliana
Ghiorghisor, Alina
Berbecila, Laurentiu
Tofan, Vlad
Bowen, Richard A.
Marlenee, Nicole
Hartwig, Airn
Bielefeldt-Ohmann, Helle
Baldwin, Susan L.
Van Hoeven, Neal
Vedvick, Thomas S.
Huynh, Chuong
O'Hara, Michael K.
Noah, Diana L.
Fox, Christopher B.
Title Technology transfer of oil-in-water emulsion adjuvant manufacturing for pandemic influenza vaccine production in Romania: preclinical evaluation of split virion inactivated H5N1 vaccine with adjuvant
Journal name Human Vaccines and Immunotherapeutics   Check publisher's open access policy
ISSN 2164-554X
2164-5515
Publication date 2016-03-04
Year available 2015
Sub-type Article (original research)
DOI 10.1080/21645515.2015.1111495
Open Access Status Not Open Access
Volume 12
Issue 4
Start page 1009
End page 1026
Total pages 18
Place of publication New York, NY, United States
Publisher Taylor & Francis
Collection year 2017
Language eng
Abstract Millions of seasonal and pandemic influenza vaccine doses containing oil-in-water emulsion adjuvant have been administered in order to enhance and broaden immune responses and to facilitate antigen sparing. Despite the enactment of a Global Action Plan for Influenza Vaccines and a multi-fold increase in production capabilities over the past 10 years, worldwide capacity for pandemic influenza vaccine production is still limited. In developing countries, where routine influenza vaccination is not fully established, additional measures are needed to ensure adequate supply of pandemic influenza vaccines without dependence on the shipment of aid from other, potentially impacted first-world countries. Adaptation of influenza vaccine and adjuvant technologies by developing country influenza vaccine manufacturers may enable antigen sparing and corresponding increases in global influenza vaccine coverage capacity. Following on previously described work involving the technology transfer of oil-in-water emulsion adjuvant manufacturing to a Romanian vaccine manufacturing institute, we herein describe the preclinical evaluation of inactivated split virion H5N1 influenza vaccine with emulsion adjuvant, including immunogenicity, protection from virus challenge, antigen sparing capacity, and safety. In parallel with the evaluation of the bioactivity of the tech-transferred adjuvant, we also describe the impact of concurrent antigen manufacturing optimization activities. Depending on the vaccine antigen source and manufacturing process, inclusion of adjuvant was shown to enhance and broaden functional antibody titers in mouse and rabbit models, promote protection from homologous virus challenge in ferrets, and facilitate antigen sparing. Besides scientific findings, the operational lessons learned are delineated in order to facilitate adaptation of adjuvant technologies by other developing country institutes to enhance global pandemic influenza preparedness.
Keyword Oil-in-water emulsion
Pandemic influenza
Technology transfer
Vaccine adjuvant
Vaccine manufacturing
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: HERDC Pre-Audit
School of Chemistry and Molecular Biosciences
 
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