Technology transfer of an oil-in-water vaccine-adjuvant for strengthening pandemic influenza preparedness in Indonesia

Ventura, Roland; Brunner, Livia; Heriyanto, Bambang; Boer, Otto de; O’Hara, Michael; Huynh, Chuong; Suhardono, Mahendra; Collin, Nicolas

doi:10.1016/j.vaccine.2012.07.074

Cited by 33 publications

(32 citation statements)

References 11 publications

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“…To determine whether the enhanced immunogenicity we observed in mice is also obtained in a species closer to humans, we immunized Indian rhesus macaques with trimeric DS-Cav1 or DS-Cav1-I53-50 formulated in SWE, a squalene-based oil-in-water emulsion (Ventura et al., 2013) (Figures 7A and S7). In agreement with the data obtained in mice, DS-Cav1-I53-50 induced higher antigen-specific (Figure 7B) and neutralizing (Figure 7C) antibody titers than trimeric DS-Cav1, and the ratio of binding to neutralizing antibodies was again lower for the nanoparticle immunogen (Figure 7D).…”

Section: Resultsmentioning

confidence: 99%

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Induction of Potent Neutralizing Antibody Responses by a Designed Protein Nanoparticle Vaccine for Respiratory Syncytial Virus

Marcandalli

Fiala

Ols

et al. 2019

Cell

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398

405

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SummaryRespiratory syncytial virus (RSV) is a worldwide public health concern for which no vaccine is available. Elucidation of the prefusion structure of the RSV F glycoprotein and its identification as the main target of neutralizing antibodies have provided new opportunities for development of an effective vaccine. Here, we describe the structure-based design of a self-assembling protein nanoparticle presenting a prefusion-stabilized variant of the F glycoprotein trimer (DS-Cav1) in a repetitive array on the nanoparticle exterior. The two-component nature of the nanoparticle scaffold enabled the production of highly ordered, monodisperse immunogens that display DS-Cav1 at controllable density. In mice and nonhuman primates, the full-valency nanoparticle immunogen displaying 20 DS-Cav1 trimers induced neutralizing antibody responses ∼10-fold higher than trimeric DS-Cav1. These results motivate continued development of this promising nanoparticle RSV vaccine candidate and establish computationally designed two-component nanoparticles as a robust and customizable platform for structure-based vaccine design.

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Section: Resultsmentioning

confidence: 99%

“…Squalene-in-water emulsion adjuvant (SWE) was prepared by the Vaccine Formulation Institute (VFI) as previously described (Ventura et al., 2013). 1 M Trizma hydrochloride, pH 8.0, 5 M sodium chloride, and glycerol were purchased from Sigma-Aldrich.…”

Section: Methodsmentioning

confidence: 99%

Induction of Potent Neutralizing Antibody Responses by a Designed Protein Nanoparticle Vaccine for Respiratory Syncytial Virus

Marcandalli

Fiala

Ols

et al. 2019

Cell

Self Cite

398

405

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“…O/w emulsion #2 (SWE02) was manufactured by the Vaccine Formulation Laboratory [19, 20] at the University of Lausanne (Epalinges, Switzerland) and contained 3.9% (w/v) squalene, 0.5% (w/v) Tween ® 80 and 0.5% (w/v) Span® 85 in 10mM citrate buffer. The particle size was as determined by DLS 140±3 nm (PI 0.07).…”

Section: Methodsmentioning

confidence: 99%

Antigen sparing with adjuvanted inactivated polio vaccine based on Sabin strains

Westdijk

Koedam²,

Barro

et al. 2013

Vaccine

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Six different adjuvants, each in combination with inactivated polio vaccine (IPV) produced with attenuated Sabin strains (sIPV), were evaluated for their ability to enhance virus neutralizing antibody titers (VNTs) in the rat potency model. The increase of VNTs was on average 3-, 15-, 24-fold with adjuvants after one immunization (serotype 1, 2, and 3, respectively). Also after a boost immunization the VNTs of adjuvanted sIPV were on average another 7- 20- 27 times higher than after two inoculations of sIPV without adjuvant. The results indicate that it is feasible to increase the potency of inactivated polio vaccines by using adjuvants.

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“…This is important since there are very few vaccine technology transfer efforts reported in the literature, even though such efforts are considered a critical necessity to enhance global health. [14][15][16] Overall, the preclinical studies demonstrated the antigen sparing capacity of the adjuvant manufactured by CI (tech transfer recipient) and its comparability to adjuvant manufactured by IDRI (tech transfer partner) and thus validated that the technology transfer of adjuvant manufacturing succeeded in bioactivity as well as physicochemical expectations. However, this success was tempered by variability in vaccine bioactivity apparently attributable to different antigen preparations and/or HI assay reagents which prevented a linear preclinical development process.…”

Section: Discussionmentioning

confidence: 68%

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

Stăvaru

Onu

Lupulescu

et al. 2015

Human Vaccines & Immunotherapeutics

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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-inwater 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.

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Technology transfer of an oil-in-water vaccine-adjuvant for strengthening pandemic influenza preparedness in Indonesia

Cited by 33 publications

References 11 publications

Induction of Potent Neutralizing Antibody Responses by a Designed Protein Nanoparticle Vaccine for Respiratory Syncytial Virus

Induction of Potent Neutralizing Antibody Responses by a Designed Protein Nanoparticle Vaccine for Respiratory Syncytial Virus

Antigen sparing with adjuvanted inactivated polio vaccine based on Sabin strains

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

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