Safety of MF59™ adjuvant

Schultze, Viola; D’Agosto, Vicente; Wack, Andreas; Novicki, Deborah L.; Zorn, Juergen; Hennig, Renald

doi:10.1016/j.vaccine.2008.03.093

Cited by 202 publications

(111 citation statements)

References 59 publications

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“…Nine cases of Guillain–Barré syndrome were reported, irrespective of causality, giving an overall incidence of 0·03 cases per 100 000 doses. Importantly, there were no deaths considered possibly related to Fluad vaccination 41 . This incidence is similar to that observed after vaccination with conventional, non‐adjuvanted vaccines 42 …”

Section: Safety Of Mf59supporting

confidence: 70%

“…Importantly, this meta‐analysis showed no increased reactogenicity or significant change in the safety profile of Fluad between first and subsequent vaccine doses, showing long‐term good tolerability of MF59 across multiple seasonal vaccinations 39 . Extensive Fluad pharmacovigilance data are also available, which further confirm the low frequency of adverse reactions associated with MF59 41 . This database contains all reports of adverse drug reactions following vaccination with Fluad or Fluad‐like vaccines, and contains only 387 case reports from over 27 million doses, of which 107 cases fulfilled at least one seriousness criterion regardless of the severity and causality.…”

Section: Safety Of Mf59mentioning

confidence: 54%

“… 41 ADEM, acute disseminated encephalomyelitis; GBS, Guillain–Barré syndrome.*Sold doses of Fluad or Fluad‐like vaccine 27 374 412.…”

Section: Enhancing and Broadening Seasonal Vaccine Immune Responses Imentioning

confidence: 99%

“…Early clinical studies also showed no increase in anti‐squalene IgG or IgM antibody titres following immunization with an MF59‐adjuvanted vaccine 40 . Clinical trials and post‐marketing pharmacovigilance data from subjects who received the Fluad vaccine have provided extensive MF59 safety data base, covering more than 10 years of use, with more than 40 million doses distributed worldwide 27 , 28 , 39 , 41 …”

Section: Safety Of Mf59mentioning

confidence: 99%

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MF59^®‐adjuvanted vaccines for seasonal and pandemic influenza prophylaxis

Banzhoff

Pellegrini

Giudice

et al. 2008

Influenza Resp Viruses

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Influenza is a major cause of worldwide morbidity and mortality through frequent seasonal epidemics and infrequent pandemics. Morbidity and mortality rates from seasonal influenza are highest in the most frail, such as the elderly, those with underlying chronic conditions and very young children. Antigenic mismatch between strains recommended for vaccine formulation and circulating viruses can further reduce vaccine efficacy in these populations. Seasonal influenza vaccines with enhanced, cross‐reactive immunogenicity are needed to address these problems and can confer a better immune protection, particularly in seasons were antigenic mismatch occurs. A related issue for vaccine development is the growing threat of pandemic influenza caused by H5N1 avian strains. Vaccines against strains with pandemic potential offer the best approach for reducing the potential impact of a pandemic. However, current non‐adjuvanted pre‐pandemic vaccines offer suboptimal immunogenicity against H5N1. For both seasonal and pre‐pandemic vaccines, the addition of adjuvants may be the best approach for providing enhanced cross‐reactive immunogenicity. MF59®, the first oil‐in‐water emulsion licensed as an adjuvant for human use, can enhance vaccine immune responses through multiple mechanisms. A trivalent MF59‐adjuvanted seasonal influenza vaccine (Fluad®) has shown to induce significantly higher immune responses to influenza vaccination in the elderly, compared with non‐adjuvanted vaccines, and to provide cross‐reactive immunity against divergent influenza strains. Similar results have been generated with a MF59‐adjuvanted H5N1 pre‐pandemic vaccine, which showed higher and broader immunogenicity compared with non‐adjuvanted pre‐pandemic vaccines.

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Section: Safety Of Mf59supporting

confidence: 70%

Section: Safety Of Mf59mentioning

confidence: 54%

“… 41 ADEM, acute disseminated encephalomyelitis; GBS, Guillain–Barré syndrome.*Sold doses of Fluad or Fluad‐like vaccine 27 374 412.…”

Section: Enhancing and Broadening Seasonal Vaccine Immune Responses Imentioning

confidence: 99%

Section: Safety Of Mf59mentioning

confidence: 99%

See 2 more Smart Citations

MF59^®‐adjuvanted vaccines for seasonal and pandemic influenza prophylaxis

Banzhoff

Pellegrini

Giudice

et al. 2008

Influenza Resp Viruses

View full text Add to dashboard Cite

show abstract

“…Many studies have investigated these abilities and ascribed immune boosting response to one, other or both qualities. 26 Mucosal adjuvants that have been tested for intranasal vaccine delivery including: MF59 emulsion (containing squalene oil, the surfactants Span 85 and Tween 80 and citrate buffer), 105,106 lipopolysaccharide, 84,107 TLR agonists, 41,108,109 chitosan, 110 trimethylchitosan, 91,110 bacterial outer membrane protein 111 and cholera toxin 112 or heat-labile enterotoxin (LT) from E.coli. 113 Some side effects have been found with the use of bacterial toxin when given intranasally, including Bell's palsy (Facial paralysis) and other adverse events related to disorders of the facial nerves.…”

Section: Adjuvantsmentioning

confidence: 99%

Current prospects and future challenges for nasal vaccine delivery

Yusuf

Kett

2016

Human Vaccines & Immunotherapeutics

117

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Nasal delivery offers many benefits over traditional approaches to vaccine administration. These include ease of administration without needles that reduces issues associated with needlestick injuries and disposal. Additionally, this route offers easy access to a key part of the immune system that can stimulate other mucosal sites throughout the body. Increased acceptance of nasal vaccine products in both adults and children has led to a burgeoning pipeline of nasal delivery technology. Key challenges and opportunities for the future will include translating in vivo data to clinical outcomes. Particular focus should be brought to designing delivery strategies that take into account the broad range of diseases, populations and healthcare delivery settings that stand to benefit from this unique mucosal route. In this review the current state of the art in nasal vaccine delivery will be described along with future prospects. A brief introduction to the anatomy and physiology of the nasal cavity will highlight the advantages and disadvantages of the route. Encapsulation and presentation methods along with particular formulation considerations for the nasal route will also be discussed.There are many mucosal routes which have been regarded as potential sites for vaccine delivery such as oral, nasal, pulmonary, conjunctival, rectal and vaginal mucosa. However, for practical and cultural reasons researchers have tended to focus only on oral, nasal, and pulmonary administration. 1 Needlefree vaccines offer many advantages over traditional vaccination approaches including convenience, cost, ease of administration and disposal.There are several needle free methods of vaccination such as transdermal delivery and mucosal delivery. 2,3 Mucosal immunization has been successfully used in human vaccination. The human mucosal immune system is large and specialized in performing inspection for foreign antigens to protect the surfaces themselves and of course human body interior. Since most infections affect or start from mucosal surfaces, using a mucosal route of vaccination is of great interest and provides a rational reason to induce a protective immune response. 3 Nasal delivery of vaccine offers an easily accessible route to the immune system.The nose has the function of olfactory detection (sense of smell) and also filtration, humidification and temperature control of air as it enters the respiratory system. Moving from front to back the areas of the nasal cavity are the nasal vestibule, the respiratory region, and the olfactory region. The nasal cavity is divided by the septum to form the left and right nares, which lead into the left and right choana before opening onto the nasopharynx at the top of the throat. The turbinates bound the nasal walls and are responsible for air conditioning and the large mucosal surface area of the nasal cavity. The nose is also the main port of entry for many pathogens. The first barrier to foreign bodies is hair at the entrance to the nares, the nostrils, which successfully keeps ou...

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