Development and approval of live attenuated influenza vaccines based on Russian master donor viruses: Process challenges and success stories

Rudenko, Larisa; Yeolekar, Leena; Kiseleva, Irina; Isakova–Sivak, Irina

doi:10.1016/j.vaccine.2016.08.018

Cited by 48 publications

(34 citation statements)

References 21 publications

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“…LAIVs have been introduced firstly by Russia . They have been used in adults since the 1950s, and from 1987 onwards, the use of Russian LAIV for the prophylaxis of influenza has been widely extended to all age groups including children aged over 3 years . LAIVs have been licensed in the Unites States (US) in 2003 for healthy subjects aged 2‐49 years and in the European Union (EU) in 2012 for healthy children aged 2‐17 years .…”

Section: Iga Immune Response Upon Influenza Vaccinationmentioning

confidence: 99%

“…39 They have been used in adults since the 1950s, and from 1987 onwards, the use of Russian LAIV for the prophylaxis of influenza has been widely extended to all age groups including children aged over 3 years. 40 Fluenz R in the EU. 42 Studies performed in mice have demonstrated the predominant protective role played by sIgA, 43,44 even in case of absence of T cells.…”

Section: G a Immune Re S P On S E Up On Influenz A Vaccinationmentioning

confidence: 99%

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How to assess the effectiveness of nasal influenza vaccines? Role and measurement of sIgA in mucosal secretions

Gianchecchi

Manenti

Kistner

et al. 2019

Influenza Resp Viruses

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Secretory IgAs (sIgA) constitute the principal isotype of antibodies present in nasal and mucosal secretions. They are secreted by plasma cells adjacent to the mucosal epithelial cells, the site where infection occurs, and are the main humoral mediator of mucosal immunity. Mucosally delivered vaccines, such as live attenuated influenza vaccine (LAIV), are able to mimic natural infection without causing disease or virus transmission and mainly elicit a local immune response. The measurement of sIgA concentrations in nasal swab/wash and saliva samples is therefore a valuable tool for evaluating their role in the effectiveness of such vaccines. Here, we describe two standardized assays (enzyme‐linked immunosorbent assay and microneutralization) available for the quantification of sIgA and discuss the advantages and limitations of their use.

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Section: Iga Immune Response Upon Influenza Vaccinationmentioning

confidence: 99%

Section: G a Immune Re S P On S E Up On Influenz A Vaccinationmentioning

confidence: 99%

How to assess the effectiveness of nasal influenza vaccines? Role and measurement of sIgA in mucosal secretions

Gianchecchi

Manenti

Kistner

et al. 2019

Influenza Resp Viruses

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“… Milestones in the history of influenza vaccines [ 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 ]. IIV, inactivated influenza vaccine; WHO, World Health Organization; LAIV, live attenuated influenza vaccine.…”

Section: Figurementioning

confidence: 99%

The Future of Influenza Vaccines: A Historical and Clinical Perspective

Bouvier

2018

Vaccines

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For centuries, the development of vaccines to prevent infectious disease was an empirical process. From smallpox variolation in Song dynasty China, through the polysaccharide capsule vaccines developed in the 1970s, vaccines were made either from the pathogen itself, treated in some way to render it attenuated or non-infectious, or from a closely related non-pathogenic strain. In recent decades, new scientific knowledge and technologies have enabled rational vaccine design in a way that was unimaginable before. However, vaccines optimal against some infectious diseases, influenza among them, have remained elusive. This review will highlight the challenges that influenza viruses pose for rational vaccine design. In particular, it will consider the clinically beneficial endpoints, beyond complete sterilizing immunity, that have been achieved with vaccines against other infectious diseases, as well as the barriers to achieving similar success against influenza.

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“…33 LAIV has been highlighted as a particularly valuable technology given that the straightforward, high-yield manufacturing process and needle-free administration are more transferable to low-and middle-income countries and advantageous for pandemic surge production. 34 There are very few studies of LAIV in such populations but two recent RCTs assessed efficacy of "Leningrad" LAIV in Senegal 35 and Bangladesh 36 . Surprisingly, the results from these two studies are very different, with no efficacy demonstrated in Senegal, but 41% efficacy in Bangladesh ( Table 2).…”

Section: Introductionmentioning

confidence: 99%

Urgent challenges in implementing live attenuated influenza vaccine

Singanayagam

Zambon

Lalvani

et al. 2018

The Lancet Infectious Diseases

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SummaryConflicting reports have emerged about the effectiveness of the live attenuated influenza vaccine (LAIV). LAIV appears to be protecting particularly poorly against currently circulating H1N1 viruses that are derived from the 2009 pandemic H1N1 (pH1N1) viruses. During the 2015/16 influenza season, when pH1N1 was the predominant virus, studies from the United States (US) reported a complete lack of effectiveness of LAIV in children. This led to a critical decision in the US to recommend that LAIV not be used in 2016/17 and to switch to the inactivated influenza vaccine. Other countries, including the UK, Canada and Finland, have continued to recommend use of LAIV. This policy divergence and uncertainty has far reaching implications for the entire global community, given the importance of LAIV production capability for pandemic preparedness. In this Personal View, we discuss possible explanations for the observed reduced effectiveness of LAIV and highlight underpinning scientific questions. Further research to understand the reasons for these observations is essential to enable informed public health policy and commercial decisions about vaccine production and development in coming years. 3 IntroductionInfluenza vaccination remains the main strategy to control the burden of seasonal influenza disease that affects 5-10% of adults and 20-30% of children, resulting in 250,000-500,000 deaths worldwide each year. 1,2 In the US, 140 million doses of vaccine are distributed each year and vaccination is estimated to prevent nearly a quarter of predicted influenza-associated deaths. 3 Vaccination is also the primary public health response to a global influenza pandemic.Influenza vaccines contain a mixture of three or four components designed to protect against the different viruses that circulate contemporaneously as seasonal influenza viruses. Currently, these are two influenza A viruses (H1N1 and H3N2 subtypes) and two influenza B viruses (Victoria and Yamagata lineages). Vaccine components are reviewed and updated regularly by the WHO in line with observed antigenic drift of influenza viruses.The traditional inactivated influenza vaccine (IIV) was introduced in the 1940s. IIV is administered by intramuscular/intradermal injection, is licensed for use in all ages and has a good safety record. However, effectiveness rates vary, averaging around 50-60%. 4,5 More recently, live attenuated influenza vaccine (LAIV) was demonstrated to have greater efficacy than IIV in children, with absolute efficacy rates of 75-80%. [6][7][8] Internal genes of LAIV viruses are derived from a cold-adapted, attenuated strain of virus, either Ann Arbor/1960 (from the US) or Leningrad/1957 (from Russia). Haemagglutinin (HA) and neuraminidase (NA) surface antigens are engineered to be representative of currently circulating strains. LAIV is nasally administered and vaccine viruses replicate only in the air-cooled environment of the human upper respiratory tract. This results in a mild and self-limiting infection; virus cannot replicate at t...

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Development and approval of live attenuated influenza vaccines based on Russian master donor viruses: Process challenges and success stories

Cited by 48 publications

References 21 publications

How to assess the effectiveness of nasal influenza vaccines? Role and measurement of sIgA in mucosal secretions

How to assess the effectiveness of nasal influenza vaccines? Role and measurement of sIgA in mucosal secretions

The Future of Influenza Vaccines: A Historical and Clinical Perspective

Urgent challenges in implementing live attenuated influenza vaccine

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