Safety and immunogenicity of two different doses of a Vero cell-derived, whole virus clade 2 H5N1 (A/Indonesia/05/2005) influenza vaccine

Tambyah, Paul Ananth; Wilder-Smith, Annelies; Pavlova, Borislava G.; Barrett, Perry; Oh, Hong Choon; Hui, David S.; Yuen, Kwok‐Yung; Fritsch, Sandor; Aichinger, Gerald; Loew-Baselli, Alexandra; Velden, Maikel van der; Maritsch, Friedrich; Kistner, Otfried; Ehrlich, Hartmut J.

doi:10.1016/j.vaccine.2011.10.088

Cited by 22 publications

(19 citation statements)

References 26 publications

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“…67,69,71,72 Seroprotective levels of antibodies were achieved in 10-100% of the individuals, generally mirroring the variation observed in seroconversion. [67][68][69][70][71][72] In general, SRP levels were observed in >70% of the subjects after 2 conventional doses, and the proportion of subjects rose to >90% of the adults and >70% of the elderly following another dose at 6, 12-15 or 24 months following a single or a double dose administered earlier. 70 GMRs ranging from 1.6 to 32.8 have been observed, again following a pattern similar to SRC and SRP.…”

Section: Introductionmentioning

confidence: 94%

“…[67][68][69][70][71][72] In general, SRP levels were observed in >70% of the subjects after 2 conventional doses, and the proportion of subjects rose to >90% of the adults and >70% of the elderly following another dose at 6, 12-15 or 24 months following a single or a double dose administered earlier. 70 GMRs ranging from 1.6 to 32.8 have been observed, again following a pattern similar to SRC and SRP. 67,69,71,72 The vaccine could also induce (a) strong and effective, albeit not boostable, anti-neuraminidase antibodies, 73 and (b) clade and cross-clade-reactive CD4 C T cell responses in both adults and the elderly, the responses lasting at least 6 months at significant levels in adults.…”

Section: Introductionmentioning

confidence: 94%

“…66 Human clinical trials for Vero cell-derived A/H5N1 influenza vaccines showed that doses ranging from 3.75 to 45 mg of hemagglutinin (HA) protein equivalent were well tolerated, induced robust clade-and cross-clade-reactive antibodies in pediatric and adult populations, and that these responses could be boosted 6-24 months later. [67][68][69][70][71][72] Seroconversion rates ranged from 6% to 86%; the responses were typically higher with a higher dose or following boosting, but lower when adjuvanted with aluminum salts, in older individuals, and against viruses belonging to heterologous clades. Significantly, responses persisted for 12-24 months in a considerable proportion (26-86%) of the subjects.…”

Section: Introductionmentioning

confidence: 99%

“…67,70,71,79 The most frequently reported local AEs have been pain at injection site (10-43% of the subjects), followed by redness, swelling, induration and ecchymosis. 67,70,71,[79][80][81] Total systemic AEs have been reported in 18-51% of the subjects, 65,68,69 the most common being headache, fatigue, myalgia and malaise (3-20% of the subjects) in adults as well as the elderly. 70,71,81 A wider variety of events have been reported in children.…”

Section: Introductionmentioning

confidence: 99%

“…67,70,71,[79][80][81] Total systemic AEs have been reported in 18-51% of the subjects, 65,68,69 the most common being headache, fatigue, myalgia and malaise (3-20% of the subjects) in adults as well as the elderly. 70,71,81 A wider variety of events have been reported in children. 79,80 However, the frequency of occurrence of the AEs is not significantly different from subjects administered a placebo or an ECE-derived vaccine.…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

Cell culture-based influenza vaccines: A necessary and indispensable investment for the future

Hegde

2015

Human Vaccines & Immunotherapeutics

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Section: Introductionmentioning

confidence: 94%

Section: Introductionmentioning

confidence: 94%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Cell culture-based influenza vaccines: A necessary and indispensable investment for the future

Hegde

2015

Human Vaccines & Immunotherapeutics

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Emerging influenza viruses and the prospect of a universal influenza virus vaccine

Krammer

2015

Biotechnology Journal

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Influenza viruses cause annual seasonal epidemics and pandemics at irregular intervals. Several cases of human infections with avian and swine influenza viruses have been detected recently, warranting enhanced surveillance and the development of more effective countermeasures to address the pandemic potential of these viruses. The most effective countermeasure against influenza virus infection is the use of prophylactic vaccines. However, vaccines that are currently in use for seasonal influenza viruses have to be re-formulated and re-administered in a cumbersome process every year due to the antigenic drift of the virus. Furthermore, current seasonal vaccines are ineffective against novel pandemic strains. This paper reviews zoonotic influenza viruses with pandemic potential and technological advances towards better vaccines that induce broad and long lasting protection from influenza virus infection. Recent efforts have focused on the development of broadly protective/universal influenza virus vaccines that can provide immunity against drifted seasonal influenza virus strains but also against potential pandemic viruses.

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Enhanced protective efficacy of H5 subtype influenza vaccine with modification of the multibasic cleavage site of hemagglutinin in retroviral pseudotypes

et al. 2013

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Traditionally, the multibasic cleavage site (MBCS) of surface protein H5-hemagglutinin (HA) is converted to a monobasic one so as to weaken the virulence of recombinant H5N1 influenza viruses and to produce inactivated and live attenuated vaccines. Whether such modification benefits new candidate vaccines has not been adequately investigated. We previously used retroviral vectors to generate wtH5N1 pseudotypes containing the wild-type HA (wtH5) from A/swine/Anhui/ca/2004 (H5N1) virus. Here, we generated mtH5N1 pseudotypes, which contained a mutant-type HA (mtH5) with a modified monobasic cleavage site. Groups of mice were subcutaneously injected with the two types of influenza pseudotypes. Compared to the group immunized with wtH5N1 pseudotypes, the inoculation of mtH5N1 pseudotypes induced significantly higher levels of HA specific IgG and IFN-γ in immunized mice, and enhanced protection against the challenge of mouse-adapted avian influenza virus A/Chicken/Henan/12/2004 (H5N1). This study suggests modification of the H5-hemagglutinin MBCS in retroviral pseudotypes enhances protection efficacy in mice and this information may be helpful for development of vaccines from mammalian cells to fight against H5N1 influenza viruses.

show abstract

Safety and immunogenicity of two different doses of a Vero cell-derived, whole virus clade 2 H5N1 (A/Indonesia/05/2005) influenza vaccine

Cited by 22 publications

References 26 publications

Cell culture-based influenza vaccines: A necessary and indispensable investment for the future

Cell culture-based influenza vaccines: A necessary and indispensable investment for the future

Emerging influenza viruses and the prospect of a universal influenza virus vaccine

Enhanced protective efficacy of H5 subtype influenza vaccine with modification of the multibasic cleavage site of hemagglutinin in retroviral pseudotypes

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