Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine in Children 6 Months to 17 Years of Age, Previously Vaccinated with an AS03-Adjuvanted A(H1N1)Pdm09 Vaccine

Vesikari, Timo; Richardus, Jan Hendrik; Berglund, Johan; Korhonen, Tiina; Flodmark, Carl‐Erik; Lindstrand, Ann; Silfverdal, Sven‐Arne; Bambure, Vinod; Caplanusi, Adrian; Dieussaert, Ilse; Roy-Ghanta, Sumita; Vaughn, David W.

doi:10.1097/inf.0000000000000709

Cited by 6 publications

(5 citation statements)

References 21 publications

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“…The V1 group showed limited spread of viral antigen in the lungs consistent with the minimal to mild histopathological pulmonary lesions observed. These results confirm the higher level of protection achieved by the V1 vaccine against viral replication in comparison with other inactivated vaccines, as reported previously 17‐19 . V2 and NVC showed similar histopathology in lungs following challenge.…”

Section: Discussionsupporting

confidence: 91%

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Inactivated pandemic 2009 H1N1 influenza A virus human vaccines have different efficacy after homologous challenge in the ferret model

Vidaña

Brookes

Everett

et al. 2020

Influenza Resp Viruses

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Section: Discussionsupporting

confidence: 91%

“…These results confirm the higher level of protection achieved by the V1 vaccine against viral replication in comparison with other inactivated vaccines, as reported previously. [17][18][19] V2 and NVC showed similar histopathology in lungs following challenge.…”

Section: Discussionmentioning

confidence: 72%

Inactivated pandemic 2009 H1N1 influenza A virus human vaccines have different efficacy after homologous challenge in the ferret model

Vidaña

Brookes

Everett

et al. 2020

Influenza Resp Viruses

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“…The A(H1N1)pdm09 virus continues to circulate as a seasonal influenza virus and has been included as the H1N1 strain in seasonal influenza vaccines since its appearance. Sustained immune responses elicited by A(H1N1)pdm09 vaccines should be boostable to putatively protective levels by either revaccination or administration of a seasonal vaccine containing the same viral antigens, particularly in seasons when A(H1N1)pdm09 is the predominant circulating strain (7). …”

Section: Introductionmentioning

confidence: 99%

Long-Term Persistence of Cell-Mediated and Humoral Responses to A(H1N1)pdm09 Influenza Virus Vaccines and the Role of the AS03 Adjuvant System in Adults during Two Randomized Controlled Trials

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Clement

Willekens

et al. 2017

Clin Vaccine Immunol

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We investigated the role of AS03A (here AS03), an α-tocopherol oil-in-water emulsion-based adjuvant system, on the long-term persistence of humoral and cell-mediated immune responses to A(H1N1)pdm09 influenza vaccines. In two studies, a total of 261 healthy adults (≤60 years old) were randomized to receive two doses of AS03-adjuvanted vaccine containing 3.75 μg of hemagglutinin (HA) or nonadjuvanted vaccine containing 15 μg of hemagglutinin (in study A) or 3.75 μg of hemagglutinin (in study B) 21 days apart. Hemagglutination inhibition (HI) antibody, memory B-cell, and CD4+/CD8+ T-cell responses were characterized up to 1 year following dose 1. We also assessed the effects of age and seasonal influenza vaccination history. AS03-adjuvanted (3.75 μg HA) vaccine and nonadjuvanted vaccine at 15 μg but not at 3.75 μg HA elicited HI antibody responses persisting at levels that continued to meet European licensure criteria through month 12. At month 12, the geometric mean titer for AS03-adjuvanted vaccine was similar to that for nonadjuvanted (15-μg) vaccine in study A (1:86 and 1:88, respectively) and higher than that for nonadjuvanted (3.75-μg) vaccine in study B (1:77 and 1:35, respectively). A(H1N1)pdm09-specific CD4+ T-cell and B-cell responses were stronger in AS03-adjuvanted groups and persisted only in these groups for 12 months at levels exceeding prevaccination frequencies. Advancing age and a seasonal vaccination history tended to reduce HI antibody and memory B-cell responses and, albeit less consistently, CD4+ T-cell responses. Thus, AS03 seemed to enhance the persistence of humoral and cell-mediated responses to A(H1N1)pdm09 vaccine, allowing for antigen sparing and mitigating potential negative effects of age and previous seasonal vaccination. (These studies have been registered at ClinicalTrials.gov under registration no. NCT00968539 and NCT00989287.)

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“…Immunity to influenza is dependent on both antibody and cell mediated immune responses, and both are critical to inducing protective immunity [19–22]. Oil in water adjuvants including MF59 and AS03 were shown to significantly improve humoral and T cell responses against human or avian influenza [8–11]. In the current study, although all vaccinated mice induced amplified H3N2 specific ELISA antibodies, only the EAS and MF59 vaccinated groups induced both strong IgG1 and IgG2a antibodies, while the W/O formulation or antigen alone induced predominantly IgG1 antibodies.…”

Section: Discussionmentioning

confidence: 99%

“…The most successful adjuvants of influenza vaccines for human use are squalene-based oil-in-water emulsions, such as MF59 (Novartis) and ASO3 (GlaxoSmithKline). A number of clinical trials indicate that squalene-in-water emulsions outperform aluminum salts or W/O emulsions at increasing vaccine immunogenicity and affording cross-reactivity without causing unacceptable adverse reactions [8–11]. Squalene or squalane (hydrogenated form of squalene) has been used as an alternative to mineral oil for its tolerance and investigated extensively in vaccine adjuvant applications.…”

Section: Introductionmentioning

confidence: 99%

Development of a novel oil-in-water emulsion and evaluation of its potential adjuvant function in a swine influenza vaccine in mice

et al. 2018

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BackgroundVaccination is the principal strategy for prevention and control of diseases, and adjuvant use is an effective strategy to enhance vaccine efficacy. Traditional mineral oil-based adjuvants have been reported with post-immunization reactions. Developing new adjuvant formulations with improved potency and safety will be of great value.ResultsIn the study reported herein, a novel oil-in-water (O/W) Emulsion Adjuvant containing Squalane (termed EAS) was developed, characterized and investigated for swine influenza virus immunization. The data show that EAS is a homogeneous nanoemulsion with small particle size (~ 105 nm), low viscosity (2.04 ± 0.24 cP at 20 °C), excellent stability (at least 24 months at 4 °C) and low toxicity. EAS-adjuvanted H3N2 swine influenza vaccine was administrated in mice subcutaneously to assess the adjuvant potency of EAS. The results demonstrated that in mice EAS-adjuvanted vaccine induced significantly higher titers of hemagglutination inhibition (HI) and IgG antibodies than water-in-oil (W/O) vaccines or antigen alone, respectively, at day 42 post vaccination (dpv) (P < 0.05). EAS-adjuvanted vaccine elicited significantly stronger IgG1 and IgG2a antibodies and higher concentrations of Th1 (IFN-γ and IL-2) cytokines compared to the W/O vaccine or antigen alone. Mice immunized with EAS-adjuvanted influenza vaccine conferred potent protection after homologous challenge.ConclusionThe O/W emulsion EAS developed in the present work induced potent humoral and cellular immune responses against inactivated swine influenza virus, conferred effective protection after homologous virus challenge and showed low toxicity in mice, indicating that EAS is as good as the commercial adjuvant MF59. The superiority of EAS to the conventional W/O formulation in adjuvant activity, safety and stability will make it a potential veterinary adjuvant.

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Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine in Children 6 Months to 17 Years of Age, Previously Vaccinated with an AS03-Adjuvanted A(H1N1)Pdm09 Vaccine

Cited by 6 publications

References 21 publications

Inactivated pandemic 2009 H1N1 influenza A virus human vaccines have different efficacy after homologous challenge in the ferret model

Inactivated pandemic 2009 H1N1 influenza A virus human vaccines have different efficacy after homologous challenge in the ferret model

Long-Term Persistence of Cell-Mediated and Humoral Responses to A(H1N1)pdm09 Influenza Virus Vaccines and the Role of the AS03 Adjuvant System in Adults during Two Randomized Controlled Trials

Development of a novel oil-in-water emulsion and evaluation of its potential adjuvant function in a swine influenza vaccine in mice

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