Immunogenicity of Avian Influenza A/Anhui/01/2005(H5N1) Vaccine With MF59 Adjuvant

Belshe, Robert B.; Frey, Sharon E.; Graham, Irene; Anderson, Edwin L.; Jackson, Lisa A.; Spearman, Paul; Edupuganti, Srilatha; Mulligan, Mark J.; Rouphael, Nadine; Winokur, Patricia L.; Dolor, Rowena J; Woods, Christopher W.; Walter, Emmanuel B.; Chen, Wilbur H.; Turley, Christine B.; Edwards, Kathryn M.; Creech, C. Buddy; Hill, Heather; Bellamy, Abbie R.

doi:10.1001/jama.2014.12609

Cited by 48 publications

(31 citation statements)

References 12 publications

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“…Interestingly, evidence of inverse dose response was recently reported in clinical studies of MF59-adjuvanted H5N1 and H7N9 IIV vaccines, but no mechanistic explanation was provided [11,34,35]. [16][17][18][36][37][38] The requirements for generation of cross-reactive antibodies are not fully understood.…”

Section: Discussionmentioning

confidence: 99%

ISCOMATRIX™ adjuvant promotes epitope spreading and antibody affinity maturation of influenza A H7N9 virus like particle vaccine that correlate with virus neutralization in humans

Chung¹,

Coyle²,

Jani³

et al. 2015

Vaccine

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Section: Discussionmentioning

confidence: 99%

ISCOMATRIX™ adjuvant promotes epitope spreading and antibody affinity maturation of influenza A H7N9 virus like particle vaccine that correlate with virus neutralization in humans

Chung¹,

Coyle²,

Jani³

et al. 2015

Vaccine

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“…Considering the poor immunogenicity of HA, several experimental approaches have been tested for improving the immunogenicity and efficacy of A(H5N1) vaccines [12, 22]. Some of these approaches include high-dose vaccination, dose-sparing regimens, different formulations of adjuvanted vaccine, and different routes of vaccination [23–26].…”

Section: Discussionmentioning

confidence: 99%

“…Consequently, higher doses of antigen and/or other vaccine strategies are necessary to elicit effective protection against an emerging avian influenza virus such as A(H5N1), which may constitute the use of an adjuvanted system to limit the amount of antigen and improve the host immune response. More recently, safety and immunogenicity studies have underscored the feasibility of using adjuvants for improving immunogenicity of A(H5N1) vaccines [11, 12]. …”

mentioning

confidence: 99%

An Adjuvanted A(H5N1) Subvirion Vaccine Elicits Virus-Specific Antibody Response and Improves Protection Against Lethal Influenza Viral Challenge in Mouse Model of Protein Energy Malnutrition

Jones

Amoah

Cao

et al. 2017

The Journal of Infectious Diseases

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Background Protein energy malnutrition (PEM) increases susceptibility to infectious diseases, including influenza infection, but no studies have addressed the potential influences of PEM on the immunogenicity and protective efficacy of avian influenza A(H5N1) vaccine. Methods We investigated the role of PEM on vaccine-mediated protection after a lethal challenge with recombinant A(H5N1) virus using isocaloric diets providing either adequate protein (AP; 18% protein) or very low protein (VLP; 2% protein) in an established murine model of influenza vaccination. Results We demonstrated that mice maintained on a VLP diet succumb to lethal challenge at greater rates than mice maintained on an AP diet, despite comparable immunization regimens. Importantly, there was no virus-induced mortality in both VLP and AP groups of mice when either group was immunized with adjuvanted low-dose A(H5N1) subvirion vaccine. Conclusions Our results suggest that adjuvanted vaccination in populations where PEM is endemic may be one strategy to boost vaccination-promoted immunity and improve outcomes associated with highly pathogenic A(H5N1).

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“…Fever was the most common systemic reaction reported in the 2 arms, as has been previously reported for other inactivated vaccines. 27,28,36 Systemic reactions (excluding allergy) were reported significantly more frequently in younger vaccine recipients, suggesting better tolerance with increasing age. 37 Since a similar trend was observed in the placebo group, these reactions may be attributed to the adjuvant.…”

Section: Discussionmentioning

confidence: 99%

Comprehensive safety assessment of a human inactivated diploid enterovirus 71 vaccine based on a phase III clinical trial

Zhang

Jiang

et al. 2016

Human Vaccines & Immunotherapeutics

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Human enterovirus 71 (EV71) is a causative agent of hand, foot, and mouth disease (HFMD). In a previous phase III trial in children, a human diploid cell-based inactivated EV71 vaccine elicited EV71 specific immune responses and protection against EV71 associated HFMD. This study aimed to assess the factors influencing the severity of adverse events observed in this previous trial. This was a randomized, doubleblinded, placebo-controlled, phase III clinical trial of a human diploid vaccine carried out in 12,000 children in Guangxi Zhuang Autonomous Region, China (ClinicalTrials.gov: NCT01569581). Solicited events were recorded for 7 days and unsolicited events were reported for 28 days after each injection. Age trend analysis of adverse reaction was conducted in each treatment group. Multiple logistic regression models were built to identify factors influencing the severity of adverse reactions. Fewer solicited adverse reactions were observed in older participants within the first 7 days after vaccination (P < 0.0001), except local pain and pruritus. More severe adverse reactions were observed after the initial injection than after the booster injection. Serious cold or respiratory tract infections (RTI) were observed more often in children aged 6-36 months than in older children. Only the severity of local swelling was associated with body mass index. Children with throat discomfort before injection had a higher risk of serious cold or RTI. These results indicated that the human diploid cell-based vaccine achieved a satisfactory safety profile.

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Immunogenicity of Avian Influenza A/Anhui/01/2005(H5N1) Vaccine With MF59 Adjuvant

Abstract: clinicaltrials.gov Identifier: NCT00680069.

Cited by 48 publications

References 12 publications

ISCOMATRIX™ adjuvant promotes epitope spreading and antibody affinity maturation of influenza A H7N9 virus like particle vaccine that correlate with virus neutralization in humans

ISCOMATRIX™ adjuvant promotes epitope spreading and antibody affinity maturation of influenza A H7N9 virus like particle vaccine that correlate with virus neutralization in humans

An Adjuvanted A(H5N1) Subvirion Vaccine Elicits Virus-Specific Antibody Response and Improves Protection Against Lethal Influenza Viral Challenge in Mouse Model of Protein Energy Malnutrition

Comprehensive safety assessment of a human inactivated diploid enterovirus 71 vaccine based on a phase III clinical trial

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