Safety and immunogenicity profiles of an adjuvanted seasonal influenza vaccine in Guatemalan children

Solares, Adib Rodriguez; Aragon, Carlos Grazioso; Pivaral, Rodolfo Urruela; Prado-Cohrs, David; Sales-Carmona, Victor; Pellegrini, Michele; Groth, Nicola

doi:10.3855/jidc.4594

Cited by 11 publications

(4 citation statements)

References 33 publications

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“…Seventeen trials reported seroprotection rate data (Supplementary Table 2). Fifteen trials reported SAE, neurological events, and reactogenicity data (Supplementary Tables 3-5); 14 of these 15 trials also reported seroprotection rate data) [25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42] . Some trials consisted of several comparisons that assessed the same vaccines in different age groups or assessed different hemagglutinin antigen doses.…”

Section: Resultsmentioning

confidence: 99%

Oil-in-water emulsion adjuvants for pediatric influenza vaccines: a systematic review and meta-analysis

et al. 2020

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Standard inactivated influenza vaccines are poorly immunogenic in immunologically naive healthy young children, who are particularly vulnerable to complications from influenza. For them, there is an unmet need for better influenza vaccines. Oil-in-water emulsion-adjuvanted influenza vaccines are promising candidates, but clinical trials yielded inconsistent results.Here, we meta-analyze randomized controlled trials with efficacy data (3 trials, n = 15,310) and immunogenicity data (17 trials, n = 9062). Compared with non-adjuvanted counterparts, adjuvanted influenza vaccines provide a significantly better protection (weighted estimate for risk ratio of RT-PCR-confirmed influenza: 0.26) and are significantly more immunogenic (weighted estimates for seroprotection rate ratio: 4.6 to 7.9) in healthy immunologically naive young children. Nevertheless, in immunologically non-naive children, adjuvanted and non-adjuvanted vaccines provide similar protection and are similarly immunogenic. These results indicate that oil-in-water emulsion adjuvant improves the efficacy of inactivated influenza vaccines in healthy young children at the first-time seasonal influenza vaccination.

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Section: Resultsmentioning

confidence: 99%

Oil-in-water emulsion adjuvants for pediatric influenza vaccines: a systematic review and meta-analysis

et al. 2020

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“…One phase Ib study: Study 1 (Della . Three phase II studies: Studies 2 (Vesikari et al, 2009), 3 (Solares et al, 2014), and 4 (Zedda et al, 2015). Two phase III studies: Studies 5 (Vesikari et al, 2011) and 6 (Nolan et al, 2014).…”

Section: Included Studiesmentioning

confidence: 99%

Cumulative clinical experience with MF59-adjuvanted trivalent seasonal influenza vaccine in young children

Patel

Bizjajeva

Lindert

et al. 2019

International Journal of Infectious Diseases

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To demonstrate the potential of an MF59-adjuvanted inactivated trivalent seasonal influenza vaccine (aIIV3; Fluad TM ) to improve the immune response in young children, we review the immunogenicity, efficacy, and safety/tolerability of aIIV3 from a comprehensive clinical development program in a pediatric population with a specific need for improved influenza vaccines. Methods: Data were analyzed from a series of 1 phase Ib, 3 phase II, and 2 phase III studies involving 11,942 children aged 6 months through 5 years. Results: The clinical data showed that aIIV3 had statistically significantly greater immunogenicity and efficacy in the prevention of influenza compared to conventional inactivated trivalent seasonal influenza vaccines (IIV3s). The safety profile of aIIV3 was generally similar to that of nonadjuvanted IIV3, apart from an increased frequency of solicited adverse events (AEs) following vaccination. The majority of solicited AEs were mild or moderate in severity and resolved within 1 to 3 days. Conclusions: aIIV3 was well tolerated, with immunogenicity and efficacy exceeding that of conventional IIV3 in children 6 months through 5 years of age. The MF59-adjuvanted vaccine has the potential to fulfill an unmet clinical need in the prevention of seasonal influenza in this age group.

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“…There are extensive data regarding the safety of MF59-adjuvanted influenza vaccines which have demonstrated an acceptable safety profile in young children ( 26 , 27 , 30 , 32 , 33 , 119 , 138 – 147 ). Most adverse reactions are mild-to-moderate and transient in nature and serious adverse reactions are rare.…”

Section: Safetymentioning

confidence: 99%

AS03- and MF59-Adjuvanted Influenza Vaccines in Children

et al. 2017

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Influenza is a major cause of respiratory disease leading to hospitalization in young children. However, seasonal trivalent influenza vaccines (TIVs) have been shown to be ineffective and poorly immunogenic in this population. The development of live-attenuated influenza vaccines and adjuvanted vaccines are important advances in the prevention of influenza in young children. The oil-in-water emulsions MF59 and adjuvant systems 03 (AS03) have been used as adjuvants in both seasonal adjuvanted trivalent influenza vaccines (ATIVs) and pandemic monovalent influenza vaccines. Compared with non-adjuvanted vaccine responses, these vaccines induce a more robust and persistent antibody response for both homologous and heterologous influenza strains in infants and young children. Evidence of a significant improvement in vaccine efficacy with these adjuvanted vaccines resulted in the use of the monovalent (A/H1N1) AS03-adjuvanted vaccine in children in the 2009 influenza pandemic and the licensure of the seasonal MF59 ATIV for children aged 6 months to 2 years in Canada. The mechanism of action of MF59 and AS03 remains unclear. Adjuvants such as MF59 induce proinflammatory cytokines and chemokines, including CXCL10, but independently of type-1 interferon. This proinflammatory response is associated with improved recruitment, activation and maturation of antigen presenting cells at the injection site. In young children MF59 ATIV produced more homogenous and robust transcriptional responses, more similar to adult-like patterns, than did TIV. Early gene signatures characteristic of the innate immune response, which correlated with antibody titers were also identified. Differences were detected when comparing child and adult responses including opposite trends in gene set enrichment at day 3 postvaccination and, unlike adult data, a lack of correlation between magnitude of plasmablast response at day 7 and antibody titers at day 28 in children. These insights show the utility of novel approaches in understanding new adjuvants and their importance for developing improved influenza vaccines for children.

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Safety and immunogenicity profiles of an adjuvanted seasonal influenza vaccine in Guatemalan children

Cited by 11 publications

References 33 publications

Oil-in-water emulsion adjuvants for pediatric influenza vaccines: a systematic review and meta-analysis

Oil-in-water emulsion adjuvants for pediatric influenza vaccines: a systematic review and meta-analysis

Cumulative clinical experience with MF59-adjuvanted trivalent seasonal influenza vaccine in young children

AS03- and MF59-Adjuvanted Influenza Vaccines in Children

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