Immunogenicity and safety of MF59-adjuvanted and full-dose unadjuvanted trivalent inactivated influenza vaccines among vaccine-naïve children in a randomized clinical trial in rural Senegal

Diallo, Aldiouma; Victor, John C.; Feser, Jodi; Ortiz, Justin R.; Kanesa-thasan, Niranjan; Moustapha, Ndiaye; Diarra, Bou; Cheikh, Sathie; Diene, Djibril; Ndiaye, T.; Ndiaye, Assane; Lafond, Kathryn E.; Widdowson, Marc‐Alain; Neuzil, Kathleen M.

doi:10.1016/j.vaccine.2018.08.032

Cited by 11 publications

(4 citation statements)

References 24 publications

(23 reference statements)

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“…To generate a strong immune response to an influenza vaccine, an adjuvant is usually added to enhance the immunogenicity of the antigens in vivo. [50][51][52] Although alum, MF59 and AS03 were the adjuvants used in 9 of the 10 studies included in this review, only two studies had control groups that were given unadjuvanted vaccines. 25,35 The AS03-adjuvanted vaccine showed stronger antibody responses than the unadjuvanted vaccine in older adults, with high SCR (>70%) for two doses of AS03-adjuvanted vaccines.…”

Section: Discussionmentioning

confidence: 99%

Immunogenicity of H5N1 influenza vaccines in elderly adults: a systematic review and meta-analysis

Zhang

Shi

et al. 2020

Human Vaccines & Immunotherapeutics

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Several different vaccines have been produced for human use to prevent the highly pathogenic H5N1 influenza. Some studies reported that the clinical effectiveness of influenza vaccines in older adults may be lower than in younger adults. In this study, a meta-analysis of the immunogenicity of H5N1 influenza vaccines in elderly adults was performed. Database search was conducted in EMBASE, PubMed, the Cochrane Library, Chinese VIP, Wanfang and CBM. A total of 3951 elderly adults from 10 articles were included in the meta-analysis. Compared to a single dose, two doses of H5N1 vaccines resulted in the higher seroconversion and seroprotection. For all groups treated with adjuvanted vaccines, there were significant increases (1.55- to 2.16-fold) in the seroconversion rates (SCRs) and seroprotection rates (SPRs) after two immunizations. Oil-in-water emulsion (OE)-adjuvanted 7.5 μg vaccine caused higher antibody responses than 3.75 μg of vaccine (SCR: risk ratio (RR) = 1.26 (1.19, 1.33); SPR: RR = 1.25 (1.14, 1.36)). Elderly adults exhibited slightly lower antibody responses only when given 7.5 μg of OE-adjuvanted vaccine (SCR: RR = 1.06 (1.01, 1.11)) than younger adults. After treatment with the 7.5 μg of OE-adjuvanted vaccines, the most commonly reported adverse events were injection site pain, swelling and erythema, with the incidence of 32%, 3% and 2%, respectively, and no serious adverse events were found. These data demonstrate that two doses of 7.5 µg of OE-adjuvanted H5N1 vaccine are well tolerated and induce a robust antibody response in elderly adults.

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Section: Discussionmentioning

confidence: 99%

Immunogenicity of H5N1 influenza vaccines in elderly adults: a systematic review and meta-analysis

Zhang

Shi

et al. 2020

Human Vaccines & Immunotherapeutics

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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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“…Full dose IIV3 vaccines may further improve immunogenicity and facilitate program implementation [26,27]. Additionally, adjuvanted vaccines have shown improved responses in younger and seronegative children [28]. Finally, increased influenza vaccine coverage in children will provide not only same-season protection but may also likely enhance immunologic responses to future influenza vaccines.…”

Section: Discussionmentioning

confidence: 99%

Immunogenicity of seasonal inactivated influenza and inactivated polio vaccines among children in Senegal: Results from a cluster-randomized trial

Niang

Deming

Goudiaby

et al. 2020

Vaccine

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Immunogenicity and safety of MF59-adjuvanted and full-dose unadjuvanted trivalent inactivated influenza vaccines among vaccine-naïve children in a randomized clinical trial in rural Senegal

Abstract: Both aTIV and full-dose TIV were well-tolerated and immunogenic in children aged 6-71 months. These vaccines may play a role in programmatically suitable strategies to prevent influenza in low-resource settings.

Cited by 11 publications

References 24 publications

Immunogenicity of H5N1 influenza vaccines in elderly adults: a systematic review and meta-analysis

Immunogenicity of H5N1 influenza vaccines in elderly adults: a systematic review and meta-analysis

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

Immunogenicity of seasonal inactivated influenza and inactivated polio vaccines among children in Senegal: Results from a cluster-randomized trial

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Immunogenicity and safety of MF59-adjuvanted and full-dose unadjuvanted trivalent inactivated influenza vaccines among vaccine-naïve children in a randomized clinical trial in rural Senegal

Abstract: Both aTIV and full-dose TIV were well-tolerated and immunogenic in children aged 6-71 months. These vaccines may play a role in programmatically suitable strategies to prevent influenza in low-resource settings.

Cited by 11 publications

References 24 publications

Immunogenicity of H5N1 influenza vaccines in elderly adults: a systematic review and meta-analysis

Immunogenicity of H5N1 influenza vaccines in elderly adults: a systematic review and meta-analysis

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

Immunogenicity of seasonal inactivated influenza and inactivated polio vaccines among children in Senegal: Results from a cluster-randomized trial

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Abstract: Both aTIV and full-dose TIV were well-tolerated and immunogenic in children aged 6-71 months. These vaccines may play a role in programmatically suitable strategies to prevent influenza in low-resource settings.