tetano
Editor, Senior Moderator
Vaccine. 2017 Mar 13. pii: S0264-410X(17)30270-0. doi: 10.1016/j.vaccine.2017.02.057. [Epub ahead of print]
[h=1]Immunogenicity and safety of an AS03-adjuvanted H7N1 vaccine in adults 65years of age and older: A phase II, observer-blind, randomized, controlled trial.[/h] Madan A[SUP]1[/SUP], Ferguson M[SUP]2[/SUP], Rheault P[SUP]3[/SUP], Seiden D[SUP]4[/SUP], Toma A[SUP]5[/SUP], Friel D[SUP]6[/SUP], Soni J[SUP]7[/SUP], Li P[SUP]8[/SUP], Innis BL[SUP]9[/SUP], Schuind A[SUP]10[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] H7 influenza strains can cause severe and often fatal human infections, especially in the elderly. This phase II, observer-blind, randomized trial (www.ClinicalTrials.gov: NCT01949090) assessed the immunogenicity and safety of a novel AS03-adjuvanted H7N1 vaccine that may serve as a model H7-subtype vaccine.
[h=4]METHODS:[/h] 360 adults ≥65years of age in stable health received either 1 of 4 adjuvanted A/mallard/Netherlands/12/2000 split virion vaccine formulations (3.75μg or 7.5μg hemagglutinin adjuvanted with either AS03[SUB]A[/SUB] or AS03[SUB]B[/SUB]) or saline placebo, given as a 2-dose series. Immunogenicity was assessed using hemagglutination-inhibition (HI) and microneutralization (MN) assays for the per-protocol cohort, comprising 332 participants at 21days post-each dose, 332 at month 6, and 309 at month 12 (HI assay only). Safety was assessed up to month 12 for all participants who had received ≥1 dose (360 participants).
[h=4]RESULTS:[/h] For H7N1 HI antibody assessment at day 42 (21days post-dose 2), seroprotection rates (SPR) in the vaccinated groups were 69.6%-88.7%, seroconversion rates (SCR) 69.6%-88.5%, mean geometric increase (MGI) 11.0-18.9, and HI geometric mean titers (GMTs) 55.0-104.8. These parameters declined by month 6 and month 12. Microneutralization GMTs were 46.2-74.7 in the vaccinated groups at day 42, while vaccine response rate (VRR; proportion with ≥4-fold increase in MN titer) was 46.4%-81.5%. For the cross-reactive H7N9 strain, at day 42, HI GMT were 64.3-201.3, SPR 78.6%-96.3%, SCR 79.3%-96.3%, and MGI 14.1-37.7; MN GMTs were 44.0-85.6, and VRR 46.4-85.2%. The most frequent solicited symptom was injection site pain (41.7%-65.0% of vaccine recipients). In total, 40 participants reported 67 serious adverse events; none were considered causally related to vaccination.
[h=4]CONCLUSIONS:[/h] In adults aged ≥65years, the adjuvanted H7N1 vaccine was immunogenic after 2 doses, and had an acceptable safety profile. www.ClinicalTrials.gov: NCT01949090.
Copyright ? 2017 GlaxoSmithKline. Published by Elsevier Ltd.. All rights reserved.
[h=4]KEYWORDS:[/h] AS03 adjuvant; Elderly population; H7 influenza vaccine; H7N1; H7N9; Pandemic flu
PMID: 28302407 DOI: 10.1016/j.vaccine.2017.02.057
[h=1]Immunogenicity and safety of an AS03-adjuvanted H7N1 vaccine in adults 65years of age and older: A phase II, observer-blind, randomized, controlled trial.[/h] Madan A[SUP]1[/SUP], Ferguson M[SUP]2[/SUP], Rheault P[SUP]3[/SUP], Seiden D[SUP]4[/SUP], Toma A[SUP]5[/SUP], Friel D[SUP]6[/SUP], Soni J[SUP]7[/SUP], Li P[SUP]8[/SUP], Innis BL[SUP]9[/SUP], Schuind A[SUP]10[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] H7 influenza strains can cause severe and often fatal human infections, especially in the elderly. This phase II, observer-blind, randomized trial (www.ClinicalTrials.gov: NCT01949090) assessed the immunogenicity and safety of a novel AS03-adjuvanted H7N1 vaccine that may serve as a model H7-subtype vaccine.
[h=4]METHODS:[/h] 360 adults ≥65years of age in stable health received either 1 of 4 adjuvanted A/mallard/Netherlands/12/2000 split virion vaccine formulations (3.75μg or 7.5μg hemagglutinin adjuvanted with either AS03[SUB]A[/SUB] or AS03[SUB]B[/SUB]) or saline placebo, given as a 2-dose series. Immunogenicity was assessed using hemagglutination-inhibition (HI) and microneutralization (MN) assays for the per-protocol cohort, comprising 332 participants at 21days post-each dose, 332 at month 6, and 309 at month 12 (HI assay only). Safety was assessed up to month 12 for all participants who had received ≥1 dose (360 participants).
[h=4]RESULTS:[/h] For H7N1 HI antibody assessment at day 42 (21days post-dose 2), seroprotection rates (SPR) in the vaccinated groups were 69.6%-88.7%, seroconversion rates (SCR) 69.6%-88.5%, mean geometric increase (MGI) 11.0-18.9, and HI geometric mean titers (GMTs) 55.0-104.8. These parameters declined by month 6 and month 12. Microneutralization GMTs were 46.2-74.7 in the vaccinated groups at day 42, while vaccine response rate (VRR; proportion with ≥4-fold increase in MN titer) was 46.4%-81.5%. For the cross-reactive H7N9 strain, at day 42, HI GMT were 64.3-201.3, SPR 78.6%-96.3%, SCR 79.3%-96.3%, and MGI 14.1-37.7; MN GMTs were 44.0-85.6, and VRR 46.4-85.2%. The most frequent solicited symptom was injection site pain (41.7%-65.0% of vaccine recipients). In total, 40 participants reported 67 serious adverse events; none were considered causally related to vaccination.
[h=4]CONCLUSIONS:[/h] In adults aged ≥65years, the adjuvanted H7N1 vaccine was immunogenic after 2 doses, and had an acceptable safety profile. www.ClinicalTrials.gov: NCT01949090.
Copyright ? 2017 GlaxoSmithKline. Published by Elsevier Ltd.. All rights reserved.
[h=4]KEYWORDS:[/h] AS03 adjuvant; Elderly population; H7 influenza vaccine; H7N1; H7N9; Pandemic flu
PMID: 28302407 DOI: 10.1016/j.vaccine.2017.02.057