[Source: US National Library of Medicine, full page: (LINK). Abstract, edited.]
Vaccine. 2017 Mar 13. pii: S0264-410X(17)30270-0. doi: 10.1016/j.vaccine.2017.02.057. [Epub ahead of print]
Immunogenicity and safety of an AS03-adjuvanted H7N1 vaccine in adults 65years of age and older: A phase II, observer-blind, randomized, controlled trial.
Madan A1, Ferguson M2, Rheault P3, Seiden D4, Toma A5, Friel D6, Soni J7, Li P8, Innis BL9, Schuind A10.
Author information: 1 GSK, 2301 Renaissance Blvd, RN0220, King of Prussia, PA 19406, USA. Electronic address: Anu.2.Madan@gsk.com. 2 Colchester Research Group, 68 Robie Street, Truro, Nova Scotia B2N 1L2, Canada. 3 Medicor Research Inc, 202-1280 Lasalle Blvd, Sudbury P3A 1Y8, Canada. 4 Broward Research Group, 7261 Sheridan Street, Suite 210, Hollywood 33024, USA. 5 Manna Research, 2291 Kipling Avenue Suite 117B, Toronto, Ontario M9W 4L6, Canada. Electronic address: azhar.toma@mannaresearch.com. 6 GSK, Avenue Fleming, 1300 Wavre, Belgium. Electronic address: damien.j.friel@gsk.com. 7 GSK, No. 5, Embassy, Bangalore 560052, India. 8 GSK, 2301 Renaissance Blvd, RN0220, King of Prussia, PA 19406, USA. Electronic address: ping.li4@pfizer.com. 9 GSK, 2301 Renaissance Blvd, RN0220, King of Prussia, PA 19406, USA. Electronic address: bruce.2.innis@gsk.com. 10 GSK, 2301 Renaissance Blvd, RN0220, King of Prussia, PA 19406, USA.
Abstract
BACKGROUND:
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.
METHODS:
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 AS03A or AS03B) 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).
RESULTS:
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.
CONCLUSIONS:
In adults aged ≥65years, the adjuvanted H7N1 vaccine was immunogenic after 2 doses, and had an acceptable safety profile. http://www.ClinicalTrials.gov: NCT01949090.
Copyright © 2017 GlaxoSmithKline. Published by Elsevier Ltd.. All rights reserved.
KEYWORDS: AS03 adjuvant; Elderly population; H7 influenza vaccine; H7N1; H7N9; Pandemic flu
PMID: 28302407 DOI: 10.1016/j.vaccine.2017.02.057
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Keywords: Avian Influenza; H7N1; H7N9; Vaccines.
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