Immunogenicity, Safety, and Efficacy of a Standalone Universal Influenza Vaccine, FLU-v, in Healthy Adults: A Randomized Clinical Trial

Annals of Internal Medicine
Olga PleguezuelosEelko Hak

Abstract

FLU-v is a broad-spectrum influenza vaccine that induces antibodies and cell-mediated immunity. To compare the safety, immunogenicity, and exploratory efficacy of different formulations and dosing regimens of FLU-v versus placebo. Randomized, double-blind, placebo-controlled, single-center phase 2b clinical trial. (ClinicalTrials.gov: NCT02962908; EudraCT: 2015-001932-38). The Netherlands. 175 healthy adults aged 18 to 60 years. 0.5-mL subcutaneous injection of 500 µg of adjuvanted (1 dose) or nonadjuvanted (2 doses) FLU-v (A-FLU-v or NA-FLU-v) or adjuvanted or nonadjuvanted placebo (A-placebo or NA-placebo) (2:2:1:1 ratio). Vaccine-specific cellular responses at days 0, 42, and 180 were assessed via flow cytometry and enzyme-linked immunosorbent assay. Solicited information on adverse events (AEs) was collected for 21 days after vaccination. Unsolicited information on AEs was collected throughout the study. The AEs with the highest incidence were mild to moderate injection site reactions. The difference between A-FLU-v and A-placebo in the median fold increase in secreted interferon-γ (IFN-γ) was 38.2-fold (95% CI, 4.7- to 69.7-fold; P = 0.001) at day 42 and 25.0-fold (CI, 5.7- to 50.9-fold; P < 0.001) at day 180. The differen...Continue Reading

References

Jan 1, 1981·Journal of Clinical Microbiology·A S Monto, H F Maassab
Oct 20, 2007·The Journal of Immunology : Official Journal of the American Association of Immunologists·Biao ZhengShuhua Han
Sep 5, 2008·The Journal of Immunology : Official Journal of the American Association of Immunologists·Damian M CarragherTroy D Randall
Mar 20, 2010·Journal of Interferon & Cytokine Research : the Official Journal of the International Society for Interferon and Cytokine Research·Ido D WeissAmnon Peled
Jan 16, 2013·The Journal of Immunology : Official Journal of the American Association of Immunologists·Sinthujan JegaskandaStephen J Kent
Jul 28, 2013·Biostatistics·Greg FinakRaphael Gottardo
May 26, 2015·Nature Biotechnology·Lin LinRaphael Gottardo
Jun 7, 2015·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Peter C SoemaGideon F A Kersten
Oct 6, 2016·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Richard K ZimmermanUNKNOWN U.S. Flu VE Investigators
Dec 19, 2017·Lancet·A Danielle IulianoUNKNOWN Global Seasonal Influenza-associated Mortality Collaborator Network

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Citations

Sep 23, 2020·Viruses·Wenqiang SunJing Li
Oct 7, 2020·Deutsche medizinische Wochenschrift·Ulrich Seybold
Dec 17, 2020·Vaccines·Lu LuKelvin Kai-Wang To
Feb 15, 2021·Journal of the American Pharmacists Association : JAPhA·Jennifer WallingKatherine S O'Neal
Jun 3, 2021·Viruses·Quyen-Thi Nguyen, Young-Ki Choi
Aug 6, 2021·Expert Review of Vaccines·Irina Isakova-SivakLarisa Rudenko

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Methods Mentioned

BETA
enzyme-linked
flow cytometry
ELISA

Software Mentioned

FlowG
SPSS
R
MIMOSA
FlowG MiddleWare solution
SAS
ALEA
Oracle Clinical

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