A phase 2/3 double-blind, randomized, placebo-controlled study to evaluate the safety and immunogenicity of a seasonal trivalent inactivated split-virion influenza vaccine (IVACFLU-S) in healthy adults in Vietnam.

A phase 2/3 double-blind, randomized, placebo-controlled study to evaluate the safety and... Background: Under the WHO's Global Action Plan for influenza vaccines, we conducted a phase 2-3 study of IVACFLU-S, a trivalent, seasonal inactivated influenza vaccine candidate.Methods: In the phase 2 portion of the study, 252 participants received one dose of 15 mcg hemagglutinin (HA) vaccine per strain or placebo. Following determination of safety, 636 additional participants were randomized in phase 3 to receive vaccine or placebo. Immunogenicity was assessed in a subset of the participants in the phase 3 study.Results: Higher proportion (70%) of participants in the IVACFLU-S arm reported solicited local adverse events (AEs) (p < .0001) as compared to placebo (25%). Mild injection site pain and tenderness were most common AEs seen in 55% and 60% of participants in the vaccine group. The solicited systemic AEs were comparable (p = .4149). The majority of solicited and unsolicited AEs were mild to moderate in severity. In the vaccine arm for the combined age group of 18-60 years of age, seroconversion against antigens A/H1N1, A/H3N2, and B was achieved in 70.3%, 76.1%, and 54.1% of participants respectively; seroprotection against antigens A/H1N1, A/H3N2, and B was achieved in 83.3%, 86.6%, and 60.3% of participants respectively; and the geometric mean fold rise for the hemagglutinin-inhibition (HI) antibody titers against antigen A/H1N1, A/H3N2, and B were 13.15, 11.85, and 5.87, respectively.Conclusion: This study demonstrates the local reactogenicity, other safety, and immunogenicity of IVACFLU-S, first domestically produced influenza vaccine in Vietnam.ClinicalTrials.gov number NCT03095599 (March 29, 2017). http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Human vaccines & immunotherapeutics Pubmed

A phase 2/3 double-blind, randomized, placebo-controlled study to evaluate the safety and immunogenicity of a seasonal trivalent inactivated split-virion influenza vaccine (IVACFLU-S) in healthy adults in Vietnam.

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A phase 2/3 double-blind, randomized, placebo-controlled study to evaluate the safety and immunogenicity of a seasonal trivalent inactivated split-virion influenza vaccine (IVACFLU-S) in healthy adults in Vietnam.

Human vaccines & immunotherapeutics, Volume 15 (12): 7 – Jan 4, 2020

Abstract

Background: Under the WHO's Global Action Plan for influenza vaccines, we conducted a phase 2-3 study of IVACFLU-S, a trivalent, seasonal inactivated influenza vaccine candidate.Methods: In the phase 2 portion of the study, 252 participants received one dose of 15 mcg hemagglutinin (HA) vaccine per strain or placebo. Following determination of safety, 636 additional participants were randomized in phase 3 to receive vaccine or placebo. Immunogenicity was assessed in a subset of the participants in the phase 3 study.Results: Higher proportion (70%) of participants in the IVACFLU-S arm reported solicited local adverse events (AEs) (p < .0001) as compared to placebo (25%). Mild injection site pain and tenderness were most common AEs seen in 55% and 60% of participants in the vaccine group. The solicited systemic AEs were comparable (p = .4149). The majority of solicited and unsolicited AEs were mild to moderate in severity. In the vaccine arm for the combined age group of 18-60 years of age, seroconversion against antigens A/H1N1, A/H3N2, and B was achieved in 70.3%, 76.1%, and 54.1% of participants respectively; seroprotection against antigens A/H1N1, A/H3N2, and B was achieved in 83.3%, 86.6%, and 60.3% of participants respectively; and the geometric mean fold rise for the hemagglutinin-inhibition (HI) antibody titers against antigen A/H1N1, A/H3N2, and B were 13.15, 11.85, and 5.87, respectively.Conclusion: This study demonstrates the local reactogenicity, other safety, and immunogenicity of IVACFLU-S, first domestically produced influenza vaccine in Vietnam.ClinicalTrials.gov number NCT03095599 (March 29, 2017).
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DOI
10.1080/21645515.2019.1613127

Abstract

Background: Under the WHO's Global Action Plan for influenza vaccines, we conducted a phase 2-3 study of IVACFLU-S, a trivalent, seasonal inactivated influenza vaccine candidate.Methods: In the phase 2 portion of the study, 252 participants received one dose of 15 mcg hemagglutinin (HA) vaccine per strain or placebo. Following determination of safety, 636 additional participants were randomized in phase 3 to receive vaccine or placebo. Immunogenicity was assessed in a subset of the participants in the phase 3 study.Results: Higher proportion (70%) of participants in the IVACFLU-S arm reported solicited local adverse events (AEs) (p < .0001) as compared to placebo (25%). Mild injection site pain and tenderness were most common AEs seen in 55% and 60% of participants in the vaccine group. The solicited systemic AEs were comparable (p = .4149). The majority of solicited and unsolicited AEs were mild to moderate in severity. In the vaccine arm for the combined age group of 18-60 years of age, seroconversion against antigens A/H1N1, A/H3N2, and B was achieved in 70.3%, 76.1%, and 54.1% of participants respectively; seroprotection against antigens A/H1N1, A/H3N2, and B was achieved in 83.3%, 86.6%, and 60.3% of participants respectively; and the geometric mean fold rise for the hemagglutinin-inhibition (HI) antibody titers against antigen A/H1N1, A/H3N2, and B were 13.15, 11.85, and 5.87, respectively.Conclusion: This study demonstrates the local reactogenicity, other safety, and immunogenicity of IVACFLU-S, first domestically produced influenza vaccine in Vietnam.ClinicalTrials.gov number NCT03095599 (March 29, 2017).

Journal

Human vaccines & immunotherapeuticsPubmed

Published: Jan 4, 2020

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