tetano
Editor, Senior Moderator
Hum Vaccin Immunother. 2019 May 9. doi: 10.1080/21645515.2019.1613127. [Epub ahead of print]
[h=1]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.[/h] Lan PT[SUP]1[/SUP], Toan NT[SUP]1[/SUP], Thang HA[SUP]1[/SUP], Thang TC[SUP]2[/SUP], Be LV[SUP]3[/SUP], Thai DH[SUP]3[/SUP], Huong VM[SUP]2[/SUP], Nga NT[SUP]2[/SUP], Tang Y[SUP]4[/SUP], Holt R[SUP]4[/SUP], Francesco BS[SUP]4[/SUP], Flores J[SUP]4[/SUP], Tewari T[SUP]4[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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.
[h=4]METHODS:[/h] 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.
[h=4]RESULTS:[/h] Higher proportion (70 percent) of participants in the IVACFLU-S arm reported solicited local AEs (p<0.0001) as compared to placebo (25 percent). Mild injection site pain and tenderness were most common AEs seen in 55 percent and 60 percent of participants in the vaccine group. The solicited systemic AEs were comparable (p=0.4149). The majority of solicited and unsolicited AEs were mild to moderate in severity. In the vaccine arm for the combined age group of 18 to 60 years of age, seroconversion against antigens A/H1N1, A/H3N2, and B was achieved in 70.3 percent, 76.1 percent, and 54.1 percent of participants respectively; seroprotection against antigens A/H1N1, A/H3N2, and B was achieved in 83.3 percent, 86.6 percent, and 60.3 percent 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.
[h=4]CONCLUSION:[/h] 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).
[h=4]KEYWORDS:[/h] Trivalent seasonal influenza vaccine; Vietnam; immunogenicity; safety
PMID: 31070986 DOI: 10.1080/21645515.2019.1613127
[h=1]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.[/h] Lan PT[SUP]1[/SUP], Toan NT[SUP]1[/SUP], Thang HA[SUP]1[/SUP], Thang TC[SUP]2[/SUP], Be LV[SUP]3[/SUP], Thai DH[SUP]3[/SUP], Huong VM[SUP]2[/SUP], Nga NT[SUP]2[/SUP], Tang Y[SUP]4[/SUP], Holt R[SUP]4[/SUP], Francesco BS[SUP]4[/SUP], Flores J[SUP]4[/SUP], Tewari T[SUP]4[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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.
[h=4]METHODS:[/h] 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.
[h=4]RESULTS:[/h] Higher proportion (70 percent) of participants in the IVACFLU-S arm reported solicited local AEs (p<0.0001) as compared to placebo (25 percent). Mild injection site pain and tenderness were most common AEs seen in 55 percent and 60 percent of participants in the vaccine group. The solicited systemic AEs were comparable (p=0.4149). The majority of solicited and unsolicited AEs were mild to moderate in severity. In the vaccine arm for the combined age group of 18 to 60 years of age, seroconversion against antigens A/H1N1, A/H3N2, and B was achieved in 70.3 percent, 76.1 percent, and 54.1 percent of participants respectively; seroprotection against antigens A/H1N1, A/H3N2, and B was achieved in 83.3 percent, 86.6 percent, and 60.3 percent 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.
[h=4]CONCLUSION:[/h] 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).
[h=4]KEYWORDS:[/h] Trivalent seasonal influenza vaccine; Vietnam; immunogenicity; safety
PMID: 31070986 DOI: 10.1080/21645515.2019.1613127