tetano
Editor, Senior Moderator
Vaccine. 2018 Oct 15. pii: S0264-410X(18)31365-3. doi: 10.1016/j.vaccine.2018.10.013. [Epub ahead of print]
[h=1]Safety and immunogenicity of inactivated monovalent influenza A/H1N1 vaccine candidate manufactured in Vietnam.[/h] Thang HV[SUP]1[/SUP], Huong VM[SUP]2[/SUP], Victor JC[SUP]3[/SUP], Van CB[SUP]1[/SUP], Nga NT[SUP]2[/SUP], Be LV[SUP]4[/SUP], Cuong NP[SUP]2[/SUP], Tsvetnitsky V[SUP]3[/SUP], Neuzil KM[SUP]3[/SUP], Power M[SUP]3[/SUP], Flores J[SUP]5[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] We tested a new A/H1N1 inactivated influenza vaccine (IIV) manufactured by Institute of Vaccines and Medical Biologics (IVAC), Vietnam in 48 adults in a Phase 1, double-blinded, randomized, placebo-controlled trial. Two doses of unadjuvanted vaccine or placebo were administered three weeks apart. The vaccine was well tolerated with only transient mild local reactions and low-grade fever in a small proportion of the subjects. One serious adverse event considered unrelated to the study product was reported. The IVAC vaccine proved to be highly immunogenic with 91 percent (95% CI: 0.78, 1) of the subjects developing a ≥4 fold immune responses by hemagglutination inhibition (HAI) assay, and 96 percent (95% CI: 0.78, 1) by the microneutralization (MN) assay. Post-vaccination geometric mean titers (GMTs) were 283.7 (95% CI: 161.7, 497.5) in the HAI and 725.7 (95% CI: 411.3, 1280.3) in the MN assay. These promising results merit further development of the vaccine. ClinicalTrials.gov number: NCT01507779.
[h=4]KEYWORDS:[/h] A/H1N1; IVAC; Influenza; Vaccine immunogenicity; Vaccine safety; Vietnam
PMID: 30337172 DOI: 10.1016/j.vaccine.2018.10.013
[h=1]Safety and immunogenicity of inactivated monovalent influenza A/H1N1 vaccine candidate manufactured in Vietnam.[/h] Thang HV[SUP]1[/SUP], Huong VM[SUP]2[/SUP], Victor JC[SUP]3[/SUP], Van CB[SUP]1[/SUP], Nga NT[SUP]2[/SUP], Be LV[SUP]4[/SUP], Cuong NP[SUP]2[/SUP], Tsvetnitsky V[SUP]3[/SUP], Neuzil KM[SUP]3[/SUP], Power M[SUP]3[/SUP], Flores J[SUP]5[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] We tested a new A/H1N1 inactivated influenza vaccine (IIV) manufactured by Institute of Vaccines and Medical Biologics (IVAC), Vietnam in 48 adults in a Phase 1, double-blinded, randomized, placebo-controlled trial. Two doses of unadjuvanted vaccine or placebo were administered three weeks apart. The vaccine was well tolerated with only transient mild local reactions and low-grade fever in a small proportion of the subjects. One serious adverse event considered unrelated to the study product was reported. The IVAC vaccine proved to be highly immunogenic with 91 percent (95% CI: 0.78, 1) of the subjects developing a ≥4 fold immune responses by hemagglutination inhibition (HAI) assay, and 96 percent (95% CI: 0.78, 1) by the microneutralization (MN) assay. Post-vaccination geometric mean titers (GMTs) were 283.7 (95% CI: 161.7, 497.5) in the HAI and 725.7 (95% CI: 411.3, 1280.3) in the MN assay. These promising results merit further development of the vaccine. ClinicalTrials.gov number: NCT01507779.
[h=4]KEYWORDS:[/h] A/H1N1; IVAC; Influenza; Vaccine immunogenicity; Vaccine safety; Vietnam
PMID: 30337172 DOI: 10.1016/j.vaccine.2018.10.013