A Phase 2/3 double blinded, randomized, placebo-controlled study in healthy adult participants in Vietnam to examine the safety and immunogenicity of an inactivated whole virion, alum adjuvanted, A(H5N1) influenza vaccine (IVACFLU-A/H5N1).

摘要: Abstract Background A global shortfall of vaccines for avian influenza A(H5N1) would occur, especially in low- and-middle income countries, if a pandemic were to occur. To address this issue, development pre-pandemic vaccine was initiated 2012, leveraging recently established manufacturing capacity Vietnam. Methods This Phase 2/3, double-blinded, randomized, placebo-controlled study test the safety and immunogenicity IVACFLU-A/H5N1 healthy adults. 2 dose selection study, which 300 participants randomized one three groups (15 mcg, 30 mcg, or placebo). Safety assessed all participants. In 3, 630 receive selected n = 525) placebo (n = 105). 3 measured subset Results The well tolerated most adverse events mild short duration. Mild pain at injection site common event seen 60 percent group 3. 2, both 15 mcg 30 mcg doses immunogenic, so lower further testing overall seroconversion rates 68 hemagglutination inhibition (HI), 51 microneutralization (MN) 56 single radial hemolysis (SRH). seroprotection 44 HI, 41 MN 55 SRH. GMT ratio 5.31 3.7 HI respectively; GMA 4.75 Conclusion IVACFLU A/H5N1 safe immunogenic. Development is welcome addition limited pool these vaccines. ClinicalTrials.gov register NCT02612909.