Pre-vaccination (Day 1) and post-vaccination (Day 22) geometric mean titre against a) A/H1N1, b) A/H3N2 and c) B viral strains in subjects without pre-vaccination immunoprotection

<p><b>Copyright information:</b></p><p>Taken from "Safety and immunogenicity of an MF59™-adjuvanted subunit influenza vaccine in elderly Chinese subjects"</p><p>http://www.immunityageing.com/content/5/1/2</p><p>Immunity & ageing : I & A 2008;5():2-2.</p><p>Published online 20 Feb 2008</p><p>PMCID:PMC2291031.</p><p></p

Geometric mean titre ratios (Day22:Day1) in all subjects in the Phase II/III trial

<p><b>Copyright information:</b></p><p>Taken from "Safety and immunogenicity of an MF59™-adjuvanted subunit influenza vaccine in elderly Chinese subjects"</p><p>http://www.immunityageing.com/content/5/1/2</p><p>Immunity & ageing : I & A 2008;5():2-2.</p><p>Published online 20 Feb 2008</p><p>PMCID:PMC2291031.</p><p></p

Literature search flow-chart.

<p>Literature search flow-chart.</p

Absolute Neutrophil Counts Grading.

<p>Absolute Neutrophil Counts Grading.</p

Absolute neutrophil count at different time points after vaccination on day 0.

<p>(A & B) adjuvanted seasonal TIV. (C) seasonal TIV. (D) attenuated live yellow fever vaccine. (A, C & D) conducted as inpatients. (B) conducted as outpatients. Red dots indicate subjects who had an absolute neutrophil count less than laboratory normal range on at least one time point after vaccination. Bars indicate median and interquartile range.</p

Ghent trial study flow chart.

<p>Ghent trial study flow chart.</p

Grade 3 Cases of Neutropenia Occurred in two Trials After Administration of the First Dose of the Shigella GMMA Vaccine.

<p>Grade 3 Cases of Neutropenia Occurred in two Trials After Administration of the First Dose of the Shigella GMMA Vaccine.</p

PubMed Search Strings.

<p>PubMed Search Strings.</p

H03_01TP and H03_02TP study flow charts.

<p>H03_01TP and H03_02TP study flow charts.</p

Table_1_Complement-mediated serum bactericidal activity of antibodies elicited by the Shigella sonnei GMMA vaccine in adults from a shigellosis-endemic country: Exploratory analysis of a Phase 2a randomized study.docx

Shigella is associated with a significant burden of disease worldwide among individuals of all ages and is the major cause of moderate and severe diarrhea in children under five years of age in low- and middle-income countries. Several candidate vaccines against Shigella species are currently under clinical development. The investigational 1790GAHB vaccine against Shigella sonnei is based on GMMA (Generalized Modules for Membrane Antigens) technology. The vaccine was well tolerated and induced high antibody levels in early-phase clinical trials in both Shigella-endemic and non-endemic settings. The present analysis assessed the bactericidal activity of antibodies induced by 1790GAHB in healthy Kenyan adults during a phase 2a, controlled, randomized study (NCT02676895). Participants received two doses of 1790GAHB 4 weeks apart containing either 1.5/25 µg or 6/100 µg O antigen/protein, or active comparator vaccines (Control). Serum bactericidal activity (SBA) against S. sonnei was assessed at pre-vaccination (D1), 28 days post-first dose (D29) and 28 days post-second dose (D57), using a luminescence-based assay. Most participants had SBA titers above the lower limit of quantification of the assay at D1. SBA geometric mean titers increased 3.4-fold in the 1.5/25 µg group and 6.3-fold in the 6/100 µg group by D29 and were maintained at D57. There was no increase in SBA geometric mean titers in the Control group. A strong correlation was observed between SBA titers and anti-S. sonnei lipopolysaccharide serum immunoglobulin G antibody concentrations (Pearson correlation coefficient = 0.918), indicating that SBA can effectively complement enzyme-linked immunosorbent assay data by indicating the functionality of 1790GAHB-induced antibodies.</p