Safety and immunogenicity of monovalent H7N9 influenza vaccine with AS03 adjuvant given sequentially or simultaneously with a seasonal influenza vaccine: A randomized clinical trial.

BACKGROUND: Influenza A/H7N9 viruses have pandemic potential. METHODS: We conducted an open-label, randomized, controlled trial of AS03-adjuvanted 2017 inactivated influenza A/H7N9 vaccine (H7N9 IIV) in healthy adults. Group 1 received H7N9 IIV and seasonal quadrivalent influenza vaccine (IIV4) simultaneously, followed by H7N9 IIV three weeks later. Group 2 received IIV4 alone and then two doses of H7N9 IIV at three-week intervals. Group 3 received one dose of IIV4. We used hemagglutination inhibition (HAI) and microneutralization (MN) assays to measure geometric mean titers and seroprotection (≥1:40 titer) to vaccine strains and monitored for safety. RESULTS: Among 149 subjects, seroprotection by HAI three weeks after H7N9 IIV dose 2 was 51% (95 %CI 37%-65%) for Group 1 and 40% (95 %CI 25%-56%) for Group 2. Seroprotection by MN at the same timepoint was 84% (95 %CI 72%-93%) for Group 1 and 74% (95 %CI 60%-86%) for Group 2. By 180 days after H7N9 IIV dose 2, seroprotection by HAI or MN was low for Groups 1 and 2. Responses measured by HAI and MN against each IIV4 strain three weeks after IIV4 vaccination were similar in all groups. Solicited local and systemic reactions were similar after a single vaccination, while those receiving simultaneous H7N9 and IIV4 had slightly more reactogenicity. There were no serious adverse events or medically-attended adverse events related to study product receipt. CONCLUSIONS: Adjuvanted H7N9 IIV was modestly immunogenic whether administered simultaneously or sequentially with IIV4, though responses declined by 180 days. IIV4 was immunogenic regardless of schedule. CLINICAL TRIALS REGISTRATION: NCT03318315.

Evaluation of test strips for the rapid identification of ethylenediaminetetraacetic acid (EDTA) specimens.

BACKGROUND: Identification of specimens that contain ethylenediaminetetraacetic acid (EDTA) is frequently necessary when investigating potentially mislabeled or improperly collected specimens. OBJECTIVE: To evaluate the performance of rapid EDTA detection test strips in clinical specimens. METHODS: We applied specimens to test strips designed to detect EDTA (QUANTOFIX EDTA) using a pipet (drop mode). Reactions were scored visually on a scale from red (no EDTA) to orange (low/indeterminate EDTA) to yellow (contains EDTA). RESULTS: Test strips reliably identified specimens from EDTA-containing tube types. Although test strips did not detect strong reactivity in other specimens, tubes containing NaFl/K-oxalate produced an orange (low/indeterminate EDTA) reaction. Bismuth and citrate levels were higher in specimens after we dipped test strips into solution (dip mode). CONCLUSIONS: Test strips detected the presence of EDTA in concentrations found in EDTA-containing primary tubes. Test strips were less effective in evaluating low-level EDTA concentrations expected with intravenous line contamination or backflow. Indeterminate reactions required further investigation. Dip mode can produce analytical problems for assays that measure (or are interfered by) the contents of test strips.