IMPORTANCE Human infections with the avian influenza A(H7N9) virus were first reported in China in 2013 and continue to occur. Hemagglutinin H7 administered alone is a poor immunogen necessitating evaluation of adjuvanted H7N9 vaccines.OBJECTIVE To evaluate the immunogenicity and safety of an inactivated H7N9 vaccine with and without AS03 adjuvant, as well as mixed vaccine schedules that included sequential administration of AS03-and MF59-containing formulations and of adjuvanted and unadjuvanted formulations. DESIGN, SETTING, AND PARTICIPANTS Double-blind, phase 2 trial at 5 US sites enrolled 980 adults aged 19 through 64 years from September 2013 through November 2013; safety follow-up was completed in January 2015.
INTERVENTIONSThe H7N9 vaccine was given on days 0 and 21 at nominal doses of 3.75 μg, 7.5 μg, 15 μg, and 45 μg of hemagglutinin with or without AS03 or MF59 adjuvant mixed on site.
MAIN OUTCOMES AND MEASURESProportions achieving a hemagglutination inhibition antibody (HIA) titer of 40 or higher at 21 days after the second vaccination; vaccine-related serious adverse events through 12 months after the first vaccination; and solicited signs and symptoms after vaccination through day 7.RESULTS Two doses of vaccine were required to induce detectable antibody titers in most participants. After 2 doses of an H7N9 formulation containing 15 μg of hemagglutinin given without adjuvant, with AS03 adjuvant, or with MF59 adjuvant, the proportion achieving an HIA titer of 40 or higher was 2% (95% CI, 0%-7%) without adjuvant (n = 94), 84% (95% CI, 76%-91%) with AS03 adjuvant (n = 96), and 57% (95% CI, 47%-68%) with MF59 adjuvant (n = 92) (P < .001 for comparison of the AS03 and MF59 schedules). The 2 schedules alternating AS03-and MF59-adjuvanted formulations led to lower geometric mean titers (GMTs) of (41.5 [95% CI, 31.7-54.4]; n = 92) and (58.6 [95% CI,; n = 96) than the group induced by 2 AS03-adjuvanted formulations (n = 96) (103.4 [95% CI, 78.7-135.9]; P < .001) but higher GMTs than 2 doses of MF59-adjuvanted formulation (n = 94) (29.0 [95% CI, 22.4-37.6]; P < .001).
CONCLUSIONS AND RELEVANCEThe AS03 and MF59 adjuvants augmented the immune responses to 2 doses of an inactivated H7N9 influenza vaccine, with AS03-adjuvanted formulations inducing the highest titers. This study of 2 adjuvants used in influenza vaccine formulations with adjuvant mixed on site provides immunogenicity information that may be informative to influenza pandemic preparedness programs.
S aureus colonization (including MRSA) was extremely common in this cohort of maternal-infant pairs. Infants born to mothers with staphylococcal colonization were more likely to be colonized, and early postnatal acquisition appeared to be the primary mechanism.
S u rn rn a r y An icosahedral cytoplasmic deoxyvirus has been isolated from moribund sheatfish (Sifurus gfanis) fry of a commercial warm water recirculation aquaculture unit with cumulative mortalities of up to 100%. The agent replicated in BF-2 and in FHM cells at 20-30°C producing cytoplasmatic inclusion bodies followed by lysis of the cells. The DNA containing virus proved to be labile to chloroform. Infected BF-2 cells revealed hexagonal particles in the cytoplasm measuring about 125-135nm in diameter. The virus consisted of a central electron-dense core and a electrontranslucent zone. The isolate shares characteristics with the Iridoviridae.
Objectives
Clostridium difficile, a common cause of antibiotic-associated diarrhea, has been reported to recur in high rates in adults. The rates and risk factors for recurrent Clostridium difficile infection (rCDI) in children have not been well established.
Methods
We conducted a retrospective cohort study of 186 pediatric patients seen at a tertiary care referral center over a 5-year period diagnosed with a primary infection with Clostridium difficile. Children with recurrent disease, defined as return of symptoms of Clostridium difficile infection and positive testing ≤60 days after the completion of therapy, were compared to children who did not experience an episode of recurrence.
Results
Of the 186 pediatric patients included in this study, 41 (22%) experienced recurrent Clostridium difficile infection. On univariable analysis, factors significantly associated with recurrent Clostridium difficile infection included malignancy, recent hospitalization, recent surgery, antibiotic use, number of antibiotic exposures by class, acid blocker use, immunosuppressant use, and hospital acquired disease. On multivariable analysis, malignancy (OR=3.39, 95% CI=1.52–7.85), recent surgery (OR=2.40, 95% CI=1.05–5.52), and the number of antibiotic exposures by class (OR=1.33, 95% CI=1.01–1.75) were significantly associated with recurrent disease in children.
Conclusions
The rate of recurrent Clostridium difficile infection in children was 22%. Recurrence was significantly associated with the risk factors of malignancy, recent surgery, and the number of antibiotic exposures by class.
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