Search

Vaccine safety and immunogenicity data in human immunodeficiency virus (HIV)-exposed uninfected (HEU) children are important for decision-making in HIV and typhoid co-endemic countries. In an open-label study, we recruited Malawian HEU and HIV unexposed uninfected (HUU) infants aged 9 - 11 months. HEU participants were randomized to receive Vi-tetanus toxoid conjugate vaccine (Vi-TT) at 9 months, Vi-TT at 15 months, or Vi-TT at 9 and 15 months. HUU participants received Vi-TT at 9 and 15 months. Safety outcomes included solicited and unsolicited adverse events (AE) and serious AEs (SAEs) within 7 days, 28 days, and 6 months of vaccination, respectively. Serum was collected before and at day 28 after each vaccination to measure anti-Vi IgG antibodies by enzyme-linked immunosorbent assay (ELISA). Cohort 1 (66 participants) enrollment began 02 December 2019, and follow-up was terminated before completion due to the COVID-19 pandemic. Cohort 2 (100 participants) enrollment began 25 March 2020. Solicited AEs were mostly mild, with no significant differences between HEU and HUU participants or one- and two-dose groups. All six SAEs were unrelated to vaccination. Anti-Vi geometric mean titers (GMT) increased significantly from 4.1 to 4.6 ELISA units (EU)/mL at baseline to 2572.0 - 4117.6 EU/mL on day 28 post-vaccination, and similarly between HEU and HUU participants for both one- and two-dose schedules. All participants seroconverted (>4-fold increase in GMT) by the final study visit. Our findings of comparable safety and immunogenicity of Vi-TT in HUU and HEU children support country introductions with single-dose Vi-TT in HIV-endemic countries.

Objective: Identify operational lessons to support hospital and health system preparedness and response for sea-sonal and pandemic influenza based on firsthand experiences from the 2017-2018 influenza season., Design: We conducted semistructured, retrospective interviews with New York City Health+Hospitals (NYCH+H) personnel to gather firsthand experiences from the 2017-2018 influenza season and evaluated stress data across four operational domains reported by NYCH+H hospitals during the 2017-2018 influenza season., Setting: Frontline hospitals in the NYCH+H health system during and after the 2017-2018 influenza season., Participants: Interviews conducted with personnel from 5 NYCH+H frontline hospitals. Operational stress data re-ported by 11 NYCH+H hospitals during the 2017-2018 influenza season., Main Outcome Measures: Operational challenges and lessons from frontline hospitals responding to severe sea-sonal influenza., Results: Operational stresses during the 2017-2018 influenza season varied over the influenza season, between facilities, and across operational domains. Patient surge and staff absenteeism pushed some facilities to their limits, and supply shortages highlighted shortcomings in existing procurement systems. Resources tied to pandemic influ-enza were unavailable without a pandemic declaration., Conclusion: Seasonal influenza poses dynamic operational stresses across health systems and cities, potentially causing major impacts outside of declared pandemics. Lessons from NYCH+H can help other hospitals and health systems anticipate operational challenges, but novel solutions are needed to mitigate effects of patient surge and per-sonnel and supply shortages during severe influenza seasons and pandemics. Improved data collection can help health systems better understand operational stresses and challenges across their facilities.