Safety, Tolerability, and Immunogenicity of SPVX02, a Room Temperature-stabilised Tetanus-diphtheria Vaccine, Compared to Two Established Tetanus-diphtheria Booster Vaccines: A Multicentre, Single-blind, Randomised, First-in-human Phase 1 Trial in the UK:
Cold chain requirements limit vaccine accessibility and deployment. SPVX02, is a lyophilised, fridge-free version of Tetadif tetanus-diphtheria vaccine, stable for at least 24 months at temperatures up to 30 °C. This multicentre, first-in-human phase 1, single-blind, randomised clinical trial was conducted at three sites in the UK to evaluate the safety and tolerability of SPVX02 compared to existing approved tetanus-diphtheria (Td) vaccines. Findings suggest that SPVX02 is safe, well tolerated, with TT and DT immunogenicity similar to the two existing approved Td vaccines investigated herein. This trial provides first-in-human evidence that StablevaX technology can be used to safely reformulate an aluminium-adjuvanted vaccine stable up to 30 °C for 24 months. A phase 2/3 trial is planned, and further research will investigate temperature stability at higher temperatures, and technology application to other vaccines and biological products.
Effectiveness of Oseltamivir in Hospitalized Children With Laboratory-Confirmed Influenza, 2014-2023
This cohort study used data from the Influenza Hospitalization Surveillance Network (FluSurv-NET), which conducts U.S. population-based surveillance for laboratory-confirmed influenza hospitalizations for all ages across 13 states. The primary outcome was time from symptom onset to ICU admission. Secondary outcome was time from admission to discharge (LOS). 6,044 influenza cases were included in the primary ICU analysis, of whom 4,240 (70.2%) received oseltamivir. 7,103 cases were included in the secondary LOS analysis, of whom 5,746 (80.9%) received oseltamivir. Compared with untreated children, oseltamivir treatment reduced the hazard of ICU admission by 31%n (aHR, 0.69; 95% CI, 0.60-0.80) and shortened LOS (analyzed as hazard of hospital discharge; aHR, 1.13; 95% CI, 1.06-1.21).
Impact of COVID-19 Monoclonal Antibody Therapy on Subsequent Vaccine-Elicited SARS-CoV-2 Immune Responses
Researchers asked how anti-SARS-CoV-2 monoclonal antibodies (mAbs) change subsequent vaccine responses. They conducted a prospective, phase IV, open-label study of adults who received mRNA-1273 or BNT162b2. Cohort 1 included outpatients with acute COVID-19 previously randomized to mAbs (tixagevimab/cilgavimab or amubarvimab/romlusevimab), camostat, or placebo in ACTIV-2/A5401. Cohort 2 included unvaccinated adults without reported prior COVID-19 and was analyzed as naive or non-naive by baseline neutralizing antibodies (nAbs). They measured binding IgG, nAbs, spike-specific memory B cells, and CD4+/CD8+ T cells at baseline and days 28, 56, and 140. Forty-three participants were analyzed. At day 140, nAb titers were lower among prior mAb recipients and COVID-19–naive participants than among placebo/camostat recipients and those with evidence of prior infection (overall P = .018). RBD-specific, but not spike-specific, memory B cells were reduced after prior mAb therapy at days 56 and 140. Frequency of spike-specific CD4 + and CD8+ T-cell responses did not differ by prior mAb exposure. Prior anti-SARS-CoV-2 mAb treatment limits endogenous RBD-focused B-cell responses to later mRNA vaccination without measurably affecting T-cell immunity. Timing of vaccination after mAb therapy may matter and warrants study.
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