Daily Respiratory Research Analysis

BACKGROUND: The adenovirus-vaccine platform has come to prominence with the COVID-19 vaccination campaigns. The objective of this study was to validate a formulation that was suitable for lyophilisation and long-term storage at 5 (2-8) °C. METHODS: Vaccine stability was assessed up to five years at 5 °C using a lyophilised formulation of the chimpanzee-adenovirus vector ChAd155 encoding a respiratory syncytial virus (RSV) antigen. Vaccine potency was assessed by functional infectivity assay. Other assessments of vaccine stability included those for capsid integrity, particle content, and DNA release. Vaccine efficacy and safety were assessed after two years in a murine model of RSV challenge and a rabbit toxicology model, respectively. RESULTS: Here, we show that the potency loss from lyophilisation was 0.12 log CONCLUSIONS: The 5-year stability of the lyophilised adenovirus-vector vaccine is within our acceptable limit ( < 0.3 log Being able to store vaccines for several years in the fridge rather than the freezer should increase their availability, especially in low-income countries, and enable more immediate use in epidemics. The challenge is greater for vaccines that are based on functional viruses. Here we evaluate a freeze-dried formulation of a vaccine that uses a genetically manipulated adenovirus, a similar design to that of many of the successful COVID-19 vaccines. We tested how stable the vaccine was in various ways and checked that it still worked in animal models. Our method could be used to store vaccines for up to five years in a fridge, which would enable them to be used more quickly across the world when required.

AIM: To analyse whether respiratory syncytial virus (RSV) vaccination during pregnancy increases the odds of preterm birth. METHODS: A rapid review and meta-analysis was performed. The main outcome was the risk of preterm (gestational week less than 37) birth. A fixed-effects model was used to analyse pooled odds ratios (OR) with 95% confidence intervals (CI). Evidence certainty was assessed according to GRADE. RESULTS: We included six randomised controlled trials with 17 656 births and two observational studies with 3446 births. The odds for preterm birth were increased in the randomised studies (OR 1.17, CI 1.02-1.34). No evidence of a difference was seen in the observational studies (OR 0.93, CI 0.69-1.25). Combined, these showed increased odds for preterm birth (OR 1.13, CI 1.00-1.27). Evidence certainty was rated to be moderate. When restricted to market-approved vaccine, the odds seemed to be increased in RCTs (OR 1.21, CI 0.98-1.49). CONCLUSION: Based on the available evidence, RSV vaccination seems to be associated with increased odds for preterm birth. RSV vaccination needs continuous population-level observational safety data monitoring on the perinatal outcomes during the early phases of vaccine rollouts to detect possible safety signals and further confirm the magnitude of the effect on preterm birth.

BACKGROUND: Cystic fibrosis is a multisystem disease characterised by the production of thick secretions causing recurrent pulmonary infection, often with unusual bacteria. Intravenous (IV) antibiotics are commonly used in the treatment of acute deteriorations in symptoms (pulmonary exacerbations); however, recently the assumption that exacerbations are due to increases in bacterial burden has been questioned. This is an update of a previously published review. OBJECTIVES: To establish whether IV antibiotics for the treatment of pulmonary exacerbations in people with cystic fibrosis improve short-term and long-term clinical outcomes. SEARCH METHODS: We searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the reference lists of relevant articles and reviews and ongoing trials registers. Date of last search of Cochrane Trials Register: 19 June 2024. SELECTION CRITERIA: Randomised controlled trials and the first treatment cycle of cross-over studies comparing IV antibiotics (given alone or in an antibiotic combination) with placebo, or inhaled or oral antibiotics for people with cystic fibrosis experiencing a pulmonary exacerbation. Studies comparing different IV antibiotic regimens were also eligible. DATA COLLECTION AND ANALYSIS: We assessed studies for eligibility and risk of bias, and extracted data. Using GRADE, we assessed the certainty of the evidence for the outcomes lung function % predicted (forced expiratory volume in one second (FEV MAIN RESULTS: We included 45 studies involving 2810 participants. The included studies were mostly small, and inadequately reported, many of which were quite old. The certainty of the evidence was mostly low. Combined intravenous antibiotics versus placebo Data reported for absolute change in % predicted FEV AUTHORS' CONCLUSIONS: The evidence of benefit from administering IV antibiotics for pulmonary exacerbations in cystic fibrosis is often poor, especially in terms of size of studies and risk of bias, particularly in older studies. We are not certain whether there is any difference between specific antibiotic combinations, and neither is there evidence of a difference between the IV route and the inhaled or oral routes. There is limited evidence that shorter antibiotic duration in adults who respond early to treatment is not different to a longer period of treatment. There remain several unanswered questions regarding optimal IV antibiotic treatment regimens.