305 research outputs found

    Comparison of bivalent and monovalent SARS-CoV-2 variant vaccines: the phase 2 randomized open-label COVAIL trial

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    Vaccine protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection wanes over time, requiring updated boosters. In a phase 2, open-label, randomized clinical trial with sequentially enrolled stages at 22 US sites, we assessed safety and immunogenicity of a second boost with monovalent or bivalent variant vaccines from mRNA and protein-based platforms targeting wild-type, Beta, Delta and Omicron BA.1 spike antigens. The primary outcome was pseudovirus neutralization titers at 50% inhibitory dilution (ID titers) with 95% confidence intervals against different SARS-CoV-2 strains. The secondary outcome assessed safety by solicited local and systemic adverse events (AEs), unsolicited AEs, serious AEs and AEs of special interest. Boosting with prototype/wild-type vaccines produced numerically lower ID titers than any variant-containing vaccine against all variants. Conversely, boosting with a variant vaccine excluding prototype was not associated with decreased neutralization against D614G. Omicron BA.1 or Beta monovalent vaccines were nearly equivalent to Omicron BA.1‚ÄČ+‚ÄČprototype or Beta‚ÄČ+‚ÄČprototype bivalent vaccines for neutralization of Beta, Omicron BA.1 and Omicron BA.4/5, although they were lower for contemporaneous Omicron subvariants. Safety was similar across arms and stages and comparable to previous reports. Our study shows that updated vaccines targeting Beta or Omicron BA.1 provide broadly crossprotective neutralizing antibody responses against diverse SARS-CoV-2 variants without sacrificing immunity to the ancestral strain. ClinicalTrials.gov registration: NCT05289037

    Exploring the cost-effectiveness of high versus low perioperative fraction of inspired oxygen in the prevention of surgical site infections among abdominal surgery patients in three low- and middle-income countries

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    Background: This study assessed the potential cost-effectiveness of high (80‚Äď100%) vs low (21‚Äď35%) fraction of inspired oxygen (FiO2) at preventing surgical site infections (SSIs) after abdominal surgery in Nigeria, India, and South Africa. Methods: Decision-analytic models were constructed using best available evidence sourced from unbundled data of an ongoing pilot trial assessing the effectiveness of high FiO2, published literature, and a cost survey in Nigeria, India, and South Africa. Effectiveness was measured as percentage of SSIs at 30 days after surgery, a healthcare perspective was adopted, and costs were reported in US dollars ().Results:HighFiO2maybecost‚ąíeffective(cheaperandeffective).InNigeria,theaveragecostforhighFiO2was). Results: High FiO2 may be cost-effective (cheaper and effective). In Nigeria, the average cost for high FiO2 was 216 compared with 222forlowFiO2leadingtoa¬†‚ąí222 for low FiO2 leading to a¬†‚ąí6 (95% confidence interval [CI]:¬†‚ąí13to¬†‚ąí13 to¬†‚ąí1) difference in costs. In India, the average cost for high FiO2 was 184comparedwith184 compared with 195 for low FiO2 leading to a¬†‚ąí11(9511 (95% CI:¬†‚ąí15 to¬†‚ąí6)differenceincosts.InSouthAfrica,theaveragecostforhighFiO2was6) difference in costs. In South Africa, the average cost for high FiO2 was 1164 compared with 1257forlowFiO2leadingtoa¬†‚ąí1257 for low FiO2 leading to a¬†‚ąí93 (95% CI:¬†‚ąí132to¬†‚ąí132 to¬†‚ąí65) difference in costs. The high FiO2 arm had few SSIs, 7.33% compared with 8.38% for low FiO2, leading to a¬†‚ąí1.05 (95% CI:¬†‚ąí1.14 to¬†‚ąí0.90) percentage point reduction in SSIs. Conclusion: High FiO2 could be cost-effective at preventing SSIs in the three countries but further data from large clinical trials are required to confirm this

    A second update on mapping the human genetic architecture of COVID-19