Immunogenicity and safety of an egg culture-based quadrivalent inactivated non-adjuvanted subunit influenza vaccine in subjects ≥3 years: A randomized,multicenter, double-blind,active-controlled phase III,non-inferiority trial

Subunit influenza vaccine only formulated with surface antigen proteins has better safety profiles relative to split-virion influenza vaccine. Compared to the traditional quadrivalent split-virion influenza vaccine, a novel quadrivalent subunit influenza vaccine is urgently needed in China. We completed a phase 3, randomized, double-blind, active-controlled, non-inferiority clinical study at two sites in Henan Province, China. Eligible volunteers were split into four age cohorts (3–8 years, 9–17 years, 18–64 years, and ≥ 65 years, based on their dates of birth) and randomly assigned (1:1) to the subunit and the split-virion ecNAIIV4 groups. All volunteers were intramuscularly administered a single vaccine dose at baseline, and children aged 3–8 years received a boosting dose at day 28. And the immune response was evaluated by measuring hemagglutinin-inhibition antibody titers against the four vaccine strains in blood samples. Safety profiles had nonsignificant differences between the study groups in ≥ 3 years cohort. Most adverse reactions post-vaccination, both local and systemic, were mild to moderate and resolved within 3 days. And no serious adverse events occurred. The immunogenicity of the trial vaccine was non-inferior to the comparator. Further, a two-dose vaccine series can provide better seroprotection than that of a one-dose series in children aged 3–8 years, with clinically acceptable safety profiles.Clinical Trials Registration. ChiCTR2100049934.     

Vaccines do not cause atopic dermatitis: A systematic review and meta-analysis

BackgroundPrevious studies found conflicting results about the association of vaccinations and likelihood of atopic dermatitis (AD).ObjectivesTo determine whether vaccinations increase the likelihood of AD.MethodsA systematic review was performed of all published studies in MEDLINE, EMBASE, LILACS, Scopus, and Web of Science databases. At least 2 reviewers conducted title/abstract, full-text review, and data extraction. Quality of evidence was assessed using the Newcastle-Ottawa Scale (NOS).ResultsForty-four studies met inclusion criteria; 37 had sufficient data for meta-analysis. There were no associations any vaccine regimen (random-effects logistic regression: odds ratio [95% confidence interval]: 0.961 [0.822–1.124]; n = 21 studies) BCG (0.927 [0.701–1.226]; n = 8), pertussis (0.790 [0.416–1.499]; n = 4), single (1.031 [0.920–1.155]; n = 17) or multiple vaccines (0.902 [0.608–1.338]; n = 7) with likelihood of AD. This remained true in studies with high-quality (NOS ≥ 7) (OR [95% CI]: 0.941 [0.793–1.117]; n = 13 studies) or low-quality (NOS < 7) (OR [95% CI]: 1.058 [0.669–1.674]; n = 8 studies).LimitationsNo randomized controlled trials.ConclusionsNo vaccine regimen was consistently associated with developing AD.     

Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older

BackgroundThe MenB-FHbp vaccine (Trumenba®) is licensed in various countries for the prevention of meningococcal serogroup B disease in individuals ≥ 10 years of age. The clinical development program included 11 completed trials where, in each trial, MenB-FHbp had an acceptable safety profile after a primary vaccination series was administered to individuals 10–65 years of age. However, the detection of potential rare events was limited because of individual clinical trial size. The current safety analysis evaluates pooled reactogenicity and other adverse events (AEs) reported in these trials to identify new safety signals not detectable in individual trials.MethodsEleven trials contributed safety data, of which 10 recorded local and systemic reactogenicity events; 8 of the trials were controlled, and reactogenicity data were pooled for 7 of these 8 trials. Additional AE evaluations included immediate AEs (IAEs), medically attended AEs (MAEs), serious AEs (SAEs), newly diagnosed chronic medical conditions (NDCMCs), and autoimmune or neuroinflammatory conditions.ResultsLocal and systemic reactions were more frequent in the MenB-FHbp group (n = 15,294) compared with controls (n = 5509), although most reactions were transient and mild to moderate in severity. Frequencies of IAEs, SAEs, MAEs, NDCMCs, and autoimmune or neuroinflammatory conditions were similar between the MenB-FHbp and control groups.ConclusionsMenB-FHbp demonstrated a favorable safety and tolerability profile in the clinical development program of > 15,000 vaccine recipients ≥ 10 years of age. No new safety signals were identified in the pooled analysis compared with data from the individual trials. Continued postmarketing safety surveillance is important for the identification of rare events.Clinicaltrials.gov: NCT01299480; NCT000808028; NCT00879814; NCT00780806; NCT01352845; NCT01352793; NCT01461993; NCT01323270; NCT01830855; NCT01461980; NCT01768117.     

Ethnoracial Disparity in Hospital Survival following Transjugular Intrahepatic Portosystemic Shunt Creation for Acute Variceal Bleeding in the United States

PurposeTo investigate the magnitude of racial/ethnic differences in hospital mortality after transjugular intrahepatic portosystemic shunt (TIPS) creation for acute variceal bleeding and whether hospital care processes contribute to them.MethodsPatients aged ≥18 years undergoing TIPS creation for acute variceal bleeding in the United States (n = 10,331) were identified from 10 years (2007–2016) available in the National Inpatient Sample. Hierarchical logistic regression was used to examine the relationship between patient race and inpatient mortality, controlling for disease severity, treatment utilization, and hospital characteristics.ResultsA total of 6,350 (62%) patients were White, 1,780 (17%) were Hispanic, and 482 (5%) were Black. A greater proportion of Black patients were admitted to urban teaching hospitals (Black, n = 409 (85%); Hispanic, n = 1,310 (74%); and White, n = 4,802 (76%); P < .001) and liver transplant centers (Black, n = 215 (45%); Hispanic, n = 401 (23%); and White, n = 2,267 (36%); P < .001). Being Black was strongly associated with mortality (Black, 32% vs non-Black, 15%; odds ratio, 3.0 [95% confidence interval, 1.6–5.8]; P = .001), as assessed using the risk-adjusted regression model. This racial disparity disappeared in a sensitivity analysis including only patients with a maximum Child-Pugh score of 13 (odds ratio 1.2 [95% confidence interval, 0.4–3.6]; P = .68), performed to compensate for the absence of Model for End-stage Liver Disease scores. Ethnoracial differences in access to teaching hospitals, liver transplant centers, first-line endoscopy, and transfusion did not significantly contribute (P > .05) to risk-adjusted mortality.ConclusionsBlack patients have a 2-fold higher inpatient mortality than non-Black patients following TIPS creation for acute variceal bleeding, possibly related to greater disease severity before the procedure.