Racial disparities in U.S. maternal influenza vaccine uptake: Results from analysis of Pregnancy Risk Assessment Monitoring System (PRAMS) data, 2012–2015

Background

Pregnant women are at increased risk of hospitalization, serious complications, poor pregnancy outcomes, and mortality from influenza. Prior research suggests that there are racial/ethnic disparities in vaccination coverage and that a healthcare provider vaccination recommendation is associated with significantly higher vaccine uptake than without such a recommendation. The purpose of this study is to examine racial/ethnic disparities in healthcare providers’ recommendations for pregnant women to receive the influenza vaccine and in vaccine uptake.

Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials

Background

The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies.

Vaccinations in prison settings: A systematic review to assess the situation in EU/EEA countries and in other high income countries

IntroductionIn 2016, more than 600,000 persons were being held in EU/EEA correctional facilities on a given day. People in prison may be at risk of vaccine-preventable diseases. While vaccination recommendations for people in prison exist, little is known on coverage and implementation options.MethodsWe performed a systematic review on existing evidence on vaccination in prison settings in the EU/EEA. We searched peer-reviewed and grey literature following international methodology and reporting standards, to gather records published between 1980 and 2016 in all languages. We analysed quantitative (acceptance, uptake, cost-effectiveness) and qualitative (barriers) outcomes.ResultsOut of 7041 identified records, 19 full-text articles were included from peer-reviewed literature and two from grey literature. Of these, 18 reported on hepatitis A and/or B virus (HAV/HBV), two on influenza and one on MMR vaccination. Two studies on HAV vaccine reported varying acceptance (5–91%) and uptake rates (62.9–70.5%). Seven studies reported on HBV vaccination. A comparative study showed a significantly higher uptake of the third HBV vaccine dose with the very rapid (63%) compared to the standard schedule (20%). HBV vaccination was generally well accepted (54–100%), whereas uptake was variable (dose 1:23–100%, dose 2:48–92%, dose 3:19–80%). One study on the combined HAV/HBV vaccine reported an acceptance rate of 34%, and declining uptake following dose 1. One study on influenza vaccine showed an uptake of 42–46%, while another reported a MMR vaccine acceptance of 80% and an uptake of 74%. Overall, main reasons for non-vaccination included release from/or transfer between prisons, and refusal.ConclusionsThis systematic review highlighted important knowledge gaps and operational challenges for vaccination in prison settings. Vaccination is an effective measure that warrants comprehensive and tailored implementation to reduce the preventable disease burden, avoid risks of large outbreaks of vaccine-preventable diseases, and contribute to health equity for people in prison.     

Statin use and medically attended acute respiratory illness among influenza vaccine recipients

BackgroundPrevious studies have suggested that statins decrease influenza vaccine effectiveness and increase risk of medically attended acute respiratory illness (MAARI).ObjectivesTo examine the association of incident statin use and MAARI in a cohort of influenza vaccine recipients.MethodsThis retrospective cohort study evaluated influenza vaccine recipients within the Tricare population. The primary outcome compared MAARI incidence during the follow-up period in a propensity score-matched cohort of incident statin users and statin non-users. Secondary analysis included propensity score-adjusted comparisons between incident statin users and statin non-users in the entire cohort and prespecified sub-cohorts with and without comorbidities. The propensity score was derived from 72 variables encompassing demographics, medical history, comorbidities, medication use, and healthcare utilization.ResultsMAARI incidence in statin users was similar to non-users in the propensity score-matched cohort (odds ratio [OR] 0.92; 95% confidence interval [CI] 0.84–1.01). In contrast, statin users with lower comorbidity had lower OR for MAARI compared to non-users (Charlson Score zero cohort: 0.85 [CI 0.74–0.98]; No Diabetes cohort: 0.88 [CI 0.80–0.96]).ConclusionIncident statin use was not associated with increased MAARI incidence and may be associated with lower incidence of MAARI in those with less comorbidity. This study thus offers reassurance regarding the effectiveness of the influenza vaccine in statin users.     

Stabilization and formulation of a recombinant Human Cytomegalovirus vector for use as a candidate HIV-1 vaccine

Live attenuated viral vaccine/vector candidates are inherently unstable and infectivity titer losses can readily occur without defining appropriate formulations, storage conditions and clinical handling practices. During initial process development of a candidate vaccine against HIV-1 using a recombinant Human Cytomegalovirus vector (rHCMV-1), large vector titer losses were observed after storage at 4 °C and after undergoing freeze-thaw. Thus, the goal of this work was to develop candidate frozen liquid formulations of rHCMV-1 with improved freeze-thaw and short-term liquid stability for potential use in early clinical trials. To this end, a virus stability screening protocol was developed including use of a rapid, in vitro cell-based immunofluorescence focus assay to quantitate viral titers. A library of ∼50 pharmaceutical excipients (from various known classes of additives) were evaluated for their effect on vector stability after freeze-thaw cycling or incubation at 4 °C for several days. Certain additives including sugars and polymers (e.g., trehalose, sucrose, sorbitol, hydrolyzed gelatin, dextran 40) as well as removal of NaCl (lower ionic strength) protected rHCMV-1 against freeze-thaw mediated losses in viral titers. Optimized solution conditions (e.g., solution pH, buffers and sugar type) slowed the rate of rHCMV-1 titer losses in the liquid state at 4 °C. After evaluating various excipient combinations, three new candidate formulations were designed and rHCMV-1 stability was benchmarked against both the currently-used and a previously reported formulation. The new candidate formulations were significantly more stable in terms of reducing rHCMV-1 titer losses after 5 freeze-thaw cycles or incubation at 4 °C for 30 days. This case study highlights the utility of semi-empirical design of frozen liquid formulations of a live viral vaccine candidate, where protection against infectivity titer losses due to freeze-thaw and short-term liquid storage are sufficient to enable more rapid initiation of early clinical trials.     

A case-control study of risk factors for intussusception among infants in eastern France after the introduction of the rotavirus vaccine

ObjectiveThe objective of the present study was to investigate the risk factors for intussusception (IS) among infants, including vaccination against rotavirus.MethodsCase-control study with systematic inclusion of all infants aged <1 year with suspected IS admitted to emergency departments in the eastern region of France between 1 April 2008 and 31 March 2012. All cases classed level 1 according to the Brighton classification were matched to 4 hospital controls. Two exposure windows were examined; exposure to the first dose of rotavirus vaccine in the 7 and in the 14 days prior to the occurrence of IS.ResultsA total of 115 cases were matched with 457 controls. The average vaccination coverage rate over the 4 years of study was 8.6%. Rotavirus vaccine was not found to be significantly associated with the occurrence of IS in the 7 days (odds ratio (OR) not calculated; p = 0.99) and in the 14 days after administration of one dose vaccine (OR 1.33, 95% confidence interval (CI) 0.14–12.82). Infant formula alone or combined with breastfeeding was associated with an excess risk of IS (OR 2.74, 95% CI 1.10–6.79). A history of gastroenteritis within 2 weeks prior to hospitalisation was also associated with an increased risk (OR 2.24, 95% CI 1.07–4.67).ConclusionOur study indicates that infant formula alone or combined with breastfeeding is a risk factor for IS. A small, non-significant increase in the risk of IS was observed after rotavirus vaccination, although the low vaccine coverage rate likely precluded detection of a significant increase in risk.     

Measuring Discomfort in Health Research Relative to Everyday Events and Routine Care: An Application to Sexual and Gender Minority Youth

Purpose

Understanding how sexual and gender minority (SGM) youth's comfort with research procedures compares to their comfort with everyday experiences and routine health care can help calibrate decisions about whether a study meets minimal risk criteria. We sought to quantify SGM adolescents' comfort with sexual health research relative to everyday events and activities often cited as benchmarks of minimal risk.

Glycine‐modified growth hormone secretagogues identified in seized doping material

A number of unknown pharmaceutical preparations seized by Danish customs authorities were submitted for liquid chromatography–high resolution mass spectrometry (LC–HRMS) analysis. Comparison with reference standards unequivocally identified the content of the powders as analogs of the growth hormone secretagogues GHRP‐2 (Pralmorelin), GHRP‐6, Ipamorelin, and modified growth hormone releasing factor (modified GRF 1–29), which can be used as performance‐enhancing substances in sports. In all cases, the detected modification involved the addition of an extra glycine amino acid at the N‐terminus, and analytical methods targeting growth hormone secretagogues should hence be updated accordingly.     

Treatment of skeletal open bite using a navigation system: CAD/CAM osteotomy and drilling guides combined with pre-bent titanium plates

Severe skeletal open bite associated with posterior vertical maxillary excess and mandibular deformity is considered a difficult problem in orthodontic and surgical treatment. This study used a navigation system for the correction of severe skeletal open bite in order to accurately transfer the virtual plan to the actual operation and achieve precise rigid internal fixation in bimaxillary osteotomies of the jaws. Twelve patients with a severe skeletal open bite associated with vertical maxillary excess and mandibular deformity were recruited. All patients underwent Le Fort I osteotomy and bilateral sagittal split ramus osteotomy with the guidance of this navigation system. Computed tomography and cephalometric examinations were performed to evaluate the correction of the deformity. Deviations between the simulated plan and actual postoperative outcome were measured to determine the precision of the surgery. Satisfactory and stable results were achieved in all patients postoperatively, without complications or relapse during follow-up. Photographs and cephalometric evaluations showed that the facial profile and occlusion were improved. Assessment of the deviations between the simulated plan and actual postoperative outcome showed that the navigation system can precisely transfer the virtual plan to the actual operation. The results suggest that the navigation system can accurately transfer the virtual plan to the actual operation during bimaxillary jaw osteotomies, without relapse, in patients with a severe skeletal open bite.