High temperature effect on daily all-cause mortality in Tunis 2005–2007

BackgroundThe relationship between thermal stress and health has been only marginally investigated in North Africa. This study aimed to estimate the short-term effect of heat on total mortality, in the city of Tunis in 2005–2007, using time series analysis.MethodsThe study period was restricted to the summer season (May–October) and heat effect was assessed using maximum temperature as exposure variable. We estimated the breakpoint above which heat-related mortality begins to increase using a segmented linear regression. A Poisson Generalized Estimating Equations (GEE) model was then used to estimate the impact of heat on daily mortality. Models were adjusted for nitrogen dioxide (NO₂), trend, calendar month, day of the week, the Ramadan period, and holidays.ResultsThe estimated breakpoint was 31.5 °C (standard deviation: 0.9 °C). After adjustment for potential confounders, the daily mortality increased significantly by 2.00% [95% confidence interval: 0.68–3.16] for a 1 °C increase in daily maximum temperature above the breakpoint. An increase of 10 mg/m³ in NO₂ was associated with a significant increase in daily mortality (0.48% [0.08–0.88]).ConclusionThere is an important effect of heat on daily mortality in the city of Tunis. This is the first evaluation of such an association in a North African city with hot and dry summers and a lower middle economy.     

Differences in the Associations between Body Dissatisfaction and Eating Outcomes by Gender? A Lebanese Population Study

BackgroundThe objective of this study was to evaluate the impact of the interaction between body dissatisfaction and gender on eating disorders (restrained eating, binge eating, orthorexia nervosa, and emotional eating) among a sample of Lebanese adults.MethodsThis cross-sectional study, conducted between January and May 2018, enrolled 811 participants selected randomly from all Lebanese Mohafazat. The mean age of the participants was 27.6 ± 11.8 years. The majority were females (66.5%), had a high level of education (73.2%), and low income (77.9%). This study used the following scales: body dissatisfaction subscale of the Eating Disorder Inventory-second version, binge eating scale, Dutch restrained eating scale, orthorexia nervosa scale (ORTHO-15 scale), emotional eating scale, perceived stress scale, Hamilton Anxiety Rating Scale, and Hamilton Depression Rating Scale.ResultsBody dissatisfaction was positively correlated to restrained eating (r = 0.293, P < 0.001), emotional eating (r = 0.073, P = 0.042) and binge eating (r = 0.250, P < 0.001). The interaction between body dissatisfaction and gender was significantly associated with more restrained eating (Beta = 0.01, P < 0.001) and orthorexia nervosa (Beta = ?0.09, P < 0.001), but not with emotional (Beta = ?0.43, P = 0.103) and binge eating (Beta = ?0.08, P = 0.358). When stratifying the analysis by gender, the results revealed that higher body dissatisfaction was significantly associated with more restrained eating in both genders, but particularly among women. Body dissatisfaction was significantly associated with higher emotional eating in men only and with higher orthorexia nervosa tendencies and behaviors in females only.ConclusionThe interaction between body dissatisfaction and gender was significantly associated with orthorexia nervosa and restrained eating but not with binge or emotional eating. Higher body dissatisfaction was significantly associated with higher restrained eating, more pronounced in women, while it was significantly associated with higher orthorexia tendencies (lower ORTO-15 scores) in women only. Body dissatisfaction was associated with emotional eating in men only.     

Combination of inulin and compound probiotic exert synergism in attenuating HFD-induced obesity but shows gender-difference

ObjectivesOur goal was to test the anti-obesity effects of supplementing inulin and compound probiotic (CP) alone or in combination on HFD-mice model.Material and methodsFifty C57BL/6 mice were randomly divided into five groups of varying diets as follows: normal chow diet (NCD), high-fat diet(HFD), HFD + inulin, HFD + CP, HFD + inulin + CP. Each group consisted of five males and five females. All mice were sacrificed to test obesity parameters adipocytokines、blood lipid parameters and inflammatory factor after seven weeks.ResultsCompared to male mice HFD group, the supplement of inulin and CP alone significantly improved HFD-induced obesity by regulating weight gain blood lipid metabolism inflammatory cytokines and adipokines. However, inulin combined CP had a better anti-obesity effect. For the female mice, body weight blood lipids and glucose liver weight and Free fatty acid (FFA) were influenced to different degrees. Besides, the beneficial effects of inulin and CP treatment on HFD-induced obesity showed gender-difference.ConclusionThis study demonstrated that prebiotic inulin and CP could have paly antiobesity effects on HFD male mice, respectively. The synergism of inulin combined with CP on improving HFD-induced obesity was observed in our study. Meanwhile, there were differences between male and female mice of above beneficial effects, providing a rational therapeutic method of HFD-induced obesity in the future.     

Long-term immunogenicity and safety of the hepatitis B vaccine HepB-CpG (HEPLISAV-B) compared with HepB-Eng (Engerix-B) in adults with chronic kidney disease

BackgroundHepatitis B virus (HBV) infection remains a significant global burden, especially for patients with chronic kidney disease (CKD) receiving hemodialysis. Three doses of HepB–CpG (HEPLISAV-B® vaccine) induced a superior immune response compared with 4 double doses of HepB–Eng (Engerix-B®) in a phase 3 trial (HBV-17) in adults with CKD. Here we report the long-term immunogenicity and safety of HepB-CpG and HepB–Eng in eligible participants of HBV-17 who enrolled in this optional 34-month follow-up trial (HBV-19).MethodsHBV-19 is a multicenter, open-label, phase 3b trial of adults with CKD who previously received a complete series of HepB-CpG or HepB-Eng in the HBV-17 trial. Participants were assigned to seroprotection categories at enrollment on the basis of their antibody response to hepatitis B surface antigen (anti-HBs) in HBV-17. The objective was to evaluate the durability of seroprotection (defined as an anti-HBs concentration ≥ 10 mIU/mL) induced by HepB-CpG and HepB-Eng. Participants whose anti-HBs concentration was below 10 mIU/mL received additional HepB-CpG or HepB-Eng doses.Results147 participants were enrolled; 66.7 % were men, median age was 65.0 years, and 83.7 % were white. The durability of seroprotection in participants with CKD was similar in those who received HepB-CpG and those who received HepB-Eng. Antibody concentrations ≥ 100 mIU/mL persisted for longer in HepB-CpG than HepB-Eng recipients, among those with anti-HBs ≥ 100 mIU/mL post vaccination. The geometric mean anti-HBs concentration in the HepB-CpG group was significantly higher than in the HepB-Eng group over time (P ≤ 0.0001). The safety profiles were similar between the vaccine groups.ConclusionsDue to the higher antibody levels induced by HepB-CpG in participants with CKD, seroprotection against HBV may be expected to persist longer than that induced by HepB-Eng. ClinicalTrials.gov: NCT01282762.     

A phase 1, randomized,observer blind,antigen and adjuvant dosage finding clinical trial to evaluate the safety and immunogenicity of an adjuvanted,trivalent subunit influenza vaccine in adults ≥ 65 years of age

ObjectiveTo assess the safety and immunogenicity of the MF59®-adjuvanted trivalent influenza vaccine (aTIV; Fluad®) compared with modified aTIV formulations.MethodsA total of 196 subjects ≥ 65 years were randomized to receive 7 different formulations of vaccine containing a range of adjuvant and antigen doses by single injection, or divided into two injections at a single time point. The primary study objective was to compare the serologic response of different formulations of aTIV containing increased amounts of adjuvant and antigen 21 days after vaccination. Subjects were followed for immunogenicity and safety for one year.ResultsThe highest immune response, as measured by hemagglutination inhibition (HI) assay, 3 weeks after vaccination was observed in subjects in Group 6 with GMT 382.2 (95% confidence interval [CI] 237.5 to 615.0), 552.3 (364.8 to 836.1), and 54.1 (36.9 to 79.4) against A/H1N1, A/H3N2, and B respectively. Rates of seroconversion were also generally highest in this treatment group: 75% (95% CI 55.1 to 89.3), 75% (55.1 to 89.3), and 42.9% (24.5 to 62.8), respectively, against A/H1N1, A/H3N2, and B strains. The highest incidence of solicited adverse events (AEs) was reported by subjects who received both the highest dosage of antigen in combination with the highest dosage of adjuvant at the same site: 67.9% and 57.1% in Groups 4 and 6, respectively. The majority of solicited AEs were mild to moderate in severity. The number of unsolicited AEs was similar across the different dosages.ConclusionIn this phase I trial of adults ≥ 65 years of age who received increased adjuvant and antigen dosages relative to the licensed aTIV, increased dosage of MF59 resulted in increased immunogenicity against all 3 components of seasonal influenza vaccine. The increase in immunogenicity was accompanied by an increase in the incidence of local reactogenicity.     

Impact of patient and provider nudges on addressing herpes zoster vaccine series completion

ObjectivesTo determine the combined impact of provider-facing and text message-based, patient nudges on herpes zoster vaccine series completion.MethodsFollowing a period during which Kroger Health implemented provider facing nudges, select US patients that initiated herpes zoster vaccination were randomized to receive timed text messages when the second dose was due and available as part of a quality improvement exercise. Main comparisons were between patients intervened by provider nudge only and those intervened by both provider and patient nudges. Data were assessed by GEE-based logistic and linear regression, controlling for available patient- and store-level characteristics, and geospatial analyses.ResultsDuring the baseline period, 100,627 adults received at least one HZ vaccine dose and 83.9% completed the series within 6 months over 88.6 days (SD: 26.53) on average. In the intervention period, 120,339 adults were vaccinated at least once and series completion was 88.3% (both provider nudges and text messaging) and 85.3% (not texted) during this observation window (both p < 0.0001). Time between doses was shorter for those who received text messages compared to both the baseline period and those in the intervention period that were not texted (both p < 0.001). Controlling for multiple characteristics, the odds of completion improved in the intervention period compared to baseline (OR: 1.07; 95% CI: 1.033–1.111), but a noticeably higher completion odds was observed amongst patients who received a text message in the intervention period (OR: 1.35; 95% CI: 1.286–1.414). Adjusting for patient and pharmacy factors, those who were texted received their second herpes zoster vaccine dose 8.6 days sooner (95% CI: ?9.08 - ?8.17, p < 0.0001) compared to those intervened by the provider nudge only.ConclusionThe combined use of clinical and patient-focused nudges is a simple mechanism by which pharmacies and other health care access points can address the multi-dose vaccine needs of diverse patient populations.     

Effect of pneumococcal conjugate vaccine on prevalence of otitis media with effusion among children in Vietnam

PurposeOtitis media with effusion (OME) is common in young children and is associated with Streptococcus pneumoniae infection. We aimed to determine the impact of pneumococcal conjugate vaccine (PCV) introduction on the prevalence of OME and OME associated with vaccine-type (VT) or non-VT.MethodsPopulation-based cross-sectional surveys were conducted in pre- (2016) and post-PCV periods (2017, 2018, and 2019) at selected communes in Nha Trang, Vietnam. For each survey, we randomly selected 60 children aged 4–11 months and 60 aged 14–23 months from each commune. Nasopharyngeal sample collection and tympanic membrane examination by digital otoscope were performed. S. pneumoniae was detected and serotyped by lytA qPCR and microarray. Odds ratios (OR) and 95% confidence intervals (CIs) were calculated using Firth’s logistic regression, stratified by age group.ResultsOver the four surveys, 2089 children had a bilateral ear examination. Compared to pre-PCV, the prevalence of OME reduced in 2018 (OR 0.51, 95 %CI 0.28–0.93) and in 2019 (OR 0.53, 95 %CI 0.29–0.97) among the <12-month-olds, but no significant reduction among the 12–23-month-olds. The prevalence of OME associated with VT pneumococcus decreased in 2018 and 2019 (2018: OR 0.14, 95 %CI 0.03–0.55; 2019: OR 0.20, 95 %CI 0.05–0.69 in the <12-months-olds, 2018: OR 0.05, 95 %CI 0.00–0.44, 2019: OR 0.41, 95 %CI 0.10–1.61 in the 12–23-months-olds). The prevalence of OME associated with non-VT pneumococcus increased in the 12–23-month-olds in 2017 (OR 3.09, 95 %CI 1.47–7.45) and returned to the pre-PCV level of prevalence in 2018 and 2019 (OR 0.94, 95 %CI 0.40–2.43 and 1.40, 95 %CI 0.63–3.49).ConclusionPCV10 introduction was associated with a reduction of OME prevalence in infants but not in older children.     

Vaccination rates and adherence in premature infants before and after pneumococcal conjugate vaccine schedule change for term infants – A claims database analysis in Germany

BackgroundIn 2015, the German Standing Committee on Vaccination (STIKO) changed the pneumococcal conjugate vaccination (PCV) schedule for mature infants from a 3+1 scheme (2, 3, 4, and 11–14 months of age) to a 2+1 scheme (2, 4, and 11–14 months of age). For premature infants, the 3+1 scheme remained. The aim of this study was to assess vaccination rates, completeness, and timeliness for PCV in premature infants before and after the modified recommendation.MethodsA retrospective claims data analysis using the “Institut für angewandte Gesundheitsforschung Berlin” Research Database was conducted. Premature infants born in 2013 and 2016 with an individual follow-up of 24 months were included. Hexavalent combination (HEXA) vaccination with a consistent 3+1 recommendation for mature and premature infants was analyzed as reference vaccination.ResultsAfter 24 months, the PCV rate for at least one dose remained stable in premature newborns of 2016 compared to 2013, while the HEXA vaccination rate increased slightly. However, a significant decrease of a completed PCV schedule (4 doses) in premature infants was noted, whereas the completeness of HEXA vaccination did not change. The timeliness of PCV in premature newborns increased for the first and the booster PCV, while the timeliness of HEXA immunization did not change from 2013 to 2016.ConclusionAlthough STIKO still recommends a 3+1 PCV schedule for premature infants in Germany, premature infants were vaccinated according to the changed recommendations for mature born infants. A substantial share of premature infants remained unvaccinated, and their vaccinations were often delayed.     

Impact of whole-cell bacterial immunoprophylaxis in the management of recurrent urinary tract infections in the frail elderly

PurposeThis study aimed to determine the effectiveness of whole-cell bacterial immunotherapy, i.e. MV140 and autovaccines, in reducing the number of urinary tract infections (UTIs) in frail elderly patients with recurrent UTI (RUTI).MethodA prospective cohort observational study was performed including 200 frail elderly subjects suffering RUTI, both females and males, between 2016 and 2018. The effectiveness of autovaccines and the polybacterial formulation MV140 (Uromune®), consisting of whole-cell heat-inactivated Escherichia coli 25%, Klebsiella pneumoniae 25%, Proteus vulgaris 25% and Enterococcus faecalis 25% were evaluated. Subjects initiated a 3-month sublingually daily course with MV140 or autovaccine, either first treatment or a new course if they had been previously vaccinated prior to inclusion in the study. Number of UTIs and quality of life (QoL, SF-36 score) were measured in the different study groups.ResultsThe mean age for participants was 82.67 (SD, 7.12) for female and 80.23 (SD, 11.12) for male subjects. In all groups, 12 months following bacterial immunotherapy, the number of UTIs significantly decreased compared to before the treatment with autovaccine or MV140: the rate of reduction ranged between 7- and 40-fold. An increase in QoL scoring was also observed in any study group. When comparing medical interventions, MV140 conferred significantly higher benefit than autovaccines. For previously vaccinated individuals, a new 3-month course with MV140 or autovaccines provided further clinical improvement.ConclusionsMV140 and autovaccines emerge as valuable immunoprophylaxis for the management of RUTI in the frail elderly, contributing to an improvement in patient’s quality of life. Herein, MV140 has shown to confer a higher effectiveness compared to autovaccines, regardless sex or course of treatment.     

High-dose influenza vaccines for the prevention of hospitalization due to cardiovascular events in older adults in the nursing home: Post-hoc analysis of a cluster-randomized trial

Older adults are at high risk of major acute cardiovascular events (MACE) linked to influenza illness and preventable by influenza vaccination. It is unknown whether high-dose vaccine might incrementally reduce the risk of MACE. We conducted a post-hoc analysis of data collected from a pragmatic cluster randomized study of 823 nursing homes (NH) randomized to standard-dose (SD) or high-dose (HD) influenza vaccine in the 2013–14 season. Adults age 65 year or older who are Medicare-enrolled long-stay residents were included in the analysis. There were no statistically significant differences in hospitalization for MACE, acute coronary syndromes (ACS), stroke or heart failure between the HD and SD arms. However, in the fee-for-service group, participants in the HD arm had significantly decreased risk of hospitalization for respiratory problems, which was not observed in the Medicare Advantage group. High-dose influenza vaccine was not shown to be incrementally protective against MACE relative to standard-dose vaccine.     

Robust antibody response after a third BNT162b2 vaccine compared to the second among immunocompromised and healthy individuals,a prospective longitudinal cohort study

PurposeAs protection from COVID-19 following two doses of the BNT162b2 vaccine showed a time dependent waning, a third (booster) dose was administrated. This study aims to compare the antibody response following the third dose versus the second and to evaluate post-booster seroconversion.MethodsA prospective observational study conducted in Maccabi Healthcare Services. Serial SARS-CoV-2 Spike IgG tests, 1,2,3 and 6 months following the second vaccine dose and one month following the third were obtained. Neutralizing antibody levels were measured in a subset of participants. Per individual SARS-CoV-2 Spike IgG titer ratios were calculated one month after the booster administration compared to titers one month following the second dose and prior to booster.ResultsAmong 110 participants, 56 (51%) were women. Mean age was 61.7 ± 1.9 years and 66 (60%) were immunocompromised. One month after third dose, IgG titers were induced 7.83 (95 %CI 5.25–11.67) folds and 2.40 (95 %CI 1.90–3.03) folds compared to one month after the second, in the immunocompromised and immunocompetent groups, respectively. Of the 17 immunocompromised participants who were seronegative after the second dose, 4 (24%) became seropositive following the third. Comparing the titers prior to the third dose, an increase of 50.7 (95 %CI 32.5–79.1) fold in the immunocompromised group and 25.7 (95 %CI 19.1–34.7) fold in and immunocompetent group, was observed.ConclusionA third BNT162b2 vaccine elicited robust humoral response, superior to the response observed following the second, among immunocompetent and immunocompromised individuals.     

Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in Japanese healthy infants: A phase III study (V114-033)

BackgroundThis phase III study evaluated safety, tolerability, and immunogenicity of V114 (15-valent pneumococcal conjugate vaccine) in Japanese infants. V114 contains all 13 serotypes in PCV13 plus additional serotypes 22F and 33F.MethodsHealthy Japanese infants were randomized to receive three primary doses of V114 or PCV13 (dose 1 at 2–6 months of age; doses 2 and 3 ≥ 27 days after prior dose), plus a toddler dose at 12–15 months of age. Adverse events (AEs) were collected on Days 1–14 following each vaccination. Serotype-specific anti-pneumococcal immunoglobulin G (IgG) was measured 30 days post-dose 3, pre-dose 4, and 30 days post-dose 4. Primary objectives included non-inferiority of V114 to PCV13 for the 13 shared serotypes based on serotype-specific IgG response rates (IgG ≥ 0.35 μg/mL) and geometric mean concentration (GMC) ratios, and for serotypes 22F and 33F based on IgG response rates and compared with the lowest response of any serotype in the PCV13 group, at 30 days post-dose 3.ResultsOverall, 694 infants were randomized to V114 (n = 347) or PCV13 (n = 347). Proportions of participants with solicited and serious AEs were comparable between vaccination groups. V114 met non-inferiority criteria for all 13 shared serotypes, based on difference in proportion of responders (lower bound of two-sided 95 % confidence interval [CI] > −10.0) and IgG GMC ratios (V114/PCV13, lower bound of two-sided 95 % CI > 0.5) at 30 days post-dose 3. The non-inferiority criterion based on IgG response rates was met for serotype 22F, but narrowly missed for serotype 33F (90.9 %, lower bound of two-sided 95 % CI −10.6).ConclusionIn Japanese infants, a four-dose series of V114 was generally well tolerated. Compared with PCV13, V114 provided non-inferior immune responses to the 13 shared serotypes and higher immune responses to serotype 22F and 33F post-primary series.Trial registration: ClinicalTrials.gov: NCT04384107; EudraCT 2019-003644-68.     

Effects of measles-containing vaccination in children with severe underlying neurologic disease

BackgroundMeasles outbreaks pose significant risk for those unvaccinated.Patients and methodsMeasles-containing vaccine was offered to unvaccinated children with severe neurologic diseases during a measles outbreak. Vaccination adverse events were reported by parents 30 days following vaccination. Long term effects were evaluated 12 months post vaccination.ResultsTwenty-seven children were vaccinated (36 doses given). Half of parents (51.8%) reported no adverse events following immunization. Adverse events included afebrile seizures (6/36), fever alone (5/36) and febrile seizures (5/36). Two children required hospitalization. Quadrivalent measles-containing vaccine combined with varicella was associated with febrile seizures (p = 0.04). No child needed adjustment of the anti-epileptic treatment or exhibited developmental regression.ConclusionIn a series of children with prior severe neurologic disease, the safety-tolerability profile of vaccines containing a measles vaccine component suggests that vaccination is justified. Main side effect was seizure aggravation in children with known epileptic disease.     

Long-term control of Coxiellosis in sheep by annual primary vaccination of gimmers

Coxiella (C.) burnetii, a Gram-negative intracellular bacterium, causes Q fever in humans and Coxiellosis in animals. Ruminants are a primary source of human infection with C. burnetii. In 2013, vaccination was implemented in a sheep flock with 650 ewes associated with two outbreaks of Q fever in humans in 2008 and 2012. Only gimmers (yearlings) received two doses of a commercial C. burnetii phase I whole cell vaccine three weeks apart (primary vaccination) without any revaccination. Vaginal and nasal swabs collected shortly after lambing were tested by qPCR. Additionally, a group of non-vaccinated sentinels was serologically monitored for phase I (PhI), II (PhII) antibodies and for Interferon γ (IFN-γ) after stimulation of whole blood cells with PhII-antigen with and without an IL-10-neutralizing monoclonal antibody. In 2021, 679 sera collected in 2014–2021 were retested retrospectively with three commercial ELISA kits and one batch of an in-house PhI/PhII-ELISA.A low-level shedding of C. burnetii (<10³ mean C. burnetii/swab) was observed until 2014. In 2021 C. burnetii was detected in two animals (<10^3.1 C. burnetii/swab), but vaginal swabs collected at two subsequent lambing seasons remained negative. Seroconversion of sentinels was detected until 2017. However, the retrospective analysis of sentinels in 2021 revealed additional single seropositive animals from 2018 to 2021. IFN-γ reactivity was observed during the whole study period; it peaked in 2014 and in 2018 and decreased thereafter.The sporadic detection of C. burnetii and the immune responses of sentinels suggested that a subliminal infection persisted despite vaccination. Nevertheless, vaccination of gimmers prevented the development of a major outbreak, it controlled the infection and reduced the risk of human infection.     

Efficacy and safety of the BNT162b2 mRNA COVID-19 vaccine in participants with a history of cancer: subgroup analysis of a global phase 3 randomized clinical trial

IntroductionIndividuals with an underlying malignancy have high risk of poor COVID-19 outcomes. In clinical trials, COVID-19 vaccines were safe and efficacious against infection, hospitalization, and death, but most trials excluded participants with cancer. We report results from participants with a history of past or active neoplasm (malignant or benign/unknown) and up to 6 months’ follow-up post-dose 2 from the placebo-controlled, observer-blinded trial of the 2-dose BNT162b2 mRNA COVID-19 vaccine.Patients and methodsBetween July 2020–January 2021, 46,429 participants aged ≥ 12 years were randomized at 152 sites in 6 countries. Healthy participants with pre-existing stable neoplasm could participate; those receiving immunosuppressive therapy were excluded. Data are reported for participants, aged ≥ 16 years for safety and ≥ 12 years for efficacy, who had any history of neoplasm at baseline (data cut-off: March 13, 2021). Adverse-event (AE) data are controlled for follow-up time before unblinding and reported as incidence rates (IRs) per 100 person-years follow-up.ResultsAt baseline, 3813 participants had a history of neoplasm; most common malignancies were breast (n = 460), prostate (n = 362), and melanoma (n = 223). Four BNT162b2 and 71 placebo recipients developed COVID-19 from 7 days post-dose 2; vaccine efficacy was 94.4% (95% CI: 85.2, 98.5) after up to 6 months’ follow-up post-dose 2. This compares favorably with vaccine efficacy of 91.1% in the overall trial population after the same follow-up. AEs were reported at IRs of 95.4 (BNT162b2) and 48.3 (placebo) per 100 person-years. Most common AEs were reactogenicity events (injection-site pain, fatigue, pyrexia). Three BNT162b2 and 1 placebo recipients withdrew because of vaccine-related AEs. No vaccine-related deaths were reported.ConclusionIn participants with past or active neoplasms, BNT162b2 vaccine has a similar efficacy and safety profile as in the overall trial population. These results can inform BNT162b2 use during the COVID-19 pandemic and future trials in participants with cancer.Clinical trial number: NCT04368728.     

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.     

A phase 1 antigen dose escalation trial to evaluate safety,tolerability and immunogenicity of the leprosy vaccine candidate LepVax (LEP-F1 + GLA–SE) in healthy adults

Healthy United States-based adult volunteers with no history of travel to leprosy-endemic countries were enrolled for the first-in-human evaluation of LepVax (LEP-F1 + GLA-SE). In total 24 volunteers participated in an open-label clinical trial, with 21 receiving three injections of LepVax consisting of either 2 µg or 10 µg recombinant polyprotein LEP-F1 mixed with 5 µg of the GLA-SE adjuvant formulation. LepVax doses were provided by intramuscular injection on Days 0, 28, and 56, and safety was evaluated for one year following the final injection. LepVax was safe and well tolerated at both antigen doses. Immunological analyses indicated that similar LEP-F1-specific antibody and Th1 cytokine secretion (IFN-γ, IL-2, TNF) were induced by each of the antigen doses evaluated within LepVax. This clinical trial of the first defined vaccine candidate for leprosy demonstrates that LepVax is safe and immunogenic in healthy subjects and supports its advancement to testing in leprosy-endemic regions.     

Human papillomavirus vaccination receipt and provider counseling rates among high-risk patients

ObjectiveWe describe provider documented counseling patterns and perception regarding HPV vaccination among patients with a history of cervical dysplasia.MethodsAll patients ages 21–45 who underwent colposcopy at a single academic medical center from 2018 to 2020 were sent a self-administered survey through the electronic medical record patient portal to assess their attitudes regarding human papillomavirus (HPV) vaccination. Demographic information, HPV vaccination history, and documented obstetrics and gynecology provider counseling at the time of colposcopy were examined.ResultsOf 1465 patients, 434 (29.6 %) reported or had documented receipt of at least one dose of the human papillomavirus vaccine. The remainder reported they were not vaccinated or had no documentation of vaccination. Proportion of vaccinated patients was higher among White compared to Black and Asian patients (P = 0.02). On multivariate analysis, private insurance (aOR 2.2, 95 % CI 1.4–3.7) was associated with vaccinated status while Asian race (aOR 0.4, 95 % CI 0.2–0.7) and hypertension (aOR 0.2, 95 % CI 0.08–0.7) were less likely to be associated with vaccination status. Among patients with unvaccinated or unknown vaccination status, 112 (10.8 %) received documented counseling regarding catch-up human papillomavirus vaccination at a gynecologic visit. Patients seen by a sub-specialist obstetrics and gynecologic provider were more likely to have documented provider counseling regarding vaccination compared to those seen by a generalist obstetric/gynecologist provider (26 % vs 9.8 %, p < 0.001). Patients cited lack of physician discussion (53.7 %) and the belief that they were too old to receive the HPV vaccine (48.8 %) as the main reasons for remaining unvaccinated.ConclusionHPV vaccination and the rate of obstetric and gynecologic provider counseling regarding HPV vaccination among patients undergoing colposcopy remains low. When surveyed, many patients with a history of colposcopy cited provider recommendation as a factor in their decision to undergo adjuvant HPV vaccination, demonstrating the importance of provider counseling in this group.     

Supporting National Immunization Technical Advisory Groups in the WHO European Region in developing national COVID-19 vaccination recommendations through online communication platform

National Immunization Technical Advisory Groups are groups of multi-disciplinary experts that provide scientific advice to policy makers to enable them to make informed immunization policy and programme decisions. NITAGs faced challenges using their routine approach to develop recommendations for COVID-19 vaccines during the pandemic. In response, the WHO Regional Office for Europe (Regional Office), with the support of the Robert Koch Institute, developed an innovative approach of a series of webinars, provision of materials, and remote technical assistance to address these challenges. Polls conducted during webinars were used to tailor future webinars and evaluate the effectiveness of these interventions. According to poll results, 76% of participants found the webinars and resources shared very useful in their work on COVID-19 vaccination. The Regional Office plans to build further upon the scope of online communication and establish a regional online platform for NITAGs to further support NITAGs and build capacity.