Optimizing human resource strategies: Investigating the dynamics of high-performance practices, psychological empowerment, and responsible leadership in a moderated-mediation framework.

Even though existing literature frequently finds High Performance Human Resource Practices' (HPHRPs) positive impact on job performance in organizational setting, still it remains short to study unexplored underlying methods by which High Performance Human Resource Practices (HPHRPs) affect employee job performance. This gap is filled by our research, which proposes psychological empowerment as a mediator in the aforementioned relationship. Based on signaling theory, the present study examines the mediating role of psychological empowerment (PE) in the relationship between high-performance human resource practices (HPHRPs) and job performance (JP). In addition, this study tests the interactive effect of HPHRPs and responsible leadership on psychological empowerment. Data were collected in three waves from representative sample of education sector employees and their supervisors (T1-557, T2-342, T3-210 responses) in Pakistan. The hypotheses were evaluated using the PROCESS macro with SPSS to measure moderated-mediated relationships. The findings of the study reveal that HPHRPs positively influence employee performance through psychological empowerment. Responsible leadership positively moderates HPHRPs' effects on psychological empowerment. Furthermore, responsible leadership moderates the mediated relationship such that this positive indirect effect is stronger for individuals possessing low levels of responsible leadership. Our study is the first of its type to investigate whether a responsible leader may moderate the indirect impact of HPHRPs on JP through psychological empowerment. The findings carry critical implications for the practitioners and academics to devise interventions for better work environments.

Comparative Analysis of Female Leadership Styles in Public and Private Sector Universities: A Study in Pakistan.

This study aimed to compare the styles of leadership practices of female leaders in public and private Universities in Pakistan. In this study, both quantitative and qualitative data were collected using a mixed-method approach. An adapted and developed questionnaire was used for quantitative data collection, whereas qualitative data were collected through a semi-structured interview schedule. A sample of 200 female leaders was selected for quantitative data collection, while 10 females from the said sample were selected for qualitative data collection through a simple random method. Quantitative data were analyzed using SPSS, whereas qualitative data were analyzed using thematic analysis. Based on the statistical results, this study discovered statistically significant differences in female transformational and transactional leadership styles and significant differences in job performance based on the university sector. This study discovered statistically insignificant differences based on the different positions of female leaders regarding transformational and transactional leadership, and job performance. Moreover, qualitative data revealed that female leaders clearly understood both leadership styles and how to improve job performance by practicing them. The originality of this study concerns the identification of the differences between leadership styles (transformational and transactional) practiced by female leaders of public and private Universities in Pakistan and explains female leaders' perceptions of the role of leadership styles in their job performance.

Corrigendum to "One pot sets another boiling: A case of social learning perspective about leader self-serving behaviour and followers self-serving counterproductive work behaviour" [Heliyon 9 (3), March 2023, Article e14611].

[This corrects the article DOI: 10.1016/j.heliyon.2023.e14611.].

Immunogenicity and Safety of a Third COVID-19 BNT162b2 mRNA Vaccine Dose in 5- to 11-Year Olds.

In this ongoing study, substantially increased ancestral SARS-CoV-2 neutralizing responses were observed 1 month after a third 10-µg BNT162b2 dose given to 5 to 11-year olds versus neutralizing responses post-dose 2. After dose 3, increased neutralizing responses against Omicron BA.1 and BA.4/BA.5 strains were also observed. The safety/tolerability profile was acceptable. (NCT04816643).

One pot sets another boiling: A case of social learning perspective about leader self-serving behaviour and followers self-serving counterproductive work behaviour.

Self-Serving leadership is a global phenomenon and requires both literary and practical attention to understand how it unfolds and impacts organizations. More specifically the investigation of this underexplored dark side of leadership in Pakistani service sector organizations has its unique significance. So, in this regard, the current study took the initiative to investigate the relationship between a Leader's self-serving behaviour and a follower's self-serving counterproductive work behaviour. Moreover, the underlying mechanism of self-serving cognitive distortions was proposed, with followers' Machivellianism strengthening the indirect relationship between leaders' self-serving behaviour with self-serving counterproductive work behaviour through the self-serving cognitive distortions. The proposed theoretical framework was explained by the Social Learning theory. This study adopted a survey method with the collection of data by utilizing the convenience sampling method, in three-time waves with peer-reported self-serving counterproductive work behaviours. The data was analyzed by utilizing confirmatory factor analysis to establish discriminant and convergent validity. Moreover, the hypotheses testing was done utilizing Hayes Process Macro 4 (Mediation) and 7(Moderated Mediation). The results proved that the self-serving cognitive distortions mediated the relationship between the leader's self-serving behaviour and the follower's self-serving counterproductive work behaviours. Moreover, it was established that the High Mach tendencies strengthed the indirect positive relationship between a leader's self-serving behaviour with self-serving counterproductive work behaviour through the self-serving cognitive distortions. It is important to note that the current study provides a view to the practitioners that formulation of effective policies and systems for identifying and discouraging the tendencies of Leaders' self-serving behaviour and employing people with low Mach Tendencies can avoid the self-serving counterproductive work behaviours harming the overall welfare of the organization.

Cognitive behavior therapy for diabetes distress, depression, health anxiety, quality of life and treatment adherence among patients with type-II diabetes mellitus: a randomized control trial.

OBJECTIVE: Diabetes distress typically causes depressive symptoms; common comorbidity of diabetes unpleasantly affects patients' medical and psychological functions. Psychotherapeutic interventions are effective treatments to treat depressive symptoms and to improve the quality of life in many chronic diseases including diabetes. The present study investigated the efficacy of cognitive behavior therapy (CBT) to treat depressive symptoms in patients with type 2 diabetes mellitus (T2DM) using experimental and waitlist control conditions. MATERIALS AND METHODS: A total of 130 diagnosed patients with T2DM were taken from outdoor patients services of different hospitals in Faisalabad. Ninety patients met the eligibility criteria and were randomly assigned to experimental (n = 45) and waitlist control (n = 45) conditions. All the patients completed clinical interviews and assessment measures at pre-and post-assessment stages (16 weeks intervals). Medical consultants at the respective hospitals diagnosed the patients on the base of their medical reports and then referred those patients to us. Then we used different scales to assess primary and secondary outcomes: Diabetes Distress Scale (DDS) and Patient Health Questionnaire (PHQ) to assess primary outcomes, and a Short Health Anxiety Inventory (SHAI), a Revised Version of the Diabetes Quality of Life Questionnaire (DQLQ), and a General Medication Adherence Scale (GMAS) were used to investigate secondary outcomes. Repeated measure ANOVA was used to analyze the results. RESULTS: The findings indicated that patients who received CBT got a significant reduction in their diabetes distress F(1,60) = 222.710, P < 0.001, η2 = .788), depressive symptoms F(1,60) = 94.436, P < 0.001, η2 = .611), health anxiety F(1,60) = 201.915, P < .0.001, η2 = 771), and a significant improvement in their quality of life F(1,60) = 83.352, P < 0.001, η2 = .581), treatment adherence F(1,60) = 67.579, P < 0.001, η2 = .566) and physical activity schedule F(1,60) = 164.245, P < .0.001, η2 = .736 as compared to the patients in waitlist control condition. CONCLUSION: It is concluded that cognitive behavior therapy is an effective and promising intervention for depressive symptoms, diabetes distress, and health anxiety which also helps the person to promote quality of life, treatment adherence and physical activity.

Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age.

BACKGROUND: Safe and effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in young children. METHODS: We conducted a phase 1 dose-finding study and are conducting an ongoing phase 2-3 safety, immunogenicity, and efficacy trial of the BNT162b2 vaccine in healthy children 6 months to 11 years of age. We present results for children 6 months to less than 2 years of age and those 2 to 4 years of age through the data-cutoff dates (April 29, 2022, for safety and immunogenicity and June 17, 2022, for efficacy). In the phase 2-3 trial, participants were randomly assigned (in a 2:1 ratio) to receive two 3-µg doses of BNT162b2 or placebo. On the basis of preliminary immunogenicity results, a third 3-µg dose (≥8 weeks after dose 2) was administered starting in January 2022, which coincided with the emergence of the B.1.1.529 (omicron) variant. Immune responses at 1 month after doses 2 and 3 in children 6 months to less than 2 years of age and those 2 to 4 years of age were immunologically bridged to responses after dose 2 in persons 16 to 25 years of age who received 30 µg of BNT162b2 in the pivotal trial. RESULTS: During the phase 1 dose-finding study, two doses of BNT162b2 were administered 21 days apart to 16 children 6 months to less than 2 years of age (3-µg dose) and 48 children 2 to 4 years of age (3-µg or 10-µg dose). The 3-µg dose level was selected for the phase 2-3 trial; 1178 children 6 months to less than 2 years of age and 1835 children 2 to 4 years of age received BNT162b2, and 598 and 915, respectively, received placebo. Immunobridging success criteria for the geometric mean ratio and seroresponse at 1 month after dose 3 were met in both age groups. BNT162b2 reactogenicity events were mostly mild to moderate, with no grade 4 events. Low, similar incidences of fever were reported after receipt of BNT162b2 (7% among children 6 months to <2 years of age and 5% among those 2 to 4 years of age) and placebo (6 to 7% among children 6 months to <2 years of age and 4 to 5% among those 2 to 4 years of age). The observed overall vaccine efficacy against symptomatic Covid-19 in children 6 months to 4 years of age was 73.2% (95% confidence interval, 43.8 to 87.6) from 7 days after dose 3 (on the basis of 34 cases). CONCLUSIONS: A three-dose primary series of 3-µg BNT162b2 was safe, immunogenic, and efficacious in children 6 months to 4 years of age. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04816643.).

Principals' leadership styles and its impact on teachers' performance at college level.

In this study, we examined the impact of principals' leadership style on the performance of teachers at the college level. For this purpose, we collect data from 300 college teachers via a random sampling approach. A self-administrated questionnaire (five-point Likert Scale) was used to collect data. For detecting relationships and differences among the opinions of the study's participants, correlation and the t-test were used. This study has revealed that the majority of college principals practice a democratic style of leadership at a higher level, Laissez-faire at a moderate level, and autocratic at a low level in their colleges. Moreover, it has been also revealed that when principals increase the use of a democratic leadership style, teacher performance may progress as well. The findings revealed that principals' leadership style had a positive impact on the performance of teachers. The study exposed a strong statistically positive relationship between college principals' leadership style and teacher performance. Thus, the results of this study suggest that college principals' should adopt the leadership style according to the level of teachers. The leadership style should be changed with specific situations in the colleges.

"Impact of leadership styles on innovative performance of female leaders in Pakistani Universities".

Leadership plays a significant role in the performance of individuals and organizations. This paper investigates the impact of leadership styles on the innovative performance of female leaders in Pakistani Universities using a survey approach. This paper aimed to (a) discover a leadership style practiced by females and (b) discover the relationship between leadership style and the innovative performance of female leaders. Several female leaders, including faculty members, heads of departments, deans, coordinators, and directors, from public and private universities of Punjab (a province of Pakistan), were involved in this study. A sample of one hundred female leaders was selected using a multistage sampling method. In the first stage, five public and five private sector universities were selected through a simple random method. In the second stage, ten female leaders (five from each of the social science and basic science departments) were selected from each university through a purposive sampling method. The researchers adopted a reliable instrument to collect the survey data. The collected data were analyzed using SPSS (Version 26). Mean scores and Pearson correlation coefficients were used to discover the relationship between various variables. The investigation revealed that most female leaders practice the transactional leadership style in their universities. This study also discovered a moderate positive relationship between both leadership styles, namely transactional and transformational, and innovative performance. The study recommends that various workshops and seminars may be conducted to increase the practices of both leadership styles to enhance innovation in Pakistani Universities.

Assessing the attitude and problem-based learning in mathematics through PLS-SEM modeling.

Mathematics plays a leading part in day-to-day life and has enhanced a necessary component for human accomplishments. Students from many countries do not reach the expected level in mathematics. Therefore, it is essential to pay close consideration to the causes related to ability in mathematics. Mathematics attitude is considered as one of the critical variables in the process of mathematics learning. This study aimed to determine students' attitudes and achievements through problem-based learning in mathematics. The selected study group contained 600 students and 35 teachers from rural public secondary schools in District Rawalpindi, Pakistan. The data collection was done using questionnaires from students and teachers and collected data analyzed by SPSS 23 and Amos 23. This study's result was carried out using Partial Least square structural equation Model (PLS-SEM), descriptive analysis, and hypotheses testing. The outcomes in this study indicated that the mean fluctuated between 1 to 4.5, 3.71 to 4.20, and Std. Deviation fluctuated between 0.6 to 2.0 and 0.75 to 1.55 in the students and teacher models, respectively. The results of the PLS-SEM students' model show a negative attitude towards mathematics. The teachers' PLS-SEM model showed the Effects of using problem-based learning (PBL) on students' achievements. According to the hypotheses testing, the acceptance of hypotheses by stating that the Confidence in Learning Mathematics Scale (C), Value of Mathematics Scale (V), and Student Mathematics Motivation Scale (M) are significant effects for the Students' Attitude Toward Problem-Based Learning (ATPBL). But the Attitude Toward Enjoyment in Mathematics Scale (AE) was rejected, and it did not significantly affect the ATPBL. As well as, the Problem-solving learning and students' achievement (PLA), Advantages of problem-solving learning (APL) and Difficulties in using problem-solving learning (DPL) have a significant positive effect on the ATPBL. Finally, this study suggested that teachers also adopt new teaching methods corresponding to mathematics, and there is a need to explore particular mathematics skills to enhance students' learning abilities.

Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age.

BACKGROUND: Safe, effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in children younger than 12 years of age. METHODS: A phase 1, dose-finding study and an ongoing phase 2-3 randomized trial are being conducted to investigate the safety, immunogenicity, and efficacy of two doses of the BNT162b2 vaccine administered 21 days apart in children 6 months to 11 years of age. We present results for 5-to-11-year-old children. In the phase 2-3 trial, participants were randomly assigned in a 2:1 ratio to receive two doses of either the BNT162b2 vaccine at the dose level identified during the open-label phase 1 study or placebo. Immune responses 1 month after the second dose of BNT162b2 were immunologically bridged to those in 16-to-25-year-olds from the pivotal trial of two 30-µg doses of BNT162b2. Vaccine efficacy against Covid-19 at 7 days or more after the second dose was assessed. RESULTS: During the phase 1 study, a total of 48 children 5 to 11 years of age received 10 µg, 20 µg, or 30 µg of the BNT162b2 vaccine (16 children at each dose level). On the basis of reactogenicity and immunogenicity, a dose level of 10 µg was selected for further study. In the phase 2-3 trial, a total of 2268 children were randomly assigned to receive the BNT162b2 vaccine (1517 children) or placebo (751 children). At data cutoff, the median follow-up was 2.3 months. In the 5-to-11-year-olds, as in other age groups, the BNT162b2 vaccine had a favorable safety profile. No vaccine-related serious adverse events were noted. One month after the second dose, the geometric mean ratio of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing titers in 5-to-11-year-olds to those in 16-to-25-year-olds was 1.04 (95% confidence interval [CI], 0.93 to 1.18), a ratio meeting the prespecified immunogenicity success criterion (lower bound of two-sided 95% CI, >0.67; geometric mean ratio point estimate, ≥0.8). Covid-19 with onset 7 days or more after the second dose was reported in three recipients of the BNT162b2 vaccine and in 16 placebo recipients (vaccine efficacy, 90.7%; 95% CI, 67.7 to 98.3). CONCLUSIONS: A Covid-19 vaccination regimen consisting of two 10-µg doses of BNT162b2 administered 21 days apart was found to be safe, immunogenic, and efficacious in children 5 to 11 years of age. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04816643.).

Authentic leadership, perceived organizational support, and psychological capital: Implications for job performance in the education sector.

The present study sifts the indirect role of psychological capital (PsyCap) in linking authentic leadership (AL) and job performance (JP). Furthermore, this study investigates the interplay of AL and perceived organizational support (POS) in PsyCap. We tested these assumptions through PROCESS macro with two sources of data collected from 350 employees and their respective colleagues working in education sector organizations in China. The study findings established that AL positively influences employee performance directly and indirectly through PsyCap. POS moderates the effects of AL on PsyCap such that this relationship gets more pronounced in individuals with high levels of POS. All organizations in the education sector can benefit from the current study's practical application. We recommend that firms create and implement these training programs to improve JP since AL is favorably correlated with JP. The organization should pick executives with a vision to encourage e-JP. To promote this behavior, firms can also hold management training seminars, conferences, and programs. Making performance a clear necessity within job criteria will encourage it among personnel. To achieve great results, top management and leadership must inform the workforce about the importance of authentic behavior in the workplace.

Frequency of primary headache disorders and association with body mass index; an ambispective study.

OBJECTIVE: To determine the association of body mass index with various primary headache disorders. METHODS: The ambispective study was conducted at the Department of Medicine, Shalamar Institute of Health Sciences, Lahore, Pakistan, from January 2020 to March 2021, and comprised data of patients who presented to outpatient departments of Neurology and Medicine with complaint of recurrent or persistent headaches. Body mass index of each subject at the time of latest headache visit was recorded. A control group of 200 individuals was also raised and the body mass index of its subjects was measured. Headache disorders were classified as per International Classification of Headache Disorders-3 beta criteria. Correlation of frequency of different types of primary headaches with body mass index was explored. Data was analysed using SPSS 20. RESULTS: Of the 400 subjects, 200(50%) each were cases and controls. There were 132(33%) males and 268(67%) females. The overall mean age was 37.4 ±14.7 years and mean body mass index was 27.3 ±5.87kg/m2. Migraine was found in 183(46%) subjects compared to tension-type headache 96(24%). Migraine was more common in subjects with high body mass index (p<0.05). CONCLUSIONS: Primary headaches constitute a significant health problem. Among various risk factors weight-gain is one that can predispose an individual to increased frequency of migraine.

Evaluation of Clinical Outcomes After Introduction of a Dedicated Infectious Diseases-Critical Care Medicine Service in Critical Care Units.

BACKGROUND: Infection is a leading cause of admission to intensive care units (ICUs), with critically ill patients often receiving empiric broad-spectrum antibiotics. Nevertheless, a dedicated infectious diseases (ID) consultation and stewardship team is not routinely established. An ID-critical care medicine (ID-CCM) pilot program was designed at a 400-bed tertiary care hospital in which an ID attending was assigned to participate in daily rounds with the ICU team, as well as provide ID consultation on select patients. We sought to evaluate the impact of this dedicated ID program on antibiotic utilization and clinical outcomes in patients admitted to the ICU. METHODS: In this single-site retrospective study, we analyzed antibiotic utilization and clinical outcomes in patients admitted to an ICU during the postintervention period from January 1 to December 31, 2017, and compared it to antibiotic utilization in the same ICUs during the preintervention period from January 1 to December 31, 2015. RESULTS: Our data showed a statistically significant reduction in usage of most frequently prescribed antibiotics including vancomycin, piperacillin-tazobactam, and cefepime during the intervention period. When compared to the preintervention period there was no difference in-hospital mortality, hospital length of stay, and readmission. CONCLUSIONS: With this multidisciplinary intervention, we saw a decrease in the use of the most frequently prescribed broad-spectrum antibiotics without a negative impact on clinical outcomes. Our study shows that the implementation of an ID-CCM service is a feasible way to promote antibiotic stewardship in the ICU and can be used as a strategy to reduce unnecessary patient exposure to broad-spectrum agents.

Treatment of severe COVID-19 with convalescent plasma in Bronx, NYC.

Convalescent plasma with severe acute respiratory disease coronavirus 2 (SARS-CoV-2) antibodies (CCP) may hold promise as a treatment for coronavirus disease 2019 (COVID-19). We compared the mortality and clinical outcome of patients with COVID-19 who received 200 mL of CCP with a spike protein IgG titer ≥ 1:2430 (median 1:47,385) within 72 hours of admission with propensity score-matched controls cared for at a medical center in the Bronx, between April 13 and May 4, 2020. Matching criteria for controls were age, sex, body mass index, race, ethnicity, comorbidities, week of admission, oxygen requirement, D-dimer, lymphocyte counts, corticosteroid use, and anticoagulation use. There was no difference in mortality or oxygenation between CCP recipients and controls at day 28. When stratified by age, compared with matched controls, CCP recipients less than 65 years had 4-fold lower risk of mortality and 4-fold lower risk of deterioration in oxygenation or mortality at day 28. For CCP recipients, pretransfusion spike protein IgG, IgM, and IgA titers were associated with mortality at day 28 in univariate analyses. No adverse effects of CCP were observed. Our results suggest CCP may be beneficial for hospitalized patients less than 65 years, but data from controlled trials are needed to validate this finding and establish the effect of aging on CCP efficacy.

Treatment of Severe COVID-19 with Convalescent Plasma in the Bronx, NYC.

Convalescent plasma with severe acute respiratory disease coronavirus 2 (SARS-CoV-2) antibodies (CCP) may hold promise as treatment for Coronavirus Disease 2019 (COVID-19). We compared the mortality and clinical outcome of patients with COVID-19 who received 200mL of CCP with a Spike protein IgG titer ≥1:2,430 (median 1:47,385) within 72 hours of admission to propensity score-matched controls cared for at a medical center in the Bronx, between April 13 to May 4, 2020. Matching criteria for controls were age, sex, body mass index, race, ethnicity, comorbidities, week of admission, oxygen requirement, D-dimer, lymphocyte counts, corticosteroids, and anticoagulation use. There was no difference in mortality or oxygenation between CCP recipients and controls at day 28. When stratified by age, compared to matched controls, CCP recipients <65 years had 4-fold lower mortality and 4-fold lower deterioration in oxygenation or mortality at day 28. For CCP recipients, pre-transfusion Spike protein IgG, IgM and IgA titers were associated with mortality at day 28 in univariate analyses. No adverse effects of CCP were observed. Our results suggest CCP may be beneficial for hospitalized patients <65 years, but data from controlled trials is needed to validate this finding and establish the effect of ageing on CCP efficacy.

Early Infectious Disease Consultation Is Associated With Lower Mortality in Patients With Severe Sepsis or Septic Shock Who Complete the 3-Hour Sepsis Treatment Bundle.

OBJECTIVE: Severe sepsis and septic shock (SS/SS) treatment bundles reduce mortality, and early infectious diseases (ID) consultation also improves patient outcomes. We retrospectively examined whether early ID consultation further improves outcomes in Emergency Department (ED) patients with SS/SS who complete the sepsis bundle. METHOD: We included 248 adult ED patients with SS/SS who completed the 3-hour bundle. Patients with ID consultation within 12 hours of ED triage (n = 111; early ID) were compared with patients who received standard care (n = 137) for in-hospital mortality, 30-day readmission, length of hospital stay (LOS), and antibiotic management. A competing risk survival analysis model compared risks of in-hospital mortality and discharge alive between groups. RESULTS: In-hospital mortality was lower in the early ID group unadjusted (24.3% vs 38.0%, P = .02) and adjusted for covariates (odds ratio, 0.47; 95% confidence interval (CI), 0.25-0.89; P = .02). There was no significant difference in 30-day readmission (22.6% vs 23.5%, P = .89) or median LOS (10.2 vs 12.1 days, P = .15) among patients who survived. A trend toward shorter time to antibiotic de-escalation in the early ID group (log-rank test P = .07) was observed. Early ID consultation was protective of in-hospital mortality (adjusted subdistribution hazard ratio (asHR), 0.60; 95% CI 0.36-1.00, P = .0497) and predictive of discharge alive (asHR 1.58, 95% CI, 1.11-2.23; P-value .01) after adjustment. CONCLUSIONS: Among patients receiving the SS/SS bundle, early ID consultation was associated with a 40% risk reduction for in-hospital mortality. The impact of team-based care and de-escalation on SS/SS outcomes warrants further study.

Safety and immunogenicity of investigational seasonal influenza hemagglutinin DNA vaccine followed by trivalent inactivated vaccine administered intradermally or intramuscularly in healthy adults: An open-label randomized phase 1 clinical trial.

BACKGROUND: Seasonal influenza results in significant morbidity and mortality worldwide, but the currently licensed inactivated vaccines generally have low vaccine efficacies and could be improved. In this phase 1 clinical trial, we compared seasonal influenza vaccine regimens with different priming strategies, prime-boost intervals, and administration routes to determine the impact of these variables on the resulting antibody response. METHODS: Between August 17, 2012 and January 25, 2013, four sites enrolled healthy adults 18-70 years of age. Subjects were randomized to receive one of the following vaccination regimens: trivalent hemagglutinin (HA) DNA prime followed by trivalent inactivated influenza vaccine (IIV3) boost with a 3.5 month interval (DNA-IIV3), IIV3 prime followed by IIV3 boost with a 10 month interval (IIV3-IIV3), or concurrent DNA and IIV3 prime followed by IIV3 boost with a 10 month interval (DNA/IIV3-IIV3). Each regimen was additionally stratified by an IIV3 administration route of either intramuscular (IM) or intradermal (ID). DNA vaccines were administered by a needle-free jet injector (Biojector). Study objectives included evaluating the safety and tolerability of each regimen and measuring the antibody response by hemagglutination inhibition (HAI). RESULTS: Three hundred and sixteen subjects enrolled. Local reactogenicity was mild to moderate in severity, with higher frequencies recorded following DNA vaccine administered by Biojector compared to IIV3 by either route (p <0.02 for pain, swelling, and redness) and following IIV3 by ID route compared to IM route (p <0.001 for swelling and redness). Systemic reactogenicity was similar between regimens. Though no overall differences were observed between regimens, the highest titers post boost were observed in the DNA-IIV3 group by ID route and in the IIV3-IIV3 group by IM route. CONCLUSIONS: All vaccination regimens were found to be safe and tolerable. While there were no overall differences between regimens, the DNA-IIV3 group by ID route, and the IIV3-IIV3 group by IM route, showed higher responses compared to the other same-route regimens.

Faces of Resistance: Using Real-World Patients and Their Advocates to Teach Medical Students About Antimicrobial Stewardship.

We engaged medical students with antimicrobial stewardship (AS) and antimicrobial resistance (AMR) through patient stories and a panel on AMR advocacy with experts from the Centers for Disease Control and Prevention and the Infectious Diseases Society of America. Students were surveyed on their perceptions about AS and AMR (response rate = 139 of 166, 84%).

DNA vaccine priming for seasonal influenza vaccine in children and adolescents 6 to 17 years of age: A phase 1 randomized clinical trial.

BACKGROUND: Children are susceptible to severe influenza infections and facilitate community transmission. One potential strategy to improve vaccine immunogenicity in children against seasonal influenza involves a trivalent hemagglutinin DNA prime-trivalent inactivated influenza vaccine (IIV3) boost regimen. METHODS: Sites enrolled adolescents, followed by younger children, to receive DNA prime (1 mg or 4 mg) intramuscularly by needle-free jet injector (Biojector), followed by split virus 2012/13 seasonal IIV3 boost by needle and syringe approximately 18 weeks later. A comparator group received IIV3 prime and boost at similar intervals. Primary study objectives included evaluation of the safety and tolerability of the vaccine regimens, with secondary objectives of measuring antibody responses at four weeks post boost by hemagglutination inhibition (HAI) and neutralization assays. RESULTS: Seventy-five children ≥6 to ≤17 years old enrolled. Local reactogenicity was higher after DNA prime compared to IIV3 prime (p<0.001 for pain/tenderness, redness, or swelling), but symptoms were mild to moderate in severity. Systemic reactogenicity was similar between vaccines. Overall, antibody responses were similar among groups, although HAI antibodies revealed a trend towards higher responses following 4 mg DNA-IIV3 compared to IIV3-IIV3. The fold increase of HAI antibodies to A/California/07/2009 [A(H1N1)pdm09] was significantly greater following 4 mg DNA-IIV3 (10.12 fold, 5.60-18.27 95%CI) compared to IIV3-IIV3 (3.86 fold, 2.32-6.44 95%CI). Similar neutralizing titers were observed between regimens, with a trend towards increased response frequencies in 4 mg DNA-IIV3. However, significant differences in fold increase, reported as geometric mean fold ratios, were detected against the H1N1 viruses within the neutralization panel: A/New Caledonia/20/1999 (1.41 fold, 1.10-1.81 95%CI) and A/South Carolina/1/1918 (1.55 fold, 1.27-1.89 95%CI). CONCLUSIONS: In this first pediatric DNA vaccine study conducted in the U.S., the DNA prime-IIV3 boost regimen was safe and well tolerated. In children, the 4 mg DNA-IIV3 regimen resulted in antibody responses comparable to the IIV3-IIV3 regimen.