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BACKGROUND: Male sex workers (MSWs), specifically cisgender men who exchange sex for money, goods, drugs, or other items of value with other cisgender men, are at high risk for HIV infection. Compared to men not engaged in sex work, MSWs are more likely to engage in frequent condomless sex with paying and non-paying sexual partners. While MSWs are often included as a subgroup of gay and bisexual men, data show that a large proportion identify as heterosexual; additionally, most MSWs do not identify as sex workers. This places MSWs in a unique position where they may not engage with traditional HIV prevention programs, and when they do, they may not feel comfortable, leading to poor retention. Thus, HIV prevention interventions that address MSWs unique life circumstances and provide support in exploring their sexual health options are needed. METHODS: In this protocol paper, we describe the design and procedures for a National Institute of Health-funded, randomized controlled trial testing the efficacy of PrEPare for Work,- a theory-based, manualized PrEP uptake and adherence intervention for MSW - using a 2-stage randomization design. Stage 1: MSWs are equally randomized to receive either the PrEPare for Work Stage 1 intervention (strength-based case management and facilitated PrEP linkage) or Standard of Care (SOC) to evaluate successful PrEP uptake (prescription filled) within two months post-randomization. Stage 2: Those who initiate PrEP are then equally re-randomized to receive either the PrEPare for Work Stage 2 intervention (1-on-1 skills training, problem-solving, and motivational interviewing adherence counseling and personalized, daily text message reminders) or SOC to assess adherence (Tenofovir concentrations in hair) over 12 months of follow up. Planned analyses will examine intervention efficacy, specific conceptual mediators, and hypothesized moderators. DISCUSSION: Based on our extensive preliminary research, multi-component, theory-informed interventions targeting this subpopulation of MSWs unique life circumstances are urgently needed. In this study, we are evaluating whether PrEPare for Work can improve PrEP uptake and adherence among MSWs. If this intervention is efficacious, it would be readily disseminated to diverse community organizations that serve MSWs and possibly other community or clinic-based settings. TRIAL REGISTRATION: ClinicalTrials.gov number NCT05736614, registered February 8, 2023.

Abstract Background Male sex workers (MSWs), specifically cisgender men who exchange sex for money, goods, drugs, or other items of value with other cisgender men, are at high risk for HIV infection. Compared to men not engaged in sex work, MSWs are more likely to engage in frequent condomless sex with paying and non-paying sexual partners. While MSWs are often included as a subgroup of gay and bisexual men, data show that a large proportion identify as heterosexual; additionally, most MSWs do not identify as “sex workers.” This places MSWs in a unique position where they may not engage with traditional HIV prevention programs, and when they do, they may not feel comfortable, leading to poor retention. Thus, HIV prevention interventions that address MSWs’ unique life circumstances and provide support in exploring their sexual health options are needed. Methods In this protocol paper, we describe the design and procedures for a National Institute of Health-funded, randomized controlled trial testing the efficacy of “PrEPare for Work,”— a theory-based, manualized PrEP uptake and adherence intervention for MSW — using a 2-stage randomization design. Stage 1: MSWs are equally randomized to receive either the “PrEPare for Work Stage 1 intervention” (strength-based case management and facilitated PrEP linkage) or Standard of Care (SOC) to evaluate successful PrEP uptake (prescription filled) within two months post-randomization. Stage 2: Those who initiate PrEP are then equally re-randomized to receive either the “PrEPare for Work Stage 2 intervention” (1-on-1 skills training, problem-solving, and motivational interviewing adherence counseling and personalized, daily text message reminders) or SOC to assess adherence (Tenofovir concentrations in hair) over 12 months of follow up. Planned analyses will examine intervention efficacy, specific conceptual mediators, and hypothesized moderators. Discussion Based on our extensive preliminary research, multi-component, theory-informed interventions targeting this subpopulation of MSWs’ unique life circumstances are urgently needed. In this study, we are evaluating whether “PrEPare for Work” can improve PrEP uptake and adherence among MSWs. If this intervention is efficacious, it would be readily disseminated to diverse community organizations that serve MSWs and possibly other community or clinic-based settings. Trial registration ClinicalTrials.gov number NCT05736614, registered February 8, 2023.

Introduction: Coronavirus disease 2019 (COVID-19) has impacted researchers' ability to continue to deliver HIV prevention and treatment interventions face to face. Although telehealth has been an important strategy to maintain research operations during the current pandemic, participants at increased risk of or living with HIV are often at higher risk of also experiencing poverty, housing instability, and other challenges that may present obstacles to successful remote delivery. Methods: We provide descriptions of remote adaptations to two randomized controlled efficacy trials of behavioral interventions for primary and secondary HIV prevention with descriptive enrollment and retention data. Results and Conclusions: Best practices for implementing telemedicine and e-health procedures are discussed, including procedures for addressing remote participation barriers (economic, health literacy, etc.) and other challenges, such as building rapport and staff support (NCT03092531 and NCT03175159).

This cluster-randomized efficacy trial evaluated the impact of the Ready for Wages intervention, a classroom-based social skills program designed to improve the employability of youth living and being educated in juvenile justice settings. Fifteen juvenile justice facility schools participated. Data were collected from 118 classrooms: 59 treatment and 59 business-as-usual control. There were no statistically significant differences across conditions on the outcome measures, although differences favored the intervention group. Implementation was hampered by challenges associated with conducting research in authentic juvenile settings during the COVID-19 pandemic. Only half of the planned data collection could be completed. Despite the null findings of this study, more research in juvenile justice facilities is warranted to identify evidence-based practices that support prosocial behavior. Group intervention offers a cost-effective approach to reducing recidivism in a very high-risk population, with potential benefits for individuals and society in general. [ABSTRACT FROM AUTHOR]

Implementation strategies used to enhance the implementation of interventions during efficacy and effectiveness studies are rarely reported. Tracking and reporting implementation strategies during these phases has potential to improve future research studies and real-world implementation. We present an exemplar of how this might be executed by specifying and reporting the implementation strategies that were used during a school-based efficacy trial, Project POWER, which tested a trauma-informed prevention program delivered by a university research team, community members, and school staff facilitators in 29 schools. Following the conclusion of the 4-year trial, core Project POWER research team members identified the implementation strategies that supported intervention delivery during the trial using an established taxonomy of school-based implementation strategies. The actors, actions, action targets, temporality, dose, and implementation outcomes were specified using established implementation strategies reporting guidelines. The research team identified 37 implementation strategies that were used during the Project POWER trial. Most strategies fell within the categories of Train and Educate Stakeholders, Use Evaluative and Iterative Strategies, and Develop Stakeholder Interrelationships. Actors included members of the research team and partner schools. Strategies were used multiple times during the preparation and implementation phases. Action targets were most often characteristics of individuals, implementation process, and characteristics of the inner setting. Strategies predominantly targeted the implementation outcomes of fidelity, acceptability, feasibility, and adoption. This study provided evidence that implementation strategies are used and can be identified in efficacy research using a retrospective approach. Identifying and specifying implementation strategies used during the initial phases of the translational research pipeline can inform the implementation strategies that are carried forward, adapted, or discontinued in future trials and routine practice to improve implementation and effectiveness outcomes.

Introduction: Coronavirus disease 2019 (COVID-19) has impacted researchers' ability to continue to deliver HIV prevention and treatment interventions face to face. Although telehealth has been an important strategy to maintain research operations during the current pandemic, participants at increased risk of or living with HIV are often at higher risk of also experiencing poverty, housing instability, and other challenges that may present obstacles to successful remote delivery. Methods: We provide descriptions of remote adaptations to two randomized controlled efficacy trials of behavioral interventions for primary and secondary HIV prevention with descriptive enrollment and retention data. Results and Conclusions: Best practices for implementing telemedicine and e-health procedures are discussed, including procedures for addressing remote participation barriers (economic, health literacy, etc.) and other challenges, such as building rapport and staff support (NCT03092531 and NCT03175159). [ABSTRACT FROM AUTHOR]

Abstract Background About half of Swedish eating disorder patients report exercising compulsively and compulsive exercise (CE) is prevalent in all diagnoses and both genders. Yet there are no systematic treatments targeting CE in specialist care. This study aims to evaluate the effects of The CompuLsive Exercise Activity TheraPy (LEAP) - a promising group treatment targeting compulsive exercise, in Swedish eating disorder patients. Method One hundred twenty-eight adult females and males suffering from anorexia nervosa, bulimia nervosa or other specified feeding and eating disorders (type 1, 2, or 4) with CE will be recruited via four specialist eating disorder treatment units. Participants will be randomized to receive treatment as usual (control group) or treatment as usual plus LEAP (intervention group). The groups will be assessed on key variables (e.g., BMI, eating disorder symptoms, exercise cognitions and behaviors) at three occasions: initially, after 3 months and after 6 months. Discussion The project takes place in a clinical setting, including both male and female patients with different eating disorder diagnoses with CE, enabling a good indication of the efficacy of LEAP. If our results are positive, LEAP has the potential of benefiting about half of the eating disorder population, with remission and recovery hopefully improving as a result. Trial registration The trial is registered with the ISRCTN registry (registration date 2020-03-25), trial ID: ISRCTN80711391 .

Abstract Background Major Depressive Disorder (MDD) is a disabling mood disorder, profoundly affecting a large number of adolescent’s quality of life. To date, no obvious treatment of choice for MDD in adolescents is available and progress in the treatment of depressed adolescents will have important public health implications. Attachment-Based Family Therapy (ABFT), as the only empirically supported family therapy model designed to treat adolescent depression, aims to repair interpersonal ruptures and rebuild an emotionally protective parent–child relationship. Objective To study the effectiveness of ABFT compared with treatment as usual (TAU) delivered within child- and adolescent mental health services (CAMHS) to adolescents with MDD. Method Sixty adolescents (86.7% girls), aged 13–18 years (M = 14.9, SD = 1.35), with MDD referred to two CAMHS were randomized to 16 weeks of ABFT or TAU. ABFT consisted of weekly therapy sessions (family/individual or both) according to the treatment manual. TAU was not monitored. Primary outcomes were assessed by blinded evaluators at baseline and post-treatment with the Hamilton Depression Scale (HAMD). Self-reported (Beck Depression Inventory-II, BDI-II) depressive symptoms were assessed at baseline, and after 4, 6, 8, 10,12, 14, and 16 weeks. Analyses were performed according to intent-to-treat principles. Results At post-treatment, clinician-rated remission rates on the HAMD (5% in ABFT and 3.33% in TAU, p = 1, OR = 1.54, Fisher’s exact test) and self-reported symptoms of depression on the BDI-II did not differ significantly between groups (X 2 [2, N = 60] = 0.06, p = 0.97). In both treatment groups participants reported significantly reduced depressive symptoms, but the majority (63.3%) of adolescents were still in the clinical range after 16 weeks of treatment. Conclusion ABFT was not superior to TAU. Remission and response rates were low in both groups, suggesting none of the treatments were effective in treating MDD in adolescents. Findings must be viewed in the context of the study’s small sample size, missing data, and implementation challenges. Continued efforts to improve treatment for MDD in outpatient clinics are warranted. Future research should examine moderators of and mechanisms for individual differences to treatment response, as well as the feasibility and cost-effectiveness of implementing treatment models which may require extensive training and expertise to yield clinically meaningful improvements in non-research settings. Trial registration Clinicaltrials.gov identifier: NCT01830088 https://clinicaltrials.gov/ct2/show/NCT01830088?term=Villab%C3%B8&draw=2&rank=1 Date of registration: April 12, 2013

Chicory can be used as herbal medicine against different ailments and also added to daily diet as vegetable or animal feed. An efficacy trial was conducted to assess the potential of this plant against liver disorders using rodent modeling. The trials comprised two modules i.e., normal diet and chicory-based supplemented diet. Moreover, experimental animals (rats) were divided into six groups with both modules including C0 (control diet), C1 (Chicory root containing diet), C2 (chicory seed containing diet), C3 (chicory stem containing diet) and C4 (chicory leaf containing diet). During 56 days of the trial period, serum lipid profile, liver and renal functioning tests were performed. The highest feed and water intake, as well as weight gain, was noted in control (C0) trailed by C1, C2, C3, C4 and C5 group in an experimental trial, respectively. The resultant diet C2 lowered the liver alkaline phosphatase level (ALP) from C0 (240.72±3.35) to 203.52±2.08 (C2), respectively. Similarly, C2 significantly lowered the ALT from 60.28±2.23 (C0) & 57.58±0.91 (C2) in rats. Moreover, C2 treatment showed a maximum reduction of AST from 145.13±2.10 (C0) to 134.52±1.24 (C2), respectively. Convincingly, chicory-based diet may be employed as an alternative to medication in the prevention and treatment of hypercholesterolemia and hepatic malfunctioning. [ABSTRACT FROM AUTHOR]

Abstract Background The spices based dietary interventions are in lime light among the scientific community owing to their promising therapeutic perspective. The bioactive components in spices can be used to exert various health promoting functions in human body such as prompting weight loss, inhibit diet-induced obesity, hypercholesterolemia, hyperglycemia, allergies and various other maladies. In current study extraction and in vitro characterization of coriander seed (CS), black cumin seed (BCS) and fenugreek seed (FS) polyphenols was conducted for further development of dietary intervention against lipid and glycemia related abnormalities in experimental Sprague Dowley rats fed with control and different spice powder supplemented diets. Methods Purposely, extraction of Coriander (CS), Black cumin (BCS) and Fenugreek seeds (FS) were carried out by using water and aqueous methanol (70:30 v/v). Afterwards, the resultant extracts were thoroughly investigated for their antioxidant potential through different indices like TPC, TFC, FRAP and β Carotene Bleaching Assay and ABTS. Furthermore, HPLC quantification were also conducted with special reference to thymoquinone, disogenin, chlorogenic acid, caffeic acid and kaempferol alongside in vitro pancreatic lipase inhibitory activity estimation. Bio-evaluation trial was consisting of three modules i.e. study-I (normal diet), study-II (high cholesterol diet) and study-III (high sucrose diet). Furthermore, rats were sub-divided in five groups in each module on the basis of diet provision including T0 (control), T1 (Diet containing CS), T2 (Diet containing BCS), T3 (Diet containing FS) and T4 (Diet containing CSP + BCSP + FSP). At the beginning of trial, some rats were dissected to evaluate the baseline values whilst rest of the rats was killed at the termination (56th day). Feed and drink intakes were quantified on daily bases whereas, body weight was calculated weekly. Cholesterol level, serum low density lipoproteins (LDL), high density lipoproteins (HDL), triglycerides, glucose concentration and insulin level of collected sera was measured by standard procedures. Results The in vitro characterization showed better extraction of spices antioxidant through aqueous methanol as compared to water. Among the spices, Black cumin seed alone or in combination revealed highest antioxidant activity in T2 (BCS) followed by T4 (CS + BCS), T7 (CS + BCS + FS), T1 (CS), T6 (BCS + FS), T5 (CS + FS) and lowest in T3 (FS). Likewise, the HPLC characterization showed the presence of thymoquinone in BCS, Dosignienin FGS and chlorogenic acid, caffeic acid and kaempferol in the other treatments. Furthermore, all the treatments showed dose dependent inhibition in Pancreatic lipase activity and order of inhibition was BCS > CS + BCS > CS + BCS + FS > CS > BCS + FC > CS + FS > FS. The maximum feed intake, drink intake and weight gain was observed in T0 (control) trailed by T1, T2, T3 and T4 group in experimental study I, II and III, respectively. The resultant diet T4 enhanced the high density lipoprotein from T0 (58.58 ± 2.51) to 61.71 ± 1.62 (T4) in hypercholesterolemia rats whereas in hyperglycaemia rats the HDL was varied from 38.77 ± 1.2 to 40.02 ± 0.99 in T0 and T4, respectively. Similarly, T2 significantly lowered the low density lipoprotein from 62.53 ± 1.22 (T1) & 46.53 ± 0.99 to 54.88 ± 0.52 & 40.94 ± 1.99 (T2) in hypercholesteraemic and diabetic rats. Moreover, T4 treatment showed maximum reduction as 10.01 & 11.53% in respective studies. Conclusions The diet prepared from the different combination of spices has been proven effective against Oxidative stress related physiological malfunctioning.

Outbreaks of emerging pathogens pose unique methodological and practical challenges for the design, implementation, and evaluation of vaccine efficacy trials. Lessons learned from COVID-19 highlight the need for innovative and flexible study design and application to quickly identify promising candidate vaccines. Trial design strategies should be tailored to the dynamics of the specific pathogen, location of the outbreak, and vaccine prototypes, within the regional socioeconomic constraints. Mathematical and statistical models can assist investigators in designing infectious disease clinical trials. We introduce key challenges for planning, evaluating, and modelling vaccine efficacy trials for emerging pathogens.

Background: About half of Swedish eating disorder patients report exercising compulsively and compulsive exercise (CE) is prevalent in all diagnoses and both genders. Yet there are no systematic treatments targeting CE in specialist care. This study aims to evaluate the effects of The CompuLsive Exercise Activity TheraPy (LEAP) - a promising group treatment targeting compulsive exercise, in Swedish eating disorder patients. Method: One hundred twenty-eight adult females and males suffering from anorexia nervosa, bulimia nervosa or other specified feeding and eating disorders (type 1, 2, or 4) with CE will be recruited via four specialist eating disorder treatment units. Participants will be randomized to receive treatment as usual (control group) or treatment as usual plus LEAP (intervention group). The groups will be assessed on key variables (e.g., BMI, eating disorder symptoms, exercise cognitions and behaviors) at three occasions: initially, after 3 months and after 6 months. Discussion: The project takes place in a clinical setting, including both male and female patients with different eating disorder diagnoses with CE, enabling a good indication of the efficacy of LEAP. If our results are positive, LEAP has the potential of benefiting about half of the eating disorder population, with remission and recovery hopefully improving as a result. Trial registration: The trial is registered with the ISRCTN registry (registration date 2020-03-25), trial ID: ISRCTN80711391. [ABSTRACT FROM AUTHOR]

Introduction: Tuberculosis (TB) is the leading infectious killer globally and new TB vaccines will be crucial to ending the epidemic. Since the introduction in 1921 of the only currently licensed TB vaccine, BCG, very few novel vaccine candidates or strategies have advanced into clinical efficacy trials. Areas covered: Recently, however, two TB vaccine efficacy trials with novel designs have reported positive results and are now driving new momentum in the field. They are the first Prevention of Infection trial, evaluating the H4:IC31 candidate or BCG revaccination in high-risk adolescents and a Prevention of Disease trial evaluating the M72/AS01E candidate in M.tuberculosis-infected, healthy adults. These trials are briefly reviewed, and lessons learned are proposed to help inform the design of future efficacy trials. The references cited were chosen by the author based on PubMed searches to provide context for the opinions expressed in this Perspective article. Expert opinion: The opportunities created by these two trials for gaining critically important knowledge are game-changing for TB vaccine development. Their results clearly establish feasibility in the relatively near term of developing novel, effective vaccines that could be crucial to ending the TB epidemic.

Background: Major Depressive Disorder (MDD) is a disabling mood disorder, profoundly affecting a large number of adolescent's quality of life. To date, no obvious treatment of choice for MDD in adolescents is available and progress in the treatment of depressed adolescents will have important public health implications. Attachment-Based Family Therapy (ABFT), as the only empirically supported family therapy model designed to treat adolescent depression, aims to repair interpersonal ruptures and rebuild an emotionally protective parent–child relationship. Objective: To study the effectiveness of ABFT compared with treatment as usual (TAU) delivered within child- and adolescent mental health services (CAMHS) to adolescents with MDD. Method: Sixty adolescents (86.7% girls), aged 13–18 years (M = 14.9, SD = 1.35), with MDD referred to two CAMHS were randomized to 16 weeks of ABFT or TAU. ABFT consisted of weekly therapy sessions (family/individual or both) according to the treatment manual. TAU was not monitored. Primary outcomes were assessed by blinded evaluators at baseline and post-treatment with the Hamilton Depression Scale (HAMD). Self-reported (Beck Depression Inventory-II, BDI-II) depressive symptoms were assessed at baseline, and after 4, 6, 8, 10,12, 14, and 16 weeks. Analyses were performed according to intent-to-treat principles. Results: At post-treatment, clinician-rated remission rates on the HAMD (5% in ABFT and 3.33% in TAU, p = 1, OR = 1.54, Fisher's exact test) and self-reported symptoms of depression on the BDI-II did not differ significantly between groups (X2[2, N = 60] = 0.06, p = 0.97). In both treatment groups participants reported significantly reduced depressive symptoms, but the majority (63.3%) of adolescents were still in the clinical range after 16 weeks of treatment. Conclusion: ABFT was not superior to TAU. Remission and response rates were low in both groups, suggesting none of the treatments were effective in treating MDD in adolescents. Findings must be viewed in the context of the study's small sample size, missing data, and implementation challenges. Continued efforts to improve treatment for MDD in outpatient clinics are warranted. Future research should examine moderators of and mechanisms for individual differences to treatment response, as well as the feasibility and cost-effectiveness of implementing treatment models which may require extensive training and expertise to yield clinically meaningful improvements in non-research settings. Trial registration Clinicaltrials.gov identifier: NCT01830088 https://clinicaltrials.gov/ct2/show/NCT01830088?term=Villab%C3%B8&draw=2&rank=1 Date of registration: April 12, 2013 [ABSTRACT FROM AUTHOR]

To rapidly evaluate the safety and efficacy of COVID-19 vaccine candidates, prioritizing vaccine trial sites in areas with high expected disease incidence can speed endpoint accrual and shorten trial duration. Mathematical and statistical forecast models can inform the process of site selection, integrating available data sources and facilitating comparisons across locations. We recommend the use of ensemble forecast modeling – combining projections from independent modeling groups – to guide investigators identifying suitable sites for COVID-19 vaccine efficacy trials. We describe an appropriate structure for this process, including minimum requirements, suggested output, and a user-friendly tool for displaying results. Importantly, we advise that this process be repeated regularly throughout the trial, to inform decisions about enrolling new participants at existing sites with waning incidence versus adding entirely new sites. These types of data-driven models can support the implementation of flexible efficacy trials tailored to the outbreak setting. [ABSTRACT FROM AUTHOR]

Purpose: High prevalence of vitamin D deficiency (VDD) justifies a cost-effective and sustainable strategy to combat VDD in the community. This study was undertaken for the first time to evaluate the efficacy of daily consumption of vitamin D fortified sunflower oil with a meal. Methods: This single-blind trial was conducted in two separate institutions: one as intervention (D-fortified sunflower oil) group (DO, n1 = 39) and the other as control (unfortified sunflower oil) group (SO, n2 = 33). Participants consumed their lunches cooked either with D-fortified or unfortified cooking sunflower oil (500 IU/30 g) for 12 weeks. Dietary, anthropometric and biochemical assessments were done for all participants before and after the intervention. Results: A total of 65 subjects from both sexes aged 32.5 ± 4 years completed the intervention period. Serum 25(OH)D showed a significant increase in DO and a decrease in SO group (8.8 ± 9.3 vs. − 7.4 ± 6.4 ng/mL, p < 0.001). The rise in serum 25(OH)D in DO group was accompanied by a significant decrease in iPTH (DO: − 10.2 ± 29.4 vs. SO: + 9.2 ± 29.5 pg/mL; p = 0.009). A significant reduction in weight (p = 0.004), BMI (p = 0.029), waist girth (p < 0.001), serum total cholesterol (p = 0.0290) and LDL-C (p = 0.010) was observed in DO, as compared with SO group. Conclusions: Cooking oil can be considered as an efficacious vehicle for mass fortification program to combat VDD. The improvement of vitamin D status may bring about betterment of certain cardiometabolic risk factors. Registration number: Clinicaltrials.gov: NCT03826654. [ABSTRACT FROM AUTHOR]

Background: The spices based dietary interventions are in lime light among the scientific community owing to their promising therapeutic perspective. The bioactive components in spices can be used to exert various health promoting functions in human body such as prompting weight loss, inhibit diet-induced obesity, hypercholesterolemia, hyperglycemia, allergies and various other maladies. In current study extraction and in vitro characterization of coriander seed (CS), black cumin seed (BCS) and fenugreek seed (FS) polyphenols was conducted for further development of dietary intervention against lipid and glycemia related abnormalities in experimental Sprague Dowley rats fed with control and different spice powder supplemented diets. Methods: Purposely, extraction of Coriander (CS), Black cumin (BCS) and Fenugreek seeds (FS) were carried out by using water and aqueous methanol (70:30 v/v). Afterwards, the resultant extracts were thoroughly investigated for their antioxidant potential through different indices like TPC, TFC, FRAP and β Carotene Bleaching Assay and ABTS. Furthermore, HPLC quantification were also conducted with special reference to thymoquinone, disogenin, chlorogenic acid, caffeic acid and kaempferol alongside in vitro pancreatic lipase inhibitory activity estimation. Bio-evaluation trial was consisting of three modules i.e. study-I (normal diet), study-II (high cholesterol diet) and study-III (high sucrose diet). Furthermore, rats were sub-divided in five groups in each module on the basis of diet provision including T0 (control), T1 (Diet containing CS), T2 (Diet containing BCS), T3 (Diet containing FS) and T4 (Diet containing CSP + BCSP + FSP). At the beginning of trial, some rats were dissected to evaluate the baseline values whilst rest of the rats was killed at the termination (56th day). Feed and drink intakes were quantified on daily bases whereas, body weight was calculated weekly. Cholesterol level, serum low density lipoproteins (LDL), high density lipoproteins (HDL), triglycerides, glucose concentration and insulin level of collected sera was measured by standard procedures. Results: The in vitro characterization showed better extraction of spices antioxidant through aqueous methanol as compared to water. Among the spices, Black cumin seed alone or in combination revealed highest antioxidant activity in T2 (BCS) followed by T4 (CS + BCS), T7 (CS + BCS + FS), T1 (CS), T6 (BCS + FS), T5 (CS + FS) and lowest in T3 (FS). Likewise, the HPLC characterization showed the presence of thymoquinone in BCS, Dosignienin FGS and chlorogenic acid, caffeic acid and kaempferol in the other treatments. Furthermore, all the treatments showed dose dependent inhibition in Pancreatic lipase activity and order of inhibition was BCS > CS + BCS > CS + BCS + FS > CS > BCS + FC > CS + FS > FS. The maximum feed intake, drink intake and weight gain was observed in T0 (control) trailed by T1, T2, T3 and T4 group in experimental study I, II and III, respectively. The resultant diet T4 enhanced the high density lipoprotein from T0 (58.58 ± 2.51) to 61.71 ± 1.62 (T4) in hypercholesterolemia rats whereas in hyperglycaemia rats the HDL was varied from 38.77 ± 1.2 to 40.02 ± 0.99 in T0 and T4, respectively. Similarly, T2 significantly lowered the low density lipoprotein from 62.53 ± 1.22 (T1) & 46.53 ± 0.99 to 54.88 ± 0.52 & 40.94 ± 1.99 (T2) in hypercholesteraemic and diabetic rats. Moreover, T4 treatment showed maximum reduction as 10.01 & 11.53% in respective studies. Conclusions: The diet prepared from the different combination of spices has been proven effective against Oxidative stress related physiological malfunctioning. [ABSTRACT FROM AUTHOR]

There is growing pressure to make efficacy experiments more useful. This requires attending to the twin goals of generalizing experimental results to those schools that will use the results and testing the intervention's theory of action. We show how electronic records, created naturally during the daily operation of technology-based interventions, contain the information needed to attend to these twin goals. These records allow researchers to define the population of schools considering adoption of an intervention and to plan an experiment to generalize to these schools. They also allow researchers to identify schools likely to fully implement the intervention, such that the theory of action can be properly tested. Designing experiments to address these goals involves many tradeoffs and prioritizing the different purposes of the planned experiment. We discuss these challenges, linking experimental purposes with design decisions. [ABSTRACT FROM AUTHOR]

Introduction: Tuberculosis (TB) is the leading infectious killer globally and new TB vaccines will be crucial to ending the epidemic. Since the introduction in 1921 of the only currently licensed TB vaccine, BCG, very few novel vaccine candidates or strategies have advanced into clinical efficacy trials. Areas covered: Recently, however, two TB vaccine efficacy trials with novel designs have reported positive results and are now driving new momentum in the field. They are the first Prevention of Infection trial, evaluating the H4:IC31 candidate or BCG revaccination in high-risk adolescents and a Prevention of Disease trial evaluating the M72/AS01E candidate in M.tuberculosis-infected, healthy adults. These trials are briefly reviewed, and lessons learned are proposed to help inform the design of future efficacy trials. The references cited were chosen by the author based on PubMed searches to provide context for the opinions expressed in this Perspective article. Expert opinion: The opportunities created by these two trials for gaining critically important knowledge are game-changing for TB vaccine development. Their results clearly establish feasibility in the relatively near term of developing novel, effective vaccines that could be crucial to ending the TB epidemic. [ABSTRACT FROM AUTHOR]

Objective: This report evaluates a dissonance-based group eating disorder treatment designed to be a cost-effective front-line transdiagnostic treatment that could be more widely implemented than extant treatments that are more intensive and expensive relative to a supportive mindfulness group treatment typical of that offered at colleges. Method: Young women with eating disorders (N = 84) were randomized to 8-week dissonance-based Body Project treatment (BPT) or supportive mindfulness treatment, completing diagnostic interviews and questionnaires at pretest, posttest, and 6-month follow up. Results: Regarding primary outcomes, by 6-month follow up 77% of BPT participants no longer met diagnosis for an eating disorder versus 60% of supportive mindfulness participants (relative risk ratio = 2.22; 95% Cl [1.01, 4.93]), though groups did not differ on eating disorder symptom change. Regarding secondary outcomes, BPT versus supportive mindfulness participants showed significantly lower dissonance about affirming the thin ideal at posttest and 6-month follow up (d = .38 and .32), body dissatisfaction at posttest and 6-month follow up (d = .62 and .62), negative affect at posttest and 6-month follow up (d = .49 and .48), and functional impairment (d = .36) at 6-month follow up; differences in thin-ideal internalization and abstinence from binge eating and compensatory behaviors were not significant. Conclusions: Whereas both treatments appeared effective, BPT produced larger effects and significantly greater remission of eating disorder diagnoses than a credible alternative treatment, which is very rare for trials that have compared active eating disorder treatments. Results suggest it would be useful to refine BPT and conduct target engagement research and efficacy trials. [ABSTRACT FROM AUTHOR]

‘Draper’ northern highbush blueberry (Vaccinium corymbosum L.) is a widely-planted mid-season cultivar with excellent fruit quality. Under the climatic conditions of Southwestern British Columbia, Canada, and Northwestern Washington, USA, it expresses a physiological disorder causing spontaneous green fruit drop (GFD) of up to half of the developing crop just prior to onset of the fruit coloring phenophase. Reduction of economic losses due to GFD required identification of the cause of this disorder and development of an agronomic solution that would reduce fruit drop. In 2014, two initial experiments were conducted to compare three foliar Ca products under a range of N fertilization rates. In 2015 and 2016, three locations were used in a first step to optimizing rates and timings of foliar Ca application. Initial experiments determined that higher N fertilization rates exacerbate GFD but that foliar Ca corrects the condition. Multi-site, multi-year trials identified key rates and timings for foliar Ca application to provide an agronomic solution for commercial growers. These trials identified an acute fruit Ca deficiency as the cause of GFD, and that foliar calcium applied frequently at high concentration from mid-bloom onward can be effective in reducing GFD, often to negligible levels. This condition has now been reported in several production regions around the world.

Increased crash incidence following deployment and veterans' reports of driving difficulty spurred traffic safety research for this population. We conducted an interim analysis on the efficacy of a simulator-based occupational therapy driving intervention (OT-DI) compared with traffic safety education (TSE) in a randomized controlled trial. During baseline and post-testing, OT-Driver Rehabilitation Specialists and one OT-Certified Driver Rehabilitation Specialist measured driving performance errors on a DriveSafety CDS-250 high-fidelity simulator. The intervention group (n = 13) received three OT-DI sessions addressing driving errors and visual-search retraining. The control group (n = 13) received three TSE sessions addressing personal factors and defensive driving. Based on Wilcoxon rank-sum analysis, the OT-DI group's errors were significantly reduced when comparing baseline with Post-Test 1 (p < .0001) and comparing the OT-DI group with the TSE group at Post-Test 1 (p = .01). These findings provide support for the efficacy of the OT-DI and set the stage for a future effectiveness study. [ABSTRACT FROM AUTHOR]

EightCylindropuntiaspecies have naturalised in Australia and pose serious economic, environmental and social impacts. The host range of four additional biotypes ofD. tomentosusfrom southern USA was investigated. Feeding and development were restricted to the genusCylindropuntia. However, they showed differences in specificity within this genus and some biotypes discriminated between the provenances ofCylindropuntia roseaandCylindropuntia tunicata. Efficacy trials were conducted to determine whether populations of each biotype could be sustained on the naturalisedCylindropuntiaspecies and if these populations could retard the growth or kill these plants. The ‘acanthocarpa’ biotype offers potential control ofC. rosea(Lorne Station), while the ‘cylindropuntia sp.’ biotype shows great potential to controlC. rosea(Grawin). The ‘cylindropuntia sp.’ biotype also had a high impact onCylindropuntia kleiniaeandCylindropuntia imbricata, and a moderate impact onCylindropuntia leptocaulisandCylindropuntia prolifera. The ‘acanthocarpa × echinocarpa’ biotype had its greatest impact onC. tunicata(Grawin), killing this plant in 18 weeks. A fourth biotype, ‘leptocaulis’, was damaging to some species, but was less effective than the other biotypes.Cylindropuntia spinosioris the only naturalised species in Australia where no effective biocontrol agent has been found. [ABSTRACT FROM PUBLISHER]

Research has consistently linked social–emotional skills to important educational and life outcomes. Many children begin their school careers, however, without the requisite social and emotional skills that facilitate learning, which has prompted schools nationwide to adopt specific curricula to teach students the social–emotional skills that enable them to maintain optimal engagement in the learning process. Second Step ® is one of the most widely disseminated social–emotional learning (SEL) programs; however, its newly revised version has never been empirically evaluated. The purpose of this study was to conduct a randomized controlled trial investigating the impact of the 4th Edition Second Step ® on social–behavioral outcomes over a 1-year period when combined with a brief training on proactive classroom management. Participants were kindergarten to 2nd grade students in 61 schools (321 teachers, 7300 students) across six school districts. Hierarchical models (time × condition) suggest that the program had few main effects from teacher-reported social and behavioral indices, with small effect sizes. The majority of significant findings were moderated effects, with 8 out of 11 outcome variables indicating the intervention-produced significant improvements in social–emotional competence and behavior for children who started the school year with skill deficits relative to their peers. All the significant findings were based on teacher-report data highlighting a need for replication using other informants and sources of data. Findings provide program validation and have implications for understanding the reach of SEL programs. [ABSTRACT FROM AUTHOR]

This study examined the efficacy of a curriculum-based intervention for high school science students. Specifically, the intervention was two years of research-based, multidisciplinary curriculum materials for science supported by comprehensive professional development for teachers that focused on those materials. A modest positive effect was detected when comparing outcomes from this intervention to those of business-as-usual materials and professional development. However, this effect was typical for interventions at this grade span that are tested using a state achievement test. Tests of mediation suggest a large treatment effect on teachers and in turn a strong effect of teacher practice on student achievement—reinforcing the hypothesized key role of teacher practice. Tests of moderation indicate no significant treatment by demographic interactions. [ABSTRACT FROM AUTHOR]

The host range of two newly imported biotypes ofDactylopius tomentosusand their potential as biological control agents ofCylindropuntiaspp. were investigated. A third biotype (‘imbricata’) ofD. tomentosuspreviously released in Australia to controlC. imbricatawas also screened to determine if it will feed on other species ofCylindropuntiaoccurring in Australia. Efficacy trials were conducted to evaluate the ability of the biotypes to retard the growth or kill those plant species supporting development of four or more individuals in the host test trials. The host range of the three biotypes ofD. tomentosuswas restricted to the genusCylindropuntia.However, the biotypes showed varying degrees of specificity within this genus. The ‘imbricata’ biotype was the only biotype to develop on AustralianC. roseaprovenances, albeit with a range of developmental success on allC. roseaprovenances tested. The Spanish provenance supported the highest development success followed by Grawin (NSW), Lorne Station (NSW) while the least preferred was the Mexican provenance. The ‘rosea’ and ‘cholla’ biotypes were unsuitable candidates to controlC. roseain Australia. However, the efficacy trials showed that the ‘cholla’ biotype had a high impact on four of the eight naturalisedCylindropuntiaspecies in Australia. This biotype established rapidly and the sustained feeding of one fecund female and her progeny killed potted plants ofC. imbricataandC. fulgidaat week 18. This biotype has the potential to be an effective agent againstC. fulgida,C. imbricata,C. kleiniaeandC. tunicataand, as a consequence, an application seeking its release in Australia has been lodged. [ABSTRACT FROM PUBLISHER]

The authors conducted a pilot trial of a new dissonance-based group eating disorder treatment designed to be a cost-effective front-line transdiagnostic treatment that could be more widely disseminated than extant individual or family treatments that are more expensive and difficult to deliver. Young women with a DSM-5 eating disorder ( N = 72) were randomized to an 8-week dissonance-based Counter Attitudinal Therapy group treatment or a usual care control condition, completing diagnostic interviews and questionnaires at pre, post, and 2-month follow-up. Intent-to-treat analyses revealed that intervention participants showed greater reductions in outcomes than usual care controls in a multivariate multilevel model (χ 2 [6] = 34.1, p < .001), producing large effects for thin-ideal internalization ( d = .79), body dissatisfaction ( d = 1.14), and blinded interview-assessed eating disorder symptoms ( d = .95), and medium effects for dissonance regarding perpetuating the thin ideal ( d = .65) and negative affect ( d = .55). Midway through this pilot we refined engagement procedures, which was associated with increased effect sizes (e.g., the d for eating disorder symptoms increased from .51 to 2.30). This new group treatment produced large reductions in eating disorder symptoms, which is encouraging because it requires about 1/20th the therapist time necessary for extant individual and family treatments, and has the potential to provide a cost-effective and efficacious approach to reaching the majority of individuals with eating disorders who do not presently received treatment. [ABSTRACT FROM AUTHOR]

Outbreaks of emerging pathogens pose unique methodological and practical challenges for the design, implementation, and evaluation of vaccine efficacy trials. Lessons learned from COVID-19 highlight the need for innovative and flexible study design and application to quickly identify promising candidate vaccines. Trial design strategies should be tailored to the dynamics of the specific pathogen, location of the outbreak, and vaccine prototypes, within the regional socioeconomic constraints. Mathematical and statistical models can assist investigators in designing infectious disease clinical trials. We introduce key challenges for planning, evaluating, and modelling vaccine efficacy trials for emerging pathogens. • We identify challenges of vaccination for pathogens with pandemic potential. • We focus on challenges of planning and evaluating trials for emerging pathogens. • Mathematical models can enhance the probability for successful conduct of trials. [ABSTRACT FROM AUTHOR]

Background: Implementation strategies used to enhance the implementation of interventions during efficacy and effectiveness studies are rarely reported. Tracking and reporting implementation strategies during these phases has potential to improve future research studies and real-world implementation. We present an exemplar of how this might be executed by specifying and reporting the implementation strategies that were used during a school-based efficacy trial, Project POWER, which tested a trauma-informed prevention program delivered by a university research team, community members, and school staff facilitators in 29 schools., Methods: Following the conclusion of the 4-year trial, core Project POWER research team members identified the implementation strategies that supported intervention delivery during the trial using an established taxonomy of school-based implementation strategies. The actors, actions, action targets, temporality, dose, and implementation outcomes were specified using established implementation strategies reporting guidelines., Results: The research team identified 37 implementation strategies that were used during the Project POWER trial. Most strategies fell within the categories of Train and Educate Stakeholders, Use Evaluative and Iterative Strategies, and Develop Stakeholder Interrelationships. Actors included members of the research team and partner schools. Strategies were used multiple times during the preparation and implementation phases. Action targets were most often characteristics of individuals, implementation process, and characteristics of the inner setting. Strategies predominantly targeted the implementation outcomes of fidelity, acceptability, feasibility, and adoption., Conclusions: This study provided evidence that implementation strategies are used and can be identified in efficacy research using a retrospective approach. Identifying and specifying implementation strategies used during the initial phases of the translational research pipeline can inform the implementation strategies that are carried forward, adapted, or discontinued in future trials and routine practice to improve implementation and effectiveness outcomes.

'Draper' northern highbush blueberry (Vaccinium corymbosum L.) is a widely-planted mid-season cultivar with excellent fruit quality. Under the climatic conditions of Southwestern British Columbia, Canada, and Northwestern Washington, USA, it expresses a physiological disorder causing spontaneous green fruit drop (GFD) of up to half of the developing crop just prior to onset of the fruit coloring phenophase. Reduction of economic losses due to GFD required identification of the cause of this disorder and development of an agronomic solution that would reduce fruit drop. In 2014, two initial experiments were conducted to compare three foliar Ca products under a range of N fertilization rates. In 2015 and 2016, three locations were used in a first step to optimizing rates and timings of foliar Ca application. Initial experiments determined that higher N fertilization rates exacerbate GFD but that foliar Ca corrects the condition. Multi-site, multi-year trials identified key rates and timings for foliar Ca application to provide an agronomic solution for commercial growers. These trials identified an acute fruit Ca deficiency as the cause of GFD, and that foliar calcium applied frequently at high concentration from mid-bloom onward can be effective in reducing GFD, often to negligible levels. This condition has now been reported in several production regions around the world. [ABSTRACT FROM AUTHOR]

Background: Complex insomnia, the comorbidity of chronic insomnia and obstructive sleep apnea (OSA), is a common sleep disorder, but the OSA component, whether presenting overtly or covertly, often goes unsuspected and undiagnosed due to a low index of suspicion. Among complex insomniacs, preliminary evidence demonstrates standard CPAP decreases insomnia severity. However, CPAP causes expiratory pressure intolerance or iatrogenic central apneas that may diminish its use. An advanced PAP mode-adaptive servo-ventilation (ASV)-may alleviate CPAP side-effects and yield superior outcomes., Methods: In a single-site protocol investigating covert complex insomnia (ClinicalTrials.gov identifier: NCT02365064), a low index of suspicion for this comorbidity was confirmed by exclusion of 455 of 660 eligible patients who presented during the study period with overt OSA signs and symptoms. Ultimately, stringent inclusion/exclusion criteria to test efficacy yielded 40 adult, covert complex insomnia patients [average Insomnia Severity Index (ISI) moderate-severe 19.30 (95% CI 18.42-20.17)] who reported no definitive OSA symptoms or risks and who failed behavioral or drug therapy for an average of one decade. All 40 were diagnosed with OSA and randomized (using block randomization) to a single-blind, prospective protocol, comparing CPAP (n = 21) and ASV (n = 19). Three successive PAP titrations fine-tuned pressure settings, facilitated greater PAP use, and collected objective sleep and breathing data. Patients received 14 weeks of treatment including intensive biweekly coaching and follow-up to foster regular PAP use in order to accurately measure efficaciousness. Primary outcomes measured insomnia severity and sleep quality. Secondary outcomes measured daytime impact: OSA-induced impairment, fatigue severity, insomnia impairment, and quality of life. Performance on these seven variables was assessed using repeated measures ANCOVA to account for the multiple biweekly time points., Findings: At intake, OSA diagnosis and OSA as a cause for insomnia were denied by all 40 patients, yet PAP significantly decreased insomnia severity scores (p = 0.021 in the primary ANCOVA analysis). To quantify effect sizes, mean intake vs endpoint analysis was conducted with ASV yielding nearly twice the effects of CPAP [- 13.2 (10.7-15.7), Hedges' g = 2.50 vs - 9.3 (6.3-12.3), g = 1.39], and between mode effect size was in the medium-large range 0.65. Clinically, ASV led to remission (ISI < 8) in 68% of cases compared to 24% on CPAP [Fisher's exact p = 0.010]. Two sleep quality measures in the ANCOVA analysis again demonstrated superior significant effects for ASV compared to CPAP (both p < 0.03), and pre- and post-analysis demonstrated substantial effects for both scales [ASV (g = 1.42; g = 1.81) over CPAP (g = 1.04; g = 0.75)] with medium size effects between modes (0.54, 0.51). Measures of impairment, residual objective sleep breathing events, and normalized breathing periods consistently demonstrated larger beneficial effects for ASV over CPAP., Interpretation: PAP therapy was highly efficacious in decreasing insomnia severity in chronic insomnia patients with previously undiagnosed co-morbid OSA. ASV proved superior to CPAP in this first efficacy trial to compare advanced to traditional PAP modes in complex insomnia. Future research must determine the following: pathophysiological mechanisms to explain how OSA causes chronic insomnia; general population prevalence of this comorbidity; and, cost-effectiveness of ASV therapy in complex insomnia. Last, efforts to raise awareness of complex insomnia are urgently needed as patients and providers appear to disregard both overt and covert signs and symptoms of OSA in the assessment of chronic insomnia., Competing Interests: Authors NDM, VAU, JK, and RMS report grants from ResMed Sciences during the conduct of the study. Additionally, author JK is the CEO of the commercial sleep center, Maimonides Sleep Arts & Sciences, where the study was conducted in part; Barry and Jessica Krakow are married. Author BK reports: 6 main activities related to his work in sleep medicine. For websites, Dr. Krakow owns and operates 6 sites that provide education and offer products and services for sleep disorders patients: www.nightmaretreatment.com, www.ptsdsleepclinic.com, www.sleeptreatment.com, www.sleepdynamictherapy.com, www.soundsleepsoundmind.com, and www.nocturiacures.com. For other professional services, he is the medical director of a national DME company Classic SleepCare for which his sole functions are consultation and QA; he has neither patient encounters nor does he benefit from the sale of any DME equipment. For intellectual property, Dr. Krakow markets and sells 3 books for sleep disorders patients: Insomnia Cures, Turning Nightmares into Dreams, and Sound Sleep, Sound Mind. For clinical services, he owns and operates one commercial sleep center: Maimonides Sleep Arts & Sciences, Ltd. For educational and consulting services: Dr. Krakow conducts CME/CEU educational programs for medical and mental health providers to learn about sleep disorders. Sometimes these programs involve the attendee paying a fee directly to Maimonides Sleep Arts & Sciences. Other times, he conducts the workshops at other locations, which may be paid for by vendors such as Respironics and ResMed or other institutions such as the AMEDDC&S, VAMC, and regional sleep center conferences. He is also president and principal investigator of a non-profit sleep research center, the Sleep & Human Health Institute (www.sleepingresearch.org, www.shhi.org) that occasionally provides consultation services or receives grants for pilot studies, the most recent: ResMed ~$400,000 January 2015 (funding for this randomized control trial of treatment in insomnia patients). Recently, and after this research had been conducted, he provided a brief consultation to ASOCorp, a medical supply company that manufactures nasal strips.

Field efficacy trials showed that Diethy Amioethyl Hexanoate 5% AS could promote growth and increase yield of cabbage. The cabbage yield increase rate was up to 40.37% by using reagent dilution 2 000 - 2 500 times twice, so Diethy Diethy Amioethyl Hexanoate 5% AS is an ideal agent for regulating cabbage growth and increasing yield. [ABSTRACT FROM AUTHOR]

Increased crash incidence following deployment and veterans' reports of driving difficulty spurred traffic safety research for this population. We conducted an interim analysis on the efficacy of a simulator-based occupational therapy driving intervention (OT-DI) compared with traffic safety education (TSE) in a randomized controlled trial. During baseline and post-testing, OT-Driver Rehabilitation Specialists and one OT-Certified Driver Rehabilitation Specialist measured driving performance errors on a DriveSafety CDS-250 high-fidelity simulator. The intervention group ( n = 13) received three OT-DI sessions addressing driving errors and visual-search retraining. The control group ( n = 13) received three TSE sessions addressing personal factors and defensive driving. Based on Wilcoxon rank-sum analysis, the OT-DI group's errors were significantly reduced when comparing baseline with Post-Test 1 ( p < .0001) and comparing the OT-DI group with the TSE group at Post-Test 1 ( p = .01). These findings provide support for the efficacy of the OT-DI and set the stage for a future effectiveness study.

Introduction: Despite many recent advances in the HIV prevention landscape, an effective vaccine remains the most promising tool to end the HIV-1 pandemic. Areas covered: This review summarizes past HIV vaccine efficacy trials and current vaccine strategies as well as new approaches about to move into first-in-human trials. Expert opinion: Despite many setbacks in early HIV vaccine efficacy trials, the success of RV144 has provided the glimmer of hope necessary to invigorate the vaccine field, and has led to the development of a large number of vaccine strategies aiming at inducing an array of different immune responses. The follow-up pox-protein trials, developed to replicate and enhance the polyfunctional antibody responses induced by the RV144 regimen, are already reaching efficacy trials, while a large body of work providing a more complete understanding of the development of broadly neutralizing antibodies is now being translated into immunogen design using several different strategies. T-cell based vaccines, fallen out of favor after Ad5-based trials showed increased infection rates in Ad5 seropositive vaccine recipients, are experiencing a comeback based in part on the promising results from non-human primate challenge studies using rhCMV-based immunogens. This diverse array of vaccine candidates may finally allow us to identify a broadly effective HIV vaccine able to contain the epidemic.

The 2014-16 Ebola outbreak in West Africa has by far been the largest and most devastating Ebola outbreak so far. At the start of the epidemic only 2 Ebola DNA vaccine candidates had been tested in clinical trials and the correlate of protection in humans was unknown. International stakeholders coordinated by the World Health Organization agreed to fast-track the development of 2 Ebola vaccine candidates, based on adenovirus and vesicular stomatitis virus (VSV) vectors. Phase I and II clinical trials were initiated in the autumn of 2014 and found both vaccines to be acceptable for proceeding to phase III trials. Despite the epidemic waning in the spring of 2015, by July 2015 preliminary results from a phase III trial in Guinea proved the Ebola VSV vaccine to be effective.