scholarly journals Immunogenicity and Immune Memory after a Pneumococcal Polysaccharide Vaccine Booster in a High-Risk Population Primed with 10-Valent or 13-Valent Pneumococcal Conjugate Vaccine: A Randomized Controlled Trial in Papua New Guinean Children

Vaccines ◽  
2019 ◽  
Vol 7 (1) ◽  
pp. 17 ◽  
Author(s):  
Anita van den Biggelaar ◽  
William Pomat ◽  
Geraldine Masiria ◽  
Sandra Wana ◽  
Birunu Nivio ◽  
...  
Keyword(s):  
High Risk ◽  
Young Children ◽  
Pneumococcal Disease ◽  
Controlled Trial ◽  
Immune Memory ◽  
High Risk Population ◽  
Pneumococcal Infections ◽  
Vaccine Booster ◽  
To Receive ◽  
Papua New Guinean

We investigated the immunogenicity, seroprotection rates and persistence of immune memory in young children at high risk of pneumococcal disease in Papua New Guinea (PNG). Children were primed with 10-valent (PCV10) or 13-valent pneumococcal conjugate vaccines (PCV13) at 1, 2 and 3 months of age and randomized at 9 months to receive PPV (PCV10/PPV-vaccinated, n = 51; PCV13/PPV-vaccinated, n = 52) or no PPV (PCV10/PPV-naive, n = 57; PCV13/PPV-naive, n = 48). All children received a micro-dose of PPV at 23 months of age to study the capacity to respond to a pneumococcal challenge. PPV vaccination resulted in significantly increased IgG responses (1.4 to 10.5-fold change) at 10 months of age for all PPV-serotypes tested. Both PPV-vaccinated and PPV-naive children responded to the 23-month challenge and post-challenge seroprotection rates (IgG ≥ 0.35 μg/mL) were similar in the two groups (80–100% for 12 of 14 tested vaccine serotypes). These findings show that PPV is immunogenic in 9-month-old children at high risk of pneumococcal infections and does not affect the capacity to produce protective immune responses. Priming with currently available PCVs followed by a PPV booster in later infancy could offer improved protection to young children at high risk of severe pneumococcal infections caused by a broad range of serotypes.

scholarly journals Impact of Social Distancing and Travel Restrictions on Non–Coronavirus Disease 2019 (Non–COVID-19) Respiratory Hospital Admissions in Young Children in Rural Alaska

2020 ◽  
Author(s):  
Leisha D Nolen ◽  
Sara Seeman ◽  
Dana Bruden ◽  
Joe Klejka ◽  
Chris Desnoyers ◽  
...  
Keyword(s):  
High Risk ◽  
Young Children ◽  
Hospital Admissions ◽  
High Risk Population ◽  
Respiratory Illnesses ◽  
Social Distancing ◽  
The Past ◽  
Secondary Benefits ◽  
Rural Alaska ◽  
Travel Restrictions

Abstract Hospitalizations due to non-coronavirus disease 2019 (non-COVID-19) respiratory illnesses decreased dramatically after social distancing was implemented in a high-risk population in rural Alaska; an unprecedented decline compared to the past 10 respiratory seasons. This demonstrates the potential secondary benefits of implementing social distancing and travel restrictions on respiratory illnesses.

Invasive pneumococcal disease in pediatric organ transplant recipients: A high-risk population

2005 ◽  
Vol 9 (2) ◽  
pp. 183-186 ◽  
Author(s):  
Leanne Tran ◽  
Diane Hébert ◽  
Anne Dipchand ◽  
Annie Fecteau ◽  
Susan Richardson ◽  
...  
Keyword(s):  
High Risk ◽  
Invasive Pneumococcal Disease ◽  
Pneumococcal Disease ◽  
Organ Transplant ◽  
High Risk Population ◽  
Transplant Recipients ◽  
Risk Population ◽  
Organ Transplant Recipients

scholarly journals Filipino Multicomponent Intervention to Maintain Cognitive Performance in High-Risk Population (FINOMAIN): Study Protocol for a Cluster Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Jacqueline Dominguez ◽  
Ma. Fe de Guzman ◽  
S. H. Annabel Chen ◽  
Mary Sano ◽  
Gunhild Waldemar ◽  
...  
Keyword(s):  
Public Health ◽  
High Risk ◽  
Cognitive Performance ◽  
Controlled Trial ◽  
The Philippines ◽  
High Risk Population ◽  
Vascular Risk ◽  
Randomized Controlled ◽  
Multicomponent Intervention ◽  
Cluster Randomized

Background: More than half of the people with dementia live in lower-middle income countries (LMIC), yet we lack research and evidence-based knowledge to guide health promotion and prevention strategies for cognitive decline. In the Philippines, the prevalence of mild cognitive impairment (MCI) and cardiovascular risk factors among older persons are high, making this population at high risk for developing dementia. This protocol describes a cluster randomized controlled trial that aims to investigate the efficacy of a multicomponent intervention to maintain cognitive performance among high-risk population.Methods: This is a cluster-randomized, two-arm, single-blind trial of a multicomponent intervention that combines dance called INDAK (Improving Neurocognition through Dance and Kinesthetics), nutrition counseling, and vascular risk management. The intervention arm will receive 12 months (1-h, twice per week) of INDAK and every 3 months of nutrition counseling and intensive vascular risk management and monitoring. The control group will receive the usual vascular care advice and referral. A total of 605 (20–25 clusters per arm) community-dwelling Filipino older adults aged ≥ 60 years old with MCI will participate in the study and will be assessed at baseline, 6th- and 12th-month follow-up. The primary outcome is cognitive performance assessed by the Alzheimer's Disease Assessment Scale—Cognitive (ADAS-Cog), Mnemonic Similarity Tasks (MST), and executive function composite (EFC). Secondary outcomes are functional connectivity assessed through brain imaging, and measures of behavioral, functional level, and quality of life.Discussion: The study aims to provide scientific evidence on a public health intervention that is contextualized in a community setting to reduce dementia risk among older adults with MCI. This model can be an ecological, low-cost, and effective program, thereby conducive to widespread implementation in the Philippines as well as in other low-resource settings with similar public health challenges. The pilot phase was underway with eight villages (clusters), but temporarily interrupted by the pandemic. The full study is anticipated to start after community restrictions are eased.

scholarly journals Internet-Delivered Dialectical Behavioral Therapy Skills Training for Suicidal and Heavy Episodic Drinkers: Protocol and Preliminary Results of a Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Chelsey Wilks ◽  
Qingqing Yin ◽  
Sin Yee Ang ◽  
Brandon Matsumiya ◽  
Anita Lungu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
High Risk ◽  
Emotion Dysregulation ◽  
Controlled Trial ◽  
Skills Training ◽  
Alcohol Problems ◽  
Heavy Episodic Drinking ◽  
High Risk Population ◽  
Treatment Needs ◽  
Randomized Controlled

BACKGROUND The need to develop effective and accessible interventions for suicidal individuals engaging in heavy episodic drinking (HED) cannot be understated. While the link between alcohol use and suicidality is a complex one that remains to be elucidated, emotion dysregulation may play a key role in alcohol-related suicide risk in these individuals. OBJECTIVE In the current study, an 8-week Internet-delivered dialectical behavior therapy (DBT) skills training intervention was developed and preliminarily evaluated for suicidal individuals who engage in HED to regulate emotions. The aim of the study is to evaluate the feasibility and effectiveness of the therapist-assisted and Internet-delivered intervention, and to inform the design of a subsequent full-scale study. METHODS The study was a pilot randomized controlled trial comparing participants receiving immediate-treatment (n=30) to waitlist controls (n=29) over a period of 16 weeks. Intervention effects will be assessed longitudinally using hierarchical linear modeling and generalized estimating equations, along with analyses of effect sizes and clinically significant change. The primary outcomes are suicidal ideation, alcohol problems, and emotion dysregulation. Secondary outcomes include alcohol-related consequences, reasons for living, skills use, and depression. RESULTS The trial is ongoing. A total of 60 individuals returned their informed consent and were randomized, of whom 59 individuals were intended to treat. A total of 50 participants in the study were retained through the 16-week enrollment. CONCLUSIONS There is a dearth of evidence-based treatment for individuals presenting with high risk and complex behaviors. Furthermore, computerized interventions may provide a beneficial alternative to traditional therapies. The particular clinical features and treatment needs of suicidal individuals who also engage in HED constitute key domains for further investigation that are needed to consolidate the design of appropriate interventions for this high-risk population. CLINICALTRIAL Clinicaltrials.gov NCT02932241; https://clinicaltrials.gov/ct2/show/NCT02932241 (Archived by WebCite at http://www.webcitation.org/6uJHdQsC2)

scholarly journals A double-blind placebo-controlled trial of azithromycin to reduce mortality and improve growth in high risk young children with non-bloody diarrhoea in low resource settings: The Antibiotic for Children with Diarrhoea (ABCD) Trial Protocol

2019 ◽  
Author(s):  
Ayesha De Costa
Keyword(s):  
High Risk ◽  
Antimicrobial Resistance ◽  
Young Children ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Acute Diarrhoea ◽  
Bloody Diarrhoea ◽  
Policy Implications ◽  
Watery Diarrhoea ◽  
Double Blind

Abstract Background Acute diarrhoea is a common cause of illness and death among children in low-middle-income settings. WHO guidelines for the clinical management of acute watery diarrhoea in children focus on oral rehydration, supplemental zinc and feeding advice. Routine use of antibiotics is not recommended except when diarrhoea is bloody or cholera is suspected. Young children who are undernourished or have a dehydrating diarrhoea are more susceptible to death in 90-days after onset of diarrhoea. Given the mortality risk associated with diarrhoea in children with malnutrition or dehydrating diarrhoea, expanding the use of antibiotics for this subset of children could be an important intervention to reduce diarrhoea associated mortality and morbidity. We designed the ‘Antibiotics for Childhood Diarrhoea’ (ABCD) trial to test this intervention. Methods ABCD is a double-blind, randomised trial recruiting 11,500 children aged 2-23 months presenting with acute non-bloody diarrhoea who are dehydrated and/or undernourished (i.e. high risk for mortality). Enrolled children in Bangladesh, India, Kenya, Malawi, Mali, Pakistan and Tanzania, are randomized (1:1) to oral azithromycin 10mg/kg or placebo once daily for 3 days and followed-up for 180 days. Primary efficacy endpoints are (i) all-cause mortality during the 180 days post-enrolment and (ii) change in linear growth 90 days post-enrolment. Discussion Expanding treatment of acute watery diarrhoea in high risk children to include an antibiotic may offer an opportunity to reduce deaths. These benefits may result from direct antimicrobial effects on pathogens or other incompletely understood mechanisms including improved nutrition, alterations in immune responsiveness or improved enteric function. The expansion of indications for antibiotic use raises concerns about the emergence of antimicrobial resistance both within treated children and the communities in which they live. ABCD will monitor antimicrobial resistance The ABCD trial has important policy implications. If the trial shows significant benefits of azithromycin use, this may provide evidence to support reconsideration of antibiotic indications in the present WHO diarrhoea management guidelines. Conversely, if there is no evidence of benefit, these results will support the current avoidance of antibiotics except in dysentery or cholera, thereby avoiding inappropriate use of antibiotics and reaffirming the current guidelines.

scholarly journals Addressing COVID-19 Challenges in a Randomized Controlled Trial on Exercise Interventions in a High-Risk Population

2020 ◽  
Author(s):  
Gunver Kienle ◽  
Paul Werthmann ◽  
Birgit Grotejohann ◽  
Theodor Hundhammer ◽  
Claudia Schmoor ◽  
...  
Keyword(s):  
High Risk ◽  
Health Care Providers ◽  
Controlled Trial ◽  
Chronically Ill ◽  
High Risk Population ◽  
Technical Equipment ◽  
Care Providers ◽  
Exercise Interventions ◽  
Elderly Individuals ◽  
Face To Face

Abstract Background: The coronavirus disease 2019 (COVID-19) pandemic is a threat to ongoing clinical trials necessitating regular face-to-face, in-person meetings, particularly in participants with a high risk of complications. Guidance on how to handle and safely continue such trials is lacking. Chronically ill elderly individuals require—in addition to protection from infection—regular physical exercise and social contacts to remain healthy. Solutions for these conflicting necessities are needed.Methods: The ENTAIER trial is investigating the influence of mindful movements on fall risk, fear of falling, mobility, balance, quality of life, and other outcomes. The study population consists of 550 chronically ill elderly individuals with a high risk of falling. The movements are regularly performed in coached groups over 6 months. After the trial began, COVID-19 lock-downs stopped all in-person meetings, and it was expected that the limitations of this pandemic would continue long term. Therefore, the exercise program, which involve complex movements and is typically conducted face-to-face in groups, had to be substituted by a telemedicine program within a short timeframe. The objectives, therefore, were to identify challenges and tasks that need to be resolved and steps that need to be taken to achieve high-quality, efficacy, safety, and enable human encounter and motivation. We proceeded with four steps: 1) A literature review on quality and feasibility issues of telemedicine in general and specifically in exercise training in elderly individuals. 2) Participation in two international telemedicine task forces on integrative medicine, particularly mind-body medicine for cancer patients. 3) A broad discussion and interviews with study therapists,[1] personnel, and international experts on providing mindful movement exercises and other physiotherapies via live telecommunication technology, and with scientists and patient representatives. 4) A review and final evaluation of the core trial team and subsequent planning and implementation of changes. Results and Conclusions: A variety of tasks and challenges were identified for the technical equipment for therapists and patients, ability of therapists and trial participants to adequately manage the technology and telemedicine intervention, reservations and concerns about the technology among therapists and participants, safety and data protection in using the technology, and study design. Steps and possible solutions led to solutions for both a complete switch to telemedicine and a partial switch in the form of risk management pertaining to the former design and implementation. These steps and possible solutions may also inform other researchers or health care providers confronted with similar challenges in the current situation or similar future scenarios. [1] For practical purposes, eurythmy therapists and Tai Chi teachers are summarized here as therapists.

Hospital-Based Pneumococcal Immunization: The Epidemiologic Rationale and Its Implementation

1982 ◽  
Vol 3 (4) ◽  
pp. 303-308 ◽  
Author(s):  
David S. Fedson
Keyword(s):  
High Risk ◽  
Pneumococcal Vaccine ◽  
Hospital Care ◽  
Pneumococcal Pneumonia ◽  
Medical Condition ◽  
Hospital Setting ◽  
Pneumococcal Infections ◽  
Pneumococcal Bacteremia ◽  
To Receive ◽  
Underlying Medical Condition

AbstractMany patients hospitalized for or dying of pneumococcal bacteremia have been discharged from a hospital with in the previous five years. In addition to age and underlying medical condition, previous hospital care, particularly for high risk conditions, is a useful marker for identifying individuals who are destined to develop serious pneumococcal infections. Relatively few patients, especially those with high risk conditions, would need to receive pneumococcal vaccine at the time of hospital discharge to prevent, within the next five years, each subsequent readmission or death from pneumococcal pneumonia. Although pneumococcal vaccine has not been widely used in the hospital setting, there are sound epidemiologic reasons to expect that organized programs for vaccine delivery in hospitals would be an effective approach to preventing many serious pneumococcal infections.

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