Does Remdesivir Lower COVID-19 Mortality? A Subgroup Analysis of Hospitalized Adults Receiving Supplemental Oxygen.

The first Adaptive COVID-19 Treatment Trial (ACTT-1) showed that remdesivir improved COVID-19 recovery time compared with placebo in hospitalized adults. The secondary outcome of mortality was almost significant overall (p = 0.07) and highly significant for people receiving supplemental oxygen at enrollment (p = 0.

Can incorporating genotyping data into efficacy estimators improve efficiency of early phase malaria vaccine trials?

Background: Early phase malaria vaccine field trials typically measure malaria infection by PCR or thick blood smear microscopy performed on serially sampled blood. Vaccine efficacy (VE) is the proportion reduction in an endpoint due to vaccination and is often calculated as VE = 1-hazard ratio or VE = 1-risk ratio. Genotyping information can distinguish different clones and distinguish multiple infections over time, potentially increasing statistical power.

Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods.

Background: Preventing progression to moderate or severe opioid use disorder (OUD) among people who exhibit risky opioid use behavior that does not meet criteria for treatment with opioid agonists or antagonists (subthreshold OUD) is poorly understood. The Subthreshold Opioid Use Disorder Prevention (STOP) Trial is designed to study the efficacy of a collaborative care intervention to reduce risky opioid use and to prevent progression to moderate or severe OUD in adult primary care patients with subthreshold OUD.

Methods: The STOP trial is a cluster randomized controlled trial, randomized at the PCP level, conducted in 5 distinct geographic sites.

Can incorporating genotyping data into efficacy estimators improve efficiency of early phase malaria vaccine trials?

Background: Early phase malaria vaccine field trials typically measure malaria infection by PCR or thick blood smear microscopy performed on serially sampled blood. Vaccine efficacy (VE) is the proportion reduction in an endpoint due to vaccination and is often calculated as - hazard ratio or - risk ratio. Genotyping information can distinguish different clones and distinguish multiple infections over time, potentially increasing statistical power.

A randomized controlled trial showing safety and efficacy of a whole sporozoite vaccine against endemic malaria.

A highly effective malaria vaccine remains elusive despite decades of research. sporozoite vaccine (PfSPZ Vaccine), a metabolically active, nonreplicating, whole parasite vaccine demonstrated safety and vaccine efficacy (VE) against endemic for 6 months in Malian adults receiving a five-dose regimen. Safety, immunogenicity, and VE of a three-dose regimen were assessed in adults in Balonghin, Burkina Faso in a two-component study: an open-label dose escalation trial with 32 participants followed by a double-blind, randomized, placebo-controlled trial (RCT) with 80 participants randomized to receive three doses of 2.

Design of an observational multi-country cohort study to assess immunogenicity of multiple vaccine platforms (InVITE).

In response to the COVID-19 pandemic, COVID-19 vaccines have been developed, and the World Health Oraganization (WHO) has granted emergency use listing to multiple vaccines. Studies of vaccine immunogenicity data from implementing COVID-19 vaccines by national immunization programs in single studies spanning multiple countries and continents are limited but critically needed to answer public health questions on vaccines, such as comparing immune responses to different vaccines and among different populations.

PfSPZ-CVac malaria vaccine demonstrates safety among malaria-experienced adults: A randomized, controlled phase 1 trial.

Background: (Pf) Sporozoite (SPZ) Chemoprophylaxis Vaccine (PfSPZ-CVac) involves concurrently administering infectious PfSPZ and malaria drug, often chloroquine (CQ), to kill liver-emerging parasites. PfSPZ-CVac (CQ) protected 100% of malaria-naïve participants against controlled human malaria infection. We investigated the hypothesis that PfSPZ-CVac (CQ) is safe and efficacious against seasonal, endemic Pf in malaria-exposed adults.

Using social contact data to improve the overall effect estimate of a cluster-randomized influenza vaccination program in Senegal.

This study estimates the overall effect of two influenza vaccination programs consecutively administered in a cluster-randomized trial in western Senegal over the course of two influenza seasons from 2009-2011. We apply cutting-edge methodology combining social contact data with infection data to reduce bias in estimation arising from contamination between clusters. Our time-varying estimates reveal a reduction in seasonal influenza from the intervention and a nonsignificant increase in H1N1 pandemic influenza.

EVITA Dengue: a cluster-randomized controlled trial to EValuate the efficacy of Wolbachia-InfecTed Aedes aegypti mosquitoes in reducing the incidence of Arboviral infection in Brazil.

Background: Arboviruses transmitted by Aedes aegypti including dengue, Zika, and chikungunya are a major global health problem, with over 2.5 billion at risk for dengue alone. There are no licensed antivirals for these infections, and safe and effective vaccines are not yet widely available.

Safety, immunogenicity and efficacy of PfSPZ Vaccine against malaria in infants in western Kenya: a double-blind, randomized, placebo-controlled phase 2 trial.

The radiation-attenuated Plasmodium falciparum sporozoite (PfSPZ) vaccine provides protection against P. falciparum infection in malaria-naïve adults. Preclinical studies show that T cell-mediated immunity is required for protection and is readily induced in humans after vaccination.

Dismantling the Fragility Index: A demonstration of statistical reasoning.

The Fragility Index has been introduced as a complement to the P-value to summarize the statistical strength of evidence for a trial's result. The Fragility Index (FI) is defined in trials with two equal treatment group sizes, with a dichotomous or time-to-event outcome, and is calculated as the minimum number of conversions from nonevent to event in the treatment group needed to shift the P-value from Fisher's exact test over the .05 threshold.

Dose-Dependent Infectivity of Aseptic, Purified, Cryopreserved Plasmodium falciparum 7G8 Sporozoites in Malaria-Naive Adults.

Direct venous inoculation of 3.2 × 103 aseptic, purified, cryopreserved, vialed Plasmodium falciparum (Pf) strain NF54 sporozoites, PfSPZ Challenge (NF54), has been used for controlled human malaria infection (CHMI) in the United States, 4 European countries, and 6 African countries. In nonimmune adults, this results in 100% infection rates.

Networks of face-to-face social contacts in Niakhar, Senegal.

We present the first analysis of face-to-face contact network data from Niakhar, Senegal. Participants in a cluster-randomized influenza vaccine trial were interviewed about their contact patterns when they reported symptoms during their weekly household surveillance visit. We employ a negative binomial model to estimate effects of covariates on contact degree.

Household members do not contact each other at random: implications for infectious disease modelling.

Airborne infectious diseases such as influenza are primarily transmitted from human to human by means of social contacts, and thus easily spread within households. Epidemic models, used to gain insight into infectious disease spread and control, typically rely on the assumption of random mixing within households. Until now, there has been no direct empirical evidence to support this assumption.

Chloroquine as weekly chemoprophylaxis or intermittent treatment to prevent malaria in pregnancy in Malawi: a randomised controlled trial.

Background: Sulfadoxine-pyrimethamine resistance threatens efficacy of intermittent preventive treatment of malaria during pregnancy, and alternative regimens need to be identified. With the return of chloroquine efficacy in southern Africa, we postulated that chloroquine either as an intermittent therapy or as weekly chemoprophylaxis would be more efficacious than intermittent sulfadoxine-pyrimethamine for prevention of malaria in pregnancy and associated maternal and newborn adverse outcomes.

Methods: We did an open-label, single-centre, randomised controlled trial at Ndirande Health Centre, Blantyre, in southern Malawi.

Modeling workplace contact networks: The effects of organizational structure, architecture, and reporting errors on epidemic predictions.

Face-to-face social contacts are potentially important transmission routes for acute respiratory infections, and understanding the contact network can improve our ability to predict, contain, and control epidemics. Although workplaces are important settings for infectious disease transmission, few studies have collected workplace contact data and estimated workplace contact networks. We use contact diaries, architectural distance measures, and institutional structures to estimate social contact networks within a Swiss research institute.

Team-based education in a palliative approach for rural nurses and unlicensed care providers.

This article describes the preparation and delivery of an educational intervention designed to improve rural nurses and unlicensed care providers' confidence in a palliative approach to care. A palliative approach takes the principles of supportive palliative care and adapts them for application earlier in nonspecialized palliative contexts for individuals living with life-limiting chronic illness. Curriculum in a palliative approach was constructed for nurses and unlicensed care providers (care aides and home health workers) and was delivered through a workshop and monthly follow-up sessions offered through distance technology.

Palliative approach education for rural nurses and health-care workers: a mixed-method study.

Background: The aim of this mixed-method study was to evaluate the outcomes of an educational intervention in a palliative approach for rural nurses and health-care workers (HCWs) using a team-based method.

Methods: Pre- and post-test measures using the Palliative Care Nursing Self-Competence (PCSNC) scale and the Self-Perceived Palliative Care Knowledge instrument were used to evaluate learning outcomes. Participant post-test scores were also compared to normative provincial data.

A penalized likelihood approach to estimate within-household contact networks from egocentric data.

Acute infectious diseases are transmitted over networks of social contacts. Epidemic models are used to predict the spread of emergent pathogens and compare intervention strategies. Many of these models assume equal probability of contact within mixing groups (homes, schools, etc.