Infection Resistance

Researchers are studying the long-term effects of reducing household air pollution (HAP) from biomass fuel use on heart, lung, and immune health among women and children in semi-rural Bangladesh. The study evaluates whether a mobile phone-based behavioral change communication (mHealth BCC) intervention can increase the adoption and exclusive use of cleaner cooking fuel, Liquid Petroleum Gas (LPG). This research also investigates how lowering pollution exposure might influence immune responses to vaccines and subclinical cardiovascular and pulmonary changes. The study is a large household-level randomized controlled trial comparing two groups: one receiving the mHealth BCC intervention encouraging exclusive LPG use and a control group receiving no such intervention. Researchers will monitor personal and area levels of air pollutants like PM2.5 and black carbon before and after intervention, alongside detailed assessments including spirometry, chest X-rays, high-resolution CT scans, blood pressure, EKG, metabolic markers such as HbA1c and lipid profiles, and immune cell function. The intervention messages are delivered via mobile phone with frequency tailored to participant responses. Participants will be followed over two years with repeated measurements to assess pollutant exposure and health effects. Evaluations include lung function tests, imaging, cardiovascular markers, metabolic blood tests, and immune function assays. The study aims to provide insights into the health benefits of sustained LPG use and improved air quality. Total participation spans pre-intervention assessments through two years of follow-up, with ongoing monitoring of pollution exposure and health outcomes.

Researchers are conducting a first-in-human phase 1 trial to study OX118, a human monoclonal antibody targeting OX40 ligand, in healthy adults aged 18 to 60 years. The trial aims to evaluate the safety, tolerability, and how the body processes OX118 when given as a single intravenous dose. This study involves 32 healthy volunteers with a body mass index between 18.5 and 30.0. Participants are divided into five groups receiving different single doses of OX118 or a placebo by intravenous infusion. The doses range from 0.1 mg/kg to 10 mg/kg, with participants randomized to receive either the drug or placebo based on a pre-arranged schedule. The trial includes sentinel dosing for initial participants in each group, and all participants stay at the clinic for at least 24 hours after dosing for monitoring. Each participant will attend 7 clinic visits over about 91 days, including a 28-day screening period. Visits include treatment administration, safety assessments such as vital signs, ECGs, physical exams, laboratory tests, and monitoring for adverse events. Safety data is reviewed by an internal committee before moving to the next dosing group. Researchers will measure adverse events, vital signs, lab results, ECG changes, and physical exam findings from Day 1 to Day 63, along with drug concentration and immune response data.

Researchers are evaluating a multilevel trauma-informed approach to increase HIV pre-exposure prophylaxis (PrEP) initiation among Black cisgender women in Baltimore, who are considered a high-risk group for HIV. This study aims to address socio-structural challenges such as intimate partner violence and gendered racism that may limit access to PrEP, focusing on both women with and without experiences of intimate partner violence. The research is sponsored by the Johns Hopkins Bloomberg School of Public Health and involves a randomized design without masking. Participants will be randomly assigned to one of two groups. The intervention group will receive behavioral lifestyle education related to biomedical HIV prevention, consisting of four weekly group sessions and four individual sessions with a peer navigator. The control group will receive a single group session. These sessions aim to increase understanding and uptake of PrEP among eligible Black women. During the study, researchers will monitor PrEP initiation up to six months after baseline and assess adherence at two, four, and six months post-randomization. Participant involvement includes attending scheduled educational sessions and follow-up assessments. The study will track how well participants start and continue PrEP use, with safety and sustainability of the intervention also evaluated. The total study duration extends through February 2028.

This research aims to understand how common antibiotic-resistant bacteria, specifically extended-spectrum beta-lactamase-producing Enterobacterales (ESBL-PE) and carbapenemase-producing Enterobacterales (CPE), are among residents in nursing homes and how these bacteria relate to their presence in the wastewater from these facilities. The study addresses the challenge of current surveillance systems that mainly use clinical samples and may miss widespread bacteria carriage in long-term care settings. It focuses on improving detection and prevention of outbreaks within healthcare networks. The study monitors nursing home residents by collecting stool samples or rectal swabs to measure the prevalence of these resistant bacteria. At the same time, wastewater discharged from the nursing homes is tested for the amount of ESBL-PE and CPE or their resistance genes. The main goal is to build a model that links the bacteria found in residents with the levels found in wastewater over a 15-month period. Participants will be evaluated through sample collection and their health and cognitive status assessed to ensure informed non-opposition to participation. Researchers will analyze the predictive accuracy of their model in estimating bacteria carriage. The study will also track the epidemiology of ESBL-PE and CPE in nursing homes, with no intervention applied. The total observation period for outcome measures spans 15 months, and participation involves sample collection and data recording during this time.

Researchers are evaluating the safety, tolerability, and how the body processes (pharmacokinetics) single and multiple intravenous doses of a drug called BWC0977 in healthy adult volunteers. This Phase 1 study involves a total of 64 healthy adults aged 18 to 55 years and is designed as a randomized, double-blind, placebo-controlled trial with multiple dose groups. The study focuses on measuring any treatment-emergent adverse events and serious adverse events to understand the drug's safety profile. Participants will be divided into two main groups: single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. In the SAD phase, volunteers receive one intravenous infusion of BWC0977 or placebo over 2 hours at doses of 750 mg or 1500 mg. In the MAD phase, participants receive multiple intravenous infusions of BWC0977 or placebo over 30 minutes to 2 hours daily for 7 to 10 consecutive days. Dose levels will increase sequentially based on safety and tolerability data collected during the study. During the study, participants will undergo various assessments including physical exams, vital signs, ECGs, laboratory tests, and blood sampling at specific times before, during, and after infusions to monitor safety and measure drug levels in the body. Researchers will track adverse events for up to 8 days after single dosing and up to 16 days after multiple dosing. Volunteers must comply with study visits and requirements throughout the trial, which lasts until August 2026.

Researchers are evaluating different doses of JDB0131 benzenesulfonate tablets compared with delamanid combined with bedaquiline, linezolid, levofloxacin or moxifloxacin, and clofazimine in patients with drug-resistant tuberculosis, including rifampicin-resistant strains. This phase 2b, multicenter, randomized, open-label clinical study aims to assess the efficacy, safety, and how the body processes these treatments over an 8-week period. Participants will be randomly assigned to one of three groups based on their fluoroquinolone resistance status. All groups receive bedaquiline, linezolid, and either levofloxacin or moxifloxacin or clofazimine for 8 consecutive weeks. Two groups receive different doses of JDB0131 (100 mg or 200 mg twice daily), while the third group receives delamanid. Dosages of accompanying drugs are adjusted by body weight and other factors as specified. During the study, participants will undergo regular assessments including sputum culture tests to measure treatment effectiveness, monitoring of vital signs, electrocardiograms, laboratory tests for safety, and pharmacokinetic evaluations to understand drug levels in the body. Adverse events and medication usage will be tracked throughout the 8-week treatment. The primary outcome is the percentage of patients achieving sputum culture conversion during and after treatment.

This research aims to evaluate how active health education methods can increase the number of schoolchildren getting the HPV vaccine. The study addresses a recent drop in HPV vaccine adherence among young people in Brazil. It involves 80 schools and 5,000 students, using a stepped-wedge design where clusters of schools are randomized every two months to one of four different interventions. The study compares four approaches: active training for both students and teachers, active training for students only, a nurse-led vaccination orientation session in schools, and usual care without specific interventions. Teacher training includes 30 hours of online self-instruction focused on vaccination, while students receive education and active vaccination efforts over two months. Each intervention is applied to clusters of schools in a randomized sequence. Participants are schoolchildren aged 9 to 14 years. Researchers will measure vaccination rates, including the proportion receiving at least one dose and those completing the full HPV vaccine series, along with tracking vaccination refusals among students and teachers over 12 months. The study monitors these outcomes following the interventions to understand their impact on vaccine coverage and refusal rates.

Researchers are evaluating the immediate effects of three different doses of a probiotic strain called Bacillus coagulans JBI-YZ6.3 (BC4U) on immune function compared to a placebo. This clinical proof-of-concept study involves 24 healthy adult participants aged 18 to 75 years. The goal is to understand how the probiotic influences immune status and cytokine levels shortly after intake. Participants will take placebo and three escalating doses of the probiotic — 0 mg (placebo), 100 mg, 200 mg, and 400 mg — each during separate clinic visits spaced at least one week apart for washout. At each visit, blood samples will be collected before the dose and again at 1, 2, and 3 hours after taking the probiotic or placebo. During the study, participants will undergo blood draws to assess immune communication, immune surveillance, cell activation, cell priming, and cytokine profiles. Researchers will monitor these immune responses up to 3 hours after dosing. The study requires participants to maintain consistent diet and lifestyle habits and involves multiple visits over the course of the trial ending in December 2025.

Researchers are evaluating a brief Acceptance and Commitment Therapy (ACT)-based intervention called ACTPrEP, designed to be culturally appropriate for young Black men who have sex with men (YBMSM). The study aims to improve engagement with pre-exposure prophylaxis (PrEP) for HIV prevention among this specific group. The trial involves developing and testing this tailored intervention through a randomized controlled process to assess its feasibility and acceptability. The study compares two groups: one receiving the ACTPrEP intervention, which includes a 60-minute initial session followed by three 30-minute follow-up sessions focusing on thoughts, emotions, and sensations related to PrEP use; and a control group receiving a single 30-minute PrEP education session as enhanced standard of care (ESOC). The intervention sessions occur at weeks 0, 2, 6, and 12. Participants will be involved for 24 weeks, during which researchers will measure how feasible and acceptable the ACTPrEP intervention is, using tools like the Client Satisfaction Questionnaire at 12 weeks. They will also track behaviors such as PrEP uptake, adherence, and persistence over time. Additional qualitative interviews will explore barriers and facilitators to implementing ACTPrEP. The study is sponsored by Rhode Island Hospital and focuses on young Black men aged 18 to 34 years who are eligible for PrEP according to CDC guidelines.

Researchers are studying nasal mucosal immunity to respiratory viruses like SARS-CoV-2 in both immunocompromised adults and healthy volunteers aged 18 to 90. The study aims to understand how immune cell makeup and virus-specific responses differ between those with weakened immune systems due to medical conditions or treatments and those without such issues. This observational study compares these two groups to learn how immunodeficiency and related therapies affect immune responses. Participants are divided into two groups: immunocompromised patients with conditions like organ or stem cell transplants, ongoing immunosuppressive therapies, or genetic immunosuppression, and healthy volunteers with no underlying medical conditions or history of immune problems. There are no interventional treatments; instead, researchers collect data during routine clinical visits over approximately six months. During the study, participants undergo assessments at four periodic intervals roughly 45 days apart, starting from enrollment. These include measuring cytokines produced by nasal and blood T cells specific to viruses, as well as characterizing immune cells at enrollment. The study tracks immune responses over time to better understand how immunity persists or changes. Participants' safety and informed consent are ensured throughout the observation period, which lasts about six months from the first visit.