Dasmarinas

This research aims to evaluate the immune response, safety, and consistency between different batches of the LBVD vaccine compared to the combined use of Pentavalent and Inactivated Poliomyelitis vaccines in healthy infants aged 6 to 8 weeks. The study is divided into two stages Stage 1 compares LBVD with licensed control vaccines, and Stage 2 confirms that LBVD is not inferior to control vaccines and assesses consistency across three lots of LBVD. Participants receive a three-dose primary vaccination series at 6, 10, and 14 weeks of age. The LBVD vaccine is administered as an intramuscular injection into the thigh. The control group receives co-administration of Pentavalent and Inactivated Polio vaccines. Stage 1 focuses on initial comparisons, while Stage 2 includes multiple LBVD lots to evaluate lot-to-lot consistency. Throughout the study, infants will be monitored for immune protection levels and antibody concentrations four weeks after completing the vaccination series. Safety is tracked by observing immediate reactions within 30 minutes, solicited side effects within 7 days, and other adverse events within 4 weeks post-vaccination. The study follows infants from 6 weeks through 8 weeks of age, including all vaccine administrations and safety assessments.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are studying the safety and immune response of the CHIKV VLP vaccine in children aged 1 to under 12 years. This Phase 3 randomized, double-blind, placebo-controlled trial aims to evaluate how well the vaccine works and its safety profile in young children against Chikungunya virus infection. Participants will be randomly assigned to one of four groups two active vaccine groups and two placebo groups. The CHIKV VLP vaccine contains chikungunya virus-like particles combined with an aluminum hydroxide adjuvant. The study includes multiple visits for vaccination and follow-up, with immune responses measured at several time points including Days 15, 22, 183, 366, and 732 after vaccination. Safety is monitored throughout via reports of adverse events and serious events. Children in the study will attend scheduled visits to receive the vaccine or placebo and undergo assessments including blood tests to measure immune response. Researchers will track any side effects from vaccination up to two years after the first dose. The main outcomes focus on immune response by Day 22 and safety events throughout the study. Participants health and adherence to study visits will be closely monitored during the entire trial period, which lasts up to approximately two years.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

This research aims to evaluate the long-term safety and explore the efficacy of astegolimab in adults aged 40 to 90 years with chronic obstructive pulmonary disease COPD. It focuses on participants who have completed a 52-week placebo-controlled treatment period in previous studies GB43311 or GB44332. The study is a phase 3, open-label extension to gather extended safety information on this drug in COPD patients. Participants from the parent studies who qualify will receive subcutaneous injections of astegolimab every two weeks throughout the study until it ends. This open-label extension allows all participants to receive the active drug without placebo comparison. The study continues treatment beyond the initial 52-week period to monitor long-term effects. During the study, participants will be monitored for adverse events up to 12 weeks after their last dose of astegolimab. Researchers will collect safety data to understand the incidence of any side effects. The study involves regular assessments and follow-ups to ensure participant well-being, with the total duration lasting until July 2034.

Tuberculosis TB remains a major global health issue with over 3 million people undiagnosed each year and 1 million deaths. The ADAPT study aims to reduce this burden by evaluating new point-of-care TB diagnostic tests that are faster, simpler, and less costly. The study focuses on adolescents and adults with suspected TB symptoms or risk factors, assessing these novel tests in real-world outpatient settings in high TB burden countries. The study also evaluates the usability and acceptability of these tests by health workers. Participants will be involved in testing novel TB triage and diagnostic tools, including semi-automated or automated molecular assays based on tongue swabs. These tests will be compared against standard reference methods like sputum Xpert MTBRIF Ultra and mycobacterial culture. The study plans to enroll about 450 participants per year at each of three sites to assess various diagnostic tests and 50 health workers to evaluate test usability. During the study, participants will undergo diagnostic testing and screening based on TB symptoms or risk factors. Health workers will be observed and surveyed regarding the ease of use and acceptance of the new tests. Researchers will track the proportion of positive and negative test results among participants with and without TB over two years. The study involves follow-up visits and consent, ensuring adherence and data collection, with the goal of improving rapid TB diagnosis and management worldwide.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and anti-mycobacterial activity of bedaquiline TMC207 combined with a standard background regimen of medications in children and adolescents aged from birth up to less than 18 years who have confirmed or probable pulmonary multidrug resistant tuberculosis MDR-TB. This phase 2 study aims to better understand how the drug works in this population and assess its effects alongside other MDR-TB treatments. Participants are grouped into four age-based cohorts, each receiving a dose of bedaquiline adjusted for their age and weight. Cohorts 1 and 2 include older children and adolescents who start with daily dosing for two weeks followed by three times weekly dosing for 22 weeks. Younger children in Cohorts 3 and 4 receive weight-based doses with similar schedules. All participants take bedaquiline along with a background regimen of MDR-TB medications according to WHO and national guidelines. During the study, participants undergo regular monitoring of drug levels in their blood at various weeks up to 120 weeks for older cohorts and 88 weeks for the youngest cohort. Researchers also track adverse events, treatment outcomes, and time to culture conversion from clinical samples. The study involves long-term follow-up to evaluate safety, drug behavior, and treatment success over time.

Researchers are evaluating new diagnostic tests to improve the detection and management of tuberculosis TB, a disease that leaves many undiagnosed and causes significant mortality worldwide. This study, known as the Rapid Research in Diagnostics Development for TB Network R2D2 TB Network, aims to assess early-stage TB triage, diagnostic, and drug resistance tests in real-world clinical settings across multiple countries. The goal is to identify faster, simpler, and less expensive tools to reduce the current gaps in timely TB diagnosis and treatment initiation. The study involves testing various novel diagnostic methods, including sputum-based and non-sputum biomarker tests, molecular assays, breath-based tests, and artificial intelligence tools to analyze images and sounds related to TB diagnosis. These tests will be compared to established reference standards like sputum culture and molecular resistance testing. The study also evaluates the usability of these tests through observations and surveys of health workers. Participants include adults with symptoms or risk factors for TB, and patients with rifampin-resistant TB for drug susceptibility test evaluations. Participants will undergo diagnostic testing and clinical assessments, with follow-up visits scheduled to monitor test performance and usability. Researchers will measure the sensitivity and specificity of these novel tests over a seven-month period. The study also tracks the ability of health workers to effectively use the new diagnostic tools. Overall participation duration varies by individual, and the study aims to provide comprehensive data to enhance TB diagnosis and treatment worldwide.