Silang

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 quabodepistat-containing treatment regimens for adults and adolescents aged 14 years and older with rifampicin-resistant or multidrug-resistant pulmonary tuberculosis RRMDR-TB. The study aims to determine if adding quabodepistat to other TB drugs can shorten treatment duration to 4 months for fluoroquinolone-sensitive TB and provide a safer alternative compared to the current 6-month WHO-endorsed regimens. This Phase 3, randomized, open-label trial also compares treatments for patients with fluoroquinolone-resistant TB. Participants will be divided into two main groups based on fluoroquinolone sensitivity. Those with fluoroquinolone-sensitive RRMDR-TB will receive either an experimental 4-month regimen BPaQM bedaquiline, pretomanid, quabodepistat, moxifloxacin or a 6-month control regimen BPaLM bedaquiline, pretomanid, linezolid, moxifloxacin. Those with fluoroquinolone-resistant RRMDR-TB will receive either an experimental 6-month regimen BPaQ bedaquiline, pretomanid, quabodepistat or a control 6-month regimen BPaL bedaquiline, pretomanid, linezolid. Dosing schedules vary by regimen and last either 4 or 6 months. During the 16-month follow-up, participants will undergo regular assessments including sputum samples, chest X-rays, laboratory tests, and safety evaluations. Researchers will measure treatment effectiveness by the proportion with unfavorable outcomes 12 months after randomization and monitor adverse events. Additional outcomes include time to sputum culture conversion, microbiological relapse, and drug plasma levels. Safety will be closely monitored throughout treatment and follow-up periods.

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.