Rexburg

Researchers are evaluating a vaccine called BLB-201 for respiratory syncytial virus (RSV) in infants and children aged 8 to 59 months. This Phase 1/2a randomized, placebo-controlled trial aims to study the safety, tolerability, and immune response after vaccination. Children included may have had prior RSV infection or not, allowing assessment in both seronegative and seropositive groups. The trial tests two doses of the BLB-201 vaccine: a low dose (10^6 PFU) and a high dose (10^7 PFU). Participants receive either one dose on Day 1 or two doses on Day 1 and Day 57. A placebo group receives a saline solution matching the low dose diluent. The study compares these groups to monitor how the vaccine is handled by the body and whether it produces an immune response. During the study, children are carefully monitored for side effects, including solicited adverse events from Day 1 to 15 and unsolicited events through Day 29. Their health is assessed through medical history, physical exams, and laboratory tests. Researchers track vaccine safety and immune response over the study period, with parents or guardians providing consent and helping with participation. The total study duration and follow-up ensure thorough evaluation of vaccine effects in young children.

Researchers are evaluating the change in hemoglobin A1c (HbA1c) levels in people with type 2 diabetes who have not reached their HbA1c goal despite stable treatment with semaglutide or tirzepatide. This phase 2, double-blind study compares the effects of LY3457263, a drug given by subcutaneous injection, with a placebo in this patient group. Participants will be adults aged 18 to 75 with type 2 diabetes and specific HbA1c and BMI criteria. Participants will receive either LY3457263 or a placebo, both administered once weekly by subcutaneous injection. All participants must be on a stable dose of either injectable semaglutide or tirzepatide for at least three months before the study. The treatment period is 24 weeks, during which researchers will monitor changes in HbA1c levels from the start of the study. Throughout the study, participants will undergo assessments to measure HbA1c at the beginning and at week 24. The total participation duration is about 9 months. Researchers will also track participants' safety and treatment adherence during this time to evaluate the effects of LY3457263 compared to placebo in managing type 2 diabetes.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

Researchers are evaluating the safety and immune response of a group B streptococcus (GBS) vaccine in healthy pregnant women and their babies in this Phase 3 randomized, placebo-controlled, double-blinded trial. The study includes pregnant women aged 49 or younger between 24 and 36 weeks of gestation with uncomplicated singleton pregnancies and no major fetal abnormalities. Participants must also have documented negative tests for HIV, syphilis, and hepatitis B during this pregnancy. The goal is to learn how the vaccine works and to monitor safety for both mothers and their infants. Participants will receive one injection of either the GBS6 vaccine or a saline placebo. Pregnant women will be followed for up to 14 months, including 6 months after delivery. Their babies will be followed for about 12 months after birth. A subset of infants will also receive routine vaccinations such as diphtheria toxoid-containing vaccines and pneumococcal vaccines according to their country's immunization schedule, with blood samples collected one month after completing primary and toddler booster doses. Mothers will be monitored for local and systemic reactions within 7 days after vaccination, adverse events through 1 month, and serious or medically attended events up to 6 months postpartum. Infants will be observed for adverse events from birth through at least one year, with serious and medically attended events tracked through 6 months. Researchers will also measure antibody levels in infants at birth to assess the vaccine's potential to protect against early and late onset GBS disease. Mothers will attend at least 3 to 4 study visits, some via telephone, to support ongoing safety and immunogenicity assessments.