South Euclid

Researchers are evaluating an investigational vaccine aimed at protecting healthy adults from Escherichia coli (E coli). The main goal is to assess the safety and how well adults tolerate these E coli vaccines when given as shots into the muscle. This is a Phase 1 study focusing on healthy volunteers aged 18 to 64 years. Participants will receive one of several candidate E coli vaccines or a placebo, each given in two doses spaced six months apart (at 0 and 6 months). The study includes different versions and doses of the vaccine, all administered intramuscularly following the same schedule. The placebo group follows the same 0 and 6-month dosing interval for comparison. Throughout the study, participants will be monitored for local and systemic reactions within seven days after each vaccination, as well as any adverse events from the first vaccination until one month after the last dose. Additionally, medically attended and serious adverse events will be tracked for up to 12 months after the final vaccination, with the entire observation period lasting up to 18 months. Safety and tolerability will be carefully evaluated through these measures.

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.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.