Imus

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 comparing the immune response and safety of the Sabin strain and wild strain inactivated poliovirus vaccines sIPV and wIPV given by two different injection methods in healthy infants. This phase IV trial involves 480 infants aged 56 to 84 days and aims to assess which vaccination schedule and injection route produce better immunity and safety profiles. The study is randomized and open-label, focusing on immunogenicity and tolerability of sequential vaccination regimens. Participants are randomly assigned into four groups receiving different sequences of three doses of poliovirus vaccine at 28-day intervals, with some receiving the vaccines intramuscularly and others subcutaneously. The four vaccination regimens include combinations of wIPV and sIPV doses. Each group has two-thirds of infants receiving injections into the muscle and one-third receiving injections under the skin. During the study, infants will be observed for immediate reactions for 30 minutes after each vaccine dose, and guardians will record adverse events for 28 days post-vaccination. Blood samples will be collected before the first dose and about 28 days after the final dose to measure antibodies against poliovirus types. Mothers will also provide blood samples or pregnancy test results to screen for infections that could affect the infant. Researchers will track immune response and safety outcomes throughout the trial, which ends in October 2026.