Vaccine Reaction

Researchers are evaluating a personalized self-DC vaccine that targets neo-antigens (Neo-DC vaccine) for treating advanced solid tumors, including head and neck cancer and certain types of non-small cell lung cancer without driver gene mutations. This study aims to explore the dose-limiting toxicity and identify the recommended dose for future Neo-DC vaccine research. About 9 patients will be enrolled, following a 3 plus 3 dose escalation design with two dose levels. Participants will receive infusions of the Neo-DC vaccine at either a lower dose (1 x 10^7 cells per infusion) or a higher dose (5 x 10^7 cells per infusion) given every 7 days. Four infusions make up one treatment cycle. If clinical benefit or certain immune responses are observed, treatment cycles may continue until four administrations are completed, disease progression occurs, new anti-tumor treatments begin, or treatment is stopped for other reasons. Dose-limiting toxicity is monitored within 28 days after the first infusion. During the study, participants will be monitored for adverse events within 28 days of the first vaccine infusion. Researchers will also assess the objective response rate over up to 2 years and observe dose-limiting toxicities in the same 28-day window. Participants must complete all study procedures, including blood collections and tumor assessments based on RECIST 1.1 standards. The total participation duration varies depending on treatment continuation and disease status.

Researchers are evaluating Siltuximab in a Phase II clinical trial for patients with multiple myeloma who develop cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) after CAR-T cell therapy. This study aims to assess the resolution of these side effects that can occur following CAR-T treatment in this patient group. Participants who have persistent grade 1 or higher CRS or ICANS after CAR-T therapy will receive an immediate dose of Siltuximab at 11 mg/kg. If symptoms continue after 12 hours, a repeat dose of Siltuximab and corticosteroids may be given. If symptoms remain unresolved or worsen, rescue treatment with tocilizumab, corticosteroids, or other medications will be provided as needed. During the study, participants will be monitored to measure the rate of complete CRS resolution within 14 days and ICANS resolution within 28 days. Researchers will also assess safety and response to treatment. The total duration and detailed follow-up plans are not specified, but assessments will include symptom monitoring after treatment interventions.

Researchers are investigating the use of ABM/P-15 bone graft compared to traditional bone graft in patients undergoing surgery for Adult Spinal Deformity (ASD). This study aims to improve clinical outcomes by promoting faster bone healing, reducing the need for additional surgeries, minimizing complications, and improving health-related quality of life. The trial is a prospective, randomized, controlled clinical study conducted at a specialized spine unit. Participants are randomly assigned to receive either the ABM/P-15 bone graft, which is a device combining anorganic bovine bone mineral with a synthetic peptide to enhance bone growth, or a standard bone graft made from locally harvested bone mixed with morselized allogenic femoral head. Both graft types are used during posterior spinal instrumentation and fusion surgery, with anterior support added as needed. The ABM/P-15 bone graft is placed on the spine structures and contained by the surrounding muscle. The study includes preoperative planning, surgery, and follow-up evaluations up to two years. Participants complete questionnaires before surgery and at 3 months, 1 year, and 2 years after surgery. They undergo X-rays at multiple time points and a CT scan one year after surgery to assess bone fusion and detect pseudarthrosis. Researchers track revision surgeries, adverse events, and cost-effectiveness during the study. Data on surgical details, complications, medication use, and rehabilitation are collected from medical records. The total participation lasts about two years, allowing for detailed assessment of outcomes and safety.

Researchers are evaluating CHO-V08, a bivalent vaccine designed to prevent infections caused by hypervirulent Klebsiella pneumoniae K1 and K2 serotypes. This Phase I study focuses on assessing the safety, reactogenicity, and immune response of the vaccine in healthy adults aged 18 to 50 years. The vaccine is being developed to reduce risks of both hospital-acquired and community-acquired Klebsiella pneumoniae infections. The study involves two experimental groups receiving different doses of the CHO-V08 glycoconjugate vaccine. Participants will be given the vaccine via injection, and the study is open-label and non-randomized, meaning both researchers and participants know the treatment given. The trial will monitor participants over one year to evaluate safety and immune response outcomes. During the study, participants will undergo health assessments including physical exams, vital signs monitoring, and laboratory tests such as blood draws and serology for infections. Researchers will track any side effects and measure immunoglobulin levels to understand vaccine response. Participants must adhere to study procedures and contraception requirements if applicable. The total participation duration will be about one year, with ongoing safety and immunogenicity evaluations.

Researchers are investigating how the gut microbiota influences immune responses to vaccines, focusing on the BCG vaccine and Yellow Fever vaccine in healthy adults aged 18 to 35. The study aims to understand whether reducing gut bacteria with antibiotics affects the protection these vaccines provide against specific infections and other immune challenges. The trial includes two sub-studies. In the first, participants receive either antibiotics or no antibiotics, followed by a BCG vaccine or placebo, with a second BCG vaccine given six months later. In the second sub-study, participants also receive antibiotics or not, followed by a BCG vaccine or placebo, then a Yellow Fever vaccine three months later. Vaccines are given by injection, and antibiotic courses last three days. Participants will undergo blood and stool sample collections at multiple times, including before and after vaccinations, with skin biopsies taken in the BCG sub-study to measure bacterial load. Blood is also tested for Yellow Fever viral load after vaccination. The study will monitor immune responses, microbiota diversity, and vaccine effects over five years, involving up to seven blood draws and three stool samples per participant.

Researchers are studying the effects of early-life supplementation with Bifidobacterium infantis Rosell44-33 in infants who were exposed to HIV but are not infected. This randomized, placebo-controlled trial aims to assess how this supplement influences the gut microbiome, intestinal inflammation, microbial translocation, and immune responses to the BCG vaccine. The study also explores potential benefits on infant growth, illness rates, neurodevelopment, and antibody responses to early vaccines during the infants' first nine months of life. The study enrolls 200 breastfed infants born to mothers with HIV in South Africa, randomly assigning them to receive either B. infantis Rosell44-33 or a placebo daily for the first 28 days starting within the first three days after birth. The supplement contains 8 x 10^9 colony-forming units of B. infantis plus maltodextrin, while the placebo includes maltodextrin alone. Infants are followed closely for 36 weeks with ongoing collection of data and biological samples. Participants will undergo assessments of gut microbiome composition and diversity, markers of intestinal health, and immune responses to BCG vaccination at multiple time points, including 4, 7, and 36 weeks of age. Additional evaluations include stool metabolome analysis, T cell subset monitoring, growth tracking, morbidity recording, and neurodevelopmental testing. The study includes detailed monitoring to understand the supplement's impact on immunity and overall infant health over the first nine months of life.

Researchers are investigating the immune response to pneumococcal vaccination strategies in adults treated for lymphoma and acute leukemia. The study compares the traditional two-step vaccination approach using a 13-valent conjugate vaccine (PCV13) followed by a 23-valent polysaccharide vaccine (PPV23) against a newer guideline recommending a single injection of PREVENAR20. These patients often have weakened immune systems due to chemotherapy, increasing their risk for pneumococcal invasive diseases, but the effectiveness of these vaccination strategies in this group is not well documented. The trial includes two groups: one group of 80 patients received PCV13 followed by PPV23 at least two months later, and another group of 80 patients will receive a single PREVENAR20 injection. The study monitors immune responses at multiple points, including before vaccination, four weeks after each vaccine injection, and up to 14 months post-vaccination. Researchers measure specific antibodies and immune activity to evaluate how well each vaccination method prompts an immune response. Participants will undergo blood tests at several time points to measure pneumococcal antibody levels and immune activity. The study also assesses vaccine safety, looking for local or general reactions and any invasive pneumococcal infections. Researchers aim to identify factors that predict poor response to vaccination by comparing patient demographics, biological data, and treatments received. The total follow-up period extends to 14 months after vaccination to assess the durability of the immune response.

Researchers are evaluating a social network approach called REDES to see if it helps increase COVID-19 vaccination rates among Latino adults and their friends and connections. The study aims to find out whether training people in motivational interviewing encourages more vaccinations compared to just providing vaccine information. It also looks at factors that make vaccination easier or harder in Latino communities and how the intervention can be used more widely in the future. In this randomized trial, 300 vaccinated Latino adults (index participants) will be split into two groups. One group receives motivational interviewing training led by community health workers to help promote vaccination within their social networks. The other group receives a brief training about vaccine safety and effectiveness, with opportunities to ask questions. Unvaccinated network members connected to these participants will also be recruited and followed. Participants will be followed for 18 months with check-ins at 6, 12, and 18 months after joining. Researchers will track COVID-19 vaccination status among the friends and connections of participants. The study will also examine barriers and facilitators to vaccination and how well the REDES intervention works in real-life settings. This will help inform efforts to expand access to effective vaccination promotion strategies.

Researchers are actively monitoring the side effects of COVID-19 vaccines worldwide in healthcare workers, adults over 65, and schoolteachers. The study aims to estimate how common local and systemic side effects are for each vaccine brand, identify demographic and medical factors influencing side effects, and evaluate long-term consequences. It also compares the relative safety of different COVID-19 vaccines and examines how palliative drugs affect short-term side effect resolution. The project has two phases: a cross-sectional survey and a prospective cohort study. Phase A uses an online questionnaire to collect information about short-term side effects occurring within 30 days after vaccination, covering either the first or second dose. Phase B follows volunteers interested in reporting long-term side effects and vaccine effectiveness after booster doses over five years, starting in 2022. Multiple COVID-19 vaccines are included, such as Pfizer-BioNTech, Moderna, AstraZeneca, Sinovac, Sinopharm, Sputnik V, Janssen, CureVac, Novavax, and Covaxin. Participants provide self-reported data through validated online questionnaires about side effect onset, duration, and intensity. The study tracks local and systemic side effects within 30 days post-vaccination as primary outcomes, with unrecognized side effects as secondary outcomes. Volunteers are followed for long-term safety and vaccine effectiveness, with a total observation period extending up to five years. This ongoing monitoring helps researchers understand vaccine safety profiles and side effect patterns in different populations.

Researchers are conducting a prospective observational study across multiple centers to assess the frequency and nature of critical events related to tracheal intubation in children undergoing general anesthesia. The goal is to understand problems that occur during intubation and identify ways to improve patient safety without interfering with standard care. This study focuses on pediatric patients from birth to 16 years old. During the three-month observation period, anesthesia staff will complete a screening questionnaire for every child requiring tracheal intubation. If a critical event occurs during intubation, a more detailed questionnaire will be filled out to document exactly what happened. Patient data will be collected from anesthesia records and securely stored in an electronic database. Each patient with a critical event will be closely followed up according to the study protocol. Participants are involved only through data collection and questionnaires completed by anesthesia providers. The research team will review various critical events such as severe hypoxemia, bradycardia, airway obstruction, and other complications within one hour of intubation. The primary outcome is the number of patients with critical intubation-related events tracked up to 30 days. The study will not change patient treatment and focuses on improving future safety practices.