Vaccination

Researchers are studying different types of videos to see which ones help increase HPV vaccination rates among adolescents. This study compares informational animation videos, personal story videos, and combinations of both to find the most effective way to encourage HPV vaccine uptake. The research is sponsored by Johns Hopkins Bloomberg School of Public Health and focuses on vaccination behavior. Participants are divided into five groups: those who receive no videos, those who watch an informational animation video, those who watch a personal narrative video, those who watch a personal narrative video followed by an informational animation video, and those who watch the informational animation video followed by the personal narrative video. The personal narratives are tailored to match the participant's race, ethnicity, and gender. During the study, participants' vaccination status is tracked over a 9-month period to measure how many receive the HPV vaccine. The study involves surveys and viewing assigned videos on the participant's device. Researchers monitor vaccine uptake as the primary outcome to understand the impact of different video approaches on HPV vaccination.

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 addressing racial disparities in colorectal cancer (CRC) by focusing on African Americans aged 45 to 75, who face higher CRC incidence and mortality and lower screening rates. The study aims to improve CRC screening by partnering with the Department of Motor Vehicles (DMV) to recruit 1,200 African American participants during their DMV visits. The research compares two approaches to increase screening: on-site distribution of Fecal Immunochemical Test (FIT) kits and on-site distribution combined with targeted social media advertising. Participants will receive a free FIT kit with a prepaid return envelope, a culturally tailored educational brochure, reminder text messages, and phone calls. The social media group will see targeted ads on Facebook, Instagram, and YouTube from August to October 2024. Participants return kits to a Nebraska Medicine lab, and results are mailed within 14 to 21 days. For those with positive results or lacking insurance or a primary care provider, a health navigator provides help with scheduling follow-up colonoscopies and accessing financial support. Throughout the study, participants provide demographic and screening information via surveys. Researchers measure FIT kit return rates, positive test rates, and follow-up colonoscopy completion rates, comparing the two groups while considering factors like age, gender, income, and health beliefs. Participants' perceptions about screening are also gathered through an online survey. The study runs until October 2026, with ongoing monitoring of screening completion and follow-up outcomes.

Researchers are studying healthy infants in Indonesia to compare the immune response and safety of two vaccines: Minhai's 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13-DT/TT, also called Pneuminvac) and Pfizer's 13-valent Pneumococcal Conjugate Vaccine (PCV13, known as Prevenar 13). The study focuses on infants aged 6 to 8 weeks and aims to show that Pneuminvac produces immune responses that are not worse than Prevenar 13 after a booster dose, while also monitoring vaccine safety when given together with a hexavalent vaccine. About 500 infants will be randomly assigned to two groups: one receiving Pneuminvac and the other receiving Prevenar 13. Both vaccines will be given at 2, 4, and 12 to 15 months of age. Additionally, all infants will receive the hexavalent vaccine at 2, 3, and 4 months of age. This design follows World Health Organization recommendations for infant vaccination schedules. Participants will attend scheduled visits for vaccinations and assessments, including blood tests to measure immune responses one month after the booster dose. Safety will be closely tracked by recording any side effects after each vaccine dose and serious adverse events up to six months after the booster. The study aims to evaluate the percentage of infants with protective antibody levels and compare immune responses between vaccines, with total participation lasting from enrollment until several months after the final vaccine dose.

Researchers are investigating the safety and immune response of an adjuvant vaccination using a patient's own dendritic cells loaded with tumor material after surgery for stage IV rare cancers, including Head and Neck tumors, Neuroendocrine Tumors, and Soft Tissue Sarcomas. This phase II, single-arm study aims to measure the increase in specific immune cells related to these cancers and monitor treatment safety carefully to prevent significant side effects. Participants receive treatment cycles starting with an intradermal injection of 7 to 14 million autologous dendritic cells loaded with their own tumor homogenate on day 1. This is followed by subcutaneous injections of Interleukin-2 at 3 million units daily for five days (days 3-7). Each treatment cycle lasts 28 days, with up to six cycles administered. The study includes a safety review after the first six patients complete three cycles, followed by enrollment of additional patients if safety criteria are met. During the study, participants undergo various assessments including CT scans or MRI to confirm no disease presence before starting. Researchers monitor treatment-emergent adverse events from leukapheresis day through 30 days after the last dose and measure immunological effects after at least three vaccinations. Secondary outcomes include overall survival, relapse-free survival, and skin test responses, with follow-up extending up to seven years. Participants are closely observed for safety and immune response throughout the study period.

Researchers are evaluating the protective efficacy and safety of a recombinant herpes zoster vaccine called LZ901 in healthy adults aged 40 years and older. This phase 3, randomized, double-blind, placebo-controlled trial aims to protect participants against shingles caused by the varicella zoster virus. The vaccine contains a tetramer of VZV glycoprotein E combined with an aluminum hydroxide adjuvant known to enhance immune response and widely used in vaccines worldwide. Participants will receive two doses of either the LZ901 vaccine or a placebo (aluminum hydroxide adjuvant) injected into the upper arm on day 0 and day 29. Around 26,000 participants will be enrolled, including a subgroup of about 3,000 to assess the consistency of immune response across three vaccine batches and monitor persistence of immunity up to 36 months. The study includes four groups: treatment main, placebo main, treatment immunization, and placebo immunization groups. Participants will undergo up to 24 visits depending on their group, including on-site and in-person visits for screening, vaccination, and follow-up assessments. Researchers will monitor vaccine efficacy 30 days after full immunization, track adverse events from immediate to 12 months post-vaccination, and evaluate immune response through antibody tests at multiple time points. The study also explores the vaccine's impact on reducing the severity and occurrence of postherpetic neuralgia in adults 40 years and older.

Researchers are conducting a phase I clinical trial to explore a new type of cancer vaccine called the polyphenol whole tumor cell vaccine for patients with advanced malignant solid tumors. These tumors include cancers originating in epithelial, mesenchymal, or nervous tissues. The study aims to find the effective dose, assess safety and tolerability, and ultimately provide new treatment options to help control the disease long-term. This vaccine is based on previous promising research that showed enhanced immune responses and tumor suppression in animal models. The trial involves administering the polyphenol whole tumor cell vaccine at different dose levels to small groups of patients using a "3+3" dose escalation design. Patients receive five doses of basal immunization on days 0, 14, 28, 42, and 56, followed by individualized treatments of one dose per month for four months, depending on tumor assessment. The vaccine includes tumor cells coated with plant polyphenols and uses bacterial lipopolysaccharide as an adjuvant to stimulate the immune system against multiple tumor antigens. Participants will be closely monitored throughout the study for safety and side effects from the first dose until 14 days after the last vaccination. Researchers will also evaluate tumor response, progression-free survival, and overall survival over about one year. The study includes thorough assessments of organ function, blood tests, and tumor measurements. The trial is expected to last until the end of 2026 and aims to provide important information on the vaccine's safety and preliminary anti-tumor activity in patients with advanced solid tumors.

Researchers are evaluating whether an online mindfulness program can reduce and prevent mood and anxiety symptoms in adolescents who are at risk due to high levels of trait negative affect, a tendency to experience frequent and intense negative emotions. This randomized clinical trial compares the mindfulness program to a supportive comparison group and a no-intervention control group. The study focuses on reducing momentary negative emotions and internalizing problems in youth aged 12 to 17 years old. Participants are randomly assigned to one of three groups: the Mindfulness Program, the Supportive Active Comparison, or a Control group. The Mindfulness Program involves nine weekly 30-minute online sessions with a coach teaching mindfulness skills like calm breathing and gratitude. The Supportive Active group also meets weekly online with a coach to discuss personal thoughts and feelings, using active listening and expressive writing. The Control group completes assessments only at the same time points as the other groups. Participants will be assessed before the intervention, after the 9-week program, and again at a six-month follow-up. Assessments include measures of momentary negative affect and internalizing symptoms using ecological momentary assessment and diagnostic evaluations. The study aims to understand how mindfulness training affects emotional regulation and the development of anxiety and depression symptoms in vulnerable youth over time.

Researchers are studying the effects of Huperzine A Injection on reducing postoperative delirium in elderly patients aged 75 and older who are undergoing non-cardiac surgery. This randomized, double-blinded, placebo-controlled trial aims to observe how this treatment may influence the occurrence of delirium after surgery in this older population. Participants will be randomly assigned to receive either Huperzine A Injection or a placebo of 0.9% Sodium Chloride Injection during their non-cardiac surgical procedure. The study includes patients with an anesthesia grade of III to IV and an estimated operation time of at least 2 hours. The treatments will be administered under controlled conditions to carefully assess their effects on postoperative delirium. During the study, participants will be monitored for delirium incidence within 7 days after surgery, with additional evaluations at 24, 48, and 72 hours post-operation. Researchers will also assess the type, severity, and duration of delirium, length of hospital stay, economic costs, complications, mortality rates, and cognitive function using the Mini-mental State Examination and EuroQol scale. Follow-up assessments will continue up to 2 months after surgery, with some evaluations occurring around 30 days after discharge.

Researchers are studying the safety of Prevenar 20, a Pneumococcal 20-valent conjugate vaccine, after it is available in the Korean market. This observational study includes participants aged 6 weeks and older, including infants, children, adolescents, and adults prescribed the vaccine by their physician according to the approved product label. The study aims to collect data on various reactions and adverse events following vaccination to understand the vaccine's safety profile in routine clinical use. Participants will receive a single 0.5 mL dose of Prevenar 20 injected into a muscle, preferably the shoulder muscle. The study uses a continuous registration method where participants receive the vaccine as part of routine care, and data is collected from their first dose through at least 28 days afterward. There is no fixed visit schedule, and data may be collected during routine or unscheduled visits, or by phone or email if clinic visits are not possible. During the 28-day participation period, researchers will monitor and record any local or systemic reactions, adverse events, serious adverse events, and any unexpected or special interest events related to the vaccine. All assessments align with usual clinical practice, and no additional tests or visits are required beyond standard care. The information collected will help evaluate the vaccine's safety in real-world use.