Polio

This research aims to evaluate the immune response, safety, and consistency between different batches of the LBVD vaccine compared to the combined use of Pentavalent and Inactivated Poliomyelitis vaccines in healthy infants aged 6 to 8 weeks. The study is divided into two stages: Stage 1 compares LBVD with licensed control vaccines, and Stage 2 confirms that LBVD is not inferior to control vaccines and assesses consistency across three lots of LBVD. Participants receive a three-dose primary vaccination series at 6, 10, and 14 weeks of age. The LBVD vaccine is administered as an intramuscular injection into the thigh. The control group receives co-administration of Pentavalent and Inactivated Polio vaccines. Stage 1 focuses on initial comparisons, while Stage 2 includes multiple LBVD lots to evaluate lot-to-lot consistency. Throughout the study, infants will be monitored for immune protection levels and antibody concentrations four weeks after completing the vaccination series. Safety is tracked by observing immediate reactions within 30 minutes, solicited side effects within 7 days, and other adverse events within 4 weeks post-vaccination. The study follows infants from 6 weeks through 8 weeks of age, including all vaccine administrations and safety assessments.

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 evaluating the safety and immune response of a new vaccine called VLP-Polio in healthy infants and toddlers. This phase I/II study is randomized, double-blind, and controlled, aiming to explore different dosing levels of the vaccine compared to a control vaccine. The trial focuses on infants starting from 6 weeks old up to toddlers aged 12 to 18 months who have already received their primary polio immunization. Participants in the toddler group will receive a single dose of either a high dose of VLP-Polio or a control vaccine. Infants will be randomly assigned to one of four groups receiving either a low-adjuvant, medium, or high dose of VLP-Polio or a control vaccine. Infants will get three doses spaced 28 days apart, plus a booster dose between 12 to 18 months of age. The study enrolls participants in descending age groups and ascending dosing levels. Throughout the study, blood and mucosal samples will be collected to evaluate immune responses. Researchers will monitor for side effects within 7 days after each vaccination and track any serious adverse events throughout the trial. The main outcomes include measuring antibodies against different types of poliovirus before vaccination and after the third dose. The total participation duration varies by age group but includes follow-up periods up to about 20 to 22 months of age.

Researchers are evaluating a new hexavalent vaccine containing diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and a reduced dose of inactivated poliovirus vaccine (IPV) antigens in healthy infants and toddlers. This study compares the immunogenicity and safety of this reduced IPV dose vaccine to the licensed full-dose SIIPL HEXASIILae vaccine. The study aims to support global polio eradication by improving IPV availability and affordability through antigen dose reduction. The study is an observer-blind, randomized, active-controlled, multi-center Phase III trial involving 1,557 infants aged 6 to 8 weeks. Participants will be randomized in a 2:1 ratio to receive either the reduced IPV hexavalent vaccine or the full-dose HEXASIILae vaccine. Both groups will receive a three-dose primary vaccination series at 6, 10, and 14 weeks, followed by a booster between 12 and 24 months of age. The vaccines are given to actively immunize infants against six diseases. Participants will be monitored closely for immune response and safety. Safety and immunogenicity data will be collected up to 28 days after the third vaccination dose. After primary vaccination, infants will be followed every three months from 6 to 21 months of age until they receive the booster dose. A final safety and immunogenicity assessment will be done 28 days after the booster. The study will measure the vaccine's ability to produce an immune response without significant adverse effects over the study period ending in May 2026.

Researchers are studying Motor Neuron Disease (MND), also known as Amyotrophic Lateral Sclerosis (ALS), a nervous system disorder that causes loss of movement and is eventually fatal. The study aims to find a non-invasive and cost-effective biomarker using combined EEG and EMG recordings to help with early diagnosis and tracking the disease's progression. Current diagnosis relies mostly on clinical methods, and better tools are needed to personalize care and treatment for individuals with ALS and its subtypes. Participants will undergo non-invasive recordings using 128-electrode EEG and either bipolar or high-density surface EMG placed on the scalp and arm muscles. These recordings will be made while participants rest or perform tasks designed to engage specific brain and muscle networks. The study includes groups of healthy volunteers and patients with ALS, Primary Lateral Sclerosis (PLS), Progressive Muscle Atrophy (PMA), Postpoliomyelitis Syndrome, and Spinal Muscular Atrophy (SMA). During the study, participants will be assessed up to two years with repeated recordings of EEG and EMG to analyze neuromuscular communication patterns. Researchers will measure specific EEG-EMG and EEG-EEG signatures to distinguish healthy individuals from different ALS patient subgroups. The goal is to develop reliable biomarkers for early diagnosis and disease progression to improve patient care and rehabilitation.

Researchers are investigating the effects of measles vaccine (MV) and Bacille Calmette-Guérin vaccine (BCG) given to women of fertile age before pregnancy, and the impact of providing early measles vaccination to their children. The study aims to understand both measles-specific and general immune benefits in mothers and children, focusing on antibody responses, viral loads after yellow fever vaccination, and overall health outcomes. This is a phase 4 randomized, triple-blind trial conducted in Guinea-Bissau, exploring the novel concept that vaccinating mothers with live vaccines may enhance protection for their children. In this trial, 2400 non-pregnant, HIV-negative women aged 15 to 35 will be randomly assigned to receive either the measles vaccine, BCG vaccine, or a saline placebo. Their children, all receiving BCG at birth as per local recommendations, will be further randomized at 20 weeks of age to receive either an early measles vaccine or placebo. All children will then receive the standard measles and yellow fever vaccines at 9 months. The study will create six groups combining maternal and child vaccination schedules to compare outcomes. Participants will be followed through regular home visits and health center monitoring. Women will have blood samples taken before and after vaccination to measure antibody levels. Children will be closely monitored monthly and have blood samples taken at specified ages to assess immune responses and viral loads. The study tracks morbidity and mortality data for both mothers and children over time, using interviews, hospital records, and vaccination documentation. The trial will continue until 2027, assessing which vaccination schedules best support health and immunity.

Researchers are evaluating the impact of the Nomad powered Knee-Ankle-Foot Orthosis (P-KAFO) in adults who have had musculoskeletal or neurological injuries affecting their ability to walk. The trial aims to measure how this device improves mobility, balance, frequency of falls, and quality of life compared to participants' own braces over a three-month period of daily home and community use. This study is a randomized clinical trial sponsored by Shirley Ryan AbilityLab. Participants are divided into two groups. Group A starts with the Nomad device, receiving fitting and training, followed by a three-month home trial, then outcomes testing. They then switch to their own traditional assistive device for another three-month home trial and testing. Group B follows the reverse order, starting with their own device and then moving to the Nomad. The Nomad is a microprocessor-controlled orthosis with powered assistance for knee movement and stance support. During the study, participants wear a sensor to record their daily activities and mobility. They will perform various mobility tests and functional assessments at baseline and after each three-month trial period with each device. Outcome measures include walking speed, balance tests, gait assessments, quality of life surveys, pain and exertion ratings, muscle strength, and range of motion. The trial lasts for about six months per participant, with careful monitoring of their progress and device use.

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.

Researchers are comparing the immune response and safety of a single dose of the inactivated poliovirus vaccine (sIPV) in healthy adolescents and adults aged 7 to 50 years with the standard three-dose pentavalent vaccine (DTaP-IPV-Hib) given to infants aged 3 months. This Phase IV, open-label study will include 180 participants divided into three groups: 60 adolescents, 60 adults, and 60 infants. The study aims to evaluate how well these vaccines stimulate immunity against poliovirus and other components. Participants aged 7 to 50 years will receive one intramuscular dose of sIPV on Day 0, while infants will receive three doses of the pentavalent vaccine at 3, 4, and 5 months of age. Blood samples will be collected before vaccination and 30 days after the last vaccine dose to measure antibody levels. The study will also monitor for any adverse events immediately after vaccination and for up to 30 days post-vaccination, including serious adverse events and pregnancy occurrences in fertile participants. Throughout the study, researchers will collect blood samples and observe participants for side effects using diary cards and follow-up contacts. Immunogenicity will be assessed by measuring antibody responses against poliovirus and other vaccine components. Safety will be closely monitored during and after vaccination. The total participation duration varies by group but includes multiple visits for vaccination, blood collection, and safety evaluations. This study is sponsored by Sinovac Biotech Co., Ltd and runs until May 2026.

This research aims to promote vaccine confidence and increase vaccination rates for the Human papillomavirus (HPV) vaccine among vulnerable and underserved youth aged 11 to 14. It focuses on addressing the suboptimal uptake of this strongly recommended vaccine by assessing a game-based educational approach. The study is a pilot randomized controlled trial designed to evaluate feasibility and preliminary effectiveness in improving vaccine intent and uptake. Participants are divided into two groups: one group receives a game-based intervention designed to educate and encourage HPV vaccination, while the other group receives usual care without any intervention. The study involves parent-child dyads, with children aged 11 to 14 who have not yet received the HPV vaccine. The intervention is delivered via a health game, and the study measures changes from before to after the intervention. During the study, researchers will track participation rates, retention, involvement, and satisfaction with the intervention. They will also measure parents' intent to vaccinate their children immediately after the intervention and two months later, alongside actual vaccination uptake. Assessments occur at enrollment, immediately post-intervention, and two months afterward. The total study duration includes follow-up to monitor these outcomes and collect participant feedback.