Tetanus

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 comparing the safety and effectiveness of a new injection called GR2001 with Human Tetanus Immunoglobulin (HTIG) for preventing tetanus. This Phase III clinical trial focuses on adults who may have been exposed to tetanus through dirty or contaminated wounds. The study aims to see how well GR2001 works in raising protective antibody levels against tetanus. Participants will be randomly assigned to receive a single intramuscular injection of either GR2001 or HTIG in the gluteal muscle on the first day of the study. GR2001 is provided in a 5mg/1ml vial with specific packaging materials, while HTIG is a licensed human plasma-derived immunoglobulin. Both treatments are given once, and the study is designed as a double-blind trial. During the trial, researchers will monitor the increase in anti-tetanus antibody levels up to 12 hours after injection and follow participants for up to 105 days to observe the occurrence of tetanus and assess safety. They will also evaluate how GR2001 behaves in the body, including its peak concentration and overall exposure. Participants will undergo assessments and safety monitoring throughout this period to gather comprehensive data on the treatment effects.

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 observing patients who receive Siltartoxatug Injection, also known as Sintetol4, to prevent tetanus following injury. This large-sample, real-world registry aims to document injury and wound conditions and evaluate clinical outcomes related to tetanus prevention. The study focuses on collecting safety information and any adverse reactions after receiving the injection. Participants in this observational study receive Siltartoxatug Injection as part of their tetanus prophylaxis after injury. The study does not involve randomization or comparison groups but follows patients over time to monitor outcomes. A key part of the study is the follow-up at 90 days after administration to assess whether tetanus develops and to record any safety events. During the study, patient injury details and wound conditions will be carefully noted. Safety data will be selectively collected to identify any adverse reactions or serious events linked to Siltartoxatug use. The main outcome measure is the occurrence of tetanus within 90 days post-injection. Participants are followed for this 90-day period to evaluate treatment outcomes and safety.

Snake bites affect thousands of people in Australia each year, with few deaths due to timely medical care and quality first aid. This research investigates and compares two first aid methods—the Pressure Bandage Immobilisation (PBI) technique currently recommended in Australia and a simpler Pressure Pad (PP) technique used internationally. The study aims to determine if the PP method is as effective as PBI in slowing venom movement through the body, which is important for improving first aid guidance. Participants will receive an injection of mock venom in the hand or foot, followed by application of either no first aid, the PBI method, or the PP method. Each technique involves specific bandaging and splinting to immobilize the limb, with pressure carefully controlled around 60mmHg. The study will monitor the flow of the mock venom in each case using nuclear medicine imaging to track its movement through the lymphatic system. During the study, participants will undergo repeated scans to observe how quickly the mock venom reaches regional lymph nodes, with each person experiencing all possible combinations of injection site and first aid method in random order. The primary measure is the time taken for the venom to travel to lymph nodes, monitored over a period spanning a minimum of 12 weeks to a maximum of 18 months. This detailed data will help assess the effectiveness and safety of these first aid techniques to inform future recommendations.

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 conducting a randomized, single-blind, active-controlled phase I clinical trial to evaluate the safety and early immune response of a combined Diphtheria-Tetanus-acellular Pertussis (DTacP) vaccine in children aged 2 months to 6 years. The study aims to assess adverse events shortly after vaccination and up to 12 months later, as well as measure antibody levels to various components of the vaccine. The trial includes infants, toddlers, and children, with careful monitoring of immune response and safety outcomes. The trial is divided into three stages by age groups: children aged 6 years, toddlers aged 18-24 months, and infants aged 2 to 3 months. Participants are randomly assigned to receive either the DTacP vaccine or other vaccines such as DT, DTaP, or Pentaxim in different dosing schedules and injection sites. Children and toddlers receive a single injection on Day 0, while infants receive three doses over 2 to 4 months following specific immunization schedules. Safety reviews occur after each stage to decide progression. Participants will be monitored closely for adverse events through diaries, phone calls, and face-to-face visits for up to 12 months after vaccination. Blood, urine, and other lab tests will be performed before and after vaccination to assess safety and immune responses. Antibody levels against diphtheria, tetanus, pertussis, and poliovirus will be measured before vaccination, 30 days after, and for infants, again at 12 months. The study duration varies by group but may last up to 16 months for infants.

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.

Researchers are investigating the spread and impact of multiple infectious diseases in Cambodia, a country facing challenges in disease surveillance and laboratory capacity. This nationwide study uses a One Health approach to better understand disease burden, transmission, and population immunity for a broad range of pathogens including zoonotic, vector-borne, vaccine-preventable, and neglected tropical diseases. The goal is to provide evidence that supports targeted and culturally appropriate public health interventions and to create a model that can be applied in similar low- and middle-income countries. The study will enroll about 10,000 participants aged 2 to 75 from urban and rural areas across Cambodia through a multi-stage population sampling method. Participants will complete standardized questionnaires covering demographics, health status, mobility, animal contact, and healthcare access. Blood samples will be collected for multiplex serology to detect antibodies against 57 priority pathogens. This observational study does not involve treatments but focuses on extensive data and sample collection to support research and policy development. Participants will be visited at home for blood sampling and questionnaire completion between December 2025 and April 2026. Researchers will measure the presence of antibodies to assess prior exposure to various pathogens. The study also includes building a biobank and curated datasets for long-term research use. Community engagement and collaboration with national stakeholders aim to facilitate the uptake of findings. The total participation period spans the inclusion period with no intervention, focusing on observation and data collection.

Snakebite envenomation is a serious health issue in many developing countries, including sub-Saharan Africa. This research evaluates the safety and effectiveness of PANAF-Premium TM, a snake venom antiserum recently introduced by Premium Serums & Vaccines Pvt. Ltd. and approved by the WHO for use in sub-Saharan Africa. The study focuses on collecting detailed safety, effectiveness, and epidemiological data related to snakebites in the North region of Cameroon, contributing to broader pharmacovigilance efforts. The study is an open-label, Phase IV post-marketing surveillance trial where eligible patients with snakebites are treated with PANAF-Premium TM according to standard protocols adapted from the African Society of Venomology guidelines. The trial documents adverse events, the dose of antiserum required, and recovery time. There are no restrictions on other treatments or medications given as needed to manage the patient’s condition. Participants admitted with snakebites will undergo clinical examinations to identify signs of envenomation. Researchers will record adverse reactions, snake species involved, and the treatment process. Safety and effectiveness outcomes are monitored for 30 days, while epidemiological data are collected over six months. The study aims to enhance understanding of snakebite treatment and safety, with ongoing reporting of any serious adverse events.