Chickenpox (Varicella)

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 immune response and safety of GlaxoSmithKline's investigational chickenpox vaccine and a marketed measles, mumps, and rubella (MMR) vaccine when given to healthy children aged 12 to 15 months. The study compares these vaccines administered by muscle injection to Merck's chickenpox vaccine given just under the skin. It also assesses the immune response and safety when the GSK vaccines are given together with other routine childhood vaccines. Participants are randomly assigned to receive either the candidate varicella vaccine intramuscularly along with MMR, hepatitis A virus (HAV) vaccine, and a pneumococcal conjugate vaccine (PCV), or the marketed varicella vaccine subcutaneously with the same additional vaccines. The PCV given may be PCV 13, Vaxneuvance, or PCV 20 depending on availability and national recommendations. All vaccines are given on Day 1. Throughout the study, children are monitored for immune responses by measuring antibody levels against varicella zoster virus and MMR antigens at Day 43. Safety is evaluated by tracking any local and systemic reactions in the days following vaccination, as well as any adverse events up to six months after the dose. The study aims to understand both the immune response and safety profile over this period in healthy young children receiving these vaccines.

Researchers are evaluating the consistency of immune responses to three different batches of an investigational chickenpox vaccine called VNS vaccine in healthy children aged 12 to 15 months who have not had chickenpox or received a chickenpox vaccine before. The study also compares the safety and immune response of the VNS vaccine to an approved chickenpox vaccine known as Varivax. This Phase 3a study is sponsored by GlaxoSmithKline and aims to better understand the immune protection provided by these vaccines. Participants are randomly assigned to receive one dose of either one of the three investigational VNS vaccine lots or one of two lots of the marketed Varivax vaccine. Along with the chickenpox vaccine, they also receive one dose each of measles, mumps, and rubella (MMR) vaccine, hepatitis A vaccine (HAV), and a pneumococcal conjugate vaccine (PCV) which could be PCV 13, Vaxneuvance, or PCV 20 depending on availability and country recommendations. All vaccines are given on Day 1 of the study. During the study, researchers monitor the participants' immune responses by measuring antibodies against varicella zoster virus (VZV) and other vaccine components at Day 43. They also track safety by recording any side effects or adverse events from Day 1 to Day 181. The study includes diary reports by parents and regular clinical evaluations to assess immune response and safety outcomes. Participation involves a single vaccination visit and follow-up assessments over approximately six months.

This research aims to evaluate the immune response and safety of an investigational chickenpox vaccine (VNS Vaccine) compared to an already approved vaccine called Varivax (VV). The study focuses on healthy children who have not previously had chickenpox or received a chickenpox vaccine, and takes place when the second dose is given three months after the first dose, which is administered between 12 and 15 months of age. Participants are randomly assigned to one of three groups: one group receives two doses of the Varivax vaccine; another group receives two doses of the investigational VNS vaccine; and the third group receives a first dose of Varivax followed by a second dose of the VNS vaccine. Additional vaccines including measles, mumps, and rubella (MMR), hepatitis A (HAV), and pneumococcal conjugate vaccine (PCV) are given on the first day. In some countries, a second dose of MMR is also given between 15 and 18 months according to national guidelines. During the study, researchers will monitor immune responses by measuring specific antibodies against the chickenpox virus after the second dose, particularly 43 days post-vaccination. They will also track any local or systemic side effects following each vaccine dose, recording adverse events up to nearly nine months after the first dose. The total participation includes multiple visits over this time, ensuring detailed safety and immune response assessment for each child.

Researchers are evaluating the safety of an investigational varicella vaccine (VNS Vaccine) compared to an approved varicella vaccine called Varivax. This study focuses on healthy children aged 12 to 15 months who have not had chickenpox or received any varicella vaccine before. The goal is to understand how well the new vaccine is tolerated in this young population. Participants will receive one dose of either the investigational varicella vaccine or the marketed Varivax vaccine, both given by injection under the skin. Along with the varicella vaccine, each child will also receive one dose each of measles, mumps, and rubella (MMR) vaccine, hepatitis A vaccine, and a pneumococcal conjugate vaccine (PCV), which may be PCV 13, Vaxneuvance, or PCV 20, depending on availability and national recommendations. All vaccines are given on the first day of the study. During the study, parents will record any side effects their child experiences, particularly those related to the injection site or systemic symptoms like fever, for up to 43 days. Researchers will monitor any adverse events, including serious and medically attended events, for up to 181 days after vaccination. This helps assess the safety and tolerability of the investigational vaccine over a period of about six months.

Researchers are collecting clinical data and biological samples from patients with severe skin reactions caused by drugs. These conditions include Stevens-Johnson syndrome, Lyell syndrome (toxic epidermal necrolysis), acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), drug-induced immunoglobulin A (IgA) bullous dermatosis, generalized bullous fixed drug reactions, maculopapular exanthema, and erythema multiforme. The goal is to better understand the biological and genetic causes of these drug reactions through research. Participants will provide various samples beyond routine care, including a small skin biopsy (6 mm punch), blood samples (43 mL), blister fluid, oral and nasal mucous membrane swabs, skin swabs, and stool samples. These samples will be stored in a specialized biological resource platform to allow detailed immunological, biological, and genetic studies. This is an observational study without specific treatment interventions. During the study, patients will undergo collection of clinical information and the biological samples described. Researchers will monitor the implementation of this collection and use the data and samples to perform various laboratory studies to explore the mechanisms of adverse drug reactions affecting the skin. Participation involves consenting and providing samples as outlined, with no therapeutic procedures. The study began in September 2018 and is expected to continue until 2028.

Researchers are studying the safety and immune response of MG1111 (BARICELA Inj.) when used as a second varicella vaccination in healthy children aged 4 to 6 years who have previously received a first varicella vaccination. This Phase 2 clinical trial aims primarily to assess safety up to 42 days after vaccination and secondarily to evaluate immune responses and ongoing safety. The study is designed as a double-blind, randomized, multi-center trial comparing MG1111 with two other varicella vaccines, VARIVAX and Suduvax. Participants receive a single 0.5ml dose of their assigned vaccine by subcutaneous injection as the second varicella vaccination. The trial includes three groups: MG1111, VARIVAX, and Suduvax arms, each receiving the same dose and method of administration. The study monitors participants closely for safety and immune response over multiple time points, including an initial 42-day period and extended monitoring for up to three years for immune markers and varicella-related events. During the study, children will be monitored for fever, local and systemic side effects, physical exams, and vital signs within 42 days post-vaccination. Serious adverse events are tracked for up to one year. Blood samples will be taken to assess antibody levels and cellular immune responses before vaccination and at 42 days post-vaccination, with additional antibody testing up to three years. Researchers also evaluate any varicella-like rash and virus genetics during the extended follow-up. Participation involves regular visits for assessments and safety monitoring throughout the study duration.

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 establishing a pediatric infectious disease surveillance network within the French ambulatory pediatric association. This network focuses on pediatric patients under 16 years diagnosed with infectious diseases such as otitis, pharyngitis, varicella, bronchiolitis, influenza, pneumonia, and gastroenteritis. The study aims to improve diagnosis quality by training pediatricians and enhancing data collection methods in ambulatory care. The participating pediatricians use the same electronic medical record software, Axi5-Infansoft, to standardize data collection. They receive specific training on infectious disease diagnoses and the use of point of care tests to assist in real-time surveillance. The network collects data automatically from pediatricians’ computers, facilitating ongoing monitoring and evaluation. Participants are children under 16 diagnosed with specific infectious diseases by trained pediatricians within the network. The study evaluates the number of infectious disease cases, the use of point of care tests, and antibiotic treatments over five years. Data collection relies on electronic records, and the study includes follow-up to monitor trends and treatment patterns in ambulatory pediatric infectious diseases.

Herpesvirus infections can be very serious, especially for children with blood cancers or those who have received a hematopoietic stem cell transplant (HSCT). These infections carry a high risk of complications and death. Although herpes simplex virus 1 (HSV-1) and varicella-zoster virus (VZV) are common worldwide, antiviral medicines like acyclovir have helped reduce infection rates in children who are at risk. This research studies how acyclovir behaves in the body of children receiving it through an intravenous (IV) or oral route for preventing or treating herpes virus infections. The study involves children with blood cancers or those undergoing high-intensity chemotherapy, as well as HSCT recipients. It uses therapeutic drug monitoring to analyze acyclovir levels in the blood during routine care. Participants will receive acyclovir either by IV or orally as part of their regular treatment. Researchers will collect blood samples to track acyclovir levels and study how the drug is processed by the body. The main measurement is the percentage of patients who reach a minimum acyclovir blood concentration after six months of treatment. Data from this study aims to help improve acyclovir dosing in children with cancer. The study is expected to continue until March 2026.