Herpes Zoster (Shingles)

Researchers are evaluating the safety, tolerability, and how the body processes the drug iN1011-N17 after oral administration in healthy volunteers and patients with post-herpetic neuralgia (PHN). This phase 1b study also compares the bioavailability of two salt forms of iN1011-N17 (Mesylate versus Hydrochloride) in healthy volunteers. The study is designed as a randomized, double-blind, placebo-controlled trial with multiple ascending doses to better understand the drug's effects and behavior. The study consists of three parts. In Part 1, participants receive either iN1011-N17 or placebo twice daily for 7 days using different formulations (suspension or capsules). Part 2 involves a crossover design where healthy volunteers receive single doses of each salt form in two separate periods with a washout time of at least 5 days. Part 3 includes two cohorts of healthy volunteers and PHN patients randomized to receive iN1011-N17 or placebo twice daily for 14 days. Throughout, dosing occurs approximately 12 hours apart with the final dose on the morning of the last day. Participants undergo various assessments including monitoring for adverse events, physical exams, vital signs, ECGs, cardiac telemetry, and laboratory tests from baseline through follow-up periods averaging 14 to 22 days depending on the part. Additional tests evaluate drug concentration levels, metabolism, and elimination. The study also tracks pharmacokinetic and pharmacodynamic properties to assess how the drug is absorbed, distributed, metabolized, and cleared. Participants are expected to attend all visits and comply with study requirements during the treatment and monitoring phases.

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 investigating whether people with herpes zoster, also known as shingles, have a higher risk of blood vessel problems, including stroke, and vascular dementia compared to those without herpes zoster. The study focuses on understanding how exosomes, small particles in the blood, might contribute to these risks by promoting inflammation and clotting, which can affect brain blood flow. This observational research aims to clarify how herpes zoster could lead to vascular dementia and stroke over time. Participants are divided into two groups: those with untreated acute herpes zoster and those without herpes zoster. The herpes zoster group will have six visits over a year, starting from the first day of rash appearance and continuing at 7 days, 1 month, 3 months, 6 months, and 12 months after. The control group will have a single visit. No study medications or devices are given; all participants receive standard care. During the visits, the study collects data and blood samples to analyze exosome content and how it affects cells involved in blood vessel function. Researchers will measure proteins and genetic material in exosomes linked to vascular damage and monitor inflammatory responses. They will also assess platelet activation, blood vessel cell health, and the risk of stroke or vascular events. The primary goal is to understand the mechanisms behind increased vascular dementia risk in herpes zoster patients over a 12-month period.

Researchers are evaluating the effect of the recombinant zoster vaccine on the risk of developing new dementia diagnoses among adults aged 76 years or older living in Finland. This phase IV pragmatic trial aims to assess whether receiving this vaccine influences the incidence of dementia, including Alzheimer's disease, over a long follow-up period. Participants will be randomly assigned to receive either the vaccine or a placebo. Participants in the vaccine group receive two doses of the recombinant zoster vaccine: the first dose on Day 1 and the second dose between 2 and 6 months later, following the approved dosing schedule. Those in the placebo group receive two doses of placebo injections on the same schedule. The study is randomized, placebo-controlled, and observer-blind to compare outcomes between these two groups. During the study, participants will be followed for up to 10 years after their first dose to monitor for new dementia diagnoses, death, or loss to follow-up. Researchers will use health register data to assess outcomes including new diagnoses of dementia and Alzheimer's disease. Safety monitoring includes exclusion of severely immunocompromised individuals and those living in nursing facilities. The total participation duration allows long-term observation of vaccine effects on dementia risk.

Researchers are evaluating the safety and immune response of two doses of a recombinant herpes zoster vaccine (RHZV) in healthy adults aged 40 and older. The study includes two parts: Substudy A (Phase I) and Substudy B (Phase II). It aims to assess different vaccine candidates, including dose levels, compared with the approved shingles vaccine and controls, to better understand their effects in various age groups. In Substudy A, participants aged 40-49 and 50+ will receive one of two RHZV candidates, the approved shingles vaccine, adjuvant controls, or saline via intramuscular injection on days 0 and 60. This phase includes a 12-month safety follow-up, totaling about 14 months of involvement. Substudy B includes age groups 40-49, 50-69, and 70+, using similar vaccination schedules and treatments. Some groups will continue to be monitored for up to 2 years to study the persistence of immunity. Participants will undergo regular safety assessments including monitoring immediate, solicited, unsolicited, and serious adverse events after vaccination. Researchers will measure antibody levels and immune response at multiple timepoints up to two years, using blood tests for specific antibodies. Study visits will include vaccinations, follow-ups, and immune response evaluations, helping to understand the vaccine's safety and the body's lasting immune reaction.

Researchers are evaluating the reactogenicity, safety, and immune response of two doses of PED-HZ/su, GlaxoSmithKline's vaccine candidate, for preventing Herpes Zoster in immunocompromised children aged 1 to 17 years who have had a kidney transplant. This Phase 1/2 study focuses on pediatric renal transplant recipients to understand how the vaccine performs in this vulnerable group. Participants are divided by age and treatment into four groups: children aged 12 to 17 receiving the vaccine, similar-aged children receiving standard care without the vaccine, children aged 1 to 11 receiving the vaccine, and the youngest group receiving standard care. Vaccinated groups receive two intramuscular doses of PED-HZ/su in the deltoid muscle on day 1 and one month later. The younger age group enrollment is staggered, starting after safety data from the older group is reviewed. During the study, participants are monitored closely for local and general adverse events within seven days after each vaccination, as well as unsolicited adverse events and serious safety concerns up to two months post-vaccination. Researchers measure antibody levels one month after the second dose to assess immune response. Follow-up continues up to 13 months to track serious events, kidney transplant rejection, and occurrence of Herpes Zoster. The study includes careful assessment of seizures and other potential side effects related to the vaccine.