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. This is a phase 1b, three-part, double-blind, randomized, placebo-controlled study also assessing the relative bioavailability of two different salt forms of the drug capsules: Mesylate and Hydrochloride. The study focuses on conditions including post-herpetic neuralgia, neuropathic pain, chronic pain, osteoarthritis, and related nerve targets.

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 adults against shingles caused by the varicella zoster virus. The study will enroll about 26,000 participants to assess how well the vaccine works compared to a placebo and to examine safety and immune response. Participants will receive two injections of either the LZ901 vaccine or a placebo containing an aluminum hydroxide adjuvant on day 0 and day 29. The vaccine is made from a glycoprotein E fusion protein produced in CHO cells, combined with an aluminum hydroxide adjuvant to enhance the immune response. A subgroup of about 3,000 participants will be involved in testing the consistency of different vaccine batches and will receive three different vaccine batches or placebo. This subgroup will be followed for up to 36 months to evaluate immune response persistence. Throughout the study, participants will attend multiple visits including on-site and in-person follow-ups (16 visits for most, 24 for the immunization subgroup). Researchers will perform tests at screening and monitor vaccine efficacy 30 days after full immunization. They will also evaluate safety, immune responses, batch consistency, and the vaccine's effect on reducing the severity and prevention of postherpetic neuralgia. The trial involves detailed monitoring and follow-up over several years to assess long-term outcomes.

Researchers are evaluating the immune response and safety of an investigational chickenpox vaccine and a marketed measles, mumps, and rubella (MMR) vaccine when given to healthy children aged 12 to 15 months. This Phase 3a study compares the investigational varicella vaccine given as a muscle injection to Merck's chickenpox vaccine administered just under the skin. The study also looks at the immune response and safety of giving these GSK vaccines together with other routine childhood vaccines via muscle injection. Participants receive either the investigational varicella vaccine by intramuscular injection or the marketed varicella vaccine given subcutaneously. The MMR vaccine is administered either subcutaneously or intramuscularly. Other vaccines such as Hepatitis A vaccine, 13-valent, 15-valent (Vaxneuvance), or 20-valent pneumococcal conjugate vaccines may be co-administered intramuscularly depending on country recommendations and availability. During the study, researchers will measure immune responses by assessing antibodies to varicella zoster virus and MMR antigens at Day 43 after vaccination. They will also monitor safety and tolerability throughout the study period. Parents or legal representatives complete diaries and return for follow-up visits to support ongoing safety and immunogenicity assessments. Overall, the study aims to understand how well the vaccines work and how safe they are when given to young children in this age group.

Researchers are evaluating the immune response consistency of three different lots of GSK's investigational varicella vaccine (VNS Vaccine) in healthy children aged 12 to 15 months who have neither had chickenpox nor received varicella vaccination. The study also compares the safety and immune response of the VNS vaccine with an approved varicella vaccine called Varivax. This is a Phase 3a, observer-blind, randomized controlled trial focused on chickenpox prevention in this young population. Participants will receive one of the three lots of the investigational varicella vaccine or one of two lots of the marketed Varivax vaccine, all given by subcutaneous injection. Alongside these vaccinations, some children may also receive other vaccines such as MMR, hepatitis A, or pneumococcal conjugate vaccines (PCV 13, PCV 20, or Vaxneuvance) depending on national immunization schedules and availability. These vaccines are given either subcutaneously or intramuscularly. The study monitors immune responses following vaccination to assess consistency between lots and compares the investigational vaccine to the approved one. During the study, children will be closely monitored with evaluations of their immune response to the varicella virus, specifically measuring seroresponse and antibody concentrations at Day 43 after vaccination. Safety is also carefully assessed throughout the trial. Parents or guardians will provide consent and support adherence to study requirements, including completion of diaries and attending follow-up visits. The total observation period includes vaccination and follow-up to ensure thorough assessment of immune response and safety in this age group.

Researchers are evaluating the immune response and safety of a new varicella vaccine (VNS Vaccine) compared to an approved vaccine called Varivax (VV) in healthy children. This study focuses on children aged 12 to 15 months who have not had chickenpox or received a varicella vaccine before. The goal is to see how well the second dose of these vaccines works when given three months after the first dose, assessing the body's immune reaction to the virus. Participants receive either the investigational varicella vaccine or the marketed Varivax vaccine as a second dose, given subcutaneously. Some children may also receive other vaccines such as MMR, Hepatitis A, or different types of pneumococcal conjugate vaccines, depending on their country's immunization schedule. Vaccines are given either subcutaneously or intramuscularly according to local recommendations. The study is randomized and observer-blind to compare the effects fairly. During the study, children will be monitored for immune response by measuring specific antibodies against the varicella virus 43 days after the second dose. Researchers will also observe safety and any side effects. Parents or caregivers will provide consent and children will undergo health checks before and during the trial. The total participation is timed around the vaccination schedule with follow-ups to evaluate vaccine effectiveness and safety.

Researchers are evaluating the safety of an investigational chickenpox (varicella) vaccine compared to an already approved vaccine called Varivax. This Phase 3 study involves healthy children aged 12 to 15 months who have not had chickenpox or received a varicella vaccine before. The goal is to assess how well children tolerate the new vaccine in comparison to the existing one. Participants will receive a single dose of either the investigational varicella vaccine or the marketed Varivax vaccine, both given by injection under the skin. Alongside, children may also receive one dose of measles, mumps, and rubella vaccine, hepatitis A vaccine, and one of several pneumococcal conjugate vaccines depending on the country’s recommendations and availability. These co-administered vaccines are given either under the skin or into the muscle. The study carefully follows national immunization guidelines regarding pneumococcal vaccines. During the study, researchers will monitor children for side effects at the injection site and systemic reactions such as fever, tracking these from the day of vaccination up to 43 days or longer depending on the event type. Safety is further assessed by recording any adverse events, medically attended events, and serious adverse events up to 181 days after vaccination. Parents will complete diaries and attend follow-up visits to help gather this information, ensuring thorough monitoring of the vaccine’s safety and tolerability.

Researchers are investigating whether people with herpes zoster (shingles) have a higher risk of blood vessel problems, including stroke and vascular dementia, than those without shingles. This study focuses on understanding how herpes zoster might increase these risks through tiny particles called exosomes, which carry proteins and microRNAs that may damage blood vessels. The study aims to uncover how these exosomes contribute to vascular dementia and stroke risk, especially given the link between shingles and increased stroke rates within a year of infection. This observational research has a strong background in vascular disease and viral effects on the brain's blood supply and cognitive function. Participants are divided into two groups: those with untreated acute herpes zoster and those without herpes zoster as controls. The herpes zoster group will have six visits over a 12-month period starting from the first day they present with shingles symptoms, with follow-ups at 7 days, 1 month, 3 months, 6 months, and 12 months. Control participants will have only one visit. No experimental medications or devices are used; all participants receive standard care. Blood samples will be collected for analysis of exosome content and their effects on vascular cells and platelets to understand how these particles might promote inflammation, blood clotting, and vessel damage. Throughout the study, participants will undergo blood draws and clinical evaluations at scheduled visits. Researchers will measure proteins and microRNAs in exosomes that may harm blood vessels, assess inflammatory and clotting activity in vascular and blood cells, and monitor clinical signs related to stroke risk over a year. Data will be correlated with laboratory tests and clinical features including immune responses to the virus. This comprehensive monitoring aims to reveal how herpes zoster triggers long-lasting changes in the body that could increase vascular dementia and stroke risk, informing future treatments and prevention strategies.

Researchers are evaluating the effect of the recombinant zoster vaccine on the risk of being newly diagnosed with dementia in adults aged 76 years or older living in Finland. This Phase IV pragmatic trial compares the vaccine to a placebo to understand its impact on dementia incidence in an older adult population. Participants will be followed for up to 10 years to monitor the occurrence of dementia diagnoses, deaths, loss to follow-up, or the end of data availability. Participants are randomly assigned in a 3:1 ratio to receive either the recombinant zoster vaccine or a placebo. Both treatments are given as two intramuscular doses: the first dose at the initial visit (Day 1) and the second dose between 2 and 6 months after the first dose, following the approved dosing schedule. This setup allows researchers to observe and compare the long-term effects of the vaccine versus placebo on new dementia diagnoses. During the study, participants will be monitored through health register data to track dementia diagnosis and related health outcomes. The main measure is the hazard ratio for new dementia diagnoses from the first dose until the earliest of dementia diagnosis, death, loss to follow-up, or study end, with assessments continuing for up to 10 years. Participants must provide informed consent and remain living in the community, as those in nursing facilities are not eligible. Safety and adherence are overseen throughout the study period.

Researchers are evaluating the safety and immune response of two doses of a recombinant herpes zoster vaccine (RHZV) made with CHO cells in healthy adults aged 40 years and older. This study includes two parts: Substudy A, which is a Phase I trial, and Substudy B, a Phase II trial. The study aims to compare different doses of the RHZV candidates with an approved shingles vaccine and other control injections to assess their effects and safety. Participants receive intramuscular injections of either one of two RHZV candidates at different dose levels, the approved shingles vaccine (Shingrix), adjuvant controls, or a placebo (normal saline). Vaccinations occur on day 0 and day 60. Substudy A divides participants into two age groups (40-49 years and 50 years or older) and includes a 12-month safety follow-up lasting about 14 months total. Substudy B includes three age groups (40-49, 50-69, and 70 years or older) and some groups continue into a persistence-of-immunity phase lasting up to 2 years to assess long-term vaccine effects. During the study, participants attend planned visits for safety assessments, adverse event monitoring, and immune response testing through blood samples. Researchers measure immediate and delayed side effects, serious adverse events up to 12 months after vaccination, and antibody levels against herpes zoster virus 30 days after the last dose. The total participation time varies by substudy, ranging from about 14 months to up to 2 years for long-term follow-up of immunity.

Researchers are evaluating the safety, immune response, and side effects of two doses of PED-HZ/su, GlaxoSmithKline's vaccine candidate for preventing Herpes Zoster (shingles) in children aged 1 to 17 years who have had kidney transplants and have weakened immune systems. This study focuses on this specific group to understand how the vaccine works and how safe it is in immunocompromised pediatric renal transplant recipients. The vaccine, PED-HZ/su, is given by injection into the muscle of the non-dominant arm on a two-dose schedule spaced one month apart. There are two investigational groups receiving the vaccine. The study monitors participants from the first dose on Day 1 through Month 2, measuring immune responses and tracking any side effects or adverse events. Participants will be closely monitored for any local or general side effects within 7 days after each vaccination and for other adverse events for up to 30 days after each dose. Researchers will also observe for serious events, immune-related diseases, seizures, and kidney transplant rejection throughout the study period. The main outcome includes measuring antibody levels one month after the second dose to evaluate immune response. The total participation duration covers about two months post-vaccination.