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Ongoing Clinical Trials for Varicella Zoster Virus Infection

This article provides information about 6 ongoing clinical trials focused on Varicella Zoster Virus Infection. These studies are investigating vaccines to protect against chickenpox and shingles in different populations, including children after cancer treatment, healthy children receiving routine vaccinations, people with rheumatic diseases, and older adults. The trials are taking place across multiple European countries and are examining how well vaccines work, how safe they are, and how long protection lasts.

Clinical trial locations

Study on Immunity to Measles and Chickenpox in Children with Cancer Using Measles, Mumps, Rubella, and Varicella Vaccines

This trial is being conducted in Sweden and focuses on children and adolescents aged 0-18 years who have completed treatment for pediatric cancer. The study examines how well these young cancer survivors can rebuild immunity to measles and chickenpox through revaccination.

Inclusion criteria: Participants must be children or adolescents who are starting or have completed cancer treatment, with known vaccination status for measles and chickenpox before their cancer treatment began. Female participants of reproductive age who are sexually active must agree to use effective birth control methods and have a negative pregnancy test before each vaccination. Parents or guardians must provide signed consent after receiving both oral and written information about the trial.

Exclusion criteria: The study excludes patients who have not completed cancer treatment or reached a stable health condition afterward. Those with known allergies to the vaccines, weakened immune systems, or who are taking immune-suppressing medications like steroids cannot participate. Recent blood transfusion recipients and those with other serious health conditions that might make participation unsafe are also excluded.

Focus: The trial aims to understand how the immune system responds to chickenpox and measles vaccines after cancer treatment. Researchers measure specific antibody levels before and after vaccination to determine vaccine effectiveness. The study also compares immune responses based on cancer type, treatment intensity, and pre-treatment immunity status. This research will continue until 2028 and could provide valuable insights into protecting young cancer survivors from these infectious diseases.

Investigational drugs: The study uses two vaccines: the Varicella Vaccine to protect against chickenpox and the Measles Vaccine. Both are administered through intramuscular injection to help the immune system develop antibodies against these diseases.

Study on the Immune Response and Safety of a New Varicella Vaccine (GSKVX000000025896) Compared to Varicella Virus Oka/Merck Strain in Healthy Children Aged 12-15 Months

This trial takes place in Czechia, Poland, Belgium, and Estonia, testing a new chickenpox vaccine in healthy children aged 12 to 15 months. The new vaccine is compared with the existing VARIVAX vaccine to evaluate immune response and safety.

Inclusion criteria: Participants must be healthy children between 12 and 15 months of age, as confirmed by medical history and physical examination. Parents or legally acceptable representatives must provide written consent before any study procedures begin. In countries where pneumococcal conjugate vaccine is recommended at this age, children must have received the primary series in their first year of life, with the last dose at least 60 days before study entry.

Exclusion criteria: Children with recent varicella virus infection or recent vaccination with another chickenpox vaccine cannot participate. Those with weakened immune systems, pregnant women or those planning pregnancy, and anyone with severe allergic reactions to vaccines are excluded. Current participation in another clinical trial or significant health issues that could interfere with results also prevent enrollment.

Focus: The study evaluates whether different batches of the new VNS vaccine produce consistent immune responses. Researchers monitor children for 43 days after vaccination, measuring antibody levels and recording any side effects through electronic diaries. The primary assessment occurs on Day 43, with safety monitoring continuing until Day 181.

Investigational drugs: The trial compares the investigational VNS vaccine with Varivax, an established chickenpox vaccine. Both are given as single doses via subcutaneous injection to help children build protection against the varicella zoster virus.

Study on Immune Response and Safety of Measles, Mumps, Rubella, and Varicella Vaccine in Healthy Children Aged 4 to 6 Years

Conducted in Latvia and Spain, this study focuses on healthy children aged 4 to 6 years receiving a combination vaccine that protects against measles, mumps, rubella, and chickenpox. The new MMRVNS vaccine is compared with the existing ProQuad vaccine.

Inclusion criteria: Children must be healthy and between 4 and 6 years old at vaccination. They must have received their first chickenpox vaccine dose and a single measles, mumps, and rubella vaccine dose during their second year of life. Parents or guardians must provide written consent and agree to participate according to local rules, including obtaining the child’s agreement where applicable. Parents must be willing and able to complete electronic diaries and attend follow-up visits.

Exclusion criteria: Children with serious health conditions, weakened immune systems, or those who are pregnant or breastfeeding cannot participate. Those with a history of allergic reactions to vaccines, recent vaccination with other vaccines, or use of immune-suppressing medications are excluded. Children with uncontrolled chronic illnesses, history of substance abuse, or recent participation in other clinical trials are also not eligible.

Focus: The study measures immune response by checking antibody levels at a follow-up visit around Day 43 after vaccination. Parents monitor and report any side effects, particularly during the first 4 days for injection site reactions and throughout 43 days for general symptoms like fever or rashes. The trial continues monitoring until Day 181 to ensure long-term safety.

Investigational drugs: The MMRVNS Vaccine is the new combination vaccine being tested, while the MMRV Vaccine (ProQuad) serves as the comparison. Both protect against measles, mumps, rubella, and chickenpox through a single injection.

Study on Immune Response to Recombinant Zoster Vaccine in Rheumatic Disease Patients Using Baricitinib, Tofacitinib, or Methotrexate

This French trial examines how well the recombinant zoster vaccine works in patients with rheumatic diseases who are taking medications that weaken the immune system. These medications include JAK inhibitors like baricitinib and tofacitinib, either alone or combined with methotrexate.

Inclusion criteria: Participants must be adults aged 18 or older with rheumatic diseases who are currently being treated with JAK inhibitors (alone or with methotrexate) or methotrexate only. They must be scheduled to receive the shingles vaccine and be in a stable clinical condition as determined by study doctors. Patients must be able and willing to provide informed consent.

Exclusion criteria: People with other serious health conditions that might interfere with the study are excluded. Those who received other vaccines within 4 weeks before the study, are currently in another clinical trial, or have known allergies to vaccine components cannot participate. Pregnant or breastfeeding women, those who received blood products or immunoglobulins within 3 months, and people with severely weakened immune systems due to conditions like HIV/AIDS are excluded. Patients with recent cancer history (within 5 years, except certain skin cancers) or uncontrolled chronic diseases are also not eligible.

Focus: The study assesses immune response through blood tests measuring antibody levels and T cell responses. Researchers monitor how JAK inhibitors and methotrexate affect the vaccine’s effectiveness. Participants are followed for up to one year with periodic blood tests and health assessments, with a key evaluation at 90 days after the first vaccination.

Investigational drugs: The trial examines the Recombinant Zoster Vaccine (RZV) in combination with immunosuppressive medications. JAK Inhibitors and Methotrexate are studied to understand their impact on vaccine effectiveness in people with rheumatic diseases.

Study on the Immune Response and Safety of a Second Dose of Investigational Varicella Vaccine (GSKVX000000025896) Compared to Varicella Virus Oka/Merck Strain in Healthy Children

This study in Denmark and Norway investigates the second dose of an investigational chickenpox vaccine in healthy children who received their first dose between 12 and 15 months of age. The vaccine is compared with VARIVAX to assess immune response and safety.

Inclusion criteria: Participants must be healthy children who received their first vaccine dose when they were 12 to 15 months old. Parents or legally acceptable representatives must provide written or witnessed consent before study procedures begin. Health status is confirmed through medical history review and clinical examination. In countries where pneumococcal conjugate vaccine is recommended at this age and included in study interventions, children must have completed the primary series in their first year, with the last dose at least 60 days before entering the study.

Exclusion criteria: Children with current or past chickenpox infection cannot participate. Those who received other vaccines within 4 weeks before the first study dose, have known allergies to vaccine components, or weakened immune systems are excluded. Pregnant women, those planning pregnancy during the study, breastfeeding mothers, and those participating in other clinical trials cannot join. Children with a history of severe vaccine reactions or medical conditions that might make participation unsafe are also excluded.

Focus: The study monitors immune response and safety after the second vaccine dose, given three months after the first dose. Researchers track injection site reactions for 4 days and general symptoms like fever for 22 days after each dose. The primary evaluation occurs 43 days after the second dose (Day 133), with continued monitoring for adverse events until Day 271.

Investigational drugs: The Investigational Varicella Vaccine (VNS) is tested as a second dose and compared with Varivax. Both vaccines are given as subcutaneous injections to help children develop immunity against chickenpox.

Study on Long-Term Effects and Safety of Herpes Zoster Vaccine with Recombinant Varicella Zoster Virus Glycoprotein E in Older Adults

This large trial across Spain, France, Germany, Sweden, Czechia, Estonia, Finland, and Italy studies the long-term effectiveness and safety of the Shingrix vaccine in older adults. The study follows participants for several years to monitor how well protection lasts.

Inclusion criteria: Participants must be able and willing to follow study requirements, including completing diary cards and quality of life questionnaires, attending follow-up visits, and being available for scheduled contacts. If participants have caregivers, they must also be able and willing to meet these requirements. Written consent is required, with options for witnessed consent or thumbprint for those who cannot write. Participants must be medically stable as determined by medical history and physical examination. They must have completed the ZOSTER-049 study and received at least one dose of the HZ/su vaccine in previous ZOSTER-006 or ZOSTER-022 studies.

Exclusion criteria: People with current or past diagnosis of shingles cannot participate. Those not within the specified age range or who are part of vulnerable populations requiring special protection or care are excluded.

Focus: The study evaluates long-term vaccine effectiveness by monitoring participants through regular follow-up visits at months 12, 24, 36, and 48. Blood samples are taken to measure antibody levels and immune cell responses. Participants complete diary cards and quality of life questionnaires throughout the study. The trial assesses whether additional vaccine doses help maintain immune protection over time, with the study expected to conclude in August 2027.

Investigational drugs: The Herpes Zoster Subunit Vaccine (Shingrix) is given as an intramuscular injection. The study examines whether one or two additional doses can maintain long-term protection against shingles in older adults who previously received the vaccine.

Summary

These six clinical trials represent a comprehensive effort to improve protection against varicella zoster virus infections across different age groups and populations. The studies are notably concentrated in several European countries, with Spain, France, and Sweden hosting multiple trials, reflecting strong research infrastructure in these regions.

A significant focus is on vaccine development and optimization for healthy children, with three trials examining chickenpox vaccines in various age groups. Two studies specifically evaluate new formulations against established vaccines like VARIVAX and ProQuad, aiming to confirm effectiveness and safety. Another trial addresses the important question of revaccination in children who have undergone cancer treatment, recognizing their special immunological needs.

The research also extends to vulnerable adult populations, including people with rheumatic diseases taking immunosuppressive medications and older adults at risk for shingles. The long-term follow-up study of the Shingrix vaccine across eight countries demonstrates commitment to understanding lasting protection against shingles.

These trials employ rigorous monitoring approaches, measuring both antibody responses and tracking side effects through electronic diaries and regular follow-up visits. The diversity of study populations and vaccine types reflects the ongoing effort to optimize protection against varicella zoster virus infections throughout life, from infancy through older adulthood, and in both healthy individuals and those with compromised immune systems.

Ongoing Clinical Trials on Varicella zoster virus infection

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