Ongoing Clinical Trials for Herpes Zoster
There are currently 3 ongoing clinical trials studying Herpes Zoster (also known as shingles). These trials are investigating vaccines to prevent shingles in different populations, including children with kidney transplants, adult kidney transplant patients receiving COVID-19 vaccines, and older adults. The trials are being conducted across multiple European countries including Belgium, Italy, France, Spain, Greece, Poland, the Netherlands, Germany, Sweden, Czechia, Estonia, and Finland.
Clinical trial locations
- Belgium
- Czechia
- Estonia
- Finland
- France
- Germany
- Greece
- Italy
- Netherlands
- Poland
- Spain
- Sweden
Study on the Safety and Immune Response of GSK’s Herpes Zoster Vaccine in Immunocompromised Children Aged 1-17 with Kidney Transplants
This trial is testing a new vaccine called PED-HZ/su, developed by GlaxoSmithKline, to prevent shingles in children and teenagers who have had kidney transplants and are taking medications that weaken their immune system.
Who can participate: Children and teenagers aged 1 to 17 years who weigh at least 6 kg are eligible if they have had a kidney transplant more than six months ago and have stable kidney function. They must also have either been vaccinated against chickenpox, had chickenpox confirmed by a doctor, or have a positive blood test showing previous exposure to the virus. Participants must be receiving ongoing treatment to prevent organ rejection for at least one month before starting. Parents or legal representatives must be willing to follow study rules, including filling out diary cards and attending follow-up visits.
Who cannot participate: Children with known allergies to any vaccine component or who have had severe allergic reactions to similar vaccines cannot join. Those with weakened immune systems due to conditions like HIV/AIDS or cancer, or those receiving treatments like chemotherapy or steroids, are excluded. Children who have already had shingles, have received another vaccine within 4 weeks, have a fever or acute illness, are pregnant or breastfeeding, or have participated in another trial within 30 days cannot take part.
What the study involves: Participants receive two doses of the vaccine as muscle injections, given about one month apart. They are closely monitored for any immediate reactions and side effects for 7 days after each dose, with longer-term monitoring for 30 days. Blood samples are taken to measure how well the immune system responds to the vaccine. Follow-up visits continue for up to 13 months to track any serious side effects, immune-related diseases, organ rejection, or occurrence of shingles.
Investigational drug: The vaccine being tested is PED-HZ/su, designed to help the body build protection against the virus that causes shingles.
Study on Everolimus and Mycophenolate Mofetil for Improving COVID-19 Vaccine Response in Kidney Transplant Patients
This trial examines whether changing from one type of anti-rejection medication to another can improve how well kidney transplant patients respond to vaccines, particularly the COVID-19 vaccine and the vaccine for shingles.
Who can participate: Adults aged 18 and older who have had a kidney transplant at least six months ago are eligible. They must have received three previous COVID-19 vaccinations and be taking specific maintenance medications including mycophenolate mofetil (MMF) or mycophenolic acid (MPA) at minimum daily doses, combined with another medication called a calcineurin inhibitor. Participants must be able to understand the study’s purpose and risks and be willing to follow study rules and attend visits.
Who cannot participate: People who are currently diagnosed with COVID-19 or have active shingles cannot join. Those with impaired immunity, meaning their immune system is not working properly, are also excluded.
What the study involves: Participants may have their current medication (MMF or MPA) switched to everolimus, which is taken orally as tablets. They will receive vaccinations for both COVID-19 (Comirnaty Omicron XBB.1.5) and shingles (Shingrix), both given as injections. The study involves regular follow-up assessments including blood tests to measure antibody levels and immune response. Participants are monitored for side effects and must report any symptoms or health changes throughout the study period, which lasts up to 18 months.
Investigational drugs: The study focuses on everolimus, a medication that helps prevent organ rejection by weakening the immune system, and compares it to mycophenolate mofetil, which is commonly used in transplant patients. The goal is to see if everolimus allows for better vaccine responses while maintaining safety.
Study on Long-Term Effects and Safety of Herpes Zoster Vaccine with Recombinant Varicella Zoster Virus Glycoprotein E in Older Adults
This trial is evaluating the long-term effectiveness and safety of the Shingrix vaccine in preventing shingles in older adults. It is a follow-up study for people who have already participated in previous vaccine studies.
Who can participate: Adults who completed the ZOSTER-049 study and received at least one dose of the vaccine in previous ZOSTER-006 or ZOSTER-022 studies are eligible. They must be medically stable, with their health condition steady and not likely to change suddenly. Participants must be able and willing to follow study rules, including completing specific diary cards and quality of life questionnaires, attending follow-up visits, and being available for scheduled contacts. If participants have caregivers, the caregivers must also be able to help with these requirements.
Who cannot participate: People who have a current or past diagnosis of shingles cannot join. Those who are not within the specified age range for the study or who are part of a vulnerable population needing special protection or care are excluded.
What the study involves: Participants receive one or two additional doses of the Shingrix vaccine as muscle injections. They attend follow-up visits at months 12, 24, 36, and 48, during which blood samples may be taken to measure antibody levels and specific immune cells. Throughout the study, participants complete diary cards specific to shingles and quality of life questionnaires to track any symptoms or side effects. The study is expected to conclude by August 2027, with a final evaluation assessing the long-term benefits and safety of the vaccine.
Investigational drug: The Herpes Zoster Subunit Vaccine (Shingrix) works by boosting the immune system’s ability to fight off the virus that causes shingles, reducing the risk of developing the painful rash.
Summary
The three ongoing trials studying prevention of shingles address different patient populations with varying needs. One trial focuses on children and teenagers with kidney transplants, reflecting the importance of protecting vulnerable young patients with weakened immune systems. Another examines adult kidney transplant patients and explores how changing anti-rejection medications might improve vaccine responses. The third trial follows older adults over several years to assess long-term vaccine protection.
Geographically, the trials show strong representation across Europe, with France, Italy, and Spain hosting multiple studies. The Shingrix vaccine appears in two of the three trials, indicating ongoing interest in understanding its effectiveness across different age groups and timeframes. All trials emphasize careful monitoring of both safety and immune response, recognizing the importance of balancing disease prevention with potential side effects in patients with special health considerations.
