Clinical Research Directory

Zoster Vaccine to Enhance Protection Against Zoster in Solid-organ Transplantation

Sponsor: Oriol Manuel

Summary

Shingles is caused by the same virus that causes chickenpox. After someone has chickenpox, the virus stays in the body and can become active again later in life. This is called shingles. People who have received a solid organ transplant (such as a kidney, liver, or heart transplant) are 3 to 10 times more likely to get shingles than the general population. In transplant patients, shingles is often more severe. It can spread to other parts of the body and may cause long-lasting nerve pain. These problems can lower quality of life, increase doctor visits and hospital care, and may even affect how well the transplanted organ works. The shingles vaccine called Shingrix® (recombinant zoster vaccine, RZV) works well in healthy adults and is generally safe for transplant patients. However, about 30% of transplant recipients still develop shingles even after receiving the recommended two doses. This may be because their immune system is weakened by the long-term medicines they take to prevent organ rejection. The purpose of this clinical trial is to find out whether giving an extra (booster) dose of the shingles vaccine after transplant can improve the immune response in solid organ transplant recipients. This study aims to answer the following questions: * How many participants have at least twice as many shingles antibodies (anti-gE antibodies) four weeks after receiving the booster compared to before the booster? * How strong and how long does the immune response last at 6 and 12 months? * Is the booster dose safe for transplant patients? In this study, researchers will compare two groups: One group will receive a booster dose of the shingles vaccine. The other group will not receive the booster. They will compare the groups to see differences in immune response, cases of shingles despite vaccination, and any side effects. Participants in the study will: * Be randomly assigned (by chance) in a 2:1 ratio to either receive the booster or not. * Have blood samples taken at the first visit, and again at 1 month, 6 months, and 12 months to measure antibody levels and immune responses. * Be monitored for any possible side effects. * Have their medical records reviewed for health events such as side effects or organ rejection.

Official title: A Single-centre Open-label Parallel Two-arms Pilot Randomized Clinical Trial of a Booster Recombinant Zoster Vaccine in Solid-Organ Transplant Recipients

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