Zoster Vaccine to Enhance Protection Against Zoster in Solid-organ Transplantation
ConditionZoster; Herpes
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOriol Manuel
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years
SOT recipient who has received two doses of the Shingrix® vaccine (primary vaccination).
At least 6 months after transplantation
At least 6 months after the completion of the Shingrix® primary vaccination series.
Disqualifiers
Acute febrile illness or active infection at the time of enrolment, as determined by the investigator (patients can be enrolled in a later stage).
Known hypersensitivity to any component of RZV.
Willing to become pregnant
Trial design
Design model
Parallel
Treatments tested in this trial
Booster dose of the recombinant zoster vaccine (RZV, Shingrix®)
Biological/VaccineParticipants randomized to the intervention arm will receive a single intramuscular injection of Shingrix® (0.5 mL recombinant glycoprotein E antigen with AS01B adjuvant) administered into the deltoid muscle. The booster will be administered at least 6 months after transplantation. Vaccine supply, storage (2-8°C), and accountability will be managed by the hospital pharmacy according to GCP standards.
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: Control (no booster)No intervention 0 interventions
Group B: RZV boosterExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants with ≥2-fold increase in anti-gE antibody titers from baseline
The primary outcome of this study is the humoral immune response 4 weeks after the booster dose of RZV. This will be defined as the proportion of participants achieving at least a two-fold increase in anti-gE antibody titers compared with baseline levels, measured by anti-gE ELISA.
Time frame
4 weeks after booster doseSecondary outcomes
1
Frequency of VZV-specific CD4+ T-cells, (as % of total CD4+ T-cells)
Magnitude and frequency of VZV-specific CD4+ T-cell responses at 1, 6, and 12 months post-vaccination, measured by flow cytometry
Time frame
4 weeks, 6 months and 12 months after booster dose2
Geometric mean anti-gE antibody titers
Geometric mean titers (GMT) at 6 and 12 months post-vaccination, including pre- and post-transplantation changes.
Time frame
6 and 12 months after booster dose3
Incidence of confirmed herpes zoster cases
Clinically diagnosed zoster cases, preferably PCR-confirmed, via medical record review.
Time frame
Through study completion, an average of 1 yearOther outcomes
1
Number of participants with vaccine-related treatment-emergent adverse events, graded according to CTCAE v4.0
Local and systemic solicited adverse events following vaccination, documented in medical records and graded according to CTCAE v4.0 where applicable.
Time frame
From baseline to 4 weeks after the booster dose.2
Number of participants with serious adverse events and episodes of graft rejection, graded according to CTCAE v4.0 where applicable
Serious adverse events and episodes of graft rejection, documented in medical records and graded according to CTCAE v4.0 where applicable.
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oriol Manuel
Lead sponsor
University of Lausanne Hospitals
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: