Recombinant Zoster Vaccine in Young Adult Solid Organ Transplant Recipients

Varicella Zoster Clinical Trial

Official title:

Recombinant Zoster Vaccine in Young Adult Solid Organ Transplant Recipients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06162494
• Other study ID #: 2022-5099
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 5, 2023
• Est. completion date: September 30, 2027

Study information

• Verified date: December 2023
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: Ravi Jhaveri, MD
• Phone: 3122774080
• Email: rjhaveri[@]luriechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This goal of this study is to assess the safety and immunogenicity of recombinant zoster virus in young adult solid organ transplant recipients. In this study, participants will receive the recombinant zoster vaccine. They will be monitored for adverse events and tested for antibody and cellular immunity.

Description:

This is an open-label, non-blinded study to assess the safety and immunogenicity of the Recombinant Zoster Vaccine (RZV) in young adult recipients of solid organ transplants (heart, liver, kidney). After obtaining consent, the patient will have pre-vaccine baseline Varicella Zoster Virus (VZV) anti-gE antibody testing performed by the Weinberg lab and then will be given first dose of vaccine. Participants will be brought back 30-60 days post-vaccine for follow up testing and second dose of vaccine. Participants will then be brought in for follow-up testing at 1-2 months, 6 months, and 12-15 months after receiving 2nd dose of vaccine. Testing for both antibody and cellular immunity to VZV will be performed throughout the study. Telephone, electronic and in-person follow up will be conducted to assess for any clinical signs of VZV reactivation, any vaccine-related side effects or any signs of acute rejection.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 30, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 18 years of age or older and willing to provide written informed consent for the study participation.
• Prior recipient of solid organ transplant more than one year prior to participation.
• Stable immunosuppressive medication regimen for last 6 months prior to participation
• Participant must have a working telephone number, email address or patient Electronic Health Record (EHR) portal access and be willing to be contacted for study follow-up by any of these means.
• For participants of childbearing potential, use of effective pregnancy prevention till 2 months post last dose.

Exclusion Criteria:

• Active treatment with corticosteroids or other immunosuppressive agents for acute or chronic rejection.
• More than 2 courses of treatment for acute rejection within last 2 years prior to study enrollment
• History of anaphylaxis or other allergic reaction after receiving prior vaccinations or vaccine components
• Receipt of any inactivated vaccine 8 days before/after dose #1, subunit vaccine 14 days before/after dose #1 and live, attenuated or mRNA vaccine 30 days before/after dose #1
• History of herpes zoster, primary varicella or VZV vaccination within past 1 year prior to study entry
• Active pregnancy as defined by positive pregnancy test at the time of screening and prior to each dose of vaccine
• Febrile illness with Temp =39°C and/or infection that require hospitalization or oral antibiotics/antivirals/antifungal/anti-parasite medication within 14 days prior to day 1.
• Any condition that, in the opinion of the investigator, may interfere with optimal participation in the study

Related Conditions & MeSH terms

• Herpes Zoster
• Varicella Zoster

Intervention

Biological:
• Recombinant Zoster Vaccine
After giving consent, participants will be given first dose of vaccine. Participants will be brought back 30-60 days post-vaccine for follow up testing and second dose of vaccine

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago	Children's Hospital Colorado, Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Outcome	Percentage of vaccinees with 4-fold rise in anti-glycoprotein E antibody concentration within groups 1)previous recipients of varicella vaccine during childhood 2)those with natural infection or 3)those with no history of either natural infection/vaccination at Day 30-60 post-dose 2 Comparison of percentage of participants with 2-fold rise in glycoprotein E-specific cellular responses between those with detectable cellular response pre-vaccine vs. those with no detectable response pre-vaccine at Day 30-60 post-dose 2 Percentage of vaccinees with 4-fold rise in anti-glycoprotein E antibody concentration comparing transplant patients with "high" vs. "low" "level of suppression" (defined as # of immunosuppressive agents and/or serum drug level of immunosuppressive agent) at the time of vaccination at Day 30-60 post-dose 2	30-60 days
Primary	Adverse Event Reporting	Percentage of vaccinees with any adverse event (AE) reported as well as those related to receipt of each dose of a 2-dose series of Recombinant Zoster Vaccine (RZV), to be analyzed within the following categories; Adverse Events of Special Interests (AESI) including local reactions, clinically diagnosed rejection, or varicella disease through the end of the study period (one year post dose 2); Serious Adverse Events (SAEs) through the end of the study period (one year post dose 2); Potential Immune Mediated Diseases (pIMDs) through the end of the study period (one year post dose 2); Any AE present within 30 days of vaccine administration (dose 1 or dose 2) or pregnancy at any point during the study	30 days-1 year
Primary	Anti-glycoprotein E antibody Concentration	Percentage of vaccinees with 4-fold rise in anti-glycoprotein E antibody concentration	30-60 days
Secondary	Glycoprotein E-Specific Cellular Responses	Percentage of vaccinees with 2-fold rise in glycoprotein E-specific cellular responses as defined by interferon and IL-2 measured by Fluorospot	30-60 days
Secondary	Acute Rejection Reporting	Percentage of vaccinees that develop complications of acute rejection within 2 months of receiving each dose of the 2-dose series compared to historical time since transplant-graft- and immunosuppressive regimen-matched unvaccinated controls	2 months