Safety and Tolerability of Herpes Zoster Vaccine Rheumatologic Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03016884
• Date of registration: 01/01/2017
• Prospective Registration: Yes
• Primary sponsor: HaEmek Medical Center, Israel
• Public title: Safety and Tolerability of Herpes Zoster Vaccine Rheumatologic Patients
• Scientific title: Safety and Tolerability of Herpes Zoster Vaccine in Patients With Rheumatoid Arthritis Immunized Prior to Biologics and Tofacitinib Therapy Initiation
• Date of first enrolment: January 2017
• Target sample size: 87
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03016884
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Israel

Key inclusion & exclusion criteria

For RA arm:

Inclusion Criteria:

1. Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legally acceptable representative) has been informed of all
pertinent aspects of the study.

2. Patients fulfilling the 2010 American College of Rheumatology/European League Against
Rheumatism Classification Criteria for RA scheduled for a biologic or small molecule
therapy (80% candidates for etanercept or tofacitinib therapies.)

3. Only subjects who are = 50 years old will be administered the zoster vaccine.

4. Subjects who are willing and able to comply with scheduled visits and other study
procedures

5. Patients on biologics may participate after a washout period as indicated below :

1. Etanercept : 2 weeks

2. Infliximab, Golimumab, Adalimumab : 35 days

3. Tocilizumab and Abatacept SC : 2 weeks

4. Tocilizumab and Abatacept IV : 35 days

Exclusion Criteria:

1. History of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other
component of the vaccine.

2. Previous vaccination with any VZV-containing vaccine.

3. Any type of malignancy, ongoing chemotherapy or radiation therapy.

4. Patients who underwent solid organ transplantation.

5. Patients with AIDS or clinical manifestations of HIV

6. Patients treated with a TNFa inhibitor at the time of recruitment or patients within a
year of rituximab administration.

7. Patients receiving daily corticosteroid therapy with a dose =10 mg/day of prednisone
(or equivalent) for = 14 days and/or methotrexate at the dose above 0.4 mg per kg per
week.

8. Patients with an active herpes zoster infection or previous herpes zoster less than 6
months before recruitment.

9. Vaccination with any live vaccine within 4 weeks prevaccination, any inactivated
vaccine within 7 days prevaccination, or either during the study period.

10. Blood products transfusion within 5 months prior to vaccination through the study
period.

11. Patients with active tuberculosis.

12. History of Guillain-Barre Syndrome

for healthy arm: Inclusion subjects who are = 50 years old will be administered the zoster
vaccine.

Exclusion

1. History of past or present autoimmune diseases

2. History or current use of immunosuppressive drugs

3. History of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other
component of the vaccine.

4. .Previous vaccination with any VZV-containing vaccine.

5. Any type of malignancy, ongoing chemotherapy or radiation therapy.

6. History of underwent solid organ transplantation.

7. Active herpes zoster infection or previous herpes zoster less than 6 months before
recruitment.

8. Vaccination with any live vaccine within 4 weeks prevaccination, any inactivated
vaccine within 7 days prevaccination, or either during the study period.

9. Blood products transfusion within 5 months prior to vaccination through the study
period.



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Herpes Zoster

Intervention(s)

Biological: Zostavax vaccine

Primary Outcome(s)

Number of patients with Hypersensitivity [Time Frame: 6 weeks]

number of patients with Post vaccination non-injection-site zoster-like and varicella-like rashes [Time Frame: 6 weeks]

Number of patients with Injection site adverse reactions [Time Frame: 6 weeks]

Number of patients with Post vaccination herpes zoster occurrence [Time Frame: 6 weeks]

Secondary Outcome(s)

Patient Global Assessment of Arthritis [Time Frame: 6 weeks]

Physician Global Assessment of Arthritis [Time Frame: 6 weeks]

Patient Assessment of Arthritis Pain [Time Frame: 6 weeks]

Tender and Swollen Joint Count (28 joint count) [Time Frame: 6 weeks]

Health Assessment Questionnaire - Disability Index (HAQ-DI) [Time Frame: 6 weeks]

Immunogenicity measured by varicella-zoster virus (VZV) antibody titers by glycoprotein enzyme-linked immunosorbent assay (gpELISA) [Time Frame: 6 weeks]

Secondary ID(s)

142-016-EMC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors