Immunogenicity of a recombinant zoster vaccine (RZV) against herpes zoster (HZ) in adults with rheumatic diseases (SECTORED)

Immunogenicity of a recombinant zoster vaccine (RZV) against herpes zoster (HZ) in adults with rheumatic diseases (SECTORED) - SECTORED

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00027579

Enrollment

150

Registered

2022-02-08

Start date

2022-04-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Group 1: RA-patients have a classical autoimmune disease with a variable drug immunosuppression including csDMARDs, tsDMARDs and biologic DMARDs. In the study, RA-patients with a stable rheumatoid art

(2) three months visits post FDV, comprising demographics, disease activity (for RA patients: DAS-28), physical functioning, AEs & flare assessment, blood sample, CMI and ELISA

(3) six months visits post FDV, comprising demographics, disease activity (for RA patients: DAS-28), physical functioning, AEs & flare assessment, blood sample and ELISA

and finally, (4) 12 months post FDV, comprising demographics, disease activity (for RA patients: DAS-28), physical functioning, AEs & flare assessment, blood sample, CMI and ELISA. Group 2: Patients

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Male and female patients aged 18 years and older who are at increased risk to develop HZ - Diagnosis of an RA, axSpA or GCA - Stable, flare-free disease status within the last 6 month prior to enrollment. - Shingrix zoster vaccination planned in routine care based on approval of Shingrix

Exclusion criteria

Exclusion criteria: - Pregnancy - Episode of zoster in the past 6 months - Inability to give consent - Previous live vaccination against shingles - VZV vaccination within 12 months prior to start of the study - Contraindications to vaccination: Allergies to components of the vaccine. Undesirable drug reactions in the temporal connection with the vaccination are also a contraindication against a repeated vaccination with the same vaccine until the cause is clarified.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is set as the number of patients with a cell-mediated vaccine response measured by gE-specific T cells against RZV (= CMI) at month 12 post FDV.	—

Secondary

Measure	Time frame
1.) cell-mediated vaccine response measured by gE-specific T cells against RZV (= CMI) at month 3 post FDV 2.) Number of gE-specific T cells at 0, 3 and 12 months post FDV 3.) Anti-gE IgG titer at 0, 3, 6 and 12 months post FDV 4.) Number, intensity and duration of injection site reactions at each follow-up visit 5.) Number, intensity and duration of systemic reactions, AESI, occurrence of HZ and/or HZ complications at each follow-up visit 6.) Number of flares at each follow-up visit	—

Measure

Time frame

1.) cell-mediated vaccine response measured by gE-specific T cells against RZV (= CMI) at month 3 post FDV 2.) Number of gE-specific T cells at 0, 3 and 12 months post FDV 3.) Anti-gE IgG titer at 0, 3, 6 and 12 months post FDV 4.) Number, intensity and duration of injection site reactions at each follow-up visit 5.) Number, intensity and duration of systemic reactions, AESI, occurrence of HZ and/or HZ complications at each follow-up visit 6.) Number of flares at each follow-up visit

—

Countries

Germany

Contacts

Public ContactUta Kiltz

Rheumazentrum Ruhrgebiet

Uta.Kiltz@elisabethgruppe.de+49 (0)2325 592 131

Outcome results