Safety and immunogenicity of the recombinant zoster vaccine in patients with rheumatoid arthritis using abatacept: a pilot multicentre, double-blind, randomised controlled trial
Authors' conclusion
Our data suggest that RZV is safe in patients with RA using abatacept, but that the vaccine response is attenuated in such patients.
Study context
- Population
- Patients with rheumatoid arthritis (RA) using abatacept
- Participants
- 70 patients
- Comparison
- Recombinant zoster vaccine (RZV), 2 doses 8 weeks apart, vs placebo
- RZVn = 56
- Placebon = 14reference
- Primary endpoint
- Proportion of humoral responders (≥4-fold increase in anti-gE IgG) and cellular responders (≥2-fold increase in IFN-γ+ or IL-2+ gE-specific spot-forming cells)
- Follow-up
- Week 12 (4 weeks post-second RZV dose)
Methodological detailspilot, multicentre, double-blind, placebo-controlled
- Pilot
- Multicentre
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
Humoral and cellular responders (RZV recipients) · week 12
| Group | Value | Humoral responders (≥4-fold) | Cellular responders |
|---|---|---|---|
| RZV | 42.3% | 22 (42.3%) | 5 (10.2%) |
RZV
Value42.3%
Humoral responders (≥4-fold)22 (42.3%)
Cellular responders5 (10.2%)
Further findings
- Anti-gE IgG geometric mean fold rise (GMFR) (RZV recipients) · week 12
- 4.55 · geometric mean fold rise · interval 3.16–6.47
Safety
RA flare
Serious adverse events (SAEs) · 52-week study period
- SAEs noted
- 6
RA flare
- Proportion with RA flare similar between RZV and placebo
Original publication
Safety and immunogenicity of the recombinant zoster vaccine in patients with rheumatoid arthritis using abatacept: a pilot multicentre, double-blind, randomised controlled trial. Ann Rheum Dis. Published 10 February 2026. doi:10.
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