Lupus & antiphospholipid syndrome
Immunogenicity, reactogenicity, and safety of two-dose adjuvanted herpes zoster subunit vaccine in patients with systemic lupus erythematosus in South Korea: a single-centre, randomised, double-blind, placebo-controlled trial
Authors' conclusion
The herpes zoster subunit vaccine induces humoral and cellular immunity against herpes zoster with a good safety profile in patients with SLE.
Study context
- Population
- Patients aged ≥19 years with clinically stable systemic lupus erythematosus (SLE) and previous exposure (≥4 weeks) to immunosuppressive drugs, Seoul National University Hospital, South Korea60 in modified ITT
- Participants
- 65 patients
- Comparison
- Adjuvanted herpes zoster subunit vaccine vs placebo
- Vaccinen = 52
- Placebon = 13reference
- Primary endpoint
- Proportion of patients with a positive humoral vaccine response
- Follow-up
- 4 weeks after the second dose
Methodological detailssingle-centre, double-blind, placebo-controlled, 4:1 randomisation
- Single-centre
- Double-blind
- Placebo-controlled
- 4:1 randomisation
Primary result
As reported in the abstract
Humoral vaccine response
P < 0.0001
Further findings
Treatment-related deaths
- None
- 0
Safety
Events
| Outcome | Vaccine | Placebo |
|---|---|---|
| Injection site reactions | 42 | 2 |
| Fever | 10 | 0 |
| Fatigue | 26 | 2 |
SLE disease activity (SLEDAI-2K) and BILAG-flare rates
- No differences between the groups
Original publication
Immunogenicity, reactogenicity, and safety of two-dose adjuvanted herpes zoster subunit vaccine in patients with systemic lupus erythematosus in South Korea: a single-centre, randomised, double-blind, placebo-controlled trial. Lancet Rheumatol. Published 3 May 2024. doi:10.
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