ArticleEClinicalMedicine2026
Safety, tolerability, and immunogenicity of SPVX02, a room temperature-stabilised tetanus-diphtheria vaccine, compared to two established tetanus-diphtheria booster vaccines: a multicentre, single-blind, randomised, first-in-human phase 1 trial in the UK.
Article in EClinicalMedicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
19 authors.
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Abstract
Background: Cold chain requirements limit vaccine accessibility and deployment. SPVX02, is a lyophilised, fridge-free version of Tetadif tetanus-diphtheria vaccine, stable for at least 24 months at temperatures up to 30 °C. Methods: This multicentre, first-in-human phase 1, single-blind, randomised clinical trial was conducted at three sites in the UK to evaluate the safety and tolerability of SPVX02 compared to existing approved tetanus-diphtheria (Td) vaccines. Healthy adults (aged 18-55 years; body-mass index (BMI) ≤32 kg/m Findings: Between April 1 and September 22, 2025, 120 healthy volunteers were screened and 60 participants were enrolled at two of three sites. Demographic characteristics of participants were similar between groups. No serious adverse reactions, suspected unexpected adverse reactions, or serious adverse events occurred. 54 participants experienced mild or moderate AEs; none were severe (grade 3 or higher AEs). Reactogenicity and tolerability profiles were similar across all groups. All participants had anti-tetanus toxoid (TT) levels ≥1.0 IU/mL at Day 28. All participants in both the SPVX02 and Tetadif groups and 19 (95%) in the diTeBooster group had anti-diphtheria (DT) toxoid levels ≥0.1 IU/mL at Day 28. Interpretation: Our findings suggest that SPVX02 is safe, well tolerated, with TT and DT immunogenicity similar to the two existing approved Td vaccines investigated herein. This trial provides first-in-human evidence that StablevaX technology can be used to safely reformulate an aluminium-adjuvanted vaccine stable up to 30 °C for 24 months. A phase 2/3 trial is planned, and further research will investigate temperature stability at higher temperatures, and technology application to other vaccines and biological products. Funding: Innovate UK Smart Grant and Stablepharma Ltd.
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