SPVX02 Safety, Immunogenicity and Tolerability Study
Research type
Research Study
Full title
A Phase 1, Randomised, Single-Blind Clinical Study to Evaluate the Safety, Immunogenicity and Tolerability of SPVX02, a Tetanus and Diphtheria Booster Vaccine, against Two Comparator Vaccines in Healthy Adult Participants
IRAS ID
1009178
Contact name
Karen O'Hanlon
Contact email
Sponsor organisation
Stablepharma Ltd
ISRCTN Number
Not available
Clinicaltrials.gov Identifier
Not available
Research summary
Stablepharma is developing a thermostable lyophilized tetanus and diphtheria (Td) vaccine (SPVX02) based on a reformulation of Tetadif® vaccine. This Phase 1, first-in-human study will be run at NHS sites in England and aims to evaluate the safety, immunogenicity and tolerability of SPVX02 whilst also providing comparative immunogenicity data with Tetadif® and diTeBooster® (comparator investigational medicinal products) using a randomised, single-blind design. The study aims to demonstrate that SPVX02, Tetadif and diTeBooster generate comparable anti-tetanus and anti-diphtheria post-boost immune responses in healthy adults. The study will be conducted in 60 healthy participants (aged 18-55) who have previously received a primary vaccination against tetanus and diphtheria but who have not received a booster vaccination in the last 10 years. Three cohorts of 20 participants will be randomised 1:1:1 in a single-blind manner to receive a single vaccination of either SPVX02, Tetadif or diTeBooster. The primary objectives of the study are to evaluate the safety of a single vaccination of SPVX02 and to evaluate the tolerability of a single dose of SPVX02, Tetadif or diTeBooster. The secondary objectives are to evaluate post-dose antibody titres to obtain immunogenicity data (seroprotection and seroconversion rates). Informed consent will be obtained before any study specific procedures are performed. Participants will be screened from Day -42 to Day 0. Eligible participants will attend the clinic to receive a single dose of SPVX02, Tetadif or diTeBooster on Day 1. On Day 1, an electronic diary , tape measure and thermometer will be provided to perform self-assessments of local and systemic safety and tolerability up to, and including, Day 7. All participants will have a follow-up telephone call on Day 2 and return to the clinic for study assessments on Days 7 and 28. End of study visit procedures will be performed at the final clinic visit on Day 28.
REC name
London - London Bridge Research Ethics Committee
REC reference
25/LO/0059
Date of REC Opinion
12 Feb 2025
REC opinion
Further Information Favourable Opinion